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K Number
K233358
Device Name
SCoV-2 Ag Detect Rapid Test
Manufacturer
InBios International, Inc.
Date Cleared
2024-08-23

(329 days)

Product Code
QVF
Regulation Number
866.3982
Type
Dual Track
Panel
MI
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SCOV-2 Ag Detect Rapid Test is a lateral flow immunochromatographic assay for the rapid, qualitative detection of the SARS CoV-2 nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory tract infection (i.e., symptomatic). This test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the SCoV-2 Ag Detect Rapid Test and followed up with a molecular test.

A negative test result is presumptive, and does not preclude SARS-CoV-2 infection; it is recommended these results be confirmed by a molecular SARS-CoV-2 assay.

Positive results do not rule out co-infection with other bacteria or viruses and should not be used as tor diagnosis, treatment, or other patient management decisions.

Performance characteristics for SARS-CoV-2 were established during the SARS-CoV-2 pandemic from April 2021- April 2024. The dominant variant in circulation varied throughout this period. Performance characteristics may vary with newly emerging SARS-CoV-2 virus variants.

Device Description

The SCOV-2 Ag Detect Rapid Test is a lateral flow immunochromatographic assay for the rapid, qualitative detection of the SARS CoV-2 nucleocapsid protein antigen directly in anterior nasal swab specimens.

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the "SCoV-2 Ag Detect Rapid Test." It primarily focuses on the regulatory aspects of the device's clearance and does not contain detailed information about the acceptance criteria, specific study design, or performance metrics from the validation study.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample size, expert qualifications, etc.) from this document. The letter itself confirms the device's substantial equivalence to legally marketed predicates but does not include the performance data that supported this determination.

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