510(k) · Cleared
ClearedBIOFIRE SPOTFIRE Vaginitis (VG) Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofire Diagnostics, LLC · PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Cleared on Oct 21, 2026 after a 118-day review. FDA has not posted a summary or statement for it, so its predicates are not known.
- Decided
- Oct 21, 2026
- Review
- 118 days
- Class
- Class II
- Product code
- PQA
- Recalls
- None
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PQA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PQA device
- #1 K260021 cobas® BV/CVscore 12.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All PQA devicesPQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PQA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PQA
87in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PQA
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PQA
3in 2025
MAUDE reports naming product code PQA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 2 | 0 |
| 2019 | 3 | 87 | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 2 | — | 0 | 7 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 2 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K262136 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262136: BIOFIRE SPOTFIRE Vaginitis (VG) Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262136
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Record history
- FDA decision record loaded Nov 3, 2026
- Page last updated Nov 3, 2026