# K052867: Vitros Chemistry Products Dtibc Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Dec 23, 2005 after 73 days
- Product code: JMO (Ferrozine (Colorimetric) Iron Binding Capacity)
- Device class: 1
- Regulation: 21 CFR 862.1415
- 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: 3 generations back to K983849 (1999). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994115: Total Iron Binding Capacity (Ibct) Flex Reagent Cartridge, Dade Behring, Inc. (2000) Summary page 3.
- K994114: Dimension Total Iron Binding Capacity (Ibct) Calibrator, Dade Behring, Inc. (2000) Summary page 3.
- K042006: Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products Calibrator Kit 25, Vitros Chemistry Products Performace, Ortho-Clinical Diagnostics, Inc. (2004) Summary page 4.

## Recalls of this device
- May 24, 2016 · Class III · Z-2119-2016: Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confirmed that incorrect calibration mathemat

## Indications for use
For in vitro diagnostic use only. VITROS Chemistry Products dTIBC Reagent is used to quantitatively measure total iron-binding capacity (TIBC) in human serum. The iron binding capacity is useful in the differential diagnosis of anemia, iron deficiency anemia, thalassemia, sideroblastic anemia, and iron poisoning. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent. For in vitro diagnostic use only. VITROS Chemistry Products Performance Verifiers are assayed controls intended for use in monitoring performance on VITROS Chemistry Systems.

Source page: https://510kreport.com/device/K052867
Methodology: https://510kreport.com/methodology