JWL · Antigen, Treponema Pallidum For Fta-Abs Test
Microbiology · 21 CFR 866.3830 · Class 2
Overview
| Product Code | JWL |
|---|---|
| Device Name | Antigen, Treponema Pallidum For Fta-Abs Test |
| Regulation | 21 CFR 866.3830 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), the Treponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies to Treponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema and provides epidemiological information on syphilis.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K831296 | POLYCHACO FIA-ABS TEST FOR SYPHILIS | Parasitic Disease Consultants | Jul 26, 1983 | SESE |
| K802276 | FTA-ABS BIOPAK | Bioware Products | Oct 23, 1980 | SESE |
| K801959 | FTA-ABS TEST | Immuno-Diagnostic Products, Inc. | Oct 23, 1980 | SESE |
| K801928 | LAB-TEK FTA-ABS KIT | Miles Laboratories, Inc. | Aug 20, 1980 | SESE |
Top Applicants
- Bioware Products — 1 clearance
- Immuno-Diagnostic Products, Inc. — 1 clearance
- Miles Laboratories, Inc. — 1 clearance
- Parasitic Disease Consultants — 1 clearance
