Cleared Traditional

K761346 - RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA)

K761346 is the FDA 510(k) clearance for RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA) by New England Nuclear. It is a Class 2 Chemistry device (product code CGR) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K761346 · New England Nuclear · Chemistry device
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Jan 1977
Decision
10d
Days
Class 2
Risk

K761346 is an FDA 510(k) clearance for the RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA). Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by New England Nuclear (Mchenry, US). The FDA issued a Cleared decision on January 7, 1977 after a review of 10 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 New England Nuclear devices

Submission Details

510(k) Number K761346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1976
Decision Date January 07, 1977
Days to Decision 10 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 88d · This submission: 10d
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 48
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K761346.
CORTISOL RIA KIT
K790268 · E. R. Squibb & Sons, Inc. · Apr 1979
RIA KIT, QUANTITOPE CORTISOL
K781903 · Kallestad Laboratories, Inc. · Jan 1979
CENTRIA CORTISOL RIA
K780725 · Union Carbide Corp. · Jun 1978
CORTISOL REAGENT SYSTEM
K760939 · Beckman Instruments, Inc. · Nov 1976
TEST SYSTEM, RIA CORTISOL
K760256 · Corning Medical & Scientific · Aug 1976