Cleared Traditional

K923673 - PRECISE STREP A

K923673 is an FDA 510(k) clearance for PRECISE STREP A, manufactured by Becton Dickinson Advanced Diagnostics. The device is a Class 1 Microbiology device with product code GTZ cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K923673 · Becton Dickinson Advanced Diagnostics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
68d
Days
Class 1
Risk

K923673 is an FDA 510(k) clearance for the PRECISE STREP A. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Becton Dickinson Advanced Diagnostics (Sparks, US). The FDA issued a Cleared decision on September 28, 1992 after a review of 68 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Becton Dickinson Advanced Diagnostics devices

FDA 510(k) Submission Details - K923673

510(k) Number K923673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1992
Decision Date September 28, 1992
Days to Decision 68 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
34d faster than avg
Panel avg: 102d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

GTZ Device Classification - Class 1, General Controls

Product Code GTZ Antisera, All Groups, Streptococcus Spp.
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.

Regulatory Peers - GTZ Antisera, All Groups, Streptococcus Spp.

All 90
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