Cleared Special

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

K200866 · Hologic, Inc. · Microbiology

May 2020

Decision

46d

Days

Class 2

Risk

About This 510(k) Submission

K200866 is an FDA 510(k) clearance for the Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System), a Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections (Class II — Special Controls, product code QEP), submitted by Hologic, Inc. (San Diedgo, US). The FDA issued a Cleared decision on May 17, 2020, 46 days after receiving the submission on April 1, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3393.

Submission Details

510(k) Number	K200866 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 2020
Decision Date	May 17, 2020
Days to Decision	46 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QEP — Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Device Class	Class II — 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.