Cleared Traditional

K892224 - D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTA...

K892224 is the FDA 510(k) clearance for D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTA... by Photec Diagnostics, Inc.. It is a Class 2 Chemistry device (product code KHQ) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K892224 · Photec Diagnostics, Inc. · Chemistry device
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Jun 1989
Decision
74d
Days
Class 2
Risk

K892224 is an FDA 510(k) clearance for the D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Photec Diagnostics, Inc. (Little Falls, US). The FDA issued a Cleared decision on June 16, 1989 after a review of 74 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 Photec Diagnostics, Inc. devices

Submission Details

510(k) Number K892224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1989
Decision Date June 16, 1989
Days to Decision 74 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 88d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 55
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K892224.
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K881855 · Syva Co. · Jun 1988
EMIT T-UPTAKE ASSAY THYROID HORMONE BINDING RATIO
K880619 · Syva Co. · Apr 1988