Cleared Traditional

K864206 - REVEAL COLOUR STREP A ZL16

K864206 is the FDA 510(k) clearance for REVEAL COLOUR STREP A ZL16 by Wellcome Diagnostics. It is a Class 1 Microbiology device (product code GTZ) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K864206 · Wellcome Diagnostics · Microbiology device
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Jan 1987
Decision
78d
Days
Class 1
Risk

K864206 is an FDA 510(k) clearance for the REVEAL COLOUR STREP A ZL16. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Wellcome Diagnostics (Research Triangle Pk, US). The FDA issued a Cleared decision on January 13, 1987 after a review of 78 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 Wellcome Diagnostics devices

Submission Details

510(k) Number K864206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1986
Decision Date January 13, 1987
Days to Decision 78 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 102d · This submission: 78d
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 63
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K864206.
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
LEECO VIS-CUBE STREP A (EIA)
K864170 · Leeco Diagnostics, Inc. · Feb 1987
SEROIDEN STREPTO KIT 'EIKEN'
K861098 · Syn-Kit, Inc. · Aug 1986
DIRECTIGEN COMBO MENINGITIS TEST
K860768 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1986
LEECO-SCREEN, STREP A (EIA)
K860947 · Leeco Diagnostics, Inc. · May 1986