Cleared Traditional

K850141 - ACTIVE CORTISOL DSL 2000-SP

K850141 is the FDA 510(k) clearance for ACTIVE CORTISOL DSL 2000-SP by Diagnostic Systems Laboratories, Inc.. It is a Class 2 Chemistry device (product code CGR) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K850141 · Diagnostic Systems Laboratories, Inc. · Chemistry device
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Feb 1985
Decision
23d
Days
Class 2
Risk

K850141 is an FDA 510(k) clearance for the ACTIVE CORTISOL DSL 2000-SP. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on February 6, 1985 after a review of 23 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Diagnostic Systems Laboratories, Inc. devices

Submission Details

510(k) Number K850141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1985
Decision Date February 06, 1985
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
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 45
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K850141.
MILENIA(TM) CORTISOL (MKCO1,5)
K895006 · Diagnostic Products Corp. · Oct 1989
DSL 7800 ACTIVE CORTISOL
K884689 · Diagnostic Systems Laboratories, Inc. · Feb 1989
CORTISOL ENHANCED LUMINESCENCE ASSAY KIT
K880687 · Amersham Corp. · Mar 1988
SOPHEIA/MP CORTISOL EIA KIT
K850008 · Diagnostic Products Corp. · Feb 1985
LEECO CORTISOL-QUANT
K843384 · Leeco Diagnostics, Inc. · Sep 1984
STRATUS CORTISOL FLUOROMETRIC ENZYME
K843183 · American Dade · Sep 1984