Cleared Traditional

K971792 - IMMULITE FREE T4 (2-STEP)

K971792 is the FDA 510(k) clearance for IMMULITE FREE T4 (2-STEP) by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code CEC) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K971792 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
71d
Days
Class 2
Risk

K971792 is an FDA 510(k) clearance for the IMMULITE FREE T4 (2-STEP). 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 July 25, 1997 after a review of 71 days - a notably fast clearance cycle.

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: 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 K971792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1997
Decision Date July 25, 1997
Days to Decision 71 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
17d faster than avg
Panel avg: 88d · This submission: 71d
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 K971792.
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR
K053531 · Dade Behring, Inc. · Mar 2006
ABBOTT ARCHITECT FREE T4
K983417 · Abbott Laboratories · Nov 1998
ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K982250 · Beckman Instruments, Inc. · Jul 1998
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT
K962408 · Nichols Institute Diagnostics · Mar 1997
ELECSYS FT4 ASSAY
K961489 · Boehringer Mannheim Corp. · Jun 1996
COBAS CORE FREE T3 EIA
K942376 · Roche Diagnostic Systems, Inc. · Apr 1995