Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)

Q: What is the product code of K200866?

The FDA product code is QEP – Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections, a Class II (moderate risk) device regulated under 21 CFR 866.3393.

FDA 510(k) K200866 · Hologic, Inc.

Substantially Equivalent

510(k) numberK200866

Submission

Device name: Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)
Applicant: Hologic, Inc.
San Diego, CA, US
Received: April 1, 2020
Decision date: May 17, 2020
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QEP – Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.3393
Specialty: Microbiology

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…

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K251501	Visby Medical Men's Sexual Health TestQEP · Dual Track	Visby Medical, Inc.	10/01/2025SE
K243343	BD CTGCTV2QEP · Traditional	Bd Integrated Diagnostic Solutions/Becton,	04/22/2025SE
K240217	cobas® liat CT/NG nucleic acid testQEP · Dual Track	Roche Molecular Systems, Inc.	01/17/2025SE
K240197	cobas® liat CT/NG/MG nucleic acid testQEP · Dual Track	Roche Molecular Systems, Inc.	01/16/2025SE
K230267	NeuMoDx CT/NG Assay 2.0QEP · Traditional	Neumodx Molecular, Inc.	12/22/2023SE
K220407	Visby Medical Sexual Health TestQEP · Dual Track	Visby Medical	03/07/2023SE
K222379	Alinity m STI AssayQEP · Traditional	Abbott Molecular, Inc.	03/03/2023SE

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Questions and answers

When was Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) cleared by the FDA?

Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) (K200866) received a 510(k) decision of Substantially Equivalent on May 17, 2020, 46 days after the submission was received.

What is the product code of K200866?

The FDA product code is QEP – Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections, a Class II (moderate risk) device regulated under 21 CFR 866.3393.