Company: BLLN
Filing Date: 2025-08-11
Form Type: DRS/A
Source: 0000950123-25-007483
Chunk: 225

Company: BillionToOne, Inc.
Filing Date: 2025-08-11
Form: DRS/A
Chunk 225
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, advertising and promotion and product sales and distribution. Unless subject to an exemption, to be commercially distributed in the United States, medical devices must receive from the FDA prior to marketing, clearance of a 510(k) premarket notification submission, grant of a request for de novo classification, or approval of an application for premarket approval (PMA). An in vitro diagnostic product (IVD) is a type of medical device that is intended for use in the diagnosis of diseases or conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. IVDs comprise reagents, instruments, and systems intended for use in the collection, preparation and examination of specimens from the human body. IVDs can be used to detect the presence of certain chemicals, genetic information or other biomarkers related to health or disease. IVDs include tests for disease prediction, prognosis, diagnosis, and screening (e.g., carrier screening). A subset of IVDs are known as analyte specific reagents (ASRs). An ASR is a single reagent (e.g., antibody, specific receptor 172

protein, ligand, nucleic acid sequence) that, through specific binding or chemical reaction with substances in a specimen, is intended for use in a diagnostic application for the identification and quantification of an individual chemical substance in biological specimens. Most ASRs are exempt from the premarket review processes but must comply with general controls, as described below, including applicable provisions of the quality system regulation (QSR). Device classifications The FDC Act classifies medical devices into one of three categories based on the risks associated with the device and the level of control necessary to provide reasonable assurance of safety and effectiveness.

| • |     | Class I devices are deemed to be low risk and are subject to the fewest regulatory controls. Many Class I devices 
 are exempt from FDA premarket review requirements.                                                                |

| • |     | Class II devices, including some software products to the extent that they qualify as a device, are deemed to be 
 moderate risk, and generally require 510(k) clearance.                                                           |

| • |     | Class III devices are generally the highest risk devices and are subject to the highest level of regulatory control to                                
 provide reasonable assurance of the device’s safety and effectiveness. Class III devices typically require a PMA by the FDA before they are marketed. |

A clinical trial is almost always required to support a PMA application and is sometimes required for 510