TC

TC

CT

COVID-19

Ag

COVID-19

Ag

If the Purple-colored Control (C) line and the Bluecolored Test (T) line are visible, the test is positive. 

Any faint visible Blue-colored Test (T) line with the 

Purple-colored Control (C) line should be read as 

positive.

If the Purple-colored Control (C) line is visible, but the Blue-colored Test (T) line is not visible, the test is negative.

A Positive test result means that the virus that causes 

COVID-19 was detected in your sample and it is very 

likely you have COVID-19 and are contagious. Please contact your doctor/primary care physician or your 

local health authority immediately and adhere to the 

local guidelines regarding self-isolation. There is a 

very small chance that this test can give a positive

result that is incorrect (a false positive).

A negative test result indicates that the virus that causes 

COVID-19 was not detected in your sample. A negative result is presumptive, meaning it is not certain that you do not have COVID-19. You may still have COVID-19 and you may still be contagious. There is a higher chance of false 

negative results with antigen tests compared to laboratorybased tests such as PCR. If you test negative and continue to experience COVID-19-like symptoms, (e.g., fever, cough, and/or shortness of breath) you should seek follow up care with your health care provider.

Report your test result(s) at MakeMyTestCount.Org (https://makemy

testcount.org) – this voluntary and anonymous reporting helps public 

health teams understand COVID-19 spread in your area and across the 

country and informs public health decisions.

You do not need to perform repeat testing if you 

have a positive result at any time. 

To increase the chance that the negative result for

COVID-19 is accurate, you should:

-Test again in 48 hours if you have

 symptoms on the first day of testing.

-Test 2 more times at least 48 hours 

 apart if you do not have symptoms 

 on the first day of testing.

If the Purple-colored Control (C) line is 

not visible, the test is invalid. Re-test 

with a new swab and new test device.

TC

IMPORTANT

Look very closely! The color intensity in the test 

region will vary. Any faint colored line in the test region should be considered as positive. 

Results 

Interpretation

Make sure you 

wait the full 

10 minutes.

Do not read test results 

before 10 minutes or after 

15 minutes. Results read 

before 10 minutes or after 

15 minutes may lead to a 

false positive, false negative,

or invalid result. 

NOTE:

Using Mobile Application Scan the QR code to download

Ensure you have an internet 

connection and download the 

App prior to starting the test

Ensure you are using a 

compatible smartphone.

(For a list of compatible 

 smartphone OS systems, 

 visit www.accessbio.net/app)

Only open the foil 

pouch packaging of test 

cassette when the App 

instructed to do so.

1. Download and open App, Othena Mobile Application Download the App on the App Store or Google Play Store. 

Ensure you are connected to the internet during your test.

Please start the test and follow the in-app 

self-paced, step-by-step test instructions.

5. Test result

The App will assist in your visual result interpretation. Please follow the instructions provided in the App. You will be required to take a picture of the test device, and then look at the test cassette and answer questions about the result interpretation.

2. Answer a few questions in the App

3. Watch the instructional video.

4. Follow step-by-step in

structions for your test.

Wash your hands thoroughly Unpack the test components Remove the test cassette Locate the extraction vial and Locate a nasal swab and 

1 for at least 20 seconds 2 from the tray. 3 and place it on a flat, clean 4 gently peel o the aluminum 5 remove from the pouch. 

before the test. surface. foil seal, being sure to keep the Be careful not to touch 

vial upright and place it in the the swab tip. 

packaging tray. 

Gently insert the swab no more than 3/4 inch into the LEFT nostril. Gently remove the swab from the LEFT nostril and place directly into the 

6 Then, slowly rotate the swab at least 5 times in a circular path pressing gently 7 RIGHT nostril, repeating the process of rotating at least 5 times in a circular 

15 seconds. Do not just

15 seconds. Do not just spin the swab. . Remove the swab from the RIGHT nostril. 

Place the swab into the extraction vial and rotate 

the swab at least 5 times 

against the walls of the vial.

Remove the swab by rotating Close the vial by With your finger, mix Invert the extraction vial and hold the 

89 against the extraction vial while 10 pushing the cap 11 thoroughly by flicking 12 sample vertically above the sample well. 

squeezing the sides of the vial to firmly onto the vial. the bottom of the vial. Squeeze the vial gently. Allow THREE (3) 

release the liquid from the swab. drops of sample to fall into the sample well. 

Discard the swab in trash. 

 13 Start a timer. Disposal 

Read the result at 10 minutes. Dispose of all used test kit 

The test result should not be components and swab 

read after 15 minutes. samples in household trash. 

IMPORTANT 

Do not move or lift 

the test cassette 

during this time.

Do not exit the 

mobile app during 

this process. 

X5 15 

 in sec 

X5 15

 insec 

3

x

against the inside walls of your nostrils for a total of path pressing gently against the inside walls of your nostrils" for a total of

WAIT 10 mins

 spin the swab. If you have questions, see the CDC Guidelines.

RCPM-00171, RCPM-00271, RCPM-00471, RCPM-00571, RCPM-02071, RCPM-02571, RCPM-03071 ENGLISH 

COVID-19 Antige Home Test QUICK REFERENCE INSTRUCTIONS 

Read all instructions carefully before performing the test. Failure to follow the instructions may result in inaccurate test results. 

FOR USE UNDER EMERGENCY USE AUTHORIZATION (EUA) ONLY. 

IMPORTANT: Swabbing the nostrils is critical for obtaining an accurate result. If you do not swab your nose, the device will produce a false negative result. 

30 oC 

86 oF

 1 oC 

34 oF 

Store the CareStartTM COVID-19 Antigen Home Test between 1-30°C (34-86°F). Ensure all kit contents are at room temperature before use. 

Kit contents are stable until the expiration date printed on the outer packaging. Do not use beyond the expiration date.

Repeat testing is needed to improve test accuracy. 

Please follow the table below when interpreting test 

results for COVID-19.

Results should be considered in the context of an individual’s 

recent exposures, history, and the presence of clinical signs 

and symptoms consistent with COVID-19.

Status on 

First Day 

of Testing

With Symptoms

Positive

Positive

N/A N/A Positive for 

COVID-19

Positive for 

COVID-19

Negative for 

COVID-19

Positive for 

COVID-19

Positive for 

COVID-19

Positive for 

COVID-19

Negative for 

COVID-19

N/A

N/A

N/A N/A

N/A

Positive

Negative

Negative

Negative Negative

Positive

Negative

Negative

Positive

Negative

Negative

Negative

Without 

Symptoms

First 

Result

Day 1

Second

 Result

Day 3

Third 

Result

Day 5

Interpretation

COVID-19 Detected (Positive) COVID-19 Not Detected (Negative)

Invalid

TCTC

You will be able to

Interpret your test results 

by following the in-app 

interpretation instructions 

or those provided 

in this section.

Serial (Repeat) Testing 

C

T

COVID-19 Ag

For more information on expiration dating for COVID-19 antigen tests, please refer to http://www.fda.gov/covid-tests.

QRI-RCPM-ES / Rev. F / Draft
Explicación de los

Dispositivo médico de diagnóstico in vitro Señala un dispositivo médico previsto para su 

utilización como dispositivo médico de diagnóstico in vitro.

Código de lote

Designa el código de lote del fabricante para

poder identificar el lote.

Fecha de fabricación

Señala la fecha de fabricación del dispositivo

médico.

Límite de temperatura

Señala los límites de temperatura a los cuales puede

exponerse el dispositivo médico de forma segura.

No lo utilice si el paquete está dañado

Señala un dispositivo médico que no debe utilizarse

si el paquete ha sido dañado o abierto.

Contiene cantidad suficiente para <n> pruebas

Señala la cantidad total de pruebas de diagnóstico

in vitro que se pueden realizar con el dispositivo.

Consulte las instrucciones de uso

Señala la necesidad de que el usuario consulte las 

instrucciones de uso.

Fabricante

Designa el fabricante del dispositivo médico. !

Intended Use Limitations CareStartTM COVID-19 Antigen Home Test 

Potential risks include: 

Potential benefits include: 

- There is a higher chance of false negative results with antigen tests than with laborato- ry-based molecular tests due to the sensitivity of the test technology. This means that there is 

a higher chance this test will give a false negative result in an individual with COVID-19 as

compared to a molecular test, especially in samples with low viral load.

- The performance of this test was established based on the evaluation of a limited number of 

clinical specimens collected between March 2021 and April 2021.The clinical performance has 

not been established for all circulating variants but is anticipated to be reflective of the

prevalent variants in circulation at the time and location of the clinical evaluation. Performance 

at the time of testing may vary depending on the variants circulating, including newly

emerging strains of SARS-CoV-2 and their prevalence, which change over time.

- All COVID-19 antigen test negative results are presumptive and confirmation with a molecular 

assay may be necessary. If you continue to have symptoms of COVID-19, and both your first 

and second tests are negative, you may not have COVID-19, however you should follow-up with 

a healthcare provider.

- If the test is positive, then proteins from the virus that causes COVID-19 have been found in 

the sample and you likely have COVID-19.

- This test is read visually and has not been validated for use by those with impaired vision or 

color-impaired vision.

- Incorrect test results may occur if a specimen is incorrectly collected or handled.

How to Use This Test

No reutilice

Indica un dispositivo médico destinado a

un solo uso.

Fecha de caducidad

Indica la fecha a partir de la cual no debe 

utilizarse el dispositivo médico.

Número de catálogo

Designa el número de catálogo del fabricante 

para poder identificar el dispositivo médico.

Precaución

Señala la necesidad de que el usuario 

consulte los documentos acompañantes.

Access Bio, Inc. Soporte técnico

Tel : 888-898-1270 (gratuito)

Correo electrónico: 

TShelp@accessbio.net

65 Clyde Road, Suite A, 

Somerset, NJ 08873, USA

Tel : 732-873-4040 Fax : 732-873-4043

info@accessbio.net

Sitio web: 

www.accessbio.net

símbolos

Dirección de correo 

electrónico:

Technical Support

Tel : 888-898-1270 (Toll Free)

E-mail : TShelp@accessbio.net

Access Bio, Inc.

65 Clyde Road, Suite A, Somerset, NJ 08873, USA 

Tel : 732-873-4040

Fax : 732-873-4043 TShelp@accessbio.net Website : www.accessbio.net

E-mail : Explanation of Symbols

In vitro diagnostic medical device Indicates a medical device that is intended to be

used as an in vitro diagnostic medical device..

Batch code

Indicates the manufacturer’s batch code so 

that the batch or lot can be identified.

Temperature limit

Indicates the temperature limits to which the 

medical device can be safely exposed.

Do not use if the package is damaged

Indicates a medical device that should not be used 

if the package has been damaged or opened.

Contains sufficient for <n> tests

Indicates the total number of IVD tests that can be 

performed with the IVD.

Consult instructions for use

Indicates the need for the user to consult the

instructions for use.

Manufacturer

Indicates the medical device manufacturer. !

Do not re-use

Indicates a medical device that is intended

for one use.

Use by date

Indicates the date after which the medical 

device is not to be used.

Caution

Indicates the need for the user to consult 

accompanying documents

Date of manufacture

Indicates the date when the medical device 

was manufactured.

Catalog number

Indicates the manufacturer’s catalog number 

so that the medical device can be identified.

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization

- For more information on EUAs please visit: 

- Serial testing should be performed in all individuals with negative results; individuals with

symptoms of COVID-19 and initial negative results should be tested again after 48 hours.

Individuals without symptoms of COVID-19, and with initial negative results, should be tested

again after 48 hours and, if the 2nd test is also negative, a 3rd time after an additional 48 hours. 

You may need to purchase additional tests to perform this serial (repeat) testing.

- If you test negative but continue to have symptoms of COVID-19, and both your first and

second tests are negative, you may not have COVID-19, however you should follow-up with your 

healthcare provider.

- If your test is positive, then proteins from the virus that causes COVID-19 have been found in 

your sample and you likely have COVID-19.

- For the most up to date information on COVID-19, please visit: 

www.cdc.gov/COVID19 

The CareStartTM COVID-19 Antigen Home Test is a lateral flow immunoassay device intended 

for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus. 

This test is authorized for non-prescription home use with self-collected anterior nasal 

(nares) swab samples from individuals aged 14 years or older or adult collected anterior 

nasal (nares) swab samples from individuals aged 2 years or older. This test is authorized for 

individuals with symptoms of COVID-19 within the first 7 days of symptom onset when 

tested at least twice over three days with at least 48 hours between tests, and for individuals 

without symptoms or other epidemiological reasons to suspect COVID-19, when tested at 

least three times over five days with at least 48 hours between tests.

The CareStartTM COVID-19 Antigen Home Test does not dierentiate between SARS-CoV or 

SARS-CoV-2.

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is 

generally detectable in anterior nasal (nares) samples during the acute phase of infection. 

Positive results indicate the presence of viral antigens, but clinical correlation with patient 

history and other diagnostic information is necessary to determine infection status. Positive 

results do not rule out bacterial infection or co-infection with other viruses and the agent 

detected may not be the definitive cause of disease. Individuals who test positive with the 

CareStartTM COVID-19 Antigen Home Test should self-isolate and seek follow up care with their 

physician or healthcare provider as additional testing may be necessary.

All negative results are presumptive and confirmation with a molecular assay, if necessary for 

patient management, may be performed. Negative results do not rule out SARS-CoV-2 

infection and should not be used as the sole basis for treatment or patient management 

decisions, including infection control measures such as isolating from others and wearing 

masks. Negative results should be considered in the context of an individual’s recent 

exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19. 

Individuals who test negative and continue to experience COVID-19 like symptoms of fever, 

cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow 

up care with their physician or healthcare provider.

Individuals should provide all results obtained with this product to their healthcare provider 

for public health reporting and to receive appropriate medical care. All healthcare providers 

will report all test results they receive from individuals who use the authorized product to 

relevant public health authorities in accordance with local, state, and federal requirements, 

using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Page 2 of 19 Mapping for SARS-CoV-2 Tests provided by CDC.

The CareStartTM COVID-19 Antigen Home Test is intended for non-prescription self-use and/or 

as applicable, for an adult lay user testing another aged 2 years or older in a non-laboratory 

setting. The CareStartTM COVID-19 Antigen Home Test is only for in vitro diagnostic use under 

the Food and Drug Administration’s Emergency Use Authorization. This product has not been 

FDA cleared or approved.

- Read all instructions carefully before performing the test. Failure to follow the instructions may 

result in inaccurate test results.

- In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA 

under an Emergency Use Authorization. This product has been authorized only for the detection 

of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this 

product is only authorized for the duration of the declaration that circumstances exist justifying 

the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of

COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §

360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

- Serial testing should be performed in individuals with negative results at least twice over

three days (with 48 hours between tests) for symptomatic individuals and three times over five 

days (with at least 48 hours between tests) for asymptomatic individuals. You may need to 

purchase additional tests to perform this serial (repeat) testing.

- If you have had symptoms longer than 7 days you should consider testing at least three times over 

five days with at least 48 hours between tests.

- An anterior nasal swab sample can be self-collected by an individual age 14 years and older.

Children age 2 to 13 years should be tested by an adult.

- Do not use on anyone under 2 years of age.

- Keep testing kit and kit components away from children and pets before and after use. Avoid contact 

with your skin or eyes. Do not ingest any kit components. The reagent solution contains harmful 

chemicals (see table below). If the solution contacts your skin or eyes, flush with large amounts of water. 

If irritation persists, seek medical advice: https://www.poisonhelp.org or 1-800-222-1222.

- Once opened, the test device should be used immediately.

- Wear a safety mask or other face-covering when collecting a specimen from a child or another individual.

- Wash hands thoroughly for at least 20 seconds before and after handling nasal swab samples. 

- Keep the test device on a flat surface during the testing.

- Keep foreign substances and household cleaning products away from the test during the testing

process. Contact with foreign substances and household cleaning products may result in an incorrect 

test result. 

- False negative results may occur if a specimen is incorrectly collected or handles, or inadequately stored. 

- Excess blood or mucus on the swab specimen may interfere with test performance and may yield a 

false-positive result. Avoid touching any bleeding areas of the nasal cavity when collecting specimens. 

- False negative results may occur if a specimen is incorrectly collected or handled, or inadequately stored. 

- When collecting a nasal swab sample, use only the Nasal Swab provided in the kit. 

- Do not touch the swab tip (specimen collection area of the swab).

- Do not operate your test outside of storage conditions. 

- Do not close the App during processing as it may cause an error and you will need a new test kit. 

- Do not read test results before 10 minutes or after 15 minutes. Results read before 10 minutes or after 

15 minutes may lead to a false positive, false negative, or invalid result.

- Do not use if any of the test kit contents or packaging is damaged.

- Test components are single-use. Do not re-use.

- Do not use kit past its expiration date.

- Do not interchange kit contents from dierent lots. 

- In the event of a spillage, ensure it is cleaned thoroughly using a suitable disinfectant.

Warnings, Precautions, and Safety Information 

Chemical Name/CAS Harms (GHS Code) for each Ingredient Concentration

Boric Acid/ 10043-35-3

Triton X-100/9002-93-1

Sodium Chloride (NaCl)/

7647-14-5

N-Lauroylsarcosine sodium 

salt/137-16-6

Ethylenediaminetetraacetic acid 

H360 May damage fertility or the unborn child. 0.38%

0.08%

4.38%

1.50%

0.15%

None

H302 Harmful if swallowed.

H315 Causes skin irritation.

H318 Causes serious eye damage.

H410 Very toxic to aquatic life with long-lasting eects.

H315 Causes skin irritation.

H318 Causes serious eye damage.

H330 Fatal if inhaled.

H302 Harmful if swallowed. (EDTA)/13235-36-4 H318 Causes serious eye damage.

-Possible discomfort during sample collection. 

-Possible incorrect test result (see Warnings and Result Interpretation sections for more information).

-The results, along with other information, can help you and your healthcare provider make informed 

recommendations about your care. 

-The results of this test may help limit the potential spread of COVID-19 to your family and others in your 

 community. 

For more information on EUAs go here: https://www.fda.gov/emergency-preparedness-and-respose/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization 

WHAT IS THE DIFFERENCE BETWEEN AN ANTIGEN AND MOLECULAR TEST?

There are dierent kinds of tests for the SARS-CoV-2 virus that causes COVID-19. Molecular tests detect genetic 

material from the virus. Antigen tests, such as the CareStartTM COVID-19 Antigen Home Test, detect proteins from 

the virus. Due to the lower sensitivity of antigen tests, there is a higher chance this test will give you a false 

negative result when you have COVID-19 than a molecular test would. 

 HOW ACCURATE IS THIS TEST? 

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serial testing approach is recommended to minimize the risk of incorrect results. For more information on the 

performance of the test and how the performance may apply to you, please refer to the performance data in the 

Healthcare Provider Instructions for Use (IFU), available at https://accessbio.net/products/covid-19-detection-kits/carestart-covid-19-antigen-home-test/home-kit-usa. 

WHAT IF I HAVE A POSITIVE TEST RESULT? 

A positive result means that it is very likely you have COVID-19 because proteins from the virus that causes 

COVID-19 were found in your sample. You should selfisolate from others and contact a healthcare provider for 

medical advice about your positive result. 

WHAT IF I HAVE A NEGATIVE TEST RESULT? 

A negative test result indicates that antigens from the virus that causes COVID-19 were not detected in your 

sample. However, if you have symptoms of COVID-19, and your first test is negative, you should test again in 48 

hours since antigen tests are not as sensitive as molecular tests. If you do not have symptoms and received a 

negative result, you should test at least two more times with 48 hours in between tests for a total of three tests. 

If you have a negative result, it does not rule out SARSCoV-2 infection; you may still be infected and you may still 

infect others. It is important that you work with your healthcare provider to help you understand the next steps 

you should take. 

WHAT IF I HAVE AN INVALID TEST RESULT? 

An invalid result means the test was not able to tell if you have COVID-19 or not. If the test is invalid, a new swab 

should be used to collect a new nasal specimen and you should test again with a new test. 

IMPORTANT

Do not use this test as the only guide to manage your illness. Consult your healthcare provider if your symptoms 

persist or become more severe. 

Individuals should provide all results obtained with this product to their healthcare provider. 

WHAT ARE THE KNOWN AND POTENTIAL RISKS AND BENEFITS OF THE TEST? 
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Items necessary to use the kit, but not included (Timer or Smartphone)

1 CareStart TM Ks/ͲϭεŐ

,ŽŵĞdĞƐƚͲϭĞĂ

dƵďĞͲϭĞĂ ĂƉͲϭĞĂ

5 Quick Reference 

/ŶƐƚƌƵĐƟŽŶƐΘ

Fact Sheet ĨŽƌ/ŶĚŝǀŝĚƵĂůƐ

Design Date : 01/26/23Part# PKCSOTC1AB

Designed by JSK DESIGN 

JSK Version. E

Lot, Exp, and UDI print here 

ςρůLJĚĞZŽĂĚ͕^ƵŝƚĞ͘^ŽŵĞƌƐĞƚ͕E:ϬΘΘϳϯ͕h^ϳϯϮͲΘϳϯͲκϬκϬǁǁǁ͘ĂĐĐĞƐƐďŝŽ͘ŶĞƚ

ĐĐĞƐƐŝŽ͕/ŶĐ͘

X5 X5 

&ŽƌŵĞƌŐĞŶĐLJhƐĞƵƚŚŽƌŝnjĂƟŽŶ;hͿŽŶůLJ

3
 Made in the USA www.accessbio.net

 1 oC34 oF

30 oC86 oF

Items necessary to use the kit, but not included (Timer or Smartphone)

Lot, Exp, and UDI print here 

The CareStartΡKs/ͲϭεŶƟŐĞŶ,ŽŵĞdĞƐƚŝƐĂůĂƚĞƌĂůŇŽǁŝŵŵƵŶŽĐŚƌŽŵĂƚŽŐƌĂƉŚŝĐĂƐƐĂLJĨŽƌ

ƚŚĞĚĞƚĞĐƟŽŶŽĨĞdžƚƌĂĐƚĞĚŶƵĐůĞŽĐĂƉƐŝĚƉƌŽƚĞŝŶĂŶƟŐĞŶƐƐƉĞĐŝĮĐƚŽ^Z^ͲŽsͲϮŝŶƐĞůĨͲĐŽůůĞĐƚĞĚĂŶƚĞƌŝŽƌŶĂƐĂů;ŶĂƌĞƐͿƐǁĂďƐƉĞĐŝŵĞŶƐ͘dŚĞƵƐĞƌƐŚŽƵůĚƉĞƌĨŽƌŵƚŚĞƚĞƐƚĨŽůůŽǁŝŶŐƚŚĞŝŶͲĂƉƉƐĞůĨͲƉĂĐĞĚ͕ƐƚĞƉͲďLJͲƐƚĞƉŝŶƐƚƌƵĐƟŽŶƐŽƌYƵŝĐŬZĞĨĞƌĞŶĐĞ/ŶƐƚƌƵĐƟŽŶƐ͘dĞƐƚƌĞƐƵůƚƐĂƌĞŝŶƚĞƌƉƌĞƚĞĚǀŝƐƵĂůůLJĂƚϭϬŵŝŶƵƚĞƐĂŌĞƌƐĂŵƉůĞůŽĂĚŝŶŐĨŽůůŽǁĞĚďLJƚŚĞŝŶƐƚƌƵĐƟŽŶƐ͘WůĞĂƐĞĐĂƌĞĨƵůůLJƌĞĂĚƚŚĞƋƵŝĐŬƌĞĨĞƌĞŶĐĞŝŶƐƚƌƵĐƟŽŶƐŝŶƚŚĞŬŝƚďĞĨŽƌĞƵƐĞ͘

1 2 4

Kit Components

2 Nasal Swab - 2ea

3 džƚƌĂĐƟŽŶsŝĂůdƵďĞͲϮĞĂ

4 džƚƌĂĐƟŽŶsŝĂůĂƉͲϮĞĂ TM 1 CareStart Ks/ͲϭεŐ ,ŽŵĞdĞƐƚͲϮĞĂ

YƵŝĐŬZĞĨĞƌĞŶĐĞ/ŶƐƚƌƵĐƟŽŶƐΘ&ĂĐƚ^ŚĞĞƚĨŽƌ/ŶĚŝǀŝĚƵĂůƐ

5

/ŶƐƚƌƵĐƟŽŶƐ

ZĞƐƵůƚƐ/ŶƚĞƌƉƌĞƚĂƟŽŶ

X5 X5 

3

COVID-19

FŽƌ ƵƐe with Žƌ withoƵt symptoms

ϮdĞƐƚƐ

HOME TEST

FAST RESULT

ZĞƐƵůƚƐŝŶϭϬŵŝŶƵƚĞƐ

^ŝŵƉůĞEĂƐĂů^ǁĂď ^ŝŵƉůĞE

EASY 

Ğ EĂƐĂů ^ǁĂď

TESTING

hƐŝŶŐDŽďŝůĞƉƉůŝĐĂƟŽŶ

Please start the test ĨŽůůŽǁƐthe in-app ƐĞůĨͲƉĂĐĞĚ͕ƐƚĞƉͲby-ƐƚĞƉƚĞƐƚŝŶƐƚƌƵĐƟŽŶƐ͘

ŽǁŶůŽĂĚĂŶĚŽƉĞŶƉƉ͕ Othena 

zŽƵƌƚĞƐƚƌĞƐƵůƚĂƉƉĞĂƌƐŽŶLJŽƵƌƐĐƌĞĞŶĂŌĞƌϭϬŵŝŶƵƚĞƐŽĨǁĂŝƚƟŵĞĂŶĚƐĞůĞĐƟŽŶŽĨǀŝƐƵĂůƌĞƐƵůƚŝŶƚĞƌƉƌĞƚĂƟŽŶƐ͘

12

3

45 dĞƐƚƌĞƐƵůƚ

tĂƚĐŚƚŚĞŝŶƐƚƌƵĐƟŽŶǀŝĚĞŽ

 Follow step-by-stepŝŶƐƚƌƵĐƟŽŶƐĨŽƌLJŽƵƌƚĞƐƚ

ŽǁŶůŽĂĚƚŚĞƉƉŽŶƚŚĞƉƉ^ƚŽƌĞŽƌ'ŽŽŐůĞWůĂLJ^ƚŽƌĞŽƌƐĐĂŶƚŚĞYZĐŽĚĞ͕ŶƐƵƌĞLJŽƵĂƌĞĐŽŶŶĞĐƚĞĚƚŽƚŚĞŝŶƚĞƌŶĞƚĚƵƌŝŶŐLJŽƵƌƚĞƐƚ͘

ŶƐǁĞƌĂĨĞǁƋƵĞƐƟŽŶƐin the App

&ŽƌĂůŝƐƚŽĨĐŽŵƉĂƟďůĞ͕ƐŵĂƌƚƉŚŽŶĞK^ƐLJƐƚĞŵƐ͕ ǀŝƐŝƚǁǁǁ͘ĂĐĐĞƐƐďŝŽ͘ŶĞƚͬĂƉƉ

&ŽƌŵĞƌŐĞŶĐLJhƐĞƵƚŚŽƌŝnjĂƟŽŶ;hͿŽŶůLJ

COVID-19

HOME TEST

ǁŝƚŚŽƵƚƐLJŵƉƚŽŵƐ Žƌ with &ŽƌƵƐĞ

^ĞůĨdĞƐƚĨŽƌ^Z^ͲŽsͲϮŶƟŐĞŶĞƚĞĐƟŽŶ;ŐĞƐϮĂŶĚhƉͿ

EŽŶͲƉƌĞƐĐƌŝƉƟŽŶŚŽŵĞƵƐĞǁŝƚŚƐĞůĨͲĐŽůůĞĐƚĞĚŶĂƐĂůƐǁĂďsamples

dŚŝƐƚĞƐƚĚŽĞƐŶŽƚĚĞƚĞƌŵŝŶĞŝĨLJŽƵŚĂĚKs/ͲϭεŝŶƚŚĞƉĂƐƚŽƌŝĨLJŽƵŚĂǀĞŝŵŵƵŶŝƚLJ͘/ƚĚĞƚĞĐƚƐƉƌŽƚĞŝŶƐĨƌŽŵƚŚĞ^Z^ͲŽsͲϮǀŝƌƵƐ͘

/ĨLJŽƵĂƌĞƉƌŽŶĞƚŽŶŽƐĞďůĞĞĚƐ͘

ŽEŽƚhƐĞ

>ŝŵŝƚŽĨƉĞƌĨŽƌŵĂŶĐĞ

/ĨLJŽƵŚĂǀĞŚĂĚĂĨĂĐŝĂůŽƌŚĞĂĚŝŶũƵƌLJͬƐƵƌŐĞƌLJŝŶƚŚĞůĂƐƚςŵŽŶƚŚƐ͘

dŚŝƐĞŵĞƌŐĞŶĐLJƵƐĞŽĨƚŚŝƐƉƌŽĚƵĐƚŝƐŽŶůLJĂƵƚŚŽƌŝnjĞĚĨŽƌƚŚĞĚƵƌĂƟŽŶŽĨƚŚĞĚĞĐůĂƌĂƟŽŶƚŚĂƚĐŝƌĐƵŵƐƚĂŶĐĞƐĞdžŝƐƚũƵƐƟĨLJŝŶŐƚŚĞĂƵƚŚŽƌŝnjĂƟŽŶŽĨĞŵĞƌŐĞŶĐLJƵƐĞŽĨin vitroĚŝĂŐŶŽƐƟĐƐĨŽƌĚĞƚĞĐƟŽŶĂŶĚͬŽƌĚŝĂŐŶŽƐŝƐŽĨKs/ͲϭεƵŶĚĞƌ^ĞĐƟŽŶρςκ;ďͿ;ϭͿŽĨƚŚĞ&ĞĚĞƌĂů&ŽŽĚ͕ƌƵŐĂŶĚŽƐŵĞƟĐĐƚ͕Ϯϭh͘^͘͘ΑϯςϬďďďͲϯ;ďͿ;ϭͿ͕ƵŶůĞƐƐĂƵƚŚŽƌŝnjĂƟŽŶŝƐƚĞƌŵŝŶĂƚĞĚŽƌƌĞǀŽŬĞĚƐŽŽŶĞƌ͘

For in vitroĚŝĂŐŶŽƐƟĐƵƐĞ

ĞƚĞƌŵŝŶŝŶŐĂŶĞŐĂƟǀĞƌĞƐƵůƚƌĞƋƵŝƌĞƐŵƵůƟƉůĞƚĞƐƚƐ͘zŽƵŵĂLJŶĞĞĚƚŽƉƵƌĐŚĂƐĞĂĚĚŝƟŽŶĂůƚĞƐƚƐƚŽƉĞƌĨŽƌŵƐĞƌŝĂů;ƌĞƉĞĂƚͿƚĞƐƟŶŐ͘dŚŝƐƚĞƐƚŝƐŵŽƌĞůŝŬĞůLJƚŽŐŝǀĞLJŽƵĂĨĂůƐĞŶĞŐĂƟǀĞƌĞƐƵůƚǁŚĞŶLJŽƵŚĂǀĞKs/ͲϭεƚŚĂŶĂůĂďͲďĂƐĞĚŵŽůĞĐƵůĂƌƚĞƐƚ͘

&ŽƌŵŽƌĞŝŶĨŽƌŵĂƟŽŶŽŶĞdžƉŝƌĂƟŽŶĚĂƟŶŐĨŽƌKs/ͲϭεĂŶƟŐĞŶƚĞƐƚƐ͕ƉůĞĂƐĞƌĞĨĞƌƚŽŚƩƉ͗ͬͬǁǁǁ͘ĨĚĂ͘ŐŽǀͬĐŽǀŝĚͲƚĞƐƚƐ

/ŶƚŚĞh^͕ƚŚŝƐƉƌŽĚƵĐƚŚĂƐŶŽƚďĞĞŶ&ĐůĞĂƌĞĚŽƌĂƉƉƌŽǀĞĚďƵƚŚĂƐďĞĞŶĂƵƚŚŽƌŝnjĞĚďLJ&ƵŶĚĞƌĂŶŵĞƌŐĞŶĐLJhƐĞƵƚŚŽƌŝnjĂƟŽŶ;hͿ͘dŚŝƐƉƌŽĚƵĐƚŚĂƐďĞĞŶĂƵƚŚŽƌŝnjĞĚŽŶůLJĨŽƌƚŚĞĚĞƚĞĐƟŽŶŽĨƉƌŽƚĞŝŶƐĨƌŽŵ^Z^ͲŽsͲϮ͕ŶŽƚĨŽƌĂŶLJŽƚŚĞƌǀŝƌƵƐĞƐŽƌƉĂƚŚŽŐĞŶƐ͘

41939R1 10/17/2022Access BioHome Test Kitseal end78 x 38 x 139(3.071 x 1.496 x 5.472)

exterior viewhorizontal grain .018 sbs change to standard

T-16 zipper

78.000

38

1.496

78

3.071 37.000

244

9.606

21

8.4

36.700

36.700

0.800

139

5.472

4.567

ZWDͲϬϬϮϳϭ

ςρůLJĚĞZŽĂĚ͕^ƵŝƚĞ͘^ŽŵĞƌƐĞƚ͕E:ϬΘΘϳϯ͕h^ϳϯϮͲΘϳϯͲκϬκϬǁǁǁ͘ĂĐĐĞƐƐďŝŽ͘ŶĞƚ

ĐĐĞƐƐŝŽ͕/ŶĐ͘
COVID-19

HOME TEST

without symptoms or with For use

 Made in the USA www.accessbio.net

COVID-19

For use with or without symptoms

2 Tests

HOME TEST

FAST RESULT

 Results in 10 minutes

 A Simple Nasal Swab A Simple N

EASY 

e Nasal Swab

TESTING

hƐŝŶŐDŽďŝůĞƉƉůŝĐĂƟŽŶ

Please start the test followsthe in-app self-paced, stepby-ƐƚĞƉƚĞƐƚŝŶƐƚƌƵĐƟŽŶƐ͘

 Download and open App,  Othena 

Your test result appears on your ƐĐƌĞĞŶĂŌĞƌϭϬŵŝŶƵƚĞƐŽĨǁĂŝƚƟŵĞĂŶĚƐĞůĞĐƟŽŶŽĨǀŝƐƵĂůƌĞƐƵůƚŝŶƚĞƌƉƌĞƚĂƟŽŶƐ͘

12

3

45 Test result

tĂƚĐŚƚŚĞŝŶƐƚƌƵĐƟŽŶǀŝĚĞŽ

 Follow step-by-stepŝŶƐƚƌƵĐƟŽŶƐĨŽƌLJŽƵƌƚĞƐƚ

ŽǁŶůŽĂĚƚŚĞƉƉŽŶƚŚĞƉƉ^ƚŽƌĞor Google Play ^ƚŽƌĞŽƌƐĐĂŶƚŚĞYZĐŽĚĞ͕ŶƐƵƌĞLJŽƵĂƌĞĐŽŶŶĞĐƚĞĚƚŽƚŚĞŝŶƚĞƌŶĞƚĚƵƌŝŶŐLJŽƵƌƚĞƐƚ͘

ŶƐǁĞƌĂĨĞǁƋƵĞƐƟŽŶƐin the App

RCPM-00271

 1 oC34 oF

30 oC86 oF

Self Test for SARS-CoVŶƟŐĞŶĞƚĞĐƟŽŶ(Ages 2 and Up) 

EŽŶͲƉƌĞƐĐƌŝƉƟŽŶŚŽŵwith self-collected nasasamples

dŚŝƐƚĞƐƚĚŽĞƐŶŽƚĚĞƚĞƌŵŝŶĞŚĂĚKs/ͲϭεŝŶƚŚĞƉĂƐƚŽƌŚĂǀĞŝŵŵƵŶŝƚLJ͘/ƚĚĞƚĞĐƚƐƉƌŽĨƌŽŵƚŚĞ^Z^ͲŽsͲϮǀŝƌƵƐ͘

/ĨLJŽƵĂƌĞƉƌŽŶĞƚŽŶŽƐĞďůĞ

 Do Not Use

 Limit of performance

/ĨLJŽƵŚĂǀĞŚĂĚĂĨĂĐŝĂůŽƌŚŝŶũƵƌLJͬƐƵƌŐĞƌLJŝŶƚŚĞůĂƐƚςŵŽ

&ŽƌĂůŝƐƚŽĨĐŽŵƉĂƟďůĞ͕ƐŵĂƌƚƉŚŽŶĞK^ƐLJƐƚĞŵƐ͕ ǀŝƐŝƚǁǁǁ͘ĂĐĐĞƐƐďŝŽ͘ŶĞƚͬĂƉƉ

ςρůLJĚĞZŽĂĚ͕^ƵŝƚĞ͘^ŽŵĞƌƐĞƚ͕E:ϬΘΘϳϯ͕h^ϳϯϮͲΘϳϯͲκϬκϬǁǁǁ͘ĂĐĐĞƐƐďŝŽ͘ŶĞƚ

Access Bio, Inc.

dŚŝƐĞŵĞƌŐĞŶĐLJƵƐĞŽĨƚŚŝƐƉƌŽĚƵĐƚŝƐŽŶůLJĂĨŽƌƚŚĞĚƵƌĂƟŽŶŽĨƚŚĞĚĞĐůĂƌĂƟŽŶƚŚĂƚĐŝƌĐƵĞdžŝƐƚũƵƐƟĨLJŝŶŐƚŚĞĂƵƚŚŽƌŝnjĂƟŽŶŽĨĞŵĞƌŐĞŶin vitroĚŝĂŐŶŽƐƟĐƐĨŽƌĚĞƚĞĐƟŽŶĂŶĚͬŽƌĚŝĂKs/ͲϭεƵŶĚĞƌ^ĞĐƟŽŶρςκ;ďͿ;ϭͿŽĨƚŚĞ&ĞĚƌƵŐĂŶĚŽƐŵĞƟĐĐƚ͕Ϯϭh͘^͘͘ΑϯςϬďďƵŶůĞƐƐĂƵƚŚŽƌŝnjĂƟŽŶŝƐƚĞƌŵŝŶĂƚĞĚŽƌƌĞǀŽŬĞ

Dimension : 3.053 x 5.500 x 1.503 inch

Design Date : 01/26/23Part# PKCSOTC2AD

Designed by JSK DESIGN 

JSK Version. G

dŚĞCareStartΡKs/ͲϭεŶƟŐĞŶ,ŽŵĞdĞƐƚŝƐĂůĂƚĞƌĂůŇŽǁŝŵŵƵŶŽĐŚƌŽŵĂƚŽŐƌĂƉŚŝĐĂƐƐĂLJĨŽƌƚŚĞĚĞƚĞĐƟŽŶŽĨĞdžƚƌĂĐƚĞĚŶƵĐůĞŽĐĂƉƐŝĚƉƌŽƚĞŝŶĂŶƟŐĞŶƐƐƉĞĐŝĮĐƚŽ^Z^ͲŽsͲϮŝŶƐĞůĨͲĐŽůůĞĐƚĞĚĂŶƚĞƌŝŽƌŶĂƐĂů;ŶĂƌĞƐͿƐǁĂďƐƉĞĐŝŵĞŶƐ͘dŚĞƵƐĞƌƐŚŽƵůĚƉĞƌĨŽƌŵƚŚĞƚĞƐƚĨŽůůŽǁŝŶŐƚŚĞŝŶͲĂƉƉƐĞůĨͲƉĂĐĞĚ͕ƐƚĞƉͲďLJͲƐƚĞƉŝŶƐƚƌƵĐƟŽŶƐŽƌYƵŝĐŬZĞĨĞƌĞŶĐĞ/ŶƐƚƌƵĐƟŽŶƐ͘dĞƐƚƌĞƐƵůƚƐĂƌĞŝŶƚĞƌƉƌĞƚĞĚǀŝƐƵĂůůLJĂƚϭϬŵŝŶƵƚĞƐĂŌĞƌƐĂŵƉůĞůŽĂĚŝŶŐĨŽůůŽǁĞĚďLJƚŚĞŝŶƐƚƌƵĐƟŽŶƐ͘WůĞĂƐĞĐĂƌĞĨƵůůLJƌĞĂĚƚŚĞƋƵŝĐŬƌĞĨĞƌĞŶĐĞŝŶƐƚƌƵĐƟŽŶƐŝŶƚŚĞŬŝƚďĞĨŽƌĞƵƐĞ͘

1 2 3 4

Kit Components

2 Nasal Swab - 2ea

3 džƚƌĂĐƟŽŶsŝĂůdƵďĞͲϮĞĂ

1 TM 4 džƚƌĂĐƟŽŶsŝĂůĂƉͲϮĞĂ CareStart COVID-19 Ag 

Home Test - 2ea 

Quick Reference /ŶƐƚƌƵĐƟŽŶƐΘFact Sheet for /ŶĚŝǀŝĚƵĂůƐ

5

Items necessary to use the kit, but not included (Timer or Smartphone)

/ŶƐƚƌƵĐƟŽŶƐ

ZĞƐƵůƚƐ/ŶƚĞƌƉƌĞƚĂƟŽŶ

X5 X5 

Lot, Exp, and UDI print here

ƐĂLJĨŽƌ

ůůĞĐƚĞĚ

For Emergency Use ƵƚŚŽƌŝnjĂƟŽŶ;hͿŽŶůLJ

For in vitroĚŝĂŐŶŽƐƟĐ

/ŶƚŚĞh^͕ƚŚŝƐƉƌŽĚƵĐƚŚĂƐŶŽƚďĞĞŶ&ŽƌĂƉƉƌŽǀĞĚďƵƚŚĂƐďĞĞŶĂƵƚŚŽƌŝnjĞĚďLJ&ĂŶŵĞƌŐĞŶĐLJhƐĞƵƚŚŽƌŝnjĂƟŽŶ;hͿ͘dŚŝƐŚĂƐďĞĞŶĂƵƚŚŽƌŝnjĞĚŽŶůLJĨŽƌƚŚĞĚĞƚĞƉƌŽƚĞŝŶƐĨƌŽŵ^Z^ͲŽsͲϮ͕ŶŽƚĨŽƌĂŶLJŽƚŚĞor ƉĂƚŚŽŐĞŶƐ͘

ĞƚĞƌŵŝŶŝŶŐĂŶĞŐĂƟǀĞƌĞƐƵůƚƌĞƋƵŝƌĞƐŵƵůƟƉzŽƵŵĂLJŶĞĞĚƚŽƉƵƌĐŚĂƐĞĂĚĚŝƟŽŶĂůƚĞƐƚƐƚŽƐĞƌŝĂů;ƌĞƉĞĂƚͿƚĞƐƟŶŐ͘dŚŝƐƚĞƐƚŝƐŵŽƌĞůŝŬĞůLJLJŽƵĂĨĂůƐĞŶĞŐĂƟǀĞƌĞƐƵůƚǁŚĞŶLJŽƵŚĂǀĞKthan a lab-based molecular test.

&ŽƌŵŽƌĞŝŶĨŽƌŵĂƟŽŶŽŶĞdžƉŝƌĂƟŽŶĚĂƟŶŐĨŽƌĂŶƟŐĞŶƚĞƐƚƐ͕ƉůĞĂƐĞƌĞĨĞƌƚŽŚƩƉ͗ͬͬǁǁǁ͘ĨĚĂtests
COVID-19

HOME TEST

www.accessbio.net

without symptoms or with For use

65 Clyde Road, Suite A.Somerset, NJ 08873, USA732-873-4040www.accessbio.net

Access Bio, Inc.

 Made in the USA www.accessbio.net

 1 oC34 oF

30 oC86 oF

The CareStartΡKs/ͲϭεŶƟŐĞŶ,ŽŵĞdĞƐƚŝƐĂůĂƚĞƌĂůŇŽǁŝŵŵƵŶŽĐŚƌŽŵĂƚŽŐƌĂƉŚŝĐĂƐƐĂLJĨŽƌ

ƚŚĞĚĞƚĞĐƟŽŶŽĨĞdžƚƌĂĐƚĞĚŶƵĐůĞŽĐĂƉƐŝĚƉƌŽƚĞŝŶĂŶƟŐĞŶƐƐƉĞĐŝĮĐƚŽ^Z^ͲŽsͲϮŝŶƐĞůĨͲĐŽůůĞĐƚĞĚĂŶƚĞƌŝŽƌŶĂƐĂů;ŶĂƌĞƐͿƐǁĂďƐƉĞĐŝŵĞŶƐ͘dŚĞƵƐĞƌƐŚŽƵůĚƉĞƌĨŽƌŵƚŚĞƚĞƐƚĨŽůůŽǁŝŶŐƚŚĞŝŶͲĂƉƉƐĞůĨͲƉĂĐĞĚ͕ƐƚĞƉͲďLJͲƐƚĞƉŝŶƐƚƌƵĐƟŽŶƐŽƌYƵŝĐŬZĞĨĞƌĞŶĐĞ/ŶƐƚƌƵĐƟŽŶƐ͘dĞƐƚƌĞƐƵůƚƐĂƌĞŝŶƚĞƌƉƌĞƚĞĚǀŝƐƵĂůůLJĂƚϭϬŵŝŶƵƚĞƐĂŌĞƌƐĂŵƉůĞůŽĂĚŝŶŐĨŽůůŽǁĞĚďLJƚŚĞŝŶƐƚƌƵĐƟŽŶƐ͘WůĞĂƐĞĐĂƌĞĨƵůůLJƌĞĂĚƚŚĞƋƵŝĐŬƌĞĨĞƌĞŶĐĞŝŶƐƚƌƵĐƟŽŶƐŝŶƚŚĞŬŝƚďĞĨŽƌĞƵƐĞ͘

1 2 4

Kit Components

2 Nasal Swab - 4ea

3 džƚƌĂĐƟŽŶsŝĂůdƵďĞͲκĞĂ

1 TM 4 džƚƌĂĐƟŽŶsŝĂůĂƉͲκĞĂ CareStart Ks/ͲϭεŐ

,ŽŵĞdĞƐƚͲκĞĂ

Quick Reference /ŶƐƚƌƵĐƟŽŶƐΘFact Sheet for Individuals 

5

Items necessary to use the kit, but not included (Timer or Smartphone)

/ŶƐƚƌƵĐƟŽŶƐ

ZĞƐƵůƚƐ/ŶƚĞƌƉƌĞƚĂƟŽŶ

COVID-19

For use with or without symptoms

κdĞƐƚƐ

HOME TEST

FAST RESULT

 Results in 10 minutes

^ŝŵƉůĞEĂƐĂů^ǁĂď ^ŝŵƉůĞ E

EASY 

Ğ EĂƐĂů ^ǁĂď

TESTING

hƐŝŶŐDŽďŝůĞƉƉůŝĐĂƟŽŶ

Please start the test follows the in-app self-paced, step-by-ƐƚĞƉƚĞƐƚŝŶƐƚƌƵĐƟŽŶƐ͘

1ŽǁŶůŽĂĚĂŶĚŽƉĞŶƉƉ͕KƚŚĞŶĂ

2

3

45 dĞƐƚƌĞƐƵůƚ

tĂƚĐŚƚŚĞŝŶƐƚƌƵĐƟŽŶǀŝĚĞŽ

ŽǁŶůŽĂĚƚŚĞƉƉŽŶƚŚĞƉƉ^ƚŽƌĞŽƌ'ŽŽŐůĞWůĂLJ^ƚŽƌĞŽƌƐĐĂŶƚŚĞYZĐŽĚĞ͕ŶƐƵƌĞLJŽƵĂƌĞĐŽŶŶĞĐƚĞĚƚŽƚŚĞŝŶƚĞƌŶĞƚĚƵƌŝŶŐLJŽƵƌƚĞƐƚ͘

ŶƐǁĞƌĂĨĞǁƋƵĞƐƟŽŶƐŝŶƚŚĞƉƉ

&ŽƌĂůŝƐƚŽĨĐŽŵƉĂƟďůĞƐŵĂƌƚƉŚŽŶĞK^ƐLJƐƚĞŵƐ͕ǀŝƐŝƚǁǁǁ͘ĂĐĐĞƐƐďŝŽ͘ŶĞƚͬĂƉƉ

&ŽůůŽǁƐƚĞƉͲďLJͲƐƚĞƉŝŶƐƚƌƵĐƟŽŶƐĨŽƌLJŽƵƌƚĞƐƚ

zŽƵƌƚĞƐƚƌĞƐƵůƚĂƉƉĞĂƌƐŽŶLJŽƵƌƐĐƌĞĞŶĂŌĞƌϭϬŵŝŶƵƚĞƐŽĨǁĂŝƚƟŵĞĂŶĚƐĞůĞĐƟŽŶŽĨǀŝƐƵĂůƌĞƐƵůƚŝŶƚĞƌƉƌĞƚĂƟŽŶƐ͘

^ĞůĨdĞƐƚĨŽƌ^Z^ͲŽsͲϮŶƟŐĞŶĞƚĞĐƟŽŶ;ŐĞƐϮĂŶĚhƉͿEŽŶͲƉƌĞƐĐƌŝƉƟŽŶŚŽŵĞƵƐĞǁŝƚŚƐĞůĨͲĐŽůůĞĐƚĞĚnasal swab samples

dŚŝƐƚĞƐƚĚŽĞƐŶŽƚĚĞƚĞƌŵŝŶĞŝĨLJŽƵŚĂĚKs/ͲϭεŝŶƚŚĞƉĂƐƚŽƌŝĨLJŽƵŚĂǀĞŝŵŵƵŶŝƚLJ͘/ƚĚĞƚĞĐƚƐƉƌŽƚĞŝŶƐĨƌŽŵƚŚĞ^Z^ͲŽsͲϮǀŝƌƵƐ͘

/ĨLJŽƵĂƌĞƉƌŽŶĞƚŽŶŽƐĞďůĞĞĚƐ͘

ŽEŽƚhƐĞ

 Limit of performance

/ĨLJŽƵŚĂǀĞŚĂĚĂĨĂĐŝĂůŽƌŚĞĂĚŝŶũƵƌLJͬƐƵƌŐĞƌLJŝŶƚŚĞůĂƐƚςŵŽŶƚŚƐ͘

dŚŝƐĞŵĞƌŐĞŶĐLJƵƐĞŽĨƚŚŝƐƉƌŽĚƵĐƚŝƐŽŶůLJĂƵƚŚŽƌŝnjĞĚĨŽƌƚŚĞĚƵƌĂƟŽŶŽĨƚŚĞĚĞĐůĂƌĂƟŽŶƚŚĂƚĐŝƌĐƵŵƐƚĂŶĐĞƐĞdžŝƐƚũƵƐƟĨLJŝŶŐƚŚĞĂƵƚŚŽƌŝnjĂƟŽŶŽĨĞŵĞƌŐĞŶĐLJƵƐĞŽĨin vitroĚŝĂŐŶŽƐƟĐƐĨŽƌĚĞƚĞĐƟŽŶĂŶĚͬŽƌĚŝĂŐŶŽƐŝƐŽĨKs/ͲϭεƵŶĚĞƌ^ĞĐƟŽŶρςκ;ďͿ;ϭͿŽĨƚŚĞ&ĞĚĞƌĂů&ŽŽĚ͕ƌƵŐĂŶĚŽƐŵĞƟĐĐƚ͕Ϯϭh͘^͘͘ΑϯςϬďďďͲϯ;ďͿ;ϭͿ͕ƵŶůĞƐƐĂƵƚŚŽƌŝnjĂƟŽŶŝƐƚĞƌŵŝŶĂƚĞĚŽƌƌĞǀŽŬĞĚƐŽŽŶĞƌ͘

Design Date : 01/26/23Part# PKCSOTC4AC

Designed by JSK DESIGN 

JSK Version. G

Lot, Exp, and UDI print here 

X5 X5 

4

&ŽƌŵĞƌŐĞŶĐLJhƐĞƵƚŚŽƌŝnjĂƟŽŶ;hͿŽŶůLJ

/ŶƚŚĞh^͕ƚŚŝƐƉƌŽĚƵĐƚŚĂƐŶŽƚďĞĞŶ&ĐůĞĂƌĞĚŽƌĂƉƉƌŽǀĞĚďƵƚŚĂƐďĞĞŶŚĂƐďĞĞŶĂƵƚŚŽƌŝnjĞĚŽŶůLJĨŽƌƚŚĞĚĞƚĞĐƟŽŶŽĨƉƌŽƚĞŝŶƐĨƌŽŵ^Z^ͲŽsͲϮ͕ŶŽƚĨŽƌĂŶLJŽƚŚĞƌǀŝƌƵƐĞƐŽƌƉĂƚŚŽŐĞŶƐ͘

For in vitroĚŝĂŐŶŽƐƟĐƵƐĞ

ĞƚĞƌŵŝŶŝŶŐĂŶĞŐĂƟǀĞƌĞƐƵůƚƌĞƋƵŝƌĞƐŵƵůƟƉůĞƚĞƐƚƐ͘zŽƵŵĂLJŶĞĞĚƚŽƉƵƌĐŚĂƐĞĂĚĚŝƟŽŶĂůƚĞƐƚƐƚŽƉĞƌĨŽƌŵƐĞƌŝĂů;ƌĞƉĞĂƚͿƚĞƐƟŶŐ͘dŚŝƐƚĞƐƚŝƐŵŽƌĞůŝŬĞůLJƚŽŐŝǀĞLJŽƵĂĨĂůƐĞŶĞŐĂƟǀĞƌĞƐƵůƚǁŚĞŶLJŽƵŚĂǀĞKs/ͲϭεƚŚĂŶĂůĂďͲďĂƐĞĚŵŽůĞĐƵůĂƌƚĞƐƚ͘

&ŽƌŵŽƌĞŝŶĨŽƌŵĂƟŽŶŽŶĞdžƉŝƌĂƟŽŶĚĂƟŶŐĨŽƌKs/ͲϭεĂŶƟŐĞŶƚĞƐƚƐ͕ƉůĞĂƐĞƌĞĨĞƌƚŽŚƩƉ͗ͬͬǁǁǁ͘ĨĚĂ͘ŐŽǀͬĐŽǀŝĚͲƚĞƐƚƐ

3
RCPM-00571

1 TM 

2 Nasal Swab - 5ea 

3 džƚƌĂĐƟŽŶsŝĂů

Tube - 5ea 

džƚƌĂĐƟŽŶsŝĂů Cap - 5ea 

4

5 YƵŝĐŬZĞĨĞƌĞŶĐĞ/ŶƐƚƌƵĐƟŽŶƐΘ

&ĂĐƚ^ŚĞĞƚĨŽƌ/ŶĚŝǀŝĚƵĂůƐ

Items necessary to use the kit, but not included (Timer or Smartphone)

The CareStartΡKs/ͲϭεŶƟŐĞŶ,ŽŵĞdĞƐƚŝƐĂůĂƚĞƌĂůŇŽǁŝŵŵƵŶŽĐŚƌŽŵĂƚŽŐƌĂƉŚŝĐĂƐƐĂLJĨŽƌƚŚĞĚĞƚĞĐƟŽŶŽĨĞdžƚƌĂĐƚĞĚŶƵĐůĞŽĐĂƉƐŝĚƉƌŽƚĞŝŶ

ĂŶƟŐĞŶƐƐƉĞĐŝĮĐƚŽ^Z^ͲŽsͲϮŝŶƐĞůĨͲĐŽůůĞĐƚĞĚĂŶƚĞƌŝŽƌŶĂƐĂů;ŶĂƌĞƐͿƐǁĂďƐƉĞĐŝŵĞŶƐ͘dŚĞƵƐĞƌƐŚŽƵůĚƉĞƌĨŽƌŵƚŚĞƚĞƐƚĨŽůůŽǁŝŶŐƚŚĞŝŶͲĂƉƉƐĞůĨͲ

ƉĂĐĞĚ͕ƐƚĞƉͲďLJͲƐƚĞƉŝŶƐƚƌƵĐƟŽŶƐŽƌYƵŝĐŬZĞĨĞƌĞŶĐĞ/ŶƐƚƌƵĐƟŽŶƐ͘dĞƐƚƌĞƐƵůƚƐĂƌĞŝŶƚĞƌƉƌĞƚĞĚǀŝƐƵĂůůLJĂƚϭϬŵŝŶƵƚĞƐĂŌĞƌƐĂŵƉůĞůŽĂĚŝŶŐĨŽůůŽǁĞĚďLJƚŚĞŝŶƐƚƌƵĐƟŽŶƐ͘WůĞĂƐĞĐĂƌĞĨƵůůLJƌĞĂĚƚŚĞƋƵŝĐŬƌĞĨĞƌĞŶĐĞŝŶƐƚƌƵĐƟŽŶƐŝŶƚŚĞŬŝƚďĞĨŽƌĞƵƐĞ͘

1 2 4 ZĞƐƵůƚƐ/ŶƚĞƌƉƌĞƚĂƟŽŶ

hƐŝŶŐDŽďŝůĞƉƉůŝĐĂƟŽŶ

WůĞĂƐĞƐƚĂƌƚƚŚĞƚĞƐƚĨŽůůŽǁƐƚŚĞŝŶͲĂƉƉƐĞůĨͲƉĂĐĞĚ͕ƐƚĞƉͲďLJͲƐƚĞƉƚĞƐƚŝŶƐƚƌƵĐƟŽŶƐ͘

3 tĂƚĐŚƚŚĞŝŶƐƚƌƵĐƟŽŶǀŝĚĞŽ

ŽǁŶůŽĂĚĂŶĚŽƉĞŶƉƉ͕KƚŚĞŶĂ

zŽƵƌƚĞƐƚƌĞƐƵůƚĂƉƉĞĂƌƐŽŶLJŽƵƌƐĐƌĞĞŶĂŌĞƌϭϬŵŝŶƵƚĞƐŽĨǁĂŝƚƟŵĞĂŶĚƐĞůĞĐƟŽŶŽĨǀŝƐƵĂůƌĞƐƵůƚŝŶƚĞƌƉƌĞƚĂƟŽŶƐ͘

1

2

4

5 Test result

&ŽůůŽǁƐƚĞƉͲďLJͲƐƚĞƉŝŶƐƚƌƵĐƟŽŶƐĨŽƌLJŽƵƌƚĞƐƚ

ŽǁŶůŽĂĚƚŚĞƉƉŽŶƚŚĞƉƉ^ƚŽƌĞŽƌ'ŽŽŐůĞWůĂLJ^ƚŽƌĞŽƌƐĐĂŶƚŚĞYZĐŽĚĞ͕ŶƐƵƌĞLJŽƵĂƌĞĐŽŶŶĞĐƚĞĚƚŽƚŚĞŝŶƚĞƌŶĞƚĚƵƌŝŶŐLJŽƵƌƚĞƐƚ͘

ŶƐǁĞƌĂĨĞǁƋƵĞƐƟŽŶƐŝŶƚŚĞƉƉ

&ŽƌĂůŝƐƚŽĨĐŽŵƉĂƟďůĞƐŵĂƌƚƉŚŽŶĞK^ƐLJƐƚĞŵƐ͕ǀŝƐŝƚǁǁǁ͘ĂĐĐĞƐƐďŝŽ͘ŶĞƚͬĂƉƉ

5 Tests

^ĞůĨdĞƐƚĨŽEŽŶͲƉƌĞƐĐƌ

dŚŝƐƚĞƐƚĚŽĞƐŶŽƚ/ƚĚĞƚĞĐƚƐƉƌŽƚĞŝŶƐ

ŽEŽƚhƐĞ>ŝŵŝƚŽĨƉĞƌ

dŚŝƐĞŵĞƌŐĞŶĐLJƵĂƵƚŚŽƌŝnjĂƟŽŶŽĨĞ&ĞĚĞƌĂů&ŽŽĚ͕ƌƵŐ

5

CareStart Ks/ͲϭεŐ,ŽŵĞdĞƐƚͲρĞĂ

Design Date : 01/26/23Part# PKCSOTC5ADesigned by JSK DESIGN JSK Version. E

Lot, Exp, and UDI print here 

ςρůLJĚĞZŽĂĚ͕^ƵŝƚĞ͘^ŽŵĞƌƐĞƚ͕E:ϬΘΘϳϯ͕h^ϳϯϮͲΘϳϯͲκϬκϬǁǁǁ͘ĂĐĐĞƐƐďŝŽ͘ŶĞƚ

ĐĐĞƐƐŝŽ͕/ŶĐ͘

X5 X5 

&ŽƌŵĞƌŐĞŶĐLJhƐĞƵƚŚŽƌŝnjĂƟŽŶ;hͿŽŶůLJ &Žƌin vitro 

/ŶƚŚĞh^͕ƚŚŝƐƉƌƵƚŚŽƌŝnjĂƟŽŶ;hŽƚŚĞƌǀŝƌƵƐĞƐŽƌ

ĞƚĞƌŵŝŶŝŶŐĂŶƚĞƐƟŶŐ͘dŚŝƐƚĞƐ

&ŽƌŵŽƌĞŝŶĨŽƌŵĂ

3
114

4.488

235

9.252

713.5

28.091

20 Tests

1 2 4 ZĞƐƵůƚƐ/ŶƚĞƌƉƌĞƚĂƟŽŶ

RCPM-02071 hƐŝŶŐDŽďŝůĞƉƉůŝĐĂƟŽŶ

WůĞĂƐĞƐƚĂƌƚƚŚĞƚĞƐƚĨŽůůŽǁƐƚŚĞŝŶͲĂƉƉƐĞůĨͲƉĂĐĞĚ͕ƐƚĞƉͲďLJͲƐƚĞƉƚĞƐƚŝŶƐƚƌƵĐƟŽŶƐ͘

ŽǁŶůŽĂĚĂŶĚŽƉĞŶƉƉ͕KƚŚĞŶĂ

zŽƵƌƚĞƐƚƌĞƐƵůƚĂƉƉĞĂƌƐŽŶLJŽƵƌƐĐƌĞĞŶĂŌĞƌϭϬŵŝŶƵƚĞƐŽĨǁĂŝƚƟŵĞĂŶĚƐĞůĞĐƟŽŶŽĨǀŝƐƵĂůƌĞƐƵůƚŝŶƚĞƌƉƌĞƚĂƟŽŶƐ͘

1

2 3

4

5 Test result

tĂƚĐŚƚŚĞŝŶƐƚƌƵĐƟŽŶǀŝĚĞŽ

ŽǁŶůŽĂĚƚŚĞƉƉŽŶƚŚĞƉƉ^ƚŽƌĞŽƌ'ŽŽŐůĞWůĂLJ^ƚŽƌĞŽƌƐĐĂŶƚŚĞYZĐŽĚĞ͕ŶƐƵƌĞLJŽƵĂƌĞĐŽŶŶĞĐƚĞĚƚŽƚŚĞŝŶƚĞƌŶĞƚĚƵƌŝŶŐLJŽƵƌƚĞƐƚ͘

ŶƐǁĞƌĂĨĞǁƋƵĞƐƟŽŶƐŝŶƚŚĞƉƉ

&ŽƌĂůŝƐƚŽĨĐŽŵƉĂƟďůĞƐŵĂƌƚƉŚŽŶĞK^ƐLJƐƚĞŵƐ͕ǀŝƐŝƚǁǁǁ͘ĂĐĐĞƐƐďŝŽ͘ŶĞƚͬĂƉƉ

20

^ĞůĨdĞƐƚĨŽƌ^Z^ͲŽsͲϮŶƟŐĞŶĞƚĞĐƟŽŶ ;ŐĞƐϮĂŶĚhƉͿEŽŶͲƉƌĞƐĐƌŝƉƟŽŶŚŽŵĞƵƐĞǁŝƚŚƐĞůĨͲĐŽůůĞĐƚĞĚŶĂƐĂůƐǁĂďƐ

dŚŝƐƚĞƐƚĚŽĞƐŶŽƚĚĞƚĞƌŵŝŶĞŝĨLJŽƵŚĂĚKs/ͲϭεŝŶƚŚĞƉĂƐƚŽƌŝĨLJŽƵŚĂǀĞŝŵŵ/ƚĚĞƚĞĐƚƐƉƌŽƚĞŝŶƐĨƌŽŵƚŚĞ^Z^ͲŽsͲϮǀŝƌƵƐ͘

/ĨLJŽƵĂƌĞƉƌŽŶĞƚŽŶŽƐĞďůĞĞĚƐ͘

ŽEŽƚhƐĞ

>ŝŵŝƚŽĨƉĞƌĨŽƌŵĂŶĐĞ

/ĨLJŽƵŚĂǀĞŚĂĚĂĨĂĐŝĂůŽƌŚĞĂĚŝŶũƵƌLJͬƐƵƌŐĞƌLJŝŶƚŚĞůĂƐƚςŵŽŶƚŚƐ͘

dŚŝƐĞŵĞƌŐĞŶĐLJƵƐĞŽĨƚŚŝƐƉƌŽĚƵĐƚŝƐŽŶůLJĂƵƚŚŽƌŝnjĞĚĨŽƌƚŚĞĚƵƌĂƟŽŶŽĨƚŚĞĚĞĞdžŝƐƚũƵƐƟĨLJŝŶŐƚŚĞĂƵƚŚŽƌŝnjĂƟŽŶŽĨĞŵĞƌŐĞŶĐLJƵƐĞŽĨŝŶǀŝƚƌŽĚŝĂŐŶŽƐƟĐƐĨŽƌĚĞKs/ͲϭεƵŶĚĞƌ^ĞĐƟŽŶρςκ;ďͿ;ϭͿŽĨƚŚĞ&ĞĚĞƌĂů&ŽŽĚ͕ƌƵŐĂŶĚŽƐŵĞƟĐĐƚ͕ƵŶůĞƐƐĂƵƚŚŽƌŝnjĂƟŽŶŝƐƚĞƌŵŝŶĂƚĞĚŽƌƌĞǀŽŬĞĚƐŽŽŶĞƌ͘ &ŽůůŽǁƐƚĞƉͲďLJͲƐƚĞƉŝŶƐƚƌƵĐƟŽŶƐĨŽƌLJŽƵƌƚĞƐƚ

1 TM 

2 EĂƐĂů^ǁĂď - 20ea 

3 džƚƌĂĐƟŽŶsŝĂů

dƵďĞ- 20ea 

džƚƌĂĐƟŽŶsŝĂů Cap - 20ea 

4

5 YƵŝĐŬZĞĨĞƌĞŶĐĞ/ŶƐƚƌƵĐƟŽŶƐΘ

&ĂĐƚ^ŚĞĞƚĨŽƌ/ŶĚŝǀŝĚƵĂůƐ

Items necessary to use the kit, but not included (Timer or Smartphone)

dŚĞCareStartΡKs/ͲϭεŶƟŐĞŶ,ŽŵĞdĞƐƚŝƐĂůĂƚĞƌĂůŇŽǁŝŵŵƵŶŽĐŚƌŽŵĂƚŽŐƌĂƉŚŝĐĂƐƐĂLJĨŽƌƚŚĞĚĞƚĞĐƟŽŶŽĨĞdžƚƌĂĐƚĞĚŶƵĐůĞŽĐĂƉƐŝĚƉƌŽƚĞŝŶ

ĂŶƟŐĞŶƐƐƉĞĐŝĮĐƚŽ^Z^ͲŽsͲϮŝŶƐĞůĨͲĐŽůůĞĐƚĞĚĂŶƚĞƌŝŽƌŶĂƐĂů;ŶĂƌĞƐͿƐǁĂďƐƉĞĐŝŵĞŶƐ͘dŚĞƵƐĞƌƐŚŽƵůĚƉĞƌĨŽƌŵƚŚĞƚĞƐƚĨŽůůŽǁŝŶŐƚŚĞŝŶͲĂƉƉƐĞůĨͲƉĂĐĞĚ͕ƐƚĞƉͲďLJͲƐƚĞƉŝŶƐƚƌƵĐƟŽŶƐŽƌYƵŝĐŬZĞĨĞƌĞŶĐĞ/ŶƐƚƌƵĐƟŽŶƐ͘dĞƐƚƌĞƐƵůƚƐĂƌĞŝŶƚĞƌƉƌĞƚĞĚǀŝƐƵĂůůLJĂƚϭϬŵŝŶƵƚĞƐĂŌĞƌƐĂŵƉůĞůŽĂĚŝŶŐ

ĨŽůůŽǁĞĚďLJƚŚĞŝŶƐƚƌƵĐƟŽŶƐ͘WůĞĂƐĞĐĂƌĞĨƵůůLJƌĞĂĚƚŚĞƋƵŝĐŬƌĞĨĞƌĞŶĐĞŝŶƐƚƌƵĐƟŽŶƐŝŶƚŚĞŬŝƚďĞĨŽƌĞƵƐĞ͘

CareStart Ks/ͲϭεŐ,ŽŵĞdĞƐƚͲϮϬĞĂ

235 x 114 x 75 (9.252 x 4.488 x 2.953) exterior viewhorizontal grain .018 sbs & .020 sbs

Lot, Exp, and UDI print here 

ςρůLJĚĞZŽĂĚ͕^ƵŝƚĞ͘^ŽŵĞƌƐĞƚ͕E:ϬΘΘϳϯ͕h^ϳϯϮͲΘϳϯͲκϬκϬǁǁǁ͘ĂĐĐĞƐƐďŝŽ͘ŶĞƚ

ĐĐĞƐƐŝŽ͕/ŶĐ͘

X5 X5 

Design Date : 01/26/23Part#PKCSOTC20C Designed by JSK DESIGN JSK Version. E

&ŽƌŵĞƌŐĞŶĐLJhƐĞƵƚŚŽƌŝnjĂƟŽŶ;hͿŽŶůLJ &Žƌ in vitro ĚŝĂŐŶŽƐƟĐƵƐĞ

/ŶƚŚĞh^͕ƚŚŝƐƉƌŽĚƵĐƚŚĂƐŶŽƚďĞĞŶ&ĐůĞĂƌĞĚŽƌĂƉƉƌŽǀĞĚďƵƚŚĂƐďĞĞŶĂƵƚŚŽƌhƐĞƵƚŚŽƌŝnjĂƟŽŶ;hͿ͘dŚŝƐƉƌŽĚƵĐƚŚĂƐďĞĞŶĂƵƚŚŽƌŝnjĞĚŽŶůLJĨŽƌƚŚĞĚĞƚĞĐƟŽŶŽƚĨŽƌĂŶLJŽƚŚĞƌǀŝƌƵƐĞƐŽƌƉĂƚŚŽŐĞŶƐ͘

ĞƚĞƌŵŝŶŝŶŐĂŶĞŐĂƟǀĞƌĞƐƵůƚƌĞƋƵŝƌĞƐŵƵůƟƉůĞƚĞƐƚƐ͘zŽƵŵĂLJŶĞĞĚƚŽƉƵƌĐŚĂƐserial ;ƌĞƉĞĂƚͿƚĞƐƟŶŐ͘dŚŝƐƚĞƐƚŝƐŵŽƌĞůŝŬĞůLJƚŽŐŝǀĞLJŽƵĂĨĂůƐĞŶĞŐĂƟǀĞƌĞƐƵůƚǁ

ĂůĂďͲďĂƐĞĚŵŽůĞĐƵůĂƌƚĞƐƚ͘

&ŽƌŵŽƌĞŝŶĨŽƌŵĂƟŽŶŽŶĞdžƉŝƌĂƟŽŶĚĂƟŶŐĨŽƌKs/ͲϭεĂŶƟŐĞŶƚĞƐƚƐ͕ƉůĞĂƐĞƌĐŽǀŝĚͲƚĞƐƚƐ

3
25 Tests

1 2 4 ZĞƐƵůƚƐ/ŶƚĞƌƉƌĞƚĂƟŽŶ

RCPM-02571 hƐŝŶŐDŽďŝůĞƉƉůŝĐĂƟŽŶ

WůĞĂƐĞƐƚĂƌƚƚŚĞƚĞƐƚĨŽůůŽǁƐƚŚĞŝŶͲĂƉƉƐĞůĨͲƉĂĐĞĚ͕ƐƚĞƉͲďLJͲƐƚĞƉƚĞƐƚŝŶƐƚƌƵĐƟŽŶƐ͘

ŽǁŶůŽĂĚĂŶĚŽƉĞŶƉƉ͕KƚŚĞŶĂ

zŽƵƌƚĞƐƚƌĞƐƵůƚĂƉƉĞĂƌƐŽŶLJŽƵƌƐĐƌĞĞŶĂŌĞƌϭϬŵŝŶƵƚĞƐŽĨǁĂŝƚƟŵĞĂŶĚƐĞůĞĐƟŽŶŽĨǀŝƐƵĂůƌĞƐƵůƚŝŶƚĞƌƉƌĞƚĂƟŽŶƐ͘

1

2 3

4

5 Test result

tĂƚĐŚƚŚĞŝŶƐƚƌƵĐƟŽŶǀŝĚĞŽ

ŽǁŶůŽĂĚƚŚĞƉƉŽŶƚŚĞƉƉ^ƚŽƌĞŽƌ'ŽŽŐůĞWůĂLJ^ƚŽƌĞŽƌƐĐĂŶƚŚĞYZĐŽĚĞ͕ŶƐƵƌĞLJŽƵĂƌĞĐŽŶŶĞĐƚĞĚƚŽƚŚĞŝŶƚĞƌŶĞƚĚƵƌŝŶŐLJŽƵƌƚĞƐƚ͘

ŶƐǁĞƌĂĨĞǁƋƵĞƐƟŽŶƐŝŶƚŚĞƉƉ

&ŽƌĂůŝƐƚŽĨĐŽŵƉĂƟďůĞƐŵĂƌƚƉŚŽŶĞK^ƐLJƐƚĞŵƐ͕ǀŝƐŝƚǁǁǁ͘ĂĐĐĞƐƐďŝŽ͘ŶĞƚͬĂƉƉ

25

^ĞůĨdĞƐƚĨŽƌ^Z^ͲŽsͲϮŶƟŐĞŶĞƚĞĐƟŽŶ ;ŐĞƐϮĂŶĚhƉͿEŽŶͲƉƌĞƐĐƌŝƉƟŽŶŚŽŵĞƵƐĞǁŝƚŚƐĞůĨͲĐŽůůĞĐƚĞĚŶĂƐĂůƐǁĂďƐ

dŚŝƐƚĞƐƚĚŽĞƐŶŽƚĚĞƚĞƌŵŝŶĞŝĨLJŽƵŚĂĚKs/ͲϭεŝŶƚŚĞƉĂƐƚŽƌŝĨLJŽƵŚĂǀĞŝŵŵ/ƚĚĞƚĞĐƚƐƉƌŽƚĞŝŶƐĨƌŽŵƚŚĞ^Z^ͲŽsͲϮǀŝƌƵƐ͘

/ĨLJŽƵĂƌĞƉƌŽŶĞƚŽŶŽƐĞďůĞĞĚƐ͘

ŽEŽƚhƐĞ

>ŝŵŝƚŽĨƉĞƌĨŽƌŵĂŶĐĞ

/ĨLJŽƵŚĂǀĞŚĂĚĂĨĂĐŝĂůŽƌŚĞĂĚŝŶũƵƌLJͬƐƵƌŐĞƌLJŝŶƚŚĞůĂƐƚςŵŽŶƚŚƐ͘

dŚŝƐĞŵĞƌŐĞŶĐLJƵƐĞŽĨƚŚŝƐƉƌŽĚƵĐƚŝƐŽŶůLJĂƵƚŚŽƌŝnjĞĚĨŽƌƚŚĞĚƵƌĂƟŽŶŽĨƚŚĞĚĞĞdžŝƐƚũƵƐƟĨLJŝŶŐƚŚĞĂƵƚŚŽƌŝnjĂƟŽŶŽĨĞŵĞƌŐĞŶĐLJƵƐĞŽĨŝŶǀŝƚƌŽĚŝĂŐŶŽƐƟĐƐĨŽƌĚĞKs/ͲϭεƵŶĚĞƌ^ĞĐƟŽŶρςκ;ďͿ;ϭͿŽĨƚŚĞ&ĞĚĞƌĂů&ŽŽĚ͕ƌƵŐĂŶĚŽƐŵĞƟĐĐƚ͕ƵŶůĞƐƐĂƵƚŚŽƌŝnjĂƟŽŶŝƐƚĞƌŵŝŶĂƚĞĚŽƌƌĞǀŽŬĞĚƐŽŽŶĞƌ͘ &ŽůůŽǁƐƚĞƉͲďLJͲƐƚĞƉŝŶƐƚƌƵĐƟŽŶƐĨŽƌLJŽƵƌƚĞƐƚ

1 TM 

2 EĂƐĂů^ǁĂď - 25ea 

3 džƚƌĂĐƟŽŶsŝĂů

dƵďĞ- 25ea 

džƚƌĂĐƟŽŶsŝĂů Cap - 25ea 

4

5 YƵŝĐŬZĞĨĞƌĞŶĐĞ/ŶƐƚƌƵĐƟŽŶƐΘ

&ĂĐƚ^ŚĞĞƚĨŽƌ/ŶĚŝǀŝĚƵĂůƐ

Items necessary to use the kit, but not included (Timer or Smartphone)

dŚĞCareStartΡKs/ͲϭεŶƟŐĞŶ,ŽŵĞdĞƐƚŝƐĂůĂƚĞƌĂůŇŽǁŝŵŵƵŶŽĐŚƌŽŵĂƚŽŐƌĂƉŚŝĐĂƐƐĂLJĨŽƌƚŚĞĚĞƚĞĐƟŽŶŽĨĞdžƚƌĂĐƚĞĚŶƵĐůĞŽĐĂƉƐŝĚƉƌŽƚĞŝŶ

ĂŶƟŐĞŶƐƐƉĞĐŝĮĐƚŽ^Z^ͲŽsͲϮŝŶƐĞůĨͲĐŽůůĞĐƚĞĚĂŶƚĞƌŝŽƌŶĂƐĂů;ŶĂƌĞƐͿƐǁĂďƐƉĞĐŝŵĞŶƐ͘dŚĞƵƐĞƌƐŚŽƵůĚƉĞƌĨŽƌŵƚŚĞƚĞƐƚĨŽůůŽǁŝŶŐƚŚĞŝŶͲĂƉƉƐĞůĨͲƉĂĐĞĚ͕ƐƚĞƉͲďLJͲƐƚĞƉŝŶƐƚƌƵĐƟŽŶƐŽƌYƵŝĐŬZĞĨĞƌĞŶĐĞ/ŶƐƚƌƵĐƟŽŶƐ͘dĞƐƚƌĞƐƵůƚƐĂƌĞŝŶƚĞƌƉƌĞƚĞĚǀŝƐƵĂůůLJĂƚϭϬŵŝŶƵƚĞƐĂŌĞƌƐĂŵƉůĞůŽĂĚŝŶŐ

ĨŽůůŽǁĞĚďLJƚŚĞŝŶƐƚƌƵĐƟŽŶƐ͘WůĞĂƐĞĐĂƌĞĨƵůůLJƌĞĂĚƚŚĞƋƵŝĐŬƌĞĨĞƌĞŶĐĞŝŶƐƚƌƵĐƟŽŶƐŝŶƚŚĞŬŝƚďĞĨŽƌĞƵƐĞ͘

CareStart Ks/ͲϭεŐ,ŽŵĞdĞƐƚͲϮρĞĂ

235 x 114 x 75 (9.252 x 4.488 x 2.953) exterior viewhorizontal grain .018 sbs & .020 sbs

Design Date : 01/26/23Part# PKCSOTC25ADesigned by JSK DESIGN JSK Version. E

Lot, Exp, and UDI print here 

ςρůLJĚĞZŽĂĚ͕^ƵŝƚĞ͘^ŽŵĞƌƐĞƚ͕E:ϬΘΘϳϯ͕h^ϳϯϮͲΘϳϯͲκϬκϬǁǁǁ͘ĂĐĐĞƐƐďŝŽ͘ŶĞƚ

ĐĐĞƐƐŝŽ͕/ŶĐ͘

X5 X5 

&ŽƌŵĞƌŐĞŶĐLJhƐĞƵƚŚŽƌŝnjĂƟŽŶ;hͿŽŶůLJ &Žƌ in vitroĚŝĂŐŶŽƐƟĐƵƐĞ

/ŶƚŚĞh^͕ƚŚŝƐƉƌŽĚƵĐƚŚĂƐŶŽƚďĞĞŶ&ĐůĞĂƌĞĚŽƌĂƉƉƌŽǀĞĚďƵƚŚĂƐďĞĞŶĂƵŵĞƌŐĞŶĐLJhƐĞƵƚŚŽƌŝnjĂƟŽŶ;hͿ͘dŚŝƐƉƌŽĚƵĐƚŚĂƐďĞĞŶĂƵƚŚŽƌŝnjĞĚŽŶůLJĨŽƌ^Z^ͲŽsͲϮ͕ŶŽƚĨŽƌĂŶLJŽƚŚĞƌǀŝƌƵƐĞƐŽƌƉĂƚŚŽŐĞŶƐ͘

ĞƚĞƌŵŝŶŝŶŐĂŶĞŐĂƟǀĞƌĞƐƵůƚƌĞƋƵŝƌĞƐŵƵůƟƉůĞƚĞƐƚƐ͘zŽƵŵĂLJŶĞĞĚƚŽƉƵƌĐŚĂƐĞserial ;ƌĞƉĞĂƚͿƚĞƐƟŶŐ͘dŚŝƐƚĞƐƚŝƐŵŽƌĞůŝŬĞůLJƚŽŐŝǀĞLJŽƵĂĨĂůƐĞŶĞŐĂƟǀĞƌĞƐƵůƚǁŚĂůĂďͲďĂƐĞĚŵŽůĞĐƵůĂƌƚĞƐƚ͘

&ŽƌŵŽƌĞŝŶĨŽƌŵĂƟŽŶŽŶĞdžƉŝƌĂƟŽŶĚĂƟŶŐĨŽƌKs/ͲϭεĂŶƟŐĞŶƚĞƐƚƐ͕ƉůĞĂƐĞƌĐŽǀŝĚͲƚĞƐƚƐ

3
30 Tests

The CareStartΡKs/ͲϭεŶƟŐĞŶ,ŽŵĞdĞƐƚŝƐĂůĂƚĞƌĂůŇŽǁŝŵŵƵŶŽĐŚƌŽŵĂƚŽŐƌĂƉŚŝĐĂƐƐĂLJĨŽƌƚŚĞĚĞƚĞĐƟŽŶŽĨĞdžƚƌĂĐƚĞĚŶƵĐůĞŽĐĂƉƐŝĚƉƌŽƚĞŝŶ

ĂŶƟŐĞŶƐƐƉĞĐŝĮĐƚŽ^Z^ͲŽsͲϮŝŶƐĞůĨͲĐŽůůĞĐƚĞĚĂŶƚĞƌŝŽƌŶĂƐĂů;ŶĂƌĞƐͿƐǁĂďƐƉĞĐŝŵĞŶƐ͘dŚĞƵƐĞƌƐŚŽƵůĚƉĞƌĨŽƌŵƚŚĞƚĞƐƚĨŽůůŽǁŝŶŐƚŚĞŝŶͲĂƉƉƐĞůĨͲƉĂĐĞĚ͕ƐƚĞƉͲďLJͲƐƚĞƉŝŶƐƚƌƵĐƟŽŶƐŽƌYƵŝĐŬZĞĨĞƌĞŶĐĞ/ŶƐƚƌƵĐƟŽŶƐ͘dĞƐƚƌĞƐƵůƚƐĂƌĞŝŶƚĞƌƉƌĞƚĞĚǀŝƐƵĂůůLJĂƚϭϬŵŝŶƵƚĞƐĂŌĞƌƐĂŵƉůĞůŽĂĚŝŶŐ

ĨŽůůŽǁĞĚďLJƚŚĞŝŶƐƚƌƵĐƟŽŶƐ͘WůĞĂƐĞĐĂƌĞĨƵůůLJƌĞĂĚƚŚĞƋƵŝĐŬƌĞĨĞƌĞŶĐĞŝŶƐƚƌƵĐƟŽŶƐŝŶƚŚĞŬŝƚďĞĨŽƌĞƵƐĞ͘

1 2 4 ZĞƐƵůƚƐ/ŶƚĞƌƉƌĞƚĂƟŽŶ

RCPM-03071 hƐŝŶŐDŽďŝůĞƉƉůŝĐĂƟŽŶ

WůĞĂƐĞƐƚĂƌƚƚŚĞƚĞƐƚĨŽůůŽǁƐƚŚĞŝŶͲĂƉƉƐĞůĨͲƉĂĐĞĚ͕ƐƚĞƉͲďLJͲƐƚĞƉƚĞƐƚŝŶƐƚƌƵĐƟŽŶƐ͘

ŽǁŶůŽĂĚĂŶĚŽƉĞŶƉƉ͕KƚŚĞŶĂ

zŽƵƌƚĞƐƚƌĞƐƵůƚĂƉƉĞĂƌƐŽŶLJŽƵƌƐĐƌĞĞŶĂŌĞƌϭϬŵŝŶƵƚĞƐŽĨǁĂŝƚƟŵĞĂŶĚƐĞůĞĐƟŽŶŽĨǀŝƐƵĂůƌĞƐƵůƚŝŶƚĞƌƉƌĞƚĂƟŽŶƐ͘

1

2 3

4

5 Test result

tĂƚĐŚƚŚĞŝŶƐƚƌƵĐƟŽŶǀŝĚĞŽ

ŽǁŶůŽĂĚƚŚĞƉƉŽŶƚŚĞƉƉ^ƚŽƌĞŽƌ'ŽŽŐůĞWůĂLJ^ƚŽƌĞŽƌƐĐĂŶƚŚĞYZĐŽĚĞ͕ŶƐƵƌĞLJŽƵĂƌĞĐŽŶŶĞĐƚĞĚƚŽƚŚĞŝŶƚĞƌŶĞƚĚƵƌŝŶŐLJŽƵƌƚĞƐƚ͘

ŶƐǁĞƌĂĨĞǁƋƵĞƐƟŽŶƐŝŶƚŚĞƉƉ

&ŽƌĂůŝƐƚŽĨĐŽŵƉĂƟďůĞƐŵĂƌƚƉŚŽŶĞK^ƐLJƐƚĞŵƐ͕ǀŝƐŝƚǁǁǁ͘ĂĐĐĞƐƐďŝŽ͘ŶĞƚͬĂƉƉ

30

^ĞůĨdĞƐƚĨŽƌ^Z^ͲŽsͲϮŶƟŐĞŶĞƚĞĐƟŽŶ ;ŐĞƐϮĂŶĚhƉͿEŽŶͲƉƌĞƐĐƌŝƉƟŽŶŚŽŵĞƵƐĞǁŝƚŚƐĞůĨͲĐŽůůĞĐƚĞĚŶĂƐĂůƐǁĂďƐ

dŚŝƐƚĞƐƚĚŽĞƐŶŽƚĚĞƚĞƌŵŝŶĞŝĨLJŽƵŚĂĚKs/ͲϭεŝŶƚŚĞƉĂƐƚŽƌŝĨLJŽƵŚĂǀĞŝŵŵ/ƚĚĞƚĞĐƚƐƉƌŽƚĞŝŶƐĨƌŽŵƚŚĞ^Z^ͲŽsͲϮǀŝƌƵƐ͘

/ĨLJŽƵĂƌĞƉƌŽŶĞƚŽŶŽƐĞďůĞĞĚƐ͘

ŽEŽƚhƐĞ

>ŝŵŝƚŽĨƉĞƌĨŽƌŵĂŶĐĞ

/ĨLJŽƵŚĂǀĞŚĂĚĂĨĂĐŝĂůŽƌŚĞĂĚŝŶũƵƌLJͬƐƵƌŐĞƌLJŝŶƚŚĞůĂƐƚςŵŽŶƚŚƐ͘

dŚŝƐĞŵĞƌŐĞŶĐLJƵƐĞŽĨƚŚŝƐƉƌŽĚƵĐƚŝƐŽŶůLJĂƵƚŚŽƌŝnjĞĚĨŽƌƚŚĞĚƵƌĂƟŽŶŽĨƚŚĞĚĞĞdžŝƐƚũƵƐƟĨLJŝŶŐƚŚĞĂƵƚŚŽƌŝnjĂƟŽŶŽĨĞŵĞƌŐĞŶĐLJƵƐĞŽĨŝŶǀŝƚƌŽĚŝĂŐŶŽƐƟĐƐĨŽƌĚĞKs/ͲϭεƵŶĚĞƌ^ĞĐƟŽŶρςκ;ďͿ;ϭͿŽĨƚŚĞ&ĞĚĞƌĂů&ŽŽĚ͕ƌƵŐĂŶĚŽƐŵĞƟĐĐƚ͕ƵŶůĞƐƐĂƵƚŚŽƌŝnjĂƟŽŶŝƐƚĞƌŵŝŶĂƚĞĚŽƌƌĞǀŽŬĞĚƐŽŽŶĞƌ͘ &ŽůůŽǁƐƚĞƉͲďLJͲƐƚĞƉŝŶƐƚƌƵĐƟŽŶƐĨŽƌLJŽƵƌƚĞƐƚ

1 TM 

2 EĂƐĂů^ǁĂď - 30ea 

3 džƚƌĂĐƟŽŶsŝĂů

dƵďĞ- 30ea 

džƚƌĂĐƟŽŶsŝĂů Cap - 30ea 

4

5 YƵŝĐŬZĞĨĞƌĞŶĐĞ/ŶƐƚƌƵĐƟŽŶƐΘ

&ĂĐƚ^ŚĞĞƚĨŽƌ/ŶĚŝǀŝĚƵĂůƐ

Items necessary to use the kit, but not included (Timer or Smartphone)

CareStart Ks/ͲϭεŐ,ŽŵĞdĞƐƚͲϯϬĞĂ

235 x 114 x 75 (9.252 x 4.488 x 2.953) exterior viewhorizontal grain .018 sbs & .020 sbs

Design Date : 01/26/23Part# PKCSOTC30ADesigned by JSK DESIGN JSK Version. E

Lot, Exp, and UDI print here 

ςρůLJĚĞZŽĂĚ͕^ƵŝƚĞ͘^ŽŵĞƌƐĞƚ͕E:ϬΘΘϳϯ͕h^ϳϯϮͲΘϳϯͲκϬκϬǁǁǁ͘ĂĐĐĞƐƐďŝŽ͘ŶĞƚ

ĐĐĞƐƐŝŽ͕/ŶĐ͘

X5 X5 

&ŽƌŵĞƌŐĞŶĐLJhƐĞƵƚŚŽƌŝnjĂƟŽŶ;hͿŽŶůLJ &Žƌ in vitro ĚŝĂŐŶŽƐƟĐƵƐĞ

/ŶƚŚĞh^͕ƚŚŝƐƉƌŽĚƵĐƚŚĂƐŶŽƚďĞĞŶ&ĐůĞĂƌĞĚŽƌĂƉƉƌŽǀĞĚďƵƚŚĂƐďĞĞŶĂƵ

ŵĞƌŐĞŶĐLJhƐĞƵƚŚŽƌŝnjĂƟŽŶ;hͿ͘dŚŝƐƉƌŽĚƵĐƚŚĂƐďĞĞŶĂƵƚŚŽƌŝnjĞĚŽŶůLJĨŽƌĨƌŽŵ^Z^ͲŽsͲϮ͕ŶŽƚĨŽƌĂŶLJŽƚŚĞƌǀŝƌƵƐĞƐŽƌƉĂƚŚŽŐĞŶƐ͘

ĞƚĞƌŵŝŶŝŶŐĂŶĞŐĂƟǀĞƌĞƐƵůƚƌĞƋƵŝƌĞƐŵƵůƟƉůĞƚĞƐƚƐ͘zŽƵŵĂLJŶĞĞĚƚŽƉƵƌĐŚĂƐĞserial ;ƌĞƉĞĂƚͿƚĞƐƟŶŐ͘dŚŝƐƚĞƐƚŝƐŵŽƌĞůŝŬĞůLJƚŽŐŝǀĞLJŽƵĂĨĂůƐĞŶĞŐĂƟǀĞƌĞƐƵůƚǁ

ĂůĂďͲďĂƐĞĚŵŽůĞĐƵůĂƌƚĞƐƚ͘

&ŽƌŵŽƌĞŝŶĨŽƌŵĂƟŽŶŽŶĞdžƉŝƌĂƟŽŶĚĂƟŶŐĨŽƌKs/ͲϭεĂŶƟŐĞŶƚĞƐƚƐ͕ƉůĞĂƐĞƌĐŽǀŝĚͲƚĞƐƚƐ

3