JZH · Factor B, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5320 · Class 2
Overview
| Product Code | JZH |
|---|---|
| Device Name | Factor B, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5320 |
| Device Class | Class 2 |
| Review Panel | Immunology |
Identification
A properdin factor B immunological test system is a device that consists of the reagents used to measure by immunochemical techniques properdin factor B in serum and other body fluids. The deposition of properdin factor B in body tissues or a corresponding depression in the amount of properdin factor B in serum and other body fluids is evidence of the involvement of the alternative to the classical pathway of activation of complement (a group of plasma proteins which cause the destruction of cells which are foreign to the body). Measurement of properdin factor B aids in the diagnosis of several kidney diseases, e.g., chronic glomerulonephritis (inflammation of the glomeruli of the kidney), lupus nephritis (kidney disease associated with a multisystem autoimmune disease, systemic lupus erythematosus), as well as several skin diseases, e.g., dermititis herpetiformis (presence of vesicles on the skin that burn and itch), and pemphigus vulgaris (large vesicles on the skin). Other diseases in which the alternate pathway of complement activation has been implicated include rheumatoid arthritis, sickle cell anemia, and gram-negative bacteremia.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K964843 | IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT | Beckman Instruments, Inc. | Mar 6, 1997 | SESE |
| K882623 | PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM | Technicon Instruments Corp. | Jul 8, 1988 | SESE |
| K831959 | RADIAL IMMUNO-TEST FOR HUMAN FACTOR B | Kent Laboratories, Inc. | Jul 19, 1983 | SESE |
| K811740 | KALLESTAD'S ENDOPLATE FACTOR B TEST | Kallestad Laboratories, Inc. | Jul 16, 1981 | SESE |
| K781016 | C3PA (GBG) PROPERDIN FACTOR B | Icl Scientific | Aug 14, 1978 | SESE |
| K772084 | LAS-R HUMAN C3 PROACTIVATOR TEST | Hyland Therapeutic Div., Travenol Laboratories | Jan 24, 1978 | SESE |
Top Applicants
- Technicon Instruments Corp. — 1 clearance
- Kent Laboratories, Inc. — 1 clearance
- Kallestad Laboratories, Inc. — 1 clearance
- Icl Scientific — 1 clearance
- Hyland Therapeutic Div., Travenol Laboratories — 1 clearance
