Cleared Traditional

K874623 - FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101

K874623 is an FDA 510(k) clearance for FIAGEN(TM) THYROXINE (T4), manufactured by Cyberfluor, Inc.. The device is a Class 2 Chemistry device with product code CDX cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K874623 · Cyberfluor, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1988
Decision
98d
Days
Class 2
Risk

K874623 is an FDA 510(k) clearance for the FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Cyberfluor, Inc. (Ontario M5t 1x4, CA). The FDA issued a Cleared decision on February 16, 1988 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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 Cyberfluor, Inc. devices

FDA 510(k) Submission Details - K874623

510(k) Number K874623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1987
Decision Date February 16, 1988
Days to Decision 98 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 88d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDX Device Classification - Class 2, Special Controls

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 Chemistry devices follow this clearance model.

Regulatory Peers - CDX Radioimmunoassay, Total Thyroxine

All 93
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K874623.
NEOCOAT T4
K901939 · Neometrics, Inc. · May 1990
TECHNICON RA SYSTEM THYROXINE T4 METHOD
K894575 · Technicon Instruments Corp. · Oct 1989
DELFIA THYROXINE (T4) KIT
K883559 · Pharmacia, Inc. · Dec 1988
IMMPULSE T4 ASSAY REAGENTS
K875081 · Sclavo, Inc. · Feb 1988
CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY
K872286 · Ciba Corning Diagnostics Corp. · Jul 1987
DELFIA(TM) THYROXINE (T4) KIT
K871303 · Lkb Instruments, Inc. · Jun 1987