Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:2a:p2
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 2A (pt 2/3)
Character Range: 339484–342384

to determine their immune status towards transmissible agents;
 (e) determining infective disease status or immune status, if there is a risk that an erroneous result will lead to a patient management decision resulting in an imminent life‑threatening situation for the patient;
 (f) the selection of patients:
 (i) for selective therapy and management; or
 (ii) for disease staging; or
 (iii) in the diagnosis of cancer;
 (fa) use as an IVD companion diagnostic;
 (g) human genetic testing;
 (h) to monitor levels of medicines, substances or biological components, when there is a risk that an erroneous result will lead to a patient management decision resulting in an immediate life‑threatening situation for the patient;
 (i) the management of patients suffering from a life‑threatening infectious disease;
 (j) screening for congenital disorders in a foetus.
Note for paragraph (f): An IVD medical device (except an IVD companion diagnostic) would fall into Class 2 under clause 1.7 if:
(a) a therapy decision would usually be made only after further investigation; or
(b) the device is used for monitoring.

1.4  IVD medical devices for self‑testing
  An IVD medical device for self‑testing is classified as a Class 3 IVD medical device unless:
 (a) the result of the examination is not determining a serious condition, ailment or defect; or
 (b) the examination is preliminary and follow‑up additional testing is required.

1.5  Non assay‑specific quality control material
  Despite clauses 1.1 to 1.4, an IVD medical device that is intended to be used as non assay‑specific quality control material is classified as a Class 2 IVD medical device or a Class 2 in‑house IVD medical device.

1.6  Reagents, instruments etc
 (1) A reagent or other article that possesses specific characteristics, intended by the manufacturer, to make it suitable for in vitro diagnostic procedures related to a specific examination is classified as a Class 1 IVD medical device or a Class 1 in‑house IVD medical device.
 (2) Despite clauses 1.1 to 1.5, the following IVD medical devices are classified as Class 1 IVD medical devices or Class 1 in‑house IVD medical devices:
 (a) an instrument, intended by the manufacturer, to be specifically used for in vitro diagnostic procedures;
 (b) a specimen receptacle, other than a specimen receptacle that is intended for use in self‑testing;
 (c) a microbiological culture medium.
 (3) In this clause:
examination means a set of operations having the object of determining the value or characteristics of a property.
Note: In some disciplines (for example, microbiology) an examination is the combination of a number of tests, observations or measurements.
specimen receptacle means a device, whether vacuum‑type or not, specifically intended by its manufacturer for the primary containment and preservation of a specimen derived from the human body for the purpose of