Atlas FDA

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

QIAGEN GmbH — Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time
227 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K254194QIAstat-Dx BCID GPF Plus AMR PanelQIAGEN GmbH2026-08-062260
K254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 MQIAGEN GmbH2026-03-09830
K252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 MQIAGEN GmbH2025-10-22890
K250080QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory PaQIAGEN GmbH2025-08-272260
K250324QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH2025-02-28230
K243813QIAstat-Dx GI Panel 2 Mini B&VQIAGEN GmbH2025-01-08280
K242256QIAstat-Dx Meningitis/Encephalitis (ME) PanelQIAGEN GmbH2024-10-29900
K242353QIAstat-Dx Respiratory Panel MiniQIAGEN GmbH2024-10-25780
K220062QIAstat-Dx Gastrointestinal Panel 2QIAGEN GmbH2024-05-318720
K233100QIAstat-Dx® Respiratory Panel PlusQIAGEN GmbH2024-05-102271
K183597QIAstat-Dx Respiratory PanelQIAGEN GmbH2019-05-181480
K133936ARTUS C. DIFFICILE QS-RGQ MDX KITQIAGEN GmbH2014-04-041020
K113319ROTOR-GENE Q MDXQIAGEN GmbH2012-02-06880
K113323ARTUS INFL A/B RG RT-PCR KITQIAGEN GmbH2012-02-06880

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