Cleared Traditional

K911417 - ICON STREP B IMMUNOENZYMETRIC ASSAY

K911417 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 GTZ cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K911417 · Hybritech, Inc. · Microbiology device
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Jul 1991
Decision
114d
Days
Class 1
Risk

K911417 is an FDA 510(k) clearance for the ICON STREP B IMMUNOENZYMETRIC ASSAY. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on July 24, 1991 after a review of 114 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hybritech, Inc. devices

FDA 510(k) Submission Details - K911417

510(k) Number K911417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1991
Decision Date July 24, 1991
Days to Decision 114 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
12d slower than avg
Panel avg: 102d · This submission: 114d
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 89
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K911417.
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GROUP A STREP POSITIVE AND NEGATIVE CONTROLS
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STREPTEX ACID EXTRACTION KIT
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REDITEST STREP A TEST KIT
K903194 · Boehringer Mannheim Corp. · Aug 1990
PATHO DX STREP D
K902038 · Diagnostic Products Corp. · May 1990