Cleared Traditional

K024116 - WIENER LAB. BILIRUBINA DIRECT AA

K024116 is an FDA 510(k) clearance for WIENER LAB. BILIRUBINA DIRECT AA, manufactured by Wiener Laboratories Saic. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K024116 · Wiener Laboratories Saic · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
61d
Days
Class 2
Risk

K024116 is an FDA 510(k) clearance for the WIENER LAB. BILIRUBINA DIRECT AA. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Wiener Laboratories Saic (Rosario, Santa Fe, AR). The FDA issued a Cleared decision on February 12, 2003 after a review of 61 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 Wiener Laboratories Saic devices

FDA 510(k) Submission Details - K024116

510(k) Number K024116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2002
Decision Date February 12, 2003
Days to Decision 61 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
27d faster than avg
Panel avg: 88d · This submission: 61d
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 185
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K024116.
MODIFICATION TO ABL800 FLEX
K050869 · Radiometer Medical Aps · Aug 2005
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VITALAB DIRECT BILIRUBIN REAGENT
K040631 · Clinical Data, Inc. · Mar 2004
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
TOTAL BILIRUBIN
K022339 · Abbott Laboratories · Sep 2002