| Device Type ID | 617 |
| Device Name | System, Test, Vitamin D |
| Regulation Description | Vitamin D 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 | 862.1825 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MRG |
| 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 | 617 |
| Device | System, Test, Vitamin D |
| Product Code | MRG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Vitamin D Test System. |
| CFR Regulation Number | 862.1825 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECKMAN COULTER | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BECKMAN COULTER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
Bio-Rad Laboratories | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BIO-RAD LABORATORIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DIASORIN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIASORIN S.P.A | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIAZYME LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
IMMUNODIAGNOSTIC SYSTEMS LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS OPERATIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS HEALTHCARE DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS HEALTHCARE DIAGNOSTICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOSOH CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
High Test Results | 58 |
Adverse Event Without Identified Device Or Use Problem | 14 |
Incorrect Or Inadequate Test Results | 12 |
Low Test Results | 10 |
Non Reproducible Results | 8 |
Mechanical Problem | 7 |
Probe | 3 |
Tube | 3 |
Pump | 3 |
Cell | 2 |
Unable To Obtain Readings | 2 |
Device Damaged Prior To Use | 2 |
Mixer | 2 |
Washer | 2 |
Seal | 1 |
Device Subassembly | 1 |
| Total Device Problems | 130 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Ireland Diagnostics Division | II | Dec-22-2018 |
| 2 | Qualigen Inc | II | Sep-07-2017 |
| 3 | R & D Systems, Inc. | III | Nov-09-2018 |
| 4 | Roche Diagnostics Corporation | II | Jul-08-2018 |
| 5 | Siemens Healthcare Diagnostics, Inc | II | Nov-11-2016 |
| 6 | Siemens Healthcare Diagnostics, Inc | II | May-23-2014 |