Axis-Shield 3-REAGENT Homocysteine Assay for Synchron
FDA 510(k) K112790 · Axis-Shield Diagnostics, Ltd.
510(k) numberK112790
Submission
- Device name
- Axis-Shield 3-REAGENT Homocysteine Assay for Synchron
- Applicant
- Axis-Shield Diagnostics, Ltd.
Dundee, Scotland, GB - Received
- September 26, 2011
- Decision date
- May 7, 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 |
| K113793 | Homocysteine TestLPS · Traditional | Roche | 06/05/2012SE |
| 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 |
|---|---|---|
| K253539 | Alere NT-proBNP for Alinity iNBC · Traditional | 02/18/2026SE |
| K241176 | Alere NT-proBNP for Alinity i Reagent KitNBC · Traditional | 01/16/2025SE |
| K233541 | ARCHITECT Active-B12 (Holotranscobalamin)CDD · Traditional | 07/31/2024SE |
| K183088 | ADVIA Centaur Erythropoietin (EPO) assayGGT · Traditional | 08/02/2019SE |
| K182012 | ADVIA Centaur Calcitonin (CALCT) assayJKR · Traditional | 12/21/2018SE |
| K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayCDD · Special | 10/27/2017SE |
| K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality…NHX · Traditional | 08/04/2016SE |
| K160757 | ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur…CDD · Traditional | 07/26/2016SE |
| K121946 | Axis-Shield ACVTIVE-B12CDD · Traditional | 03/22/2013SE |
| K121842 | Architect HBA1C, Architect HBA1C, and Architect HBA1CLCP · Traditional | 12/12/2012SE |
Questions and answers
When was Axis-Shield 3-REAGENT Homocysteine Assay for Synchron cleared by the FDA?
Axis-Shield 3-REAGENT Homocysteine Assay for Synchron (K112790) received a 510(k) decision of Substantially Equivalent on May 7, 2012, 224 days after the submission was received.
What is the product code of K112790?
The FDA product code is LPS – Urinary Homocystine (Nonquantitative) Test System, a Class II (moderate risk) device regulated under 21 CFR 862.1377.