Cleared Traditional

K880665 - MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT

K880665 is an FDA 510(k) clearance for MODIFIED GROUP A STREPTOCOCCUS DETECTIO..., manufactured by Allelix Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code GTZ cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K880665 · Allelix Diagnostics, Inc. · Microbiology device
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Mar 1988
Decision
12d
Days
Class 1
Risk

K880665 is an FDA 510(k) clearance for the MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Allelix Diagnostics, Inc. (Canada L4v 1p1, CA). The FDA issued a Cleared decision on March 1, 1988 after a review of 12 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 Allelix Diagnostics, Inc. devices

FDA 510(k) Submission Details - K880665

510(k) Number K880665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1988
Decision Date March 01, 1988
Days to Decision 12 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 102d · This submission: 12d
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.

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