Cleared Special

K050869 - MODIFICATION TO ABL800 FLEX

K050869 is an FDA 510(k) clearance for MODIFICATION TO ABL800 FLEX, manufactured by Radiometer Medical Aps. The device is a Class 2 Chemistry device with product code CIG cleared through the Special 510(k) pathway after a 127-day FDA review.

K050869 · Radiometer Medical Aps · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
127d
Days
Class 2
Risk

K050869 is an FDA 510(k) clearance for the MODIFICATION TO ABL800 FLEX. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Radiometer Medical Aps (Washington, US). The FDA issued a Cleared decision on August 11, 2005 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Radiometer Medical Aps devices

FDA 510(k) Submission Details - K050869

510(k) Number K050869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2005
Decision Date August 11, 2005
Days to Decision 127 days
Submission Type Special
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
39d slower than avg
Panel avg: 88d · This submission: 127d
Pathway characteristics
Modification to existing cleared device.

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 K050869.
DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR
K061719 · Dade Behring, Inc. · Aug 2006
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
VITALAB DIRECT BILIRUBIN REAGENT
K040631 · Clinical Data, Inc. · Mar 2004
WIENER LAB. BILIRUBINA DIRECT AA
K024116 · Wiener Laboratories Saic · Feb 2003