Cleared Traditional

K051432 - SPOTCHEM II TOTAL BILIRUBIN

K051432 is an FDA 510(k) clearance for SPOTCHEM II TOTAL BILIRUBIN, manufactured by Arkray, Inc.. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K051432 · Arkray, Inc. · Chemistry device
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Jun 2005
Decision
16d
Days
Class 2
Risk

K051432 is an FDA 510(k) clearance for the SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Arkray, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on June 17, 2005 after a review of 16 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 Arkray, Inc. devices

FDA 510(k) Submission Details - K051432

510(k) Number K051432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2005
Decision Date June 17, 2005
Days to Decision 16 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 88d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIG Device Classification - Class 2, Special Controls

Product Code CIG Diazo Colorimetry, 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 - CIG Diazo Colorimetry, Bilirubin

All 186
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K051432.
TOTAL BILIRUBIN
K060574 · Abbott Laboratories · May 2006
DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR
K060628 · Dade Behring, Inc. · Apr 2006
MODIFICATION TO ABL800 FLEX
K050869 · Radiometer Medical Aps · Aug 2005
TOTAL BILIRUBIN REAGENT SET
K040391 · Pointe Scientific, Inc., · Jun 2004
VITALAB DIRECT BILIRUBIN REAGENT
K040631 · Clinical Data, Inc. · Mar 2004
WIENER LAB. BILIRUBINA DIRECT AA
K024116 · Wiener Laboratories Saic · Feb 2003