# BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136): 510(k) cleared for Biofire Diagnostics, LLC

**Predicate Speed & CAPA Advisory Opportunity Score:** 42/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262136 |
| Device | BIOFIRE SPOTFIRE Vaginitis (VG) Panel |
| Applicant | Biofire Diagnostics, LLC |
| Specialty / panel | Microbiology |
| Product code | PQA |
| Device class | 2 |
| Clearance type | Dual Track |
| Decision | Substantially Equivalent |
| Received | 2026-06-25 |
| Decision date | 2026-10-21 |
| Review time (days) | 118 |
| Third-party review | No |
| Applicant location | Salt Lake City, UT, US |

## Why this score
- Fast 118-day review: this device is a strong predicate for similar products.
- Posted 14 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262136). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.