Cleared Traditional

K883810 - DELFIA TRIIODOTHYRONINE (T3) KIT

K883810 is an FDA 510(k) clearance for DELFIA TRIIODOTHYRONINE (T3) KIT, manufactured by Pharmacia, Inc.. The device is a Class 2 Chemistry device with product code CDP cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K883810 · Pharmacia, Inc. · Chemistry device
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Dec 1988
Decision
85d
Days
Class 2
Risk

K883810 is an FDA 510(k) clearance for the DELFIA TRIIODOTHYRONINE (T3) KIT. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on December 2, 1988 after a review of 85 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.

FDA 510(k) Submission Details - K883810

510(k) Number K883810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1988
Decision Date December 02, 1988
Days to Decision 85 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
4d faster than avg
Panel avg: 89d · This submission: 85d
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 142
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K883810.
FREE T3 RADIOIMMUNOASSAY KIT
K894200 · Advanced Magnetics, Inc. · Sep 1989
T3 CLASP-BEAD EIA KIT
K893620 · Biotecx Laboratories, Inc. · Aug 1989
AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT
K885195 · Amersham Corp. · Feb 1989
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
K883810 · DELFIA TRIIODOTHYRONINE (T3) KIT
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