Cleared Traditional

K924715 - GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST (FDA 510(k) Clearance)

Class I Microbiology device.

K924715 · Gen-Probe, Inc. · Microbiology device
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Mar 1994
Decision
536d
Days
Class 1
Risk

K924715 is an FDA 510(k) clearance for the GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST. Classified as Dna-probe, Reagents, Streptococcal (product code MDK), Class I - General Controls.

Submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on March 11, 1994 after a review of 536 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Gen-Probe, Inc. devices

Submission Details

510(k) Number K924715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1992
Decision Date March 11, 1994
Days to Decision 536 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
434d slower than avg
Panel avg: 102d · This submission: 536d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MDK Dna-probe, Reagents, Streptococcal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
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.