Cleared Traditional

K781903 - RIA KIT, QUANTITOPE CORTISOL

K781903 is an FDA 510(k) clearance for RIA KIT, manufactured by Kallestad Laboratories, Inc.. The device is a Class 2 Chemistry device with product code CGR cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K781903 · Kallestad Laboratories, Inc. · Chemistry device
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Jan 1979
Decision
74d
Days
Class 2
Risk

K781903 is an FDA 510(k) clearance for the RIA KIT, QUANTITOPE CORTISOL. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Kallestad Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1979 after a review of 74 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 Kallestad Laboratories, Inc. devices

FDA 510(k) Submission Details - K781903

510(k) Number K781903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1978
Decision Date January 26, 1979
Days to Decision 74 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
14d faster than avg
Panel avg: 88d · This submission: 74d
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 59
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K781903.
CORTI-SHURE
K791700 · Nuclear Medical Laboratories, Inc. · Oct 1979
AUTOPAK CORTISOL TEST DELIVERY SYSTEM
K790906 · Micromedic Systems · Jun 1979
CORTISOL RIA KIT
K790268 · E. R. Squibb & Sons, Inc. · Apr 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