Cleared Traditional

K821554 - ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT

K821554 is the FDA 510(k) clearance for ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT by Amf Biological and Diagnostics Co.. It is a Class 2 Chemistry device (product code CDX) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K821554 · Amf Biological and Diagnostics Co. · Chemistry device
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Jun 1982
Decision
31d
Days
Class 2
Risk

K821554 is an FDA 510(k) clearance for the ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Amf Biological and Diagnostics Co. (Mchenry, US). The FDA issued a Cleared decision on June 25, 1982 after a review of 31 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 Amf Biological and Diagnostics Co. devices

Submission Details

510(k) Number K821554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1982
Decision Date June 25, 1982
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 88d · This submission: 31d
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 72
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K821554.
COAT-A-COUNT NEONATAL T4 KIT RIA KIT
K831107 · Diagnostic Products Corp. · May 1983
MONOCLONAL ANTIBODY T4 RADIO-KIT
K823265 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1982
LEECO T4 QUANT DIAGNOSTICS TEST KIT
K822399 · Leeco Diagnostics, Inc. · Sep 1982
SPAC T4 RIA TEST KIT
K820725 · Mallinckrodt Critical Care · Jun 1982
ENDAB T4 ENZYME IMMUNOASSAY KIT
K821141 · Immunotech Corp. · May 1982
QUANTAPHASE T-4 RIA
K811787 · Bio-Rad · Jul 1981