# Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics

**Predicate Speed & CAPA Advisory Opportunity Score:** 61/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260232 |
| Device | Elecsys EBV VCA IgG |
| Applicant | Roche Diagnostics |
| Specialty / panel | Microbiology |
| Product code | LSE |
| Device class | 1 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-26 |
| Decision date | 2026-10-02 |
| Review time (days) | 249 |
| Third-party review | No |
| Applicant location | Indianapolis, IN, US |

## Why this score
- A long 249-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- 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=K260232). 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.