Cleared Traditional

ICON STREP B IMMUNOENZYMETRIC ASSAY (K902991) - FDA 510(k) Clearance

Class I Microbiology device.

K902991 · Hybritech, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
86d
Days
Class 1
Risk

K902991 is an FDA 510(k) clearance for the ICON STREP B IMMUNOENZYMETRIC ASSAY. Classified as Antigens, All Groups, Streptococcus Spp. (product code GTY), Class I - General Controls.

Submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on October 3, 1990 after a review of 86 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 Hybritech, Inc. devices

Submission Details

510(k) Number K902991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1990
Decision Date October 03, 1990
Days to Decision 86 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 102d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GTY Antigens, 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 - GTY Antigens, All Groups, Streptococcus Spp.

All 43
Devices cleared under the same product code (GTY) and FDA review panel - the closest regulatory comparables to K902991.
AllTest Strep A Rapid Test
K260342 · Hangzhou AllTest Biotech Co., Ltd. · Apr 2026
Flowflex® Plus Strep A Rapid Test Cassette
K251697 · ACON Laboratories, Inc. · Nov 2025
Healgen Strep A Rapid Test Strip (Throat Swab)
K212623 · Healgen Scientific, LLC · Mar 2022
SAS STREPALERT
K023270 · Sa Scientific, Inc. · Oct 2002
SAS STREPALERT
K013379 · Sa Scientific, Inc. · Dec 2001
SAS STREP A TEST
K993456 · Sa Scientific, Inc. · Mar 2000