Cleared Traditional

K914886 - SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG...

K914886 is the FDA 510(k) clearance for SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG... by Serono-Baker Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CGR) cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K914886 · Serono-Baker Diagnostics, Inc. · Chemistry device
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Mar 1992
Decision
124d
Days
Class 2
Risk

K914886 is an FDA 510(k) clearance for the SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE). 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 March 2, 1992 after a review of 124 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 K914886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1991
Decision Date March 02, 1992
Days to Decision 124 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 88d · This submission: 124d
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 K914886.
ACCESS CORTISOL REAGENTS
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IMMULITE CORTISOL
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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