Cleared Traditional

K850008 - SOPHEIA/MP CORTISOL EIA KIT

K850008 is the FDA 510(k) clearance for SOPHEIA/MP CORTISOL EIA KIT by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code CGR) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K850008 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1985
Decision
30d
Days
Class 2
Risk

K850008 is an FDA 510(k) clearance for the SOPHEIA/MP CORTISOL EIA KIT. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on February 1, 1985 after a review of 30 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 Products Corp. devices

Submission Details

510(k) Number K850008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1985
Decision Date February 01, 1985
Days to Decision 30 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
58d faster than avg
Panel avg: 88d · This submission: 30d
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 42
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K850008.
DSL 7800 ACTIVE CORTISOL
K884689 · Diagnostic Systems Laboratories, Inc. · Feb 1989
CORTISOL ENHANCED LUMINESCENCE ASSAY KIT
K880687 · Amersham Corp. · Mar 1988
ACTIVE CORTISOL DSL 2000-SP
K850141 · Diagnostic Systems Laboratories, Inc. · Feb 1985
LEECO CORTISOL-QUANT
K843384 · Leeco Diagnostics, Inc. · Sep 1984
STRATUS CORTISOL FLUOROMETRIC ENZYME
K843183 · American Dade · Sep 1984
CORNING MAGIC CORTISOL RADIOIMMUNO
K841641 · Corning Medical & Scientific · Sep 1984