Cleared Traditional

VISTA THYROXINE UPTAKE ASSAY (K923676) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K923676 · Syva Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
79d
Days
Class 2
Risk

K923676 is an FDA 510(k) clearance for the VISTA THYROXINE UPTAKE ASSAY. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on October 9, 1992 after a review of 79 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

Submission Details

510(k) Number K923676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1992
Decision Date October 09, 1992
Days to Decision 79 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 88d · This submission: 79d
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 92
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K923676.
ELECSYS T-UPTAKE ASSAY
K961488 · Boehringer Mannheim Corp. · Jun 1996
CEDIA T UPTAKE ASSAY
K954807 · Boehringer Mannheim Corp. · Dec 1995
AXSYM(TM) T-UPTAKE
K934312 · Abbott Laboratories · Jun 1994
IL T UPTAKE ASSAY SYSTEM
K903396 · Instrumentation Laboratory CO · Oct 1990
EMIT T-UPTAKE ASSAY
K894145 · Syva Co. · Sep 1989
EMIT CONVENIENCE PACK: T-UPTAKE ASSAY
K881855 · Syva Co. · Jun 1988