Cleared Traditional

K030014 - ATAC TOTAL BILIRUBIN REAGENT

K030014 is an FDA 510(k) clearance for ATAC TOTAL BILIRUBIN REAGENT, manufactured by Elan Diagnostics. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K030014 · Elan Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
267d
Days
Class 2
Risk

K030014 is an FDA 510(k) clearance for the ATAC TOTAL BILIRUBIN REAGENT. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Elan Diagnostics (Brea, US). The FDA issued a Cleared decision on September 26, 2003 after a review of 267 days - an extended review 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: 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.

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FDA 510(k) Submission Details - K030014

510(k) Number K030014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2003
Decision Date September 26, 2003
Days to Decision 267 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
179d slower than avg
Panel avg: 88d · This submission: 267d
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 216
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K030014.
SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS
K051432 · Arkray, Inc. · Jun 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
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