Cleared Traditional

K781953 - RIA KIT

K781953 is the FDA 510(k) clearance for RIA KIT by Corning Medical & Scientific. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K781953 · Corning Medical & Scientific · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1979
Decision
72d
Days
Class 2
Risk

K781953 is an FDA 510(k) clearance for the RIA KIT, IMMO PHASE. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on February 1, 1979 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1690 - 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 Corning Medical & Scientific devices

Submission Details

510(k) Number K781953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1978
Decision Date February 01, 1979
Days to Decision 72 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
16d faster than avg
Panel avg: 88d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JLW Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1690
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 - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 143
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K781953.
HTSH NEONATE RIA DIAGNOSTIC KIT
K791747 · Abbott Laboratories · Nov 1979
CENTRIA TSH RIA
K791855 · Union Carbide Corp. · Oct 1979
NTSH AUTOPAK TEST DELIVERY SYSTEM
K790260 · Micromedic Systems · Mar 1979
IMMO PHASE, THYROID HORMONE
K781409 · Corning Medical & Scientific · Sep 1978
QUANTIMUNE HTSH IRMA HUMAN THYROID
K781170 · Bio-Rad · Aug 1978
TSH RIA KIT
K780726 · Amersham Corp. · Jun 1978