Definition: The Test Is For Use By Health Care Professionals To Aid In The Detection Of Fetal Membrane Rupture In Pregnant Women, When They Report Signs, Symptoms Or Complaints Suggestive Of Such Rupture.
| Device Type ID | 637 |
| Device Name | Immunoassay For Detection Of Amniotic Fluid Protein(s). |
| Physical State | Cassette, Dip Stick Or Dipstrip |
| Technical Method | Immunoassay |
| Target Area | : For Testing Cervicovaginal Fluid Specimens |
| Regulation Description | Urinary PH (nonquantitative) 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) Exempt |
| CFR Regulation Number | 862.1550 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NQM |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 637 |
| Device | Immunoassay For Detection Of Amniotic Fluid Protein(s). |
| Product Code | NQM |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Urinary PH (nonquantitative) Test System. |
| CFR Regulation Number | 862.1550 [🔎] |
| Device Problems | |
|---|---|
False Negative Result | 5 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Inadequate Or Insufficient Training | 1 |
Failure Of Device To Self-Test | 1 |
| Total Device Problems | 10 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Qiagen Sciences, Inc. | I | Jul-13-2018 |