Cleared Traditional

MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION) (K952873) - FDA 510(k) Clearance

Class I Microbiology device.

K952873 · Medix Biotech, Inc. · Microbiology device
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Sep 1995
Decision
94d
Days
Class 1
Risk

K952873 is an FDA 510(k) clearance for the MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION). Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Medix Biotech, Inc. (San Carlos, US). The FDA issued a Cleared decision on September 8, 1995 after a review of 94 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 Medix Biotech, Inc. devices

Submission Details

510(k) Number K952873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1995
Decision Date September 08, 1995
Days to Decision 94 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 102d · This submission: 94d
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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