# Xpert Xpress CoV-2/Flu plus (K263120): 510(k) cleared for Cepheid®

**Predicate Speed & CAPA Advisory Opportunity Score:** 41/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K263120 |
| Device | Xpert Xpress CoV-2/Flu plus |
| Applicant | Cepheid® |
| Specialty / panel | Microbiology |
| Product code | QOF |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-09-04 |
| Decision date | 2026-10-02 |
| Review time (days) | 28 |
| Third-party review | No |
| Applicant location | Sunnyvale, CA, US |

## Why this score
- Fast 28-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 33 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=K263120). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.