Cleared Traditional

K915852 - ACCUPACE GROUP A STREPTOCOCCUS ID TEST (FDA 510(k) Clearance)

Class I Microbiology device.

K915852 · Gen-Probe, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
97d
Days
Class 1
Risk

K915852 is an FDA 510(k) clearance for the ACCUPACE GROUP A STREPTOCOCCUS ID 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 April 2, 1992 after a review of 97 days - within the typical 510(k) review window.

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: 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 Gen-Probe, Inc. devices

Submission Details

510(k) Number K915852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1991
Decision Date April 02, 1992
Days to Decision 97 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
5d faster than avg
Panel avg: 102d · This submission: 97d
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.