Cleared Traditional

K944808 - IMX T3 ASSAY

K944808 is an FDA 510(k) clearance for IMX T3 ASSAY, manufactured by Organon Teknika Corp.. The device is a Class 2 Chemistry device with product code CDP cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K944808 · Organon Teknika Corp. · Chemistry device
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Dec 1994
Decision
71d
Days
Class 2
Risk

K944808 is an FDA 510(k) clearance for the IMX T3 ASSAY. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on December 9, 1994 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K944808

510(k) Number K944808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1994
Decision Date December 09, 1994
Days to Decision 71 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
17d faster than avg
Panel avg: 88d · This submission: 71d
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 Chemistry 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 K944808.
TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS
K952557 · Sigma Diagnostics, Inc. · Jan 1996
ACCESS TOTAL T3 ASSAY (MODIFICATION)
K955435 · Bio-Rad Laboratories, Inc. · Jan 1996
OPUS T3
K953160 · Behring Diagnostics, Inc. · Aug 1995
ACCESS(R) TOTAL T3
K940833 · Bio-Rad Laboratories, Inc. · Sep 1994
AIA-PACK TT3 ASSAY
K936229 · Tosoh Medics, Inc. · Jul 1994
AXSYM TOTAL T3
K934517 · Abbott Laboratories · Jun 1994