Cleared Traditional

Alinity m STI Assay (K202977) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202977 · Abbott Molecular, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
576d
Days
Class 2
Risk

K202977 is an FDA 510(k) clearance for the Alinity m STI Assay. Classified as Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections (product code QEP), Class II - Special Controls.

Submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on April 29, 2022 after a review of 576 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3393 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Abbott Molecular, Inc. devices

Submission Details

510(k) Number K202977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2020
Decision Date April 29, 2022
Days to Decision 576 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
474d slower than avg
Panel avg: 102d · This submission: 576d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QEP Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3393
Definition A Device To Detect Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Nucleic Acids From Non-viral Microorganism(s) In Clinical Specimens Collected From Patients Suspected Of Sexually Transmitted Infections. The Device Is Intended To Aid In The Diagnosis Of Non-viral Sexually Transmitted Infections In Conjunction With Other Clinical And Laboratory Data.
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 - QEP Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections

All 22
Devices cleared under the same product code (QEP) and FDA review panel - the closest regulatory comparables to K202977.
Alinity m STI Assay
K222379 · Abbott Molecular, Inc. · Mar 2023
Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris
K220321 · Hologic, Inc. · Jun 2022
BD CTGCTV2
K210585 · Becton, Dickinson and Company · May 2022
Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit
K193081 · Rheonix, Inc. · Dec 2021
Visby Medical Sexual Health
K200748 · Visby Medical · Aug 2021
cobas CTNG for use on cobas 6800/8800 systems
K202408 · Roche Molecular Systems, Inc. · Jan 2021