Cleared Traditional

K854447 - IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST

K854447 is the FDA 510(k) clearance for IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST by American Micro Scan. It is a Class 1 Microbiology device (product code GTZ) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K854447 · American Micro Scan · Microbiology device
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Jan 1986
Decision
59d
Days
Class 1
Risk

K854447 is an FDA 510(k) clearance for the IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by American Micro Scan (Sacramento, US). The FDA issued a Cleared decision on January 3, 1986 after a review of 59 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 American Micro Scan devices

Submission Details

510(k) Number K854447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1985
Decision Date January 03, 1986
Days to Decision 59 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 102d · This submission: 59d
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 63
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K854447.
TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT
K860778 · Hybritech, Inc. · Apr 1986
DIFCO STREP A LATEX TEST
K854978 · Difco Laboratories, Inc. · Mar 1986
OXOID STREPTOCOCAL GROUPING KIT
K854929 · Oxoid U.S.A., Inc. · Mar 1986
ABBOTT STREP A P.S.D.
K852266 · Abbott Laboratories · Dec 1985
PHADIRECT STREP A TEST
K854150 · Pharmacia, Inc. · Oct 1985
CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D.
K853073 · Marion Laboratories, Inc. · Aug 1985