Cleared Traditional

K990023 - HYBRID CAPTURE II CT-ID TEST

K990023 is an FDA 510(k) clearance for HYBRID CAPTURE II CT-ID TEST, manufactured by Digene Corp.. The device is a Class 1 Microbiology device with product code LSK cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K990023 · Digene Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
293d
Days
Class 1
Risk

K990023 is an FDA 510(k) clearance for the HYBRID CAPTURE II CT-ID TEST. Classified as Dna-reagents, Chlamydia (product code LSK), Class I - General Controls.

Submitted by Digene Corp. (Beltsville, US). The FDA issued a Cleared decision on October 25, 1999 after a review of 293 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.

View all Digene Corp. devices

FDA 510(k) Submission Details - K990023

510(k) Number K990023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1999
Decision Date October 25, 1999
Days to Decision 293 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
191d slower than avg
Panel avg: 102d · This submission: 293d
Pathway characteristics
Predicate-based equivalence.

LSK Device Classification - Class 1, General Controls

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.

Regulatory Peers - LSK Dna-reagents, Chlamydia

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