ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K
Device Facts
| Record ID | K010844 |
|---|---|
| Device Name | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K |
| Applicant | Astoria-Pacific, Inc. |
| Product Code | NAK · Clinical Chemistry |
| Decision Date | Sep 21, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1118 |
| Device Class | Class 2 |
Regulatory Classification
Identification
The biotinidase test system is an in vitro diagnostic device intended to measure the activity of the enzyme biotinidase in blood. Measurements of biotinidase are used in the treatment and diagnosis of biotinidase deficiency, an inborn error of metabolism in infants, characterized by the inability to utilize dietary protein bound vitamin or to recycle endogenous biotin. The deficiency may result in irreversible neurological impairment.
Special Controls
*Classification.* Class II (special controls). The special control is sale, distribution, and use in accordance with the prescription device requirements in § 801.109 of this chapter.
In addition to the general controls of the act, the Wallac Neonatal Biotinidase Test Kit is subject to the following special controls: 1) the sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109.
