# K061588: Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy Performance Verifiers

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Jul 21, 2006 after 43 days
- Product code: LPS (Urinary Homocystine (Nonquantitative) Test System)
- Device class: 2
- Regulation: 21 CFR 862.1377
- 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: 4 generations back to K904768 (1990). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993107: Bio-Rad Homocysteine by HPLC, Bio-Rad (1999) Summary page 2.
- K052819: Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers I, II and Iii, Ortho-Clinical Diagnostics, Inc. (2005) Summary page 2.

## Most influential descendants
- K123930: Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers I, II and Iii (2013), 0 descendants of its own

## Recalls of this device
- Apr 1, 2013 · Class II · Z-1556-2013: The firm is recalling the specific lot due to lower than expected results.

## Indications for use
For in vitro diagnostic use only. VITROS Chemistry Products HCY Reagent is used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma. Serum and plasma homocysteine levels can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 27 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of homocysteine (HCY). For in vitro diagnostic use only. VITROS Chemistry Products HCY Performance Verifiers are assayed controls used to monitor performance of VITROS HCY Reagents on VITROS 5,1 FS Chemistry Systems.

Source page: https://510kreport.com/device/K061588
Methodology: https://510kreport.com/methodology