Cleared Traditional

AIA-PACK TT3 ASSAY (K936229) - FDA 510(k) Clearance

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

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

Submission Details

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
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.

Device Classification

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 143
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K936229.
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K983434 · Abbott Laboratories · Nov 1998
ABBOTT ARCHITECT FREE T3
K983439 · Abbott Laboratories · Nov 1998
IMMULITE FREE T3
K974634 · Diagnostic Products Corp. · Jan 1998
ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K973966 · Beckman Instruments, Inc. · Oct 1997
ELECSYS FT3
K963127 · Boehringer Mannheim Corp. · Dec 1996
ENZYMUN-TEST FT3
K962760 · Boehringer Mannheim Corp. · Nov 1996