Cleared Traditional

K770474 - THYROSCREEN TM T4 DIAGNOSTIC KIT

K770474 is an FDA 510(k) clearance for THYROSCREEN TM T4 DIAGNOSTIC KIT, manufactured by Abbott Laboratories. The device is a Class 2 Immunology device with product code CDX cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K770474 · Abbott Laboratories · Immunology device
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Apr 1977
Decision
48d
Days
Class 2
Risk

K770474 is an FDA 510(k) clearance for the THYROSCREEN TM T4 DIAGNOSTIC KIT. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 28, 1977 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1700 - the FDA immunology device 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K770474

510(k) Number K770474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1977
Decision Date April 28, 1977
Days to Decision 48 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 104d · This submission: 48d
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 Immunology devices follow this clearance model.

Regulatory Peers - CDX Radioimmunoassay, Total Thyroxine

All 81
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K770474.
REAGENT SET, T-4, CPB
K770737 · G.D. Searle and Co. · Jun 1977
TOTAL THYROXINE (RIA) REAGENT SET
K770940 · The Dow Chemical Co. · Jun 1977
T-4 RIA REAGENT SET
K770676 · G.D. Searle and Co. · May 1977
NEONATAL T4 RIA KIT
K770241 · Diagnostic Products Corp. · Feb 1977
SPAC TM T4 RIA KIT
K770156 · Mallinckrodt Critical Care · Feb 1977
DATA-TOPE T4 RIA PROCEDURE
K761282 · Dade, Baxter Travenol Diagnostics, Inc. · Dec 1976