21 CFR 866.3402 — Plasmodium Spp. Detection Reagents
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3402
Identification
A Plasmodium species antigen detection assay is a device that employs antibodies for the detection of specific malaria parasite antigens, including histidine-rich protein-2 (HRP2) specific antigens, and pan malarial antigens in human whole blood. These devices are used for testing specimens from individuals who have signs and symptoms consistent with malaria infection. The detection of these antigens aids in the clinical laboratory diagnosis of malaria caused by the four malaria species capable of infecting humans: Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, and Plasmodium malariae, and aids in the differential diagnosis of Plasmodium falciparum infections from other less virulent Plasmodium species. The device is intended for use in conjunction with other clinical laboratory findings.
Classification Rationale
Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Plasmodium species Antigen Detection Assays.” See § 866.1(e) for the availability of this guidance document.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| OAX | Plasmodium Spp. Detection Reagents | 2 | 1 |
Special Controls
OAX — Plasmodium Spp. Detection Reagents
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document:*Plasmodium* species Antigen Detection Assays.” See § 866.1(e) for the availability of this guidance document.
eCFR
OAX — Plasmodium Spp. Detection Reagents
The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Plasmodium species Antigen Detection Assays.” See § 866.1(e) for the availability of this guidance document.
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