# K012593: Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros Chemistry Products Calibrator Kit 2

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Aug 30, 2001 after 20 days
- Product code: LBR (Ldl & Vldl Precipitation, Hdl)
- Device class: 1
- Regulation: 21 CFR 862.1475
- 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 K984303 (1999). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984303: Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Ortho-Clinical Diagnostics, Inc. (1999) Summary page 2.
- (no number) VITROS Chemistry Products Calibrator Kit 2: named in the summary without a submission number

## Most influential descendants
- K071801: Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S) 844-5207, 166-2659 (2007), 4 descendants of its own
- K073157: Vitros Chemistry Products K+ Slides and Calibrator Kit 2 (2007), 3 descendants of its own
- K081411: Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products Calibrator Kit 2 (2008), 2 descendants of its own
- K091861: Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator Kit, Model 195 7927 (2009), 1 descendant of its own
- K093611: Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit, Models CO2 DT Slides, 172 0002; (2010), 0 descendants of its own

## Recalls of this device
- Jun 12, 2013 · Class II · Z-0304-2014: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

## Indications for use
For in vitro diagnostic use only. The VITROS Magnetic HDL-Cholesterol Reagent and VITROS CHOL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma. For in vitro diagnostic use only. VITROS Calibrator Kit 2 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of CHOL, Cl-, ECO2, HDLC, K+, Na+, and TRIG.

Source page: https://510kreport.com/device/K012593
Methodology: https://510kreport.com/methodology