Cleared Traditional

K903975 - SEROZYME CORTISOL TEST KIT

K903975 is the FDA 510(k) clearance for SEROZYME CORTISOL TEST KIT by Serono-Baker Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CGR) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K903975 · Serono-Baker Diagnostics, Inc. · Chemistry device
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Jan 1991
Decision
148d
Days
Class 2
Risk

K903975 is an FDA 510(k) clearance for the SEROZYME CORTISOL TEST KIT. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Serono-Baker Diagnostics, Inc. (Allentown, US). The FDA issued a Cleared decision on January 23, 1991 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1205 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Serono-Baker Diagnostics, Inc. devices

Submission Details

510(k) Number K903975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1990
Decision Date January 23, 1991
Days to Decision 148 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 88d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGR Radioimmunoassay, Cortisol
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1205
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CGR Radioimmunoassay, Cortisol

All 46
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K903975.
ACCESS CORTISOL REAGENTS
K940221 · Bio-Rad Laboratories, Inc. · Apr 1994
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K931177 · Elias U.S.A., Inc. · Sep 1993
IMMULITE CORTISOL
K931409 · Diagnostic Products Corp. · May 1993
ENZYMUN TEST(R) CORTISOL
K900485 · Boehringer Mannheim Corp. · May 1990
CEDIA (TM) CORTISOL ASSAY
K901296 · Microgenics Corp. · Apr 1990
MODIFIED CEDIA(TM) CORTISOL ASSAY
K896451 · Microgenics Corp. · Dec 1989