Cleared Traditional

K871620 - ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT

K871620 is an FDA 510(k) clearance for ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT, manufactured by Allelix, Inc.. The device is a Class 1 Microbiology device with product code GTZ cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K871620 · Allelix, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1987
Decision
51d
Days
Class 1
Risk

K871620 is an FDA 510(k) clearance for the ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Allelix, Inc. (Canada L4v 1p1, CA). The FDA issued a Cleared decision on June 17, 1987 after a review of 51 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, Inc. devices

FDA 510(k) Submission Details - K871620

510(k) Number K871620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1987
Decision Date June 17, 1987
Days to Decision 51 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 102d · This submission: 51d
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 K871620.
QTEST STREP
K872961 · Quidel Corp. · Sep 1987
BACTIGEN GROUP B STREPTOCOCCUS-CS TEST
K872114 · Armkel, LLC · Aug 1987
DIRECTIGEN 1-2-3(TM) GROUP A STREP TEST
K872493 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1987
PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT
K871831 · Diagnostic Products Corp. · Jun 1987
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