Cleared Traditional

K904660 - ENZYMATIC BILIRUBIN (TOTAL)

K904660 is the FDA 510(k) clearance for ENZYMATIC BILIRUBIN (TOTAL) by Diagnostic Chemicals, Ltd. (Usa). It is a Class 2 Chemistry device (product code JFM) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K904660 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Nov 1990
Decision
36d
Days
Class 2
Risk

K904660 is an FDA 510(k) clearance for the ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14. Classified as Enzymatic Method, Bilirubin (product code JFM), Class II - Special Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Charlottestown,Pei,Canada, CA). The FDA issued a Cleared decision on November 20, 1990 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - 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 Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K904660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1990
Decision Date November 20, 1990
Days to Decision 36 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
52d faster than avg
Panel avg: 88d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFM Enzymatic Method, Bilirubin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1110
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 - JFM Enzymatic Method, Bilirubin

All 8
Devices cleared under the same product code (JFM) and FDA review panel - the closest regulatory comparables to K904660.
DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
K053090 · Beckman Coulter, Inc. · Dec 2005
DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR
K050266 · Stanbio Laboratory · Jun 2005
WAKO TOTAL BILIRUBIN V
K970985 · Wako Chemicals USA, Inc. · Apr 1997
DRI-STAT ENZYMATIC BILIRUBIN TEST KIT
K843174 · Beckman Instruments, Inc. · Sep 1984