Cleared Traditional

AXSYM ULTRASENSITIVE HTSH II (K952148) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K952148 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
52d
Days
Class 2
Risk

K952148 is an FDA 510(k) clearance for the AXSYM ULTRASENSITIVE HTSH II. 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 June 29, 1995 after a review of 52 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

Submission Details

510(k) Number K952148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1995
Decision Date June 29, 1995
Days to Decision 52 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
36d faster than avg
Panel avg: 88d · This submission: 52d
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 76
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K952148.
ABBOTT ARCHITECT TSH
K983442 · Abbott Laboratories · Nov 1998
ABBOTT AXSYM 3RD GENERATION TSH ASSAY
K981060 · Abbott Laboratories · Apr 1998
ELECSYS TSH ASSAY
K961491 · Boehringer Mannheim Corp. · Jul 1996
CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAY
K951796 · Ciba Corning Diagnostics Corp. · Jun 1995
COAT-A-COUNT NEONATAL TSH IRMA
K943195 · Diagnostic Products Corp. · Mar 1995
IMMULITE RAPID TSH
K933212 · Diagnostic Products Corp. · Dec 1994