Cleared Traditional

K010893 - MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01

K010893 is an FDA 510(k) clearance for MODIFICATION TO HYBRID CAPTURE 2 GC-ID ..., manufactured by Digene Corp.. The device is a Class 2 Microbiology device with product code LSL cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K010893 · Digene Corp. · Microbiology device
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Sep 2001
Decision
182d
Days
Class 2
Risk

K010893 is an FDA 510(k) clearance for the MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01. Classified as Dna-reagents, Neisseria (product code LSL), Class II - Special Controls.

Submitted by Digene Corp. (Gaithersburg, US). The FDA issued a Cleared decision on September 24, 2001 after a review of 182 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 Digene Corp. devices

FDA 510(k) Submission Details - K010893

510(k) Number K010893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2001
Decision Date September 24, 2001
Days to Decision 182 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 102d · This submission: 182d
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 38
Devices cleared under the same product code (LSL) and FDA review panel - the closest regulatory comparables to K010893.
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE
K043144 · Gen-Probe, Inc. · Mar 2005
GEN-PROBE APTIMA COMBO 2 ASSAY
K032554 · Gen-Probe, Inc. · Dec 2003
TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS
K032194 · Gen-Probe, Inc. · Dec 2003
BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY
K012351 · Becton, Dickinson & CO · Sep 2001
GEN-PROBE APTIMA COMBO 2 ASSAY
K003395 · Gen-Probe, Inc. · May 2001
ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K974503 · Roche Molecular Systems, Inc. · Dec 1999