Cleared Traditional

K871303 - DELFIA(TM) THYROXINE (T4) KIT

K871303 is the FDA 510(k) clearance for DELFIA(TM) THYROXINE (T4) KIT by Lkb Instruments, Inc.. It is a Class 2 Chemistry device (product code CDX) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K871303 · Lkb Instruments, Inc. · Chemistry device
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Jun 1987
Decision
77d
Days
Class 2
Risk

K871303 is an FDA 510(k) clearance for the DELFIA(TM) THYROXINE (T4) KIT. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Lkb Instruments, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on June 17, 1987 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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 Lkb Instruments, Inc. devices

Submission Details

510(k) Number K871303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1987
Decision Date June 17, 1987
Days to Decision 77 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
11d faster than avg
Panel avg: 88d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDX Radioimmunoassay, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
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 - CDX Radioimmunoassay, Total Thyroxine

All 68
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K871303.
DELFIA THYROXINE (T4) KIT
K883559 · Pharmacia, Inc. · Dec 1988
IMMPULSE T4 ASSAY REAGENTS
K875081 · Sclavo, Inc. · Feb 1988
CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY
K872286 · Ciba Corning Diagnostics Corp. · Jul 1987
MICROMEDIC NEONATAL T4 KIT
K871008 · Micromedic Systems · May 1987
CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY
K870965 · Ciba Corning Diagnostics Corp. · May 1987
IQ T4 IMMUNOASSAY
K864560 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1986