Cleared Traditional

MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 (K010891) - FDA 510(k) Clearance

Class I Microbiology device.

K010891 · Digene Corp. · Microbiology device
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Sep 2001
Decision
183d
Days
Class 1
Risk

K010891 is an FDA 510(k) clearance for the MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01. Classified as Dna-reagents, Chlamydia (product code LSK), Class I - General Controls.

Submitted by Digene Corp. (Gaithersburg, US). The FDA issued a Cleared decision on September 25, 2001 after a review of 183 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3120 - 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.

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Submission Details

510(k) Number K010891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2001
Decision Date September 25, 2001
Days to Decision 183 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
81d slower than avg
Panel avg: 102d · This submission: 183d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LSK Dna-reagents, Chlamydia
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3120
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.