Cleared Traditional

K843713 - DIRECTIGEN GROUP A STREP TEST KIT

K843713 is an FDA 510(k) clearance for DIRECTIGEN GROUP A STREP TEST KIT, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 1 Microbiology device with product code GTZ cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K843713 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Jan 1985
Decision
105d
Days
Class 1
Risk

K843713 is an FDA 510(k) clearance for the DIRECTIGEN GROUP A STREP TEST KIT. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on January 4, 1985 after a review of 105 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K843713

510(k) Number K843713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1984
Decision Date January 04, 1985
Days to Decision 105 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 102d · This submission: 105d
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 81
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K843713.
STREP A QUICK
K850831 · Abbott Laboratories · Apr 1985
VENTRESCREEN STREP A TEST
K844855 · Ventrex Laboratories, Inc. · Jan 1985
RESPIRALEX LATEX AGGLUTINATION TEST
K844399 · Orion Diagnostica, Inc. · Jan 1985
PHARMACIA STREP A DIRECT SWAB TEST
K844107 · Pharmacia, Inc. · Nov 1984
STREPTEX DIRECT A ZL14
K842827 · Wellcome Diagnostics · Aug 1984
PATHO DX LATEX AGGLUTINATION STREP A
K842383 · Diagnostic Products Corp. · Jul 1984