Cleared Traditional

K934517 - AXSYM TOTAL T3

K934517 is an FDA 510(k) clearance for AXSYM TOTAL T3, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code CDP cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K934517 · Abbott Laboratories · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
274d
Days
Class 2
Risk

K934517 is an FDA 510(k) clearance for the AXSYM TOTAL T3. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), 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 274 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1710 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K934517

510(k) Number K934517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1993
Decision Date June 21, 1994
Days to Decision 274 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 87d · This submission: 274d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDP Device Classification - Class 2, Special Controls

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 Toxicology devices follow this clearance model.

Regulatory Peers - CDP Radioimmunoassay, Total Triiodothyronine

All 104
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K934517.
IMX T3 ASSAY
K944808 · Organon Teknika Corp. · Dec 1994
ACCESS(R) TOTAL T3
K940833 · Bio-Rad Laboratories, Inc. · Sep 1994
AIA-PACK TT3 ASSAY
K936229 · Tosoh Medics, Inc. · Jul 1994
VIDAS T3 ASSAY
K934764 · Biomerieux Vitek, Inc. · Mar 1994
COBAS(R) CORE T3 EIA
K932608 · Roche Diagnostic Systems, Inc. · Dec 1993
CIBA CORNING ACS FREE T3 IMMUNOASSAY
K932747 · Ciba Corning Diagnostics Corp. · Dec 1993