Device Type ID | 629 |
Device Name | Test, Natriuretic Peptide |
Regulation Description | B-type Natriuretic Peptide 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 | 862.1117 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | NBC |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 629 |
Device | Test, Natriuretic Peptide |
Product Code | NBC |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | B-type Natriuretic Peptide Test System. |
CFR Regulation Number | 862.1117 [🔎] |
Device Problems | |
---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 41 |
Low Test Results | 27 |
False Negative Result | 19 |
Incorrect Or Inadequate Test Results | 12 |
Adverse Event Without Identified Device Or Use Problem | 6 |
High Test Results | 5 |
False Positive Result | 5 |
Device Issue | 3 |
Mechanical Problem | 2 |
Low Readings | 2 |
Component Missing | 2 |
Appropriate Term/Code Not Available | 1 |
Mixer | 1 |
Probe | 1 |
Belt | 1 |
Device Markings / Labelling Problem | 1 |
Brush | 1 |
Device Subassembly | 1 |
Total Device Problems | 131 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Alere San Diego, Inc. | III | Jun-26-2014 |
2 | Alere San Diego, Inc. | II | May-02-2014 |
3 | Biomerieux France Chemin De L'Or | III | Sep-10-2016 |
4 | ORTHO-CLINICAL DIAGNOSTICS | II | Jan-03-2019 |
5 | ORTHO-CLINICAL DIAGNOSTICS | II | Apr-08-2017 |
6 | Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc | II | Sep-17-2018 |
7 | Siemens Healthcare Diagnostics Inc | II | Jan-07-2016 |
8 | Siemens Healthcare Diagnostics, Inc | II | Jun-26-2015 |
9 | Siemens Healthcare Diagnostics, Inc | III | Nov-19-2014 |
10 | Siemens Healthcare Diagnostics, Inc. | II | Jun-01-2018 |