GMT · Antigens, Ha, Treponema Pallidum
Microbiology · 21 CFR 866.3830 · Class 2
Overview
| Product Code | GMT |
|---|---|
| Device Name | Antigens, Ha, Treponema Pallidum |
| 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 (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K971502 | SERODIA TP-PA | Scimedx Tekfile Services | Nov 13, 1997 | SESE |
| K911640 | OLYMPUS PK TP(TM) SYSTEM, MODIFICATION | Olympus Corp. | Jul 24, 1991 | SESE |
| K911266 | MODIFIED PK TP CONTROL | Olympus Corp. | May 7, 1991 | SESE |
| K905038 | OLYMPUS PK-TP ABSORBENT KIT | Fujirebio America, Inc. | May 6, 1991 | SESE |
| K896410 | CELLOGNOST SYPHILIS H | Behring Diagnostics, Inc. | May 15, 1990 | SESE |
| K893124 | OLYMPUS PK(TM) TP | Fujirebio Diagnostics,Inc. | Nov 17, 1989 | SESE |
| K791897 | BACTO-HATTS | Difco Laboratories, Inc. | Nov 13, 1979 | SESE |
| K791457 | AGGLUTINOTEST-SYPHILIS | Volu Sol Medical Industries | Sep 24, 1979 | SESE |
| K760098 | REAGENT, VDRL | Gamma Biologicals, Inc. | Aug 3, 1976 | SESE |
Top Applicants
- Olympus Corp. — 2 clearances
- Behring Diagnostics, Inc. — 1 clearance
- Difco Laboratories, Inc. — 1 clearance
- Fujirebio America, Inc. — 1 clearance
- Fujirebio Diagnostics,Inc. — 1 clearance
