| Device Type ID | 241 |
| Device Name | Radioassay, Vitamin B12 |
| Regulation Description | Vitamin B[bdi1][bdi2] 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 | 862.1810 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CDD |
| 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 | 241 |
| Device | Radioassay, Vitamin B12 |
| Product Code | CDD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Vitamin B[bdi1][bdi2] Test System. |
| CFR Regulation Number | 862.1810 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BECKMAN COULTER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECKMAN COULTER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIAZYME LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS OPERATIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS HEALTHCARE DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
High Test Results | 8 |
Low Test Results | 7 |
Incorrect Or Inadequate Test Results | 4 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 3 |
Non Reproducible Results | 2 |
No Apparent Adverse Event | 2 |
Seal | 1 |
Connection Problem | 1 |
Device Operates Differently Than Expected | 1 |
Filter | 1 |
Probe | 1 |
Belt | 1 |
Photomultiplier | 1 |
Tube | 1 |
| Total Device Problems | 38 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ortho-Clinical Diagnostics | II | Nov-06-2018 |
| 2 | Siemens Healthcare Diagnostics, Inc. | II | May-04-2018 |
| 3 | Tosoh Bioscience Inc | II | Dec-22-2018 |