Cleared Traditional

K936229 - AIA-PACK TT3 ASSAY

K936229 is an FDA 510(k) clearance for AIA-PACK TT3 ASSAY, manufactured by Tosoh Medics, Inc.. The device is a Class 2 Toxicology device with product code CDP cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K936229 · Tosoh Medics, Inc. · Toxicology device
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Jul 1994
Decision
197d
Days
Class 2
Risk

K936229 is an FDA 510(k) clearance for the AIA-PACK TT3 ASSAY. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Tosoh Medics, Inc. (Foster City, US). The FDA issued a Cleared decision on July 14, 1994 after a review of 197 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 Tosoh Medics, Inc. devices

FDA 510(k) Submission Details - K936229

510(k) Number K936229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1993
Decision Date July 14, 1994
Days to Decision 197 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 87d · This submission: 197d
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 118
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K936229.
OPUS T3
K953160 · Behring Diagnostics, Inc. · Aug 1995
IMX T3 ASSAY
K944808 · Organon Teknika Corp. · Dec 1994
ACCESS(R) TOTAL T3
K940833 · Bio-Rad Laboratories, Inc. · Sep 1994
AXSYM TOTAL T3
K934517 · Abbott Laboratories · Jun 1994
VIDAS T3 ASSAY
K934764 · Biomerieux Vitek, Inc. · Mar 1994
COBAS(R) CORE T3 EIA
K932608 · Roche Diagnostic Systems, Inc. · Dec 1993