Cleared Traditional

K885259 - ACA THYRONINE UPTAKE (TU E) METHOD

K885259 is an FDA 510(k) clearance for ACA THYRONINE UPTAKE (TU E) METHOD, manufactured by The DU Pont Co.. The device is a Class 2 Chemistry device with product code KHQ cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K885259 · The DU Pont Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1989
Decision
56d
Days
Class 2
Risk

K885259 is an FDA 510(k) clearance for the ACA THYRONINE UPTAKE (TU E) METHOD. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by The DU Pont Co. (Wilmington, US). The FDA issued a Cleared decision on February 17, 1989 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1715 - 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 The DU Pont Co. devices

FDA 510(k) Submission Details - K885259

510(k) Number K885259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1988
Decision Date February 17, 1989
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 88d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHQ Device Classification - Class 2, Special Controls

Product Code KHQ Radioassay, Triiodothyronine Uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1715
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 - KHQ Radioassay, Triiodothyronine Uptake

All 60
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K885259.
OPUS TM T-UPTAKE TEST SYSTEM
K902797 · Pb Diagnostic Systems, Inc. · Jul 1990
EMIT T-UPTAKE ASSAY
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VENTREX COATED TUBE T3 UPTAKE
K891068 · Ventrex Laboratories, Inc. · Apr 1989
EMIT CONVENIENCE PACK: T-UPTAKE ASSAY
K881855 · Syva Co. · Jun 1988
EMIT T-UPTAKE ASSAY THYROID HORMONE BINDING RATIO
K880619 · Syva Co. · Apr 1988
AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144
K874362 · Amersham Corp. · Feb 1988