# K060628: Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi Calibrator

- Pathway: 510(k) (Special)
- Applicant: Dade Behring, Inc.
- Decided: Apr 6, 2006 after 28 days
- Product code: CIG (Diazo Colorimetry, Bilirubin)
- Device class: 2
- Regulation: 21 CFR 862.1110
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K861700 (1986). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861700: Dimension (TM) Clinical Chemistry System, E.I. Dupont DE Nemours & Co., Inc. (1986) Summary page 1.
- K862359: Meth./Cali./Intru. Check for the Dimension System, E.I. Dupont DE Nemours & Co., Inc. (1986) Summary page 1.

## Most influential descendants
- K222104: Atellica® CH Diazo Total Bilirubin (D_TBil) (2023), 0 descendants of its own

## Recalls of this device
- Feb 13, 2020 · Class II · Z-1540-2020: Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

## Indications for use
TBI Flex® reagent cartridge: The TBI method for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder disease. DBI Flex® reagent cartridge: The DBI method for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure direct bilirubin in human serum and plasma. Measurements of direct bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder disease. TBI/DB1 Calibrator: The Dimension® Bilirubin Calibrator is an in vitro diagnostic product intended to be used to calibrate the Direct Bilirubin (DBI) and Total Bilirubin (TBI) methods for the Dimension® clinical chemistry system. This product was designed to meet the needs of users to assure accurate results over the assay range of these methods.

Source page: https://510kreport.com/device/K060628
Methodology: https://510kreport.com/methodology