Cleared Traditional

K811315 - COAT-A-COUNT T4 RIA KIT

K811315 is an FDA 510(k) clearance for COAT-A-COUNT T4 RIA KIT, manufactured by Diagnostic Products Corp.. The device is a Class 2 Chemistry device with product code CDX cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K811315 · Diagnostic Products Corp. · Chemistry device
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May 1981
Decision
16d
Days
Class 2
Risk

K811315 is an FDA 510(k) clearance for the COAT-A-COUNT T4 RIA KIT. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on May 27, 1981 after a review of 16 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 Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K811315

510(k) Number K811315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1981
Decision Date May 27, 1981
Days to Decision 16 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
72d faster than avg
Panel avg: 88d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDX Device Classification - Class 2, Special Controls

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 93
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K811315.
ENDAB T4 ENZYME IMMUNOASSAY KIT
K821141 · Immunotech Corp. · May 1982
THYROXINE T4 KIT
K820886 · Pcl-Ria, Inc. · Apr 1982
QUANTAPHASE T-4 RIA
K811787 · Bio-Rad · Jul 1981
125 I-T4 RIA TEST KIT
K811070 · Intl. Immunoassay Laboratories, Inc. · Apr 1981
IMMU-TRACE T4 RIA PROCEDURE
K803046 · American Dade · Jan 1981
SERUM T4 BY ENZYME IMMUNOASSAY
K802573 · Worthington Diagnostic Systems · Nov 1980