Cleared Traditional

K894145 - EMIT T-UPTAKE ASSAY

K894145 is an FDA 510(k) clearance for EMIT T-UPTAKE ASSAY, manufactured by Syva Co.. The device is a Class 2 Chemistry device with product code KHQ cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K894145 · Syva Co. · Chemistry device
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Sep 1989
Decision
83d
Days
Class 2
Risk

K894145 is an FDA 510(k) clearance for the EMIT T-UPTAKE ASSAY. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on September 5, 1989 after a review of 83 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 Syva Co. devices

FDA 510(k) Submission Details - K894145

510(k) Number K894145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1989
Decision Date September 05, 1989
Days to Decision 83 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
5d faster than avg
Panel avg: 88d · This submission: 83d
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 73
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K894145.
IL T UPTAKE ASSAY SYSTEM
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OPUS TM T-UPTAKE TEST SYSTEM
K902797 · Pb Diagnostic Systems, Inc. · Jul 1990
FIAGEN T3 UPTAKE CATALOGUE #101-402
K895186 · Cyberfluor, Inc. · Nov 1989
VENTREX COATED TUBE T3 UPTAKE
K891068 · Ventrex Laboratories, Inc. · Apr 1989
T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS
K883085 · Serono Diagnostics, Inc. · Sep 1988
EMIT CONVENIENCE PACK: T-UPTAKE ASSAY
K881855 · Syva Co. · Jun 1988