Cleared Traditional

K902991 - ICON STREP B IMMUNOENZYMETRIC ASSAY

K902991 is an FDA 510(k) clearance for ICON STREP B IMMUNOENZYMETRIC ASSAY, manufactured by Hybritech, Inc.. The device is a Class 1 Microbiology device with product code GTY cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K902991 · Hybritech, Inc. · Microbiology device
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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

FDA 510(k) Submission Details - K902991

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 102d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

GTY Device Classification - Class 1, General Controls

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 37
Devices cleared under the same product code (GTY) and FDA review panel - the closest regulatory comparables to K902991.
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