Cleared Traditional

K921904 - THYROXINE (FPIA) KIT

K921904 is an FDA 510(k) clearance for THYROXINE (FPIA) KIT, manufactured by Tudor Laboratories, Inc.. The device is a Class 2 Chemistry device with product code KLI cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K921904 · Tudor Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
64d
Days
Class 2
Risk

K921904 is an FDA 510(k) clearance for the THYROXINE (FPIA) KIT. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Tudor Laboratories, Inc. (Dallas, US). The FDA issued a Cleared decision on June 24, 1992 after a review of 64 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 Tudor Laboratories, Inc. devices

FDA 510(k) Submission Details - K921904

510(k) Number K921904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1992
Decision Date June 24, 1992
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLI Device Classification - Class 2, Special Controls

Product Code KLI Enzyme Immunoassay, Non-radiolabeled, 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 - KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

All 71
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K921904.
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CEDIA T4
K915194 · Boehringer Mannheim Corp. · Dec 1991
TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES
K912616 · Technicon Instruments Corp. · Sep 1991