Cleared Traditional

K863908 - BINAX STREP A

K863908 is an FDA 510(k) clearance for BINAX STREP A, manufactured by Binax, Inc.. The device is a Class 1 Microbiology device with product code GTZ cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K863908 · Binax, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1986
Decision
76d
Days
Class 1
Risk

K863908 is an FDA 510(k) clearance for the BINAX STREP A. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Binax, Inc. (S. Portland, US). The FDA issued a Cleared decision on December 22, 1986 after a review of 76 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 Binax, Inc. devices

FDA 510(k) Submission Details - K863908

510(k) Number K863908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1986
Decision Date December 22, 1986
Days to Decision 76 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
26d faster than avg
Panel avg: 102d · This submission: 76d
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 K863908.
DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST
K870155 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1987
LEECO VIS-CUBE STREP A (EIA)
K864170 · Leeco Diagnostics, Inc. · Feb 1987
REVEAL COLOUR STREP A ZL16
K864206 · Wellcome Diagnostics · Jan 1987
CARDS(TM) STREP A CATALOG NO. CR-7545
K863647 · Pacific Biotech, Inc. · Nov 1986
SEROIDEN STREPTO KIT 'EIKEN'
K861098 · Syn-Kit, Inc. · Aug 1986
DIRECTIGEN COMBO MENINGITIS TEST
K860768 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1986