# K211079: BioFire COVID-19 Test 2

- Pathway: 510(k) (Traditional)
- Applicant: Biofire Defense, LLC
- Decided: Nov 1, 2021 after 203 days
- Product code: QQX (Respiratory Specimen Nucleic Acid Sars-Cov-2 Test)
- Device class: 2
- Regulation: 21 CFR 866.3981
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN200031 (2021). 1 ancestor in all.
11 later devices descend from it; 7 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN200031: BioFire Respiratory Panel 2.1 (RP2.1), Biofire Diagnostics, LLC (2021) Summary page 4.

## Most influential descendants
- K213804: cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems (2022), 3 descendants of its own
- K230440: Xpert® Xpress CoV-2 plus (2023), 1 descendant of its own
- K231306: cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems (2023), 1 descendant of its own
- K221460: BioFire COVID-19 Test 2 (2022), 1 descendant of its own
- K243396: Aptima SARS-CoV-2 Assay (2025), 0 descendants of its own

## Indications for use
The BioFire COVID-19 Test 2 is a qualitative nested multiplexed RT-PCR in vitro diagnostic test intended for use with the BioFire FilmArray 2.0 and BioFire FilmArray Torch Systems. The BioFire COVID-19 Test 2 detects nucleic acids from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal swabs (NPS) from symptomatic individuals suspected of COVID-19 by their healthcare provider. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in NPS specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out co-infection with other pathogens. Results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities. The BioFire COVID-19 Test 2 is intended for use by trained medical and laboratory professionals in a laboratory setting or under the supervision of a trained laboratory professional.

Source page: https://510kreport.com/device/K211079
Methodology: https://510kreport.com/methodology