GMP · Antisera, Control For Nontreponemal Tests
Microbiology · 21 CFR 866.3820 · Class 2
Overview
| Product Code | GMP |
|---|---|
| Device Name | Antisera, Control For Nontreponemal Tests |
| Regulation | 21 CFR 866.3820 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
Treponema pallidum nontreponemal test reagents are devices that consist of antigens derived from nontreponemal sources (sources not directly associated with treponemal organisms) and control sera (standardized sera with which test results are compared) used in serological tests to identify reagin, an antibody-like agent, which is produced from the reaction of treponema microorganisms with body tissues. The identification aids in the diagnosis of syphilis caused by microorganisms 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 |
|---|---|---|---|---|
| K980638 | ADI SYPHILIS RPR LIQUID CONTROLS | Ampcor Diagnostics, Inc. | Jul 6, 1998 | SESE |
| K961998 | QUALITROL SYPHSERO CONTROL SET | Consolidated Technologies, Inc. | Aug 8, 1996 | SESE |
| K955143 | RPR LIQUID CONTROLS | Remel, L.P. | Jul 30, 1996 | SESE |
| K885298 | VISUWELL REAGIN TEST 960 TEST KIT | Allelix Diagnostics, Inc. | Mar 15, 1989 | SESE |
| K875180 | V-TREND RPRL CARD TEST | Texas Immunology, Inc. | Feb 4, 1988 | SESE |
| K851504 | VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 | Ncs Diagnostics, Inc. | Aug 19, 1985 | SESE |
| K843741 | RPR TEST REDITEST | Biokit USA, Inc. | Oct 25, 1984 | SESE |
| K812425 | BECKMAN R.PR CONTROL SERUM SET | Beckman Instruments, Inc. | Sep 23, 1981 | SESE |
| K810119 | CONTROL SERUMS FOR NONTREPONEMAL TEST | Hillside Acres, Inc. | Feb 9, 1981 | SESE |
Top Applicants
- Allelix Diagnostics, Inc. — 1 clearance
- Ampcor Diagnostics, Inc. — 1 clearance
- Beckman Instruments, Inc. — 1 clearance
- Biokit USA, Inc. — 1 clearance
- Consolidated Technologies, Inc. — 1 clearance
