21 CFR 862.1118 — System, Test, Biotinidase
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1118
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| NAK | System, Test, Biotinidase | 2 | 5 | 3rd Party |
Special Controls
NAK — System, Test, Biotinidase
*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.
eCFR
NAK — System, Test, Biotinidase
The special control is sale, distribution, and use in accordance with the prescription device requirements in § 801.109 of this chapter.
Ecfr Llm
NAK — System, Test, Biotinidase
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.
De Novo Order DEN990008
