Cleared Traditional

NEONATAL T4 RIA KIT (K770241) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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
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 120
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K770241.
ELECSYS T4 ASSAY
K961490 · Boehringer Mannheim Corp. · Jun 1996
AXSYM(TM) TOTAL T4
K934384 · Abbott Laboratories · Jun 1994
ABBOTT IMX T4
K925110 · Abbott Laboratories · Jan 1993
ABBOTT TDX/TDXFLX TT4
K925109 · Abbott Laboratories · Jan 1993
MILENIA TOTAL T4, CATALOG: MKT41,5
K912541 · Diagnostic Products Corp. · Aug 1991
THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM
K904816 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1991