Cleared Traditional

K972586 - AIA-PACK TSH 3RD-GEN ASSAY

K972586 is an FDA 510(k) clearance for AIA-PACK TSH 3RD-GEN ASSAY, manufactured by Tosoh Medics, Inc.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K972586 · Tosoh Medics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
49d
Days
Class 2
Risk

K972586 is an FDA 510(k) clearance for the AIA-PACK TSH 3RD-GEN ASSAY. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Tosoh Medics, Inc. (Foster City, US). The FDA issued a Cleared decision on August 29, 1997 after a review of 49 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 Tosoh Medics, Inc. devices

FDA 510(k) Submission Details - K972586

510(k) Number K972586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1997
Decision Date August 29, 1997
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
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 199
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K972586.
ABBOTT AXSYM 3RD GENERATION TSH ASSAY
K981060 · Abbott Laboratories · Apr 1998
AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0
K980574 · Alfa Biotech (Uk) , Ltd. · Mar 1998
AUTODELFIA NEONATAL HTSH L KIT (B077-112)
K973276 · Eg &G Wallac · Nov 1997
THYROTROPIN(TSH) ELISA
K971780 · Monobind · Jun 1997
THYROID STIMULATING HORMONE METHOD
K970393 · Dade Chemistry Systems, Inc. · Mar 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)
K964558 · Johnson & Johnson Clinical Diagnostics, Inc. · Dec 1996