Cleared Traditional

RAPID COLORIMETRIC DIRECT STREP A TEST (K874761) - FDA 510(k) Clearance

Class I Microbiology device.

K874761 · New Horizons Diagnostics Co. · Microbiology device
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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

Submission Details

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.

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 104
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