Not Cleared Direct

DEN210040 - VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN210040 · Ortho-Clinical Diagnostics, Inc. · Microbiology device
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May 2023
Decision
591d
Days
Class 2
Risk

DEN210040 is an FDA 510(k) submission (not cleared) for the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS I.... Classified as Sars-cov-2 Serology Test (product code QVP), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Not Cleared (DENG) decision on May 5, 2023 after a review of 591 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3983 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 591 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Ortho-Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number DEN210040 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 21, 2021
Decision Date May 05, 2023
Days to Decision 591 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
489d slower than avg
Panel avg: 102d · This submission: 591d
Pathway characteristics

Device Classification

Product Code QVP Sars-cov-2 Serology Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3983
Definition 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, Cells, Or Tissue Donors.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - QVP Sars-cov-2 Serology Test

Devices cleared under the same product code (QVP) and FDA review panel - the closest regulatory comparables to DEN210040.
Elecsys Anti-SARS-CoV-2 S
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DEN210038 · Ortho-Clinical Diagnostics, Inc. · May 2023