Definition: A Visual, Qualitative Immunoassay For The In Vitro Detection Of Elevated Levels Of The MMP-9 Protein In Tear Fluid From Patients Suspected Of Having Dry Eye.
| Device Type ID | 657 |
| Device Name | Mmp-9 Test System |
| Physical State | Tear Collection Method And Single Use Immunoassay Test Cartridge |
| Technical Method | Immunoassay |
| Target Area | Eyes |
| Regulation Description | Osmolality 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 | 862.1540 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PFQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 657 |
| Device | Mmp-9 Test System |
| Product Code | PFQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Osmolality Test System. |
| CFR Regulation Number | 862.1540 [🔎] |
| Device Problems | |
|---|---|
Invalid Sensing | 257 |
Use Of Device Problem | 104 |
Wireless Communication Problem | 16 |
Connection Problem | 8 |
Transmitter | 7 |
No Device Output | 1 |
Imprecision | 1 |
Premature End-of-Life Indicator | 1 |
Low Battery | 1 |
No Audible Alarm | 1 |
| Total Device Problems | 397 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Quidel Corporation | II | Aug-01-2017 |