Cleared Traditional

K791855 - CENTRIA TSH RIA

K791855 is an FDA 510(k) clearance for CENTRIA TSH RIA, manufactured by Union Carbide Corp.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K791855 · Union Carbide Corp. · Chemistry device
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Oct 1979
Decision
28d
Days
Class 2
Risk

K791855 is an FDA 510(k) clearance for the CENTRIA TSH RIA. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1979 after a review of 28 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 Union Carbide Corp. devices

FDA 510(k) Submission Details - K791855

510(k) Number K791855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1979
Decision Date October 17, 1979
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JLW Device Classification - Class 2, Special Controls

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 156
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K791855.
HUMAN THYROID STIM. HORMONE/ARIA II
K800798 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1980
TSH RADIOIMMUNOASSAY
K792443 · Dade, Baxter Travenol Diagnostics, Inc. · Dec 1979
HTSH NEONATE RIA DIAGNOSTIC KIT
K791747 · Abbott Laboratories · Nov 1979
NTSH AUTOPAK TEST DELIVERY SYSTEM
K790260 · Micromedic Systems · Mar 1979
RIA KIT, IMMO PHASE
K781953 · Corning Medical & Scientific · Feb 1979
IMMO PHASE, THYROID HORMONE
K781409 · Corning Medical & Scientific · Sep 1978