Cleared Traditional

K880087 - ABBOTT IMX T3

K880087 is an FDA 510(k) clearance for ABBOTT IMX T3, 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 97-day FDA review.

K880087 · Abbott Laboratories · Chemistry device
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Apr 1988
Decision
97d
Days
Class 2
Risk

K880087 is an FDA 510(k) clearance for the ABBOTT IMX 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 April 18, 1988 after a review of 97 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 - K880087

510(k) Number K880087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1988
Decision Date April 18, 1988
Days to Decision 97 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 88d · This submission: 97d
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 K880087.
STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME
K883479 · Baxter Healthcare Corp · Oct 1988
IMMPULSE T, ASSAY REAGENTS
K881214 · Sclavo, Inc. · May 1988
AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT
K881373 · Amersham Corp. · May 1988
T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE
K880388 · Serono Diagnostics, Inc. · Mar 1988
CIBA CORNING MAGIC LITE T3 IMMUNOASSAY
K873945 · Ciba Corning Diagnostics Corp. · Nov 1987
AMERLITE TT3 ASSAY, LAN.0003/1003/2003
K873858 · Amersham Corp. · Nov 1987