LHT · Staphylococcus Aureus Somatic Antigens
Microbiology · 21 CFR 866.3700 · Class 1
Overview
| Product Code | LHT |
|---|---|
| Device Name | Staphylococcus Aureus Somatic Antigens |
| Regulation | 21 CFR 866.3700 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Staphylococcus aureus serological reagents are devices that consist of antigens and antisera used in serological tests to identify enterotoxin (toxin affecting the intestine) producing staphylococci from cultured isolates. The identification aids in the diagnosis of disease caused by this bacterium belonging to the genus Staphylococcus and provides epidemiological information on these diseases. Certain strains of Staphylococcus aureus produce an enterotoxin while growing in meat, dairy, or bakery products. After ingestion, this enterotoxin is absorbed in the gut and causes destruction of the intestinal lining (gastroenteritis).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K874303 | STAPHYLASE TEST | Oxoid U.S.A., Inc. | Nov 6, 1987 | SESE |
| K863025 | SERO-STAT R II STAPHYLOCOCCUS TEST | Scott Laboratories, Inc. | Sep 15, 1986 | SESE |
| K820683 | STAPHYLOCOCCUS LATEX AGGLUTINATION KIT | American Scientific Products | Apr 14, 1982 | SESE |
| K820531 | ENDO-STAPH TEICHOIC ACID ANTIBODY KIT | Meridian Diagnostics, Inc. | Apr 14, 1982 | SESE |
| K820347 | ACCU-STAPH | Carr-Scarborough Microbiologicals, Inc. | Mar 4, 1982 | SESE |
| K812434 | DIAGNOSTIC KITS & KIT COMPONENTS | Diagnostica, Inc. | Sep 23, 1981 | SESE |
| K812376 | SHEEP BLOOD IN ALSEVER'S, CITR., DEFIBR | Dutchland Laboratories, Inc. | Sep 9, 1981 | SESE |
| K812375 | BABY CHICK BLOOD IN ALSEVER'S | Dutchland Laboratories, Inc. | Sep 9, 1981 | SESE |
| K812374 | ADULT CHICKEN BLOOD IN ALSEVER'S, C., D. | Dutchland Laboratories, Inc. | Sep 9, 1981 | SESE |
| K812373 | RABBIT BLOOD IN ALSEVER'S, CITR., DEFIBR | Dutchland Laboratories, Inc. | Sep 9, 1981 | SESE |
| K812372 | GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEF | Dutchland Laboratories, Inc. | Sep 9, 1981 | SESE |
| K812368 | RAT BLOOD IN ALSEVER'S, CITRATED | Dutchland Laboratories, Inc. | Sep 9, 1981 | SESE |
| K812367 | GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD) | Dutchland Laboratories, Inc. | Sep 9, 1981 | SESE |
Top Applicants
- Dutchland Laboratories, Inc. — 7 clearances
- American Scientific Products — 1 clearance
- Carr-Scarborough Microbiologicals, Inc. — 1 clearance
- Diagnostica, Inc. — 1 clearance
- Meridian Diagnostics, Inc. — 1 clearance
