LIR · Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
Microbiology · 21 CFR 866.3390 · Class 2
Overview
| Product Code | LIR |
|---|---|
| Device Name | Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae |
| Regulation | 21 CFR 866.3390 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identify Neisseria spp. from cultured isolates. Additionally, some of these reagents consist of Neisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence of Neisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K023947 | GC OIA | Thermo Biostar, Inc. | Apr 17, 2003 | SESE |
| K882534 | ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL | Abbott Laboratories | Jul 12, 1988 | SESE |
| K881064 | HYGEIA GC TEST | Hygeia Sciences | Jun 2, 1988 | SESE |
Top Applicants
- Abbott Laboratories — 1 clearance
- Hygeia Sciences — 1 clearance
- Thermo Biostar, Inc. — 1 clearance
