Cleared Traditional

K884260 - THYROXINE MICROASSAY

K884260 is an FDA 510(k) clearance for THYROXINE MICROASSAY, manufactured by Diamedix Corp.. The device is a Class 2 Chemistry device with product code KLI cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K884260 · Diamedix Corp. · Chemistry device
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Feb 1989
Decision
135d
Days
Class 2
Risk

K884260 is an FDA 510(k) clearance for the THYROXINE MICROASSAY. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on February 23, 1989 after a review of 135 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K884260

510(k) Number K884260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1988
Decision Date February 23, 1989
Days to Decision 135 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
47d slower than avg
Panel avg: 88d · This submission: 135d
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 85
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K884260.
D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.
K896329 · Photec Diagnostics, Inc. · Dec 1989
T4 CLASP-BEAD EIA KIT
K892853 · Biotecx Laboratories, Inc. · May 1989
EMIT CONVENIENCE PACK: THYROXINE ASSAY
K890831 · Syva Co. · Apr 1989
EMIT THYROXINE ASSAY
K885141 · Syva Co. · Feb 1989
ACA THYROXINE (T4 E) METHOD
K885258 · The DU Pont Co. · Feb 1989
ANALYST THYROXINE (T4) ROTOR
K884700 · The DU Pont Co. · Jan 1989
K884260 · THYROXINE MICROASSAY
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