Cleared Traditional

K904589 - KODAK SURECELL(TM) STREP A CONTROL FLUID SET

K904589 is an FDA 510(k) clearance for KODAK SURECELL(TM) STREP A CONTROL FLUI..., manufactured by Eastman Kodak Company. The device is a Class 1 Microbiology device with product code GTY cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K904589 · Eastman Kodak Company · Microbiology device
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Jan 1991
Decision
101d
Days
Class 1
Risk

K904589 is an FDA 510(k) clearance for the KODAK SURECELL(TM) STREP A CONTROL FLUID SET. Classified as Antigens, All Groups, Streptococcus Spp. (product code GTY), Class I - General Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on January 18, 1991 after a review of 101 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 Eastman Kodak Company devices

FDA 510(k) Submission Details - K904589

510(k) Number K904589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1990
Decision Date January 18, 1991
Days to Decision 101 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
1d faster than avg
Panel avg: 102d · This submission: 101d
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 K904589.
BIOSTARS STREP A OIA -- MODIFICATION
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ABBOTT STREP A CONTROLS
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SLIDEX STREPTO-KIT
K905020 · Vitek Systems, Inc. · Jan 1991
ICON STREP B IMMUNOENZYMETRIC ASSAY
K902991 · Hybritech, Inc. · Oct 1990
ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL
K864752 · Abbott Laboratories · Feb 1987
RESPIRASTICK ENZYME IMMUNOASSAY TEST
K862475 · Orion Diagnostica, Inc. · Sep 1986