Cleared Traditional

K931704 - IMMULITE FREE T4

K931704 is the FDA 510(k) clearance for IMMULITE FREE T4 by Diagnostic Products Corp.. It is a Class 2 Chemistry device (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

Submission Details

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.

Device Classification

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 61
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
ACCESS(R) FREE T4 ASSAY
K925913 · Bio-Rad Laboratories, Inc. · Jan 1993