Cleared Special

K200436 - Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit

K200436 is an FDA 510(k) clearance for Aptima Combo 2 Assay (Panther) - 250 te..., manufactured by Hologic, Inc.. The device is a Class 2 Microbiology device with product code QEP cleared through the Special 510(k) pathway after a 28-day FDA review.

K200436 · Hologic, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2020
Decision
28d
Days
Class 2
Risk

K200436 is an FDA 510(k) clearance for the Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) .... Classified as Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections (product code QEP), Class II - Special Controls.

Submitted by Hologic, Inc. (San Diego, US). The FDA issued a Cleared decision on March 23, 2020 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3393 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K200436

510(k) Number K200436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2020
Decision Date March 23, 2020
Days to Decision 28 days
Submission Type Special
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
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

QEP Device Classification - Class 2, Special Controls

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 23
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K200436 · Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit
Download PDF FDA Summary Hologic, Inc.