Cleared Traditional

K872177 - TIPSEP-CORTISOL RIA DIAGNOSTIC KIT

K872177 is an FDA 510(k) clearance for TIPSEP-CORTISOL RIA DIAGNOSTIC KIT, manufactured by Nuclear Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CGR cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K872177 · Nuclear Diagnostics, Inc. · Chemistry device
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Jun 1987
Decision
9d
Days
Class 2
Risk

K872177 is an FDA 510(k) clearance for the TIPSEP-CORTISOL RIA DIAGNOSTIC KIT. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Nuclear Diagnostics, Inc. (Troy, US). The FDA issued a Cleared decision on June 17, 1987 after a review of 9 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 Nuclear Diagnostics, Inc. devices

FDA 510(k) Submission Details - K872177

510(k) Number K872177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1987
Decision Date June 17, 1987
Days to Decision 9 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
79d faster than avg
Panel avg: 88d · This submission: 9d
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 58
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K872177.
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
ACTIVE CORTISOL DSL 2000-SP
K850141 · Diagnostic Systems Laboratories, Inc. · Feb 1985
SOPHEIA/MP CORTISOL EIA KIT
K850008 · Diagnostic Products Corp. · Feb 1985
LEECO CORTISOL-QUANT
K843384 · Leeco Diagnostics, Inc. · Sep 1984