Cleared Traditional

K132251 - APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)

K132251 is an FDA 510(k) clearance for APTIMA COMBO 2 ASSAY (PANTHER SYSTEM), manufactured by Hologic / Gen-Probe Incorporated. The device is a Class 2 Microbiology device with product code LSL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K132251 · Hologic / Gen-Probe Incorporated · Microbiology device
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Oct 2013
Decision
90d
Days
Class 2
Risk

K132251 is an FDA 510(k) clearance for the APTIMA COMBO 2 ASSAY (PANTHER SYSTEM). Classified as Dna-reagents, Neisseria (product code LSL), Class II - Special Controls.

Submitted by Hologic / Gen-Probe Incorporated (San Diego, US). The FDA issued a Cleared decision on October 17, 2013 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3390 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hologic / Gen-Probe Incorporated devices

FDA 510(k) Submission Details - K132251

510(k) Number K132251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2013
Decision Date October 17, 2013
Days to Decision 90 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
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

LSL Device Classification - Class 2, Special Controls

Product Code LSL Dna-reagents, Neisseria
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3390
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Microbiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01358799 Withdrawn Observational Industry-sponsored

Clinical Evaluation of the APTIMA® Assay for Chlamydia Trachomatis Using the PANTHER™ System

7
Sites
Condition studied Chlamydia Trachomatis
Eligibility All sexes · 14 Years+ · Healthy volunteers accepted
Principal investigator Jennifer Reid, PhD
Sponsor Gen-Probe, Incorporated (industry)
Started 2010-11-01 → Primary completion 2012-01-01
Primary outcome
Positive and Negative Percent Agreement Using the TIGRIS Instrument as a Reference
Secondary outcome
Positivity Rate
View full study on ClinicalTrials.gov

Regulatory Peers - LSL Dna-reagents, Neisseria

All 42
Devices cleared under the same product code (LSL) and FDA review panel - the closest regulatory comparables to K132251.
ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG
K140354 · Abbott Molecular, Inc. · May 2014
COBAS CT/NG V2.0 TEST
K140887 · Roche Molecular Systems, Inc. · May 2014
COBAS CT/NG V2.0 TEST
K132270 · Roche Molecular Systems, Inc. · Dec 2013
XPERT CT/NG
K121710 · Cepheid · Dec 2012
APTIMA COMBO 2 ASSAY
K111409 · Gen-Probe, Inc. · May 2012
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K091730 · Becton, Dickinson & CO · Nov 2009