Cleared Traditional

K951542 - DIRECTIGEN 1-2-3 GROUP A STREP TEST (FDA 510(k) Clearance)

Class I Microbiology device.

K951542 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Optimized for regulatory review, auditing and printing
Oct 1995
Decision
200d
Days
Class 1
Risk

K951542 is an FDA 510(k) clearance for the DIRECTIGEN 1-2-3 GROUP A STREP TEST. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Columbus, US). The FDA issued a Cleared decision on October 20, 1995 after a review of 200 days - an extended review 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: 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K951542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1995
Decision Date October 20, 1995
Days to Decision 200 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
98d slower than avg
Panel avg: 102d · This submission: 200d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.