510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253839Substantially Equivalent

Elecsys Anti-SARS-CoV-2

Roche Diagnostics GmbH, Indianapolis IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253839 is the FDA 510(k) clearance record for Elecsys Anti-SARS-CoV-2, a class II device, cleared for Roche Diagnostics on under FDA product code QVP (Sars-Cov-2 Serology Test). FDA's definition for product code QVP reads: "A SARS-CoV-2 serology test is a prescription in vitro diagnostic device for the detection of specific binding antibodies to SARS-CoV-2 in clinical specimens. The detection of SARS-CoV-2 antibodies is intended to aid in identifying...". FDA records list 465 510(k) clearances for Roche Diagnostics, from to . As of , FDA records show no recalls naming K253839.

Clearance record

Decision date
Received
(16 days to decision)
Product code
QVP Sars-Cov-2 Serology Test
Regulation
21 CFR 866.3983
Device class
Class II
Review panel
Microbiology
Applicant
Roche Diagnostics 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QVP

Trailing 12 months
2 clearances under product code QVP in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QVP, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260