# K042006: Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products Calibrator Kit 25, Vitros Chemistry Products Performace

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Oct 28, 2004 after 94 days
- Product code: LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl)
- Device class: 1
- Regulation: 21 CFR 862.1475
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983849 (1999). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032798: Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A) Catalog # DF48A, Dade Behring, Inc. (2003) Summary page 3.
- K904768: Kodatrol I and II Control and Diluent Set, Eastman Kodak Company (1990) Summary page 5.

## Most influential descendants
- K120609: Vitros Chemistry Products DHDL Slides (2012), 0 descendants of its own
- K052867: Vitros Chemistry Products Dtibc Reagent (2005), 0 descendants of its own

## Recalls of this device
- Jul 10, 2017 · Class III · Z-0807-2018: VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored refrigerated for up to 6 months.
- Jun 12, 2013 · Class II · Z-0311-2014: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
- Feb 2, 2012 · Not classified · Z-1316-2012: Ortho Clinical Diagnostics (OCD) has revised the VITROS dHDL Slides Instructions for Use (IFU) and removed EDTA plasma as a recommended sample type.

## Indications for use
For in vitro diagnostic use only. VITROS dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma. High Density Lipoprotein (HDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with lower HDL cholesterol concentrations. For in vitro diagnostic use. VITROS Chemistry Products Calibrator Kit 25 is used to calibrate VITROS Chemistry Systems for the quantitative measurement of HDL cholesterol using VITROS Chemistry Products dHDL Slides. For in vitro diagnostic use only. VITROS Chemistry Products Performance Verifiers I and II are assayed controls used to monitor performance on VITROS Chemistry Systems.

Source page: https://510kreport.com/device/K042006
Methodology: https://510kreport.com/methodology