Definition: The Device Is A Qualitative Immunochromatographic Test For The Detection Of Amniotic Fluid In Cervicovaginal Secretions. The Test Is Intended For Professional Use To Help Diagnose The Rupture Of Fetal Membranes In Pregnant Women.
| Device Type ID | 641 |
| Device Name | Immunoassay, Insulin-like Growth Factor Binding Protein-1 |
| Physical State | The Kit Contains Multiple Test Packs, Each Containing One Sterile Polyester Swab For Specimen Collection, One Tube Of Specimen Extraction Solution, And One Dipstick In A Sealed Aluminum Foil Pouch. |
| Technical Method | The Test Is Based On Immunochromatography. |
| Target Area | Cervicovaginal Specimens Are Collected And Used On The Device. |
| 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 | OAM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 641 |
| Device | Immunoassay, Insulin-like Growth Factor Binding Protein-1 |
| Product Code | OAM |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Urinary PH (nonquantitative) Test System. |
| CFR Regulation Number | 862.1550 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALERE SCARBOROUGH, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |