Cleared Traditional

VISTA TRIIODOTHYRONINE ASSAY (K923571) - FDA 510(k) Clearance

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

K923571 · Syva Co. · Chemistry device
Download Printable Device Report (PDF)
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Oct 1992
Decision
90d
Days
Class 2
Risk

K923571 is an FDA 510(k) clearance for the VISTA TRIIODOTHYRONINE ASSAY. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on October 15, 1992 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - 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.

View all Syva Co. devices

Submission Details

510(k) Number K923571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1992
Decision Date October 15, 1992
Days to Decision 90 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
2d slower than avg
Panel avg: 88d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 - CDP Radioimmunoassay, Total Triiodothyronine

All 143
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K923571.
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K983439 · Abbott Laboratories · Nov 1998
AXSYM FREE TRIIODOTHYRONINE (FREE T3)
K963827 · Abbott Laboratories · Oct 1996
IMX FREE TRIIODOTHYRONINE (FREE T3)
K963833 · Abbott Laboratories · Oct 1996
AXSYM TOTAL T3
K934517 · Abbott Laboratories · Jun 1994
IMX FREE TRIIODOTHYRONINE
K905261 · Abbott Laboratories · Jan 1991