Cleared Traditional

K971141 - FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM

K971141 is an FDA 510(k) clearance for FT4 METHOD FOR THE DIMENSION RXL CLINIC..., manufactured by Dade Chemistry Systems, Inc.. The device is a Class 2 Chemistry device with product code CEC cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K971141 · Dade Chemistry Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
31d
Days
Class 2
Risk

K971141 is an FDA 510(k) clearance for the FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Dade Chemistry Systems, Inc. (Newark, US). The FDA issued a Cleared decision on April 28, 1997 after a review of 31 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 Dade Chemistry Systems, Inc. devices

FDA 510(k) Submission Details - K971141

510(k) Number K971141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1997
Decision Date April 28, 1997
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
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 73
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K971141.
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NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT
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K965142 · Johnson & Johnson Clinical Diagnostics, Inc. · Mar 1997
ACA PLUS FREE THYROXINE(FT4) METHOD
K962602 · Dade Intl., Inc. · Aug 1996