510(k) Report

FDA product code · Microbiology

Non-Sars Coronavirus Multiplex Nucleic Acid Assay

OTGClass II21 CFR 866.3980510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

A non-SARS coronavirus multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of coronavirus 229E, coronavirus NL63, coronavirus HKU1 and Coronavirus OC43 nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, microbiology panel

Twenty years of OTG at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — OTG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OTG? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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Related product codes

Other codes under 21 CFR 866.3980.

OZY Chlamydophila Pneumoniae Dna Assay SystemOMG Antisera, Fluorescent, Human MetapneumovirusOCC Respiratory Virus Panel Nucleic Acid Assay…OZX Mycoplasma Pneumoniae Dna Assay SystemOOU Parainfluenza Multiplex Nucleic Acid AssayOEM Human Metapneumovirus (Hmpv) Rna Assay SystemOZE Influenza A And Influenza B Multiplex Nucleic…OEP Influenza A Virus Subtype Differentiation…OZZ Bordetella Pertussis Dna Assay System