Cleared Traditional

K931704 - IMMULITE FREE T4

K931704 is an FDA 510(k) clearance for IMMULITE FREE T4, manufactured by Diagnostic Products Corp.. The device is a Class 2 Chemistry device with product code CEC cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K931704 · Diagnostic Products Corp. · Chemistry device
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Aug 1993
Decision
132d
Days
Class 2
Risk

K931704 is an FDA 510(k) clearance for the IMMULITE FREE T4. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on August 16, 1993 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K931704

510(k) Number K931704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1993
Decision Date August 16, 1993
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 88d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEC Device Classification - Class 2, Special Controls

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
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 - CEC Radioimmunoassay, Free Thyroxine

All 77
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K931704.
COBAS(R) CORE FT4 EIA
K932607 · Roche Diagnostic Systems, Inc. · Jan 1994
FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R)
K930322 · Heraeus Kulzer, Inc. · Nov 1993
STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC
K932912 · Baxter Diagnostics, Inc. · Oct 1993
RADIAS FREE T4 ENZYME IMMUNOASSAY
K931110 · Bio-Rad · May 1993
BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM
K925842 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1993
NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY
K925649 · Solarcare Technologies Corp,Inc. · Mar 1993