Elecsys Anti-SARS-CoV-2

Q: What is the product code of K253839?

The FDA product code is QVP – Sars-Cov-2 Serology Test, a Class II (moderate risk) device regulated under 21 CFR 866.3983.

FDA 510(k) K253839 · Roche Diagnostics

Substantially Equivalent

510(k) numberK253839

Submission

Device name: Elecsys Anti-SARS-CoV-2
Applicant: Roche Diagnostics
Indianapolis, IN, US
Received: December 1, 2025
Decision date: December 17, 2025
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QVP – Sars-Cov-2 Serology Test
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.3983
Specialty: Microbiology

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 individuals with an adaptive immune response to SARS-CoV-2. The test is not intended for the diagnosis of acute SARS-CoV-2 infection, nor screening blood, plasma…

Other 510(k)s with product code QVP

510(k)	Device	Applicant	Decision
K252280	Elecsys Anti-SARS-CoV-2 SQVP · Traditional	Roche Diagnostics	04/13/2026SE
K250768	Elecsys Anti-SARS-CoV-2QVP · Traditional	Roche Diagnostics	06/10/2025SE

More from Roche Diagnostics

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K252431	Elecsys CalcitoninJKR · Traditional	04/24/2026SE
K252280	Elecsys Anti-SARS-CoV-2 SQVP · Traditional	04/13/2026SE
K260049	Elecsys Anti-HBc IgMSEI · Traditional	04/07/2026SE
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K253491	ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional	02/12/2026SE
K253490	Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional	02/12/2026SE

Questions and answers

When was Elecsys Anti-SARS-CoV-2 cleared by the FDA?

Elecsys Anti-SARS-CoV-2 (K253839) received a 510(k) decision of Substantially Equivalent on December 17, 2025, 16 days after the submission was received.

What is the product code of K253839?

The FDA product code is QVP – Sars-Cov-2 Serology Test, a Class II (moderate risk) device regulated under 21 CFR 866.3983.