Cleared Traditional

K771117 - CENTRIA CORTISOL RIA

K771117 is an FDA 510(k) clearance for CENTRIA CORTISOL RIA, manufactured by Clinical Diagnostics, Inc.. The device is a Class 2 Immunology device with product code CGR cleared through the Traditional 510(k) pathway after a 2-day FDA review.

K771117 · Clinical Diagnostics, Inc. · Immunology device
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Jun 1977
Decision
2d
Days
Class 2
Risk

K771117 is an FDA 510(k) clearance for the CENTRIA CORTISOL RIA. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Clinical Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 23, 1977 after a review of 2 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1205 - the FDA immunology device 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 Clinical Diagnostics, Inc. devices

FDA 510(k) Submission Details - K771117

510(k) Number K771117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1977
Decision Date June 23, 1977
Days to Decision 2 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 105d · This submission: 2d
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 Immunology devices follow this clearance model.

Regulatory Peers - CGR Radioimmunoassay, Cortisol

All 61
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K771117.
RIA KIT, QUANTITOPE CORTISOL
K781903 · Kallestad Laboratories, Inc. · Jan 1979
RIA KIT, RIANEN CORTISOL
K782110 · New England Nuclear · Jan 1979
CENTRIA CORTISOL RIA
K780725 · Union Carbide Corp. · Jun 1978
RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA)
K761346 · New England Nuclear · Jan 1977
CORTISOL REAGENT SYSTEM
K760939 · Beckman Instruments, Inc. · Nov 1976
TEST SYSTEM, RIA CORTISOL
K760256 · Corning Medical & Scientific · Aug 1976