Cleared Traditional

K981060 - ABBOTT AXSYM 3RD GENERATION TSH ASSAY

K981060 is an FDA 510(k) clearance for ABBOTT AXSYM 3RD GENERATION TSH ASSAY, 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 37-day FDA review.

K981060 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
37d
Days
Class 2
Risk

K981060 is an FDA 510(k) clearance for the ABBOTT AXSYM 3RD GENERATION TSH ASSAY. 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 April 29, 1998 after a review of 37 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 - K981060

510(k) Number K981060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1998
Decision Date April 29, 1998
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 88d · This submission: 37d
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 K981060.
ACCESS HYPERSENSITIVE HTSH ASSAY
K023093 · Beckman Coulter, Inc. · Nov 2002
ABBOTT ARCHITECT TSH
K983442 · Abbott Laboratories · Nov 1998
3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K981312 · Bayer Corp. · Jun 1998
AIA-PACK TSH 3RD-GEN ASSAY
K972586 · Tosoh Medics, Inc. · Aug 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)
K964558 · Johnson & Johnson Clinical Diagnostics, Inc. · Dec 1996
THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST
K961629 · Teco Diagnostics · Sep 1996