Cleared Traditional

K884201 - FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOAS...

K884201 is the FDA 510(k) clearance for FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOAS... by Cyberfluor, Inc.. It is a Class 2 Chemistry device (product code CEE) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K884201 · Cyberfluor, Inc. · Chemistry device
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Dec 1988
Decision
69d
Days
Class 2
Risk

K884201 is an FDA 510(k) clearance for the FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT. Classified as Radioimmunoassay, Thyroxine-binding Globulin (product code CEE), Class II - Special Controls.

Submitted by Cyberfluor, Inc. (Ontario M5t 1x4, CA). The FDA issued a Cleared decision on December 14, 1988 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1685 - 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 Cyberfluor, Inc. devices

Submission Details

510(k) Number K884201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1988
Decision Date December 14, 1988
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 88d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEE Radioimmunoassay, Thyroxine-binding Globulin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1685
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 - CEE Radioimmunoassay, Thyroxine-binding Globulin

All 16
Devices cleared under the same product code (CEE) and FDA review panel - the closest regulatory comparables to K884201.
ENZYMUN TEST(R) TBK
K896991 · Boehringer Mannheim Corp. · Mar 1990
AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT
K893469 · Amersham Corp. · Aug 1989
T-UPTAKE MICROASSAY
K885034 · Diamedix Corp. · Feb 1989
TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C)
K874658 · Technicon Instruments Corp. · Dec 1987
ENZYMUN TEST TBG
K862109 · Boehringer Mannheim Corp. · Jun 1986
THYROXINE-BINDING GLOBULIN RADIOUMMU
K842010 · Nichols Institute Diagnostics · Jun 1984