Cleared Traditional

K810586 - EMIT-TFG PRISMA THYROXINE ASSAY

K810586 is the FDA 510(k) clearance for EMIT-TFG PRISMA THYROXINE ASSAY by Syva Co.. It is a Class 2 Chemistry device (product code KLI) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K810586 · Syva Co. · Chemistry device
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Mar 1981
Decision
13d
Days
Class 2
Risk

K810586 is an FDA 510(k) clearance for the EMIT-TFG PRISMA THYROXINE ASSAY. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1981 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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 K810586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1981
Decision Date March 17, 1981
Days to Decision 13 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
75d faster than avg
Panel avg: 88d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
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 - KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

All 56
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K810586.
SOPHEIA THYROXINE EIA KIT
K823751 · Diagnostic Products Corp. · Jan 1983
SYVA ADVANCE THYROXINE ASSAY
K823034 · Syva Co. · Nov 1982
ENZYMUNE-TEST T4
K820750 · Icl Scientific · Apr 1982
OREIA-Q-TY, ENZYME IMMUNOASSAY
K802693 · Organon, Inc. · Dec 1980
APPLICATION OF EMIT AED ASSAYS
K801475 · Syva Co. · Jul 1980
EMIT AAII THYROXINE ASSAY
K801288 · Syva Co. · Jun 1980