Cleared Traditional

K040631 - VITALAB DIRECT BILIRUBIN REAGENT

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

K040631 · Clinical Data, Inc. · Chemistry device
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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

Submission Details

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
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.

Device Classification

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 124
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K040631.
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
TOTAL BILIRUBIN REAGENT SET
K040391 · Pointe Scientific, Inc., · Jun 2004
BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30
K023330 · Diagnostic Chemicals , Ltd. · Dec 2002
TOTAL BILIRUBIN
K022339 · Abbott Laboratories · Sep 2002
DIRECT BILIRUBIN
K022180 · Abbott Laboratories · Sep 2002