# K113793: Homocysteine Test

- Pathway: 510(k) (Traditional)
- Applicant: Roche
- Decided: Jun 5, 2012 after 165 days
- Product code: LPS (Urinary Homocystine (Nonquantitative) Test System)
- Device class: 2
- Regulation: 21 CFR 862.1377
- 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: 1 generation back to K042448 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061296: Diazyme Homocysteine Enzymatic Assay Kit for Cobas Integra and Homocysteine Calibrator, Diazyme Laboratories (2006) Summary page 3.
- K042448: Diazyme Homocysteine Enzymatic Assay Kit, General Atomics (2004) Summary page 3.
- K071971: Diazyme Homocysteine 2 Reagent Enzymatic Assay Kit, and Calibrators, Model (S) Dzxxxa, Dzxxxa-Cal, Diazyme Laboratories (2007) Summary page 3.

## Recalls of this device
- Oct 17, 2024 · Class II · Z-0489-2025: Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
- Oct 4, 2019 · Class II · Z-0679-2020: Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
- Mar 23, 2015 · Class II · Z-1622-2015: Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. This negative bias could, in the worst case, lead to inaccura

## Indications for use
The Homocysteine Enzymatic Assay is an in vitro test far the quantitative determination of total L-homocysteine in humnan serum and plasma on Roche/Hitachi cobas c systems. The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemnia or homocystinuria. The Homocysteine Calibrator Kit is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets. The H-omocysteine Control Kit is intended for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.

Source page: https://510kreport.com/device/K113793
Methodology: https://510kreport.com/methodology