Cleared Traditional

BBL STREP GROUPING KIT (K920565) - FDA 510(k) Clearance

Class I Microbiology device.

K920565 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
45d
Days
Class 1
Risk

K920565 is an FDA 510(k) clearance for the BBL STREP GROUPING KIT. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Cockeysville, US). The FDA issued a Cleared decision on March 23, 1992 after a review of 45 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 K920565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1992
Decision Date March 23, 1992
Days to Decision 45 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 102d · This submission: 45d
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 21
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K920565.
DIRECTIGEN 1-2-3 GROUP A STREP TEST
K951542 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1995
ABBOTT TEST PACK STREP A TEST
K945571 · Abbott Laboratories · Aug 1995
TESTPACK PLUS STREP A
K922345 · Abbott Laboratories · Jul 1992
REDITEST STREP A TEST KIT
K903194 · Boehringer Mannheim Corp. · Aug 1990
PATHO DX STREP D
K902038 · Diagnostic Products Corp. · May 1990
TESTPACK PLUS STREP A
K901274 · Abbott Laboratories · May 1990