Cleared Traditional

K770241 - NEONATAL T4 RIA KIT

K770241 is the FDA 510(k) clearance for NEONATAL T4 RIA KIT by Diagnostic Products Corp.. It is a Class 2 Immunology device (product code CDX) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K770241 · Diagnostic Products Corp. · Immunology device
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Feb 1977
Decision
7d
Days
Class 2
Risk

K770241 is an FDA 510(k) clearance for the NEONATAL 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 February 14, 1977 after a review of 7 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K770241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1977
Decision Date February 14, 1977
Days to Decision 7 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
97d faster than avg
Panel avg: 104d · This submission: 7d
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 Immunology devices follow this clearance model.

Regulatory Peers - CDX Radioimmunoassay, Total Thyroxine

All 57
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K770241.
REAGENT SET, T-4, CPB
K770737 · G.D. Searle and Co. · Jun 1977
T-4 RIA REAGENT SET
K770676 · G.D. Searle and Co. · May 1977
THYROSCREEN TM T4 DIAGNOSTIC KIT
K770474 · Abbott Laboratories · Apr 1977
SPAC TM T4 RIA KIT
K770156 · Mallinckrodt Critical Care · Feb 1977
SERALUTE
K760572 · Miles Laboratories, Inc. · Nov 1976
RADIOIMMUNOASSAY
K760227 · Kallestad Laboratories, Inc. · Jul 1976