Homocysteine Test
FDA 510(k) K113793 · Roche
510(k) numberK113793
Submission
- Device name
- Homocysteine Test
- Applicant
- Roche
Indianapolis, IN, US - Received
- December 23, 2011
- Decision date
- June 5, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LPS – Urinary Homocystine (Nonquantitative) Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1377
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123930 | Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers…LPS · Traditional | Ortho-Clinical Diagnostics, Inc. | 05/15/2013SE |
| K121053 | Diazyme Homocysteine Poc Test KitLPS · Traditional | Diazyme Laboratories | 07/31/2012SE |
| K121533 | ST Aia-Pack Homocysteine; ST Aia-Pack Homocysteine Calibrator Set; Aia-Pack Homocysteine…LPS · Traditional | Tosoh Bioscience, Inc. | 06/15/2012SE |
| K112790 | Axis-Shield 3-REAGENT Homocysteine Assay for SynchronLPS · Traditional | Axis-Shield Diagnostics, Ltd. | 05/07/2012SE |
| K083222 | Axis-Shield Liquid Stable (LS) 2-PART Homocysteine Reagent, Model FHRK100LPS · Traditional | Axis-Shield Diagnostics, Ltd. | 07/31/2009SE |
| K080851 | A/C Portable Enzymatic Homocysteine AssayLPS · Traditional | Anticancer, Inc. | 10/10/2008SE |
| K073640 | Architect Homocysteine Reagents, Calibrators and ControlsLPS · Traditional | Axis-Shield Diagnostics, Ltd. | 04/24/2008SE |
| K071971 | Diazyme Homocysteine 2 Reagent Enzymatic Assay Kit, and Calibrators, Model(S) Dzxxxa…LPS · Special | Diazyme Laboratories | 09/17/2007SE |
| K063701 | Teco Homocysteine Enzymatic AssayLPS · Traditional | Teco Diagnostics | 04/11/2007SE |
| K063206 | Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1 Control…LPS · Traditional | Dade Behring, Inc. | 12/28/2006SE |
More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K102914 | TQ HBA1C GEN3LCP · Special | 01/20/2011SE |
Questions and answers
When was Homocysteine Test cleared by the FDA?
Homocysteine Test (K113793) received a 510(k) decision of Substantially Equivalent on June 5, 2012, 165 days after the submission was received.
What is the product code of K113793?
The FDA product code is LPS – Urinary Homocystine (Nonquantitative) Test System, a Class II (moderate risk) device regulated under 21 CFR 862.1377.