QIAstat-Dx BCID GPF Plus AMR Panel— 510(k) K254194
Substantially EquivalentQIAGEN GmbH
FDA 510(k) clearance K254194 for QIAstat-Dx BCID GPF Plus AMR Panel, Substantially Equivalent on 2026-08-06. Applicant: QIAGEN GmbH. Device class: 2.
Summary
QIAGEN's QIAstat-Dx BCID GPF Plus AMR Panel is filed under product code PAM, gram-positive bacteria and their resistance markers. The record doesn't expand BCID, GPF, or AMR.
Class II, 21 CFR 866.3365. Microbiology is both the classification panel and the review panel, and it was a Traditional 510(k).
QIAGEN filed from Hilden, Germany. The decision came 226 calendar days after receipt (December 23, 2025 to August 6, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- QIAGEN GmbH
- Product code
- Product code PAM
- Device class
- Class 2
- Regulation
- 21 CFR 866.3365
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hilden, DE
Recent devices under product code PAM
view all- K243490 — LIAISON PLEX Gram-Positive Blood Culture Assay
- K181663 — ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
- K163390 — iC-GPC Assay TM for use on the iC-SystemTM
- K152470 — Great Basin Staph ID/R Blood Culture Panel
- K122514 — VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
More clearances from QIAGEN GmbH
view all- K262168 — QIAstat-Dx BCID GN Plus AMR Panel
- K254032 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V
- K252329 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V
- K250080 — QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini
- K250324 — QIAstat-Dx GI Panel 2 Mini B
Adverse events under product code PAM
product code PAM- Death
- 6
- Malfunction
- 598
- Total
- 604
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.