Cleared Traditional

K872493 - DIRECTIGEN 1-2-3(TM) GROUP A STREP TEST

K872493 is the FDA 510(k) clearance for DIRECTIGEN 1-2-3(TM) GROUP A STREP TEST by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 1 Microbiology device (product code GTZ) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K872493 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1987
Decision
62d
Days
Class 1
Risk

K872493 is an FDA 510(k) clearance for the DIRECTIGEN 1-2-3(TM) 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 (Franklin Lakes, US). The FDA issued a Cleared decision on August 24, 1987 after a review of 62 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K872493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1987
Decision Date August 24, 1987
Days to Decision 62 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
40d faster than avg
Panel avg: 102d · This submission: 62d
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.

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

All 75
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K872493.
SURE-STREP A TEST KIT CATALOG NO. MB-1083
K872346 · Medix Biotech, Inc. · Sep 1987
QTEST STREP
K872961 · Quidel Corp. · Sep 1987
BACTIGEN GROUP B STREPTOCOCCUS-CS TEST
K872114 · Armkel, LLC · Aug 1987
PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT
K871831 · Diagnostic Products Corp. · Jun 1987
BACTO(R) STREP GROUP KIT
K870854 · Difco Laboratories, Inc. · Apr 1987
DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST
K870155 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1987