Cleared Traditional

K831991 - DIRECTIGEN GROUP B STREP TEST KIT-SERUM

K831991 is an FDA 510(k) clearance for DIRECTIGEN GROUP B STREP TEST KIT-SERUM, 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 97-day FDA review.

K831991 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1983
Decision
97d
Days
Class 1
Risk

K831991 is an FDA 510(k) clearance for the DIRECTIGEN GROUP B STREP TEST KIT-SERUM. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Walker, US). The FDA issued a Cleared decision on September 26, 1983 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K831991

510(k) Number K831991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1983
Decision Date September 26, 1983
Days to Decision 97 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
5d faster than avg
Panel avg: 102d · This submission: 97d
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 89
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K831991.
STREPTEX DIRECT A ZL14
K842827 · Wellcome Diagnostics · Aug 1984
PATHO DX LATEX AGGLUTINATION STREP A
K842383 · Diagnostic Products Corp. · Jul 1984
DETECT GROUP A STREP TEST
K834582 · Difco Laboratories, Inc. · Apr 1984
PHADEBACT STREP F TEST
K830445 · Pharmacia, Inc. · Apr 1983
ABBOTT LABORATORIES STREP A EIA
K823569 · Abbott Laboratories · Mar 1983
MERITECASTREP (TM)
K821100 · Meridian Diagnostics, Inc. · May 1982