Cleared Traditional

K900485 - ENZYMUN TEST CORTISOL

K900485 is an FDA 510(k) clearance for ENZYMUN TEST CORTISOL, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code CGR cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K900485 · Boehringer Mannheim Corp. · Chemistry device
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May 1990
Decision
90d
Days
Class 2
Risk

K900485 is an FDA 510(k) clearance for the ENZYMUN TEST(R) CORTISOL. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 2, 1990 after a review of 90 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K900485

510(k) Number K900485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1990
Decision Date May 02, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGR Device Classification - Class 2, Special Controls

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 47
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K900485.
ACCESS CORTISOL REAGENTS
K940221 · Bio-Rad Laboratories, Inc. · Apr 1994
SYNELISA CORTISOL
K931177 · Elias U.S.A., Inc. · Sep 1993
IMMULITE CORTISOL
K931409 · Diagnostic Products Corp. · May 1993
CEDIA (TM) CORTISOL ASSAY
K901296 · Microgenics Corp. · Apr 1990
MODIFIED CEDIA(TM) CORTISOL ASSAY
K896451 · Microgenics Corp. · Dec 1989
MILENIA(TM) CORTISOL (MKCO1,5)
K895006 · Diagnostic Products Corp. · Oct 1989