| Device Type ID | 610 |
| Device Name | Urinary Homocystine (nonquantitative) Test System |
| Regulation Description | Urinary Homocystine (nonquantitative) Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1377 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LPS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 610 |
| Device | Urinary Homocystine (nonquantitative) Test System |
| Product Code | LPS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urinary Homocystine (nonquantitative) Test System. |
| CFR Regulation Number | 862.1377 [🔎] |
| Device Problems | |
|---|---|
Low Test Results | 9 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Device Ingredient Or Reagent | 1 |
| Total Device Problems | 13 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Axis-Shield Diagnostics, Ltd. | II | Jul-01-2015 |
| 2 | CSL Behring GmbH | II | Jul-19-2016 |
| 3 | Medtest Holdings, Inc. | II | Jun-28-2016 |
| 4 | Roche Diagnostics Operations, Inc. | II | May-15-2015 |
| 5 | Siemens Healthcare Diagnostics, Inc | II | Jul-02-2014 |
| 6 | Siemens Healthcare Diagnostics, Inc. | II | Feb-21-2017 |
| 7 | Tosoh Bioscience Inc | II | Dec-22-2018 |