Cleared Traditional

K780219 - ANALYSIS SYS.

K780219 is the FDA 510(k) clearance for ANALYSIS SYS. by Syva Co.. It is a Class 2 Chemistry device (product code CDX) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K780219 · Syva Co. · Chemistry device
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Mar 1978
Decision
21d
Days
Class 2
Risk

K780219 is an FDA 510(k) clearance for the ANALYSIS SYS., EMIT MAN. THYROXINE ASSAY. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on March 3, 1978 after a review of 21 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 K780219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1978
Decision Date March 03, 1978
Days to Decision 21 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
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDX Radioimmunoassay, 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 - CDX Radioimmunoassay, Total Thyroxine

All 68
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K780219.
THYRO-ZYME-T4 ASSAY KIT
K780401 · Coulter Electronics, Inc. · Apr 1978
OREIA-T4
K780308 · Organon, Inc. · Apr 1978
REAGENTS, MANUEAL, ASSAY, THYROXINE
K780121 · Syva Co. · Mar 1978
T4 RIA KIT
K772330 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1978
EMIT CENTRIFICHEM THYROXINE ASSAY
K772170 · Syva Co. · Dec 1977
PEDIATRIC THYROXINE TEST SYS. T4
K771609 · Corning Medical & Scientific · Dec 1977