Cleared Traditional

K885003 - BACTIGEN GROUP B STREPTOCOCCUS TEST

K885003 is the FDA 510(k) clearance for BACTIGEN GROUP B STREPTOCOCCUS TEST by Armkel, LLC. It is a Class 1 Microbiology device (product code GTZ) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K885003 · Armkel, LLC · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1989
Decision
68d
Days
Class 1
Risk

K885003 is an FDA 510(k) clearance for the BACTIGEN(R) GROUP B STREPTOCOCCUS TEST. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on February 7, 1989 after a review of 68 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 Armkel, LLC devices

Submission Details

510(k) Number K885003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1988
Decision Date February 07, 1989
Days to Decision 68 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
34d faster than avg
Panel avg: 102d · This submission: 68d
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 62
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K885003.
ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.
K894711 · Gen-Probe, Inc. · Nov 1989
LEECO VIS-DISK STREP-A (EIA)
K894122 · Leeco Diagnostics, Inc. · Aug 1989
CLEARVIEW STREP A
K893422 · Unipath , Ltd. · Jun 1989
QUIDEL GROUP A STREP TEST
K883999 · Quidel Corp. · Oct 1988
KODAK SURECELL STREP A TEST KIT
K881457 · Eastman Kodak Company · Apr 1988
SURE-STREP A TEST KIT CATALOG NO. MB-1083
K872346 · Medix Biotech, Inc. · Sep 1987