Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

QOF — Predicate Candidate Screening

33 FDA 510(k) clearances under this product code; the 50 most recent screened below.

187 daysmedian FDA review time
272 days90th percentile
33clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252932Fast PCR Mini Respiratory PanelAutonomous Medical Devices Incorporated2026-06-122700
K252269FINDER Flu A&B/SARS-CoV-2 TestBaebies, Inc.2026-03-302520
K251742VELO Respiratory TestLex Diagnostics Limited2026-02-132520
K251978LIAISON NES FLU A/B, RSV & COVID-19Diasorin Molecular, LLC2025-12-231790
K252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); SimplexaDiasorin Molecular, LLC2025-10-30910
K250080QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory PaQIAGEN GmbH2025-08-272260
K243544BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniBiofire Diagnostics, LLC2025-08-142720
K243455cobas Respiratory 4-flex for use on the cobas 5800/6800/8800Roche Molecular Systems, Inc.2025-07-312660
K250996Xpert Xpress CoV-2/Flu/RSV plusCepheid®2025-05-01300
K250995Xpert Xpress CoV-2/Flu/RSV plusCepheid®2025-05-01300
K243406cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid testRoche Molecular Systems, Inc.2025-04-251750
K243400cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid testRoche Molecular Systems, Inc.2025-04-251760
K242526Visby Medical Respiratory Health TestVisby Medical, Inc.2025-02-191770
K241573Alinity m Resp-4-PlexAbbott Molecular, Inc.2025-02-142560
K242071Xpert Xpress CoV-2/Flu/RSV plusCepheid2025-01-101780
K241806Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV SelLife Technologies Corporation2025-01-082010
K241652DASH® SARS-CoV-2 & Flu A/B TestNuclein, LLC2024-12-201962
K242465Panther Fusion SARS-CoV-2/Flu A/B/RSV assayHologic, Inc.2024-11-15870
K242353QIAstat-Dx Respiratory Panel MiniQIAGEN GmbH2024-10-25780
K241240Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc.2024-07-18760
K241194BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel MiniBiofire Diagnostics, LLC2024-05-30300
K233100QIAstat-Dx® Respiratory Panel PlusQIAGEN GmbH2024-05-102271
K232954BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) PanelBiofire Diagnostics, LLC2024-03-261871
K231758NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)Luminex Molecular Diagnostics, Inc.2024-03-112690
K233410LIAISON PLEX Respiratory Flex AssayLuminex Corporation2024-03-011470
K231481Xpert Xpress CoV-2/Flu/RSV plusCepheid®2023-08-17860
K230956BD Respiratory Viral Panel for BD MAX™ System; BD RespiratorBd Integrated Diagnostic Solutions /2023-07-311180
K223591cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use Roche Molecular Systems, Inc.2023-07-272380
K222736Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc.2023-05-162491
K230719BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBiofire Diagnostics, LLC2023-04-13290
K220963Simplexa COVID-19 & Flu A/B DirectDiasorin Molecular, LLC2023-03-173500
K213954BIOFIRE SPOTFIRE Respiratory (R) PanelBiofire Diagnostics2023-02-034130
DEN200031BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC2021-03-173020

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda