# K041720: Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and Performance Verifiers I and II

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Aug 25, 2004 after 62 days
- Product code: MRR (System, Test, Low Density, Lipoprotein)
- 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 K904768 (1990). 2 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020852: Poly-Chem Glucose, Polymedco, Inc. (2002) Summary page 3.
- K904768: Kodatrol I and II Control and Diluent Set, Eastman Kodak Company (1990) Summary page 4.

## Most influential descendants
- K042477: Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator Kit 20; Vitros Chemistry Products Protein (2004), 4 descendants of its own
- K052819: Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers I, II and Iii (2005), 3 descendants of its own
- K061588: Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy Performance Verifiers (2006), 1 descendant of its own
- K123930: Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers I, II and Iii (2013), 0 descendants of its own
- K060940: Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/HPT Performance Verifier I, II, and Iii (2006), 0 descendants of its own

## Recalls of this device
- Oct 8, 2018 · Class II · Z-0476-2019: VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results

## Indications for use
For in vitro diagnostic use only. VITROS Chemistry Products dLDL Reagent is used to quantitatively measure LDL Cholesterol (LDLC) concentration in serum and plasma. Low Density Lipoprotein (LDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with higher LDL cholesterol concentrations. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 19 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of HDL and LDL cholesterol using VITROS dHDL and dLDL Reagents. 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/K041720
Methodology: https://510kreport.com/methodology