Cleared Traditional

K862871 - RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL

K862871 is an FDA 510(k) clearance for RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL, manufactured by Cambridge Medical Technology. The device is a Class 2 Chemistry device with product code CGR cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K862871 · Cambridge Medical Technology · Chemistry device
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Aug 1986
Decision
21d
Days
Class 2
Risk

K862871 is an FDA 510(k) clearance for the RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Cambridge Medical Technology (Billerica, US). The FDA issued a Cleared decision on August 19, 1986 after a review of 21 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.

FDA 510(k) Submission Details - K862871

510(k) Number K862871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1986
Decision Date August 19, 1986
Days to Decision 21 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
68d faster than avg
Panel avg: 89d · This submission: 21d
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 83
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K862871.
CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT
K870969 · Canadian Bioclinical, Ltd. · Jun 1987
TIPSEP-CORTISOL RIA DIAGNOSTIC KIT
K872177 · Nuclear Diagnostics, Inc. · Jun 1987
PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT
K862336 · Pantex, Div. Bio-Analysis, Inc. · Sep 1986
CORTISOL SYSTEM BY EIA
K852939 · American Bioclinical, Inc. · Aug 1985
ACTIVE CORTISOL DSL 2000-SP
K850141 · Diagnostic Systems Laboratories, Inc. · Feb 1985
SOPHEIA/MP CORTISOL EIA KIT
K850008 · Diagnostic Products Corp. · Feb 1985
K862871 · RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL
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