Cleared Traditional

K053289 - COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

K053289 is an FDA 510(k) clearance for COBAS AMPLICOR CT/NG TEST FOR NEISSERIA..., manufactured by Roche Diagnostics Corp.. The device is a Class 2 Microbiology device with product code LSL cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K053289 · Roche Diagnostics Corp. · Microbiology device
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Aug 2006
Decision
258d
Days
Class 2
Risk

K053289 is an FDA 510(k) clearance for the COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE. Classified as Dna-reagents, Neisseria (product code LSL), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 10, 2006 after a review of 258 days - an extended review cycle.

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 Roche Diagnostics Corp. devices

FDA 510(k) Submission Details - K053289

510(k) Number K053289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2005
Decision Date August 10, 2006
Days to Decision 258 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
156d slower than avg
Panel avg: 102d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LSL Dna-reagents, Neisseria

All 37
Devices cleared under the same product code (LSL) and FDA review panel - the closest regulatory comparables to K053289.
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091
K062440 · Gen-Probe, Inc. · Nov 2006
TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196
K061509 · Gen-Probe, Inc. · Oct 2006
TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY
K060652 · Gen-Probe, Inc. · Aug 2006
BD VIPER SYSTEM
K052481 · Becton, Dickinson & CO · Nov 2005
BD PROBE TEC URINE PRESERVATIVE TRANSPORT
K052224 · Becton, Dickinson & CO · Sep 2005
GEN-PROBE APTIMA COMBO 2 ASSAY
K043224 · Gen-Probe, Inc. · Aug 2005