Cleared Traditional

AXSYM ULTRASENSITIVE HTSH (K934410) - FDA 510(k) Clearance

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

K934410 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
284d
Days
Class 2
Risk

K934410 is an FDA 510(k) clearance for the AXSYM ULTRASENSITIVE HTSH. 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 21, 1994 after a review of 284 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

Submission Details

510(k) Number K934410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1993
Decision Date June 21, 1994
Days to Decision 284 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
196d slower than avg
Panel avg: 88d · This submission: 284d
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 K934410.
RADIAS NEONATAL TSH ENZYME IMMUNOASSAY
K935399 · Bio-Rad · Dec 1994
IMMULITE THIRD GENERATION (MODIFICATION)
K940006 · Diagnostic Products Corp. · Dec 1994
IMX ULTRASENSISTIVE HTSH II
K942566 · Abbott Laboratories · Aug 1994
RADIAS 3RD GENERATION TSH IMMUNOASSAY
K935119 · Bio-Rad · Apr 1994
COBAS CORE TSH EIA
K930776 · Roche Diagnostic Systems, Inc. · Dec 1993
SIA THYROID STIMULATING HORMONE ELISA KIT
K930050 · Sigma Chemical Co. · Aug 1993