Device Type ID | 276 |
Device Name | Radioimmunoassay, Parathyroid Hormone |
Regulation Description | Parathyroid Hormone 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 | 862.1545 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | CEW |
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 | 276 |
Device | Radioimmunoassay, Parathyroid Hormone |
Product Code | CEW |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Parathyroid Hormone Test System. |
CFR Regulation Number | 862.1545 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
DIASORIN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIASORIN S.P.A | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS HEALTHCARE DIAGNOSTICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 |
Device Problems | |
---|---|
High Test Results | 59 |
Adverse Event Without Identified Device Or Use Problem | 42 |
Device Ingredient Or Reagent Problem | 24 |
Low Test Results | 22 |
Mechanical Problem | 16 |
Incorrect Or Inadequate Test Results | 7 |
No Apparent Adverse Event | 6 |
Tube | 3 |
Device Issue | 2 |
Output Problem | 2 |
Probe | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Device Handling Problem | 1 |
Appropriate Term/Code Not Available | 1 |
Incorrect Measurement | 1 |
Non Reproducible Results | 1 |
Valve | 1 |
False Positive Result | 1 |
Total Device Problems | 192 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Diagnostic Hybrids, Inc. | III | Apr-25-2018 |
2 | ORTHO-CLINICAL DIAGNOSTICS | II | Dec-23-2016 |
3 | Siemens Healthcare Diagnostics, Inc. | II | Jan-09-2017 |