# K984303: Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Jan 28, 1999 after 57 days
- Product code: LBR (Ldl & Vldl Precipitation, Hdl)
- Device class: 1
- Regulation: 21 CFR 862.1475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K012593: Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros Chemistry Products Calibrator Kit 2 (2001), 5 descendants of its own
- 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

## Indications for use
For in vitro diagnostic use only. The VITROS Magnetic HDL reagent and VITROS Cholesterol slides quantitatively measure HDL-cholesterol (HDLC) in serum and plasma.

Source page: https://510kreport.com/device/K984303
Methodology: https://510kreport.com/methodology