Cleared Traditional

K040631 - VITALAB DIRECT BILIRUBIN REAGENT

K040631 is an FDA 510(k) clearance for VITALAB DIRECT BILIRUBIN REAGENT, manufactured by Clinical Data, Inc.. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K040631 · Clinical Data, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
8d
Days
Class 2
Risk

K040631 is an FDA 510(k) clearance for the VITALAB DIRECT BILIRUBIN REAGENT. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Clinical Data, Inc. (Brea, US). The FDA issued a Cleared decision on March 18, 2004 after a review of 8 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 Clinical Data, Inc. devices

FDA 510(k) Submission Details - K040631

510(k) Number K040631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2004
Decision Date March 18, 2004
Days to Decision 8 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 88d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Entela, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CIG Diazo Colorimetry, Bilirubin

All 213
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K040631.
MODIFICATION TO ABL800 FLEX
K050869 · Radiometer Medical Aps · Aug 2005
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K051432 · Arkray, Inc. · Jun 2005
TOTAL BILIRUBIN REAGENT SET
K040391 · Pointe Scientific, Inc., · Jun 2004
WIENER LAB. BILIRUBINA DIRECT AA
K024116 · Wiener Laboratories Saic · Feb 2003
BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30
K023330 · Diagnostic Chemicals , Ltd. · Dec 2002
WIENER LAB. BILIRRUBINA TOTAL AA
K022962 · Wiener Laboratories Saic · Nov 2002