Cleared Traditional

K791747 - HTSH NEONATE RIA DIAGNOSTIC KIT

K791747 is an FDA 510(k) clearance for HTSH NEONATE RIA DIAGNOSTIC KIT, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K791747 · Abbott Laboratories · Chemistry device
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Nov 1979
Decision
64d
Days
Class 2
Risk

K791747 is an FDA 510(k) clearance for the HTSH NEONATE RIA DIAGNOSTIC KIT. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 64 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K791747

510(k) Number K791747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1979
Decision Date November 13, 1979
Days to Decision 64 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
24d faster than avg
Panel avg: 88d · This submission: 64d
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 163
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K791747.
VENTREX/SEP TSH TEST SET
K801560 · Ventrex Laboratories, Inc. · Aug 1980
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
CENTRIA TSH RIA
K791855 · Union Carbide Corp. · Oct 1979
ORTHO TSH RIA KIT
K791301 · Ortho Diagnostics, Inc. · Sep 1979
NTSH AUTOPAK TEST DELIVERY SYSTEM
K790260 · Micromedic Systems · Mar 1979