Cleared Traditional

K050266 - DIRECT BILIRUBIN LIQUICOLOR AND TOTAL B...

K050266 is the FDA 510(k) clearance for DIRECT BILIRUBIN LIQUICOLOR AND TOTAL B... by Stanbio Laboratory. It is a Class 2 Chemistry device (product code JFM) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K050266 · Stanbio Laboratory · Chemistry device
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Jun 2005
Decision
146d
Days
Class 2
Risk

K050266 is an FDA 510(k) clearance for the DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR. Classified as Enzymatic Method, Bilirubin (product code JFM), Class II - Special Controls.

Submitted by Stanbio Laboratory (Boerne, US). The FDA issued a Cleared decision on June 30, 2005 after a review of 146 days - within the typical 510(k) review window.

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: 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 Stanbio Laboratory devices

Submission Details

510(k) Number K050266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2005
Decision Date June 30, 2005
Days to Decision 146 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
58d slower than avg
Panel avg: 88d · This submission: 146d
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 K050266.
WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
K053131 · Wako Chemicals USA, Inc. · Dec 2005
WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791
K053132 · Wako Chemicals USA, Inc. · Dec 2005
DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
K053090 · Beckman Coulter, Inc. · Dec 2005
WAKO TOTAL BILIRUBIN V
K970985 · Wako Chemicals USA, Inc. · Apr 1997
ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14
K904660 · Diagnostic Chemicals, Ltd. (Usa) · Nov 1990
DRI-STAT ENZYMATIC BILIRUBIN TEST KIT
K843174 · Beckman Instruments, Inc. · Sep 1984