Cleared Traditional

K874761 - RAPID COLORIMETRIC DIRECT STREP A TEST

K874761 is an FDA 510(k) clearance for RAPID COLORIMETRIC DIRECT STREP A TEST, manufactured by New Horizons Diagnostics Co.. The device is a Class 1 Microbiology device with product code GTZ cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K874761 · New Horizons Diagnostics Co. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1988
Decision
92d
Days
Class 1
Risk

K874761 is an FDA 510(k) clearance for the RAPID COLORIMETRIC DIRECT STREP A TEST. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by New Horizons Diagnostics Co. (Columbia, US). The FDA issued a Cleared decision on February 19, 1988 after a review of 92 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 New Horizons Diagnostics Co. devices

FDA 510(k) Submission Details - K874761

510(k) Number K874761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1987
Decision Date February 19, 1988
Days to Decision 92 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 102d · This submission: 92d
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 90
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K874761.
KODAK SURECELL STREP A TEST KIT
K881457 · Eastman Kodak Company · Apr 1988
V-TREND STREP A TEST
K880483 · Texas Immunology, Inc. · Apr 1988
TARGET STREP A
K880460 · V-Tech, Inc. · Mar 1988
BINAX EQUATE STREP B
K872904 · Binax, Inc. · Nov 1987
SURE-STREP A TEST KIT CATALOG NO. MB-1083
K872346 · Medix Biotech, Inc. · Sep 1987
QTEST STREP
K872961 · Quidel Corp. · Sep 1987