Cleared Traditional

K894238 - ABBOTT TDX TOTAL T3 PLUS

K894238 is an FDA 510(k) clearance for ABBOTT TDX TOTAL T3 PLUS, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code CDP cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K894238 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
132d
Days
Class 2
Risk

K894238 is an FDA 510(k) clearance for the ABBOTT TDX TOTAL T3 PLUS. 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 October 31, 1989 after a review of 132 days - within the typical 510(k) review window.

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: 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

FDA 510(k) Submission Details - K894238

510(k) Number K894238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1989
Decision Date October 31, 1989
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 88d · This submission: 132d
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 K894238.
CEDIA TOTAL T3 ASSAY
K904098 · Microgenics Corp. · Sep 1990
IMX FREE T3 CALCULATION
K903432 · Abbott Laboratories · Sep 1990
ENZYMUN TEST R T3
K896900 · Boehringer Mannheim Corp. · Feb 1990
MILENIA(TM) TOTAL T4 (MKT41,5)
K895840 · Diagnostic Products Corp. · Oct 1989
STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I.
K894993 · Baxter Healthcare Corp · Oct 1989
AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT
K885195 · Amersham Corp. · Feb 1989