Cleared Traditional

K770241 - NEONATAL T4 RIA KIT

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

K770241 · Diagnostic Products Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K770241

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
98d faster than avg
Panel avg: 105d · This submission: 7d
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 93
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K770241.
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
THYROSCREEN TM T4 DIAGNOSTIC KIT
K770474 · Abbott Laboratories · Apr 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
SERALUTE
K760572 · Miles Laboratories, Inc. · Nov 1976