Cleared Traditional

K822845 - SOPHEIA CORTISOL EIA KIT

K822845 is the FDA 510(k) clearance for SOPHEIA 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 34-day FDA review.

K822845 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1982
Decision
34d
Days
Class 2
Risk

K822845 is an FDA 510(k) clearance for the SOPHEIA CORTISOL EIA KIT. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1982 after a review of 34 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 K822845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1982
Decision Date October 27, 1982
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
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 K822845.
CORNING MAGIC CORTISOL RADIOIMMUNO
K841641 · Corning Medical & Scientific · Sep 1984
CORTI-COTE CORTISOL SOLID PHASE RADIO
K842365 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1984
EMIT SRD MANUAL CORTISOL ASSAY
K831141 · Syva Co. · May 1983
DSL 1020
K821068 · Diagnostic Systems Laboratories, Inc. · May 1982
COAT-A-COUNT CORTISOL RIA KIT
K810891 · Diagnostic Products Corp. · Apr 1981
ARIA II 125 I CORTISOL
K802380 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1980