NAK · System, Test, Biotinidase
Clinical Chemistry · 21 CFR 862.1118 · Class 2
Overview
| Product Code | NAK |
|---|---|
| Device Name | System, Test, Biotinidase |
| Regulation | 21 CFR 862.1118 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
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.
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.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K131284 | GSP NEONATAL BIOTINIDASE KIT | Wallac OY | Nov 14, 2013 | SESE |
| K090123 | NEONATAL BIOTINIDASE KIT, MODEL 3018 | Perkinelmer, Inc. | Mar 5, 2010 | SESE |
| K080294 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT | Astoria-Pacific, Inc. | Nov 4, 2008 | SESE |
| K010844 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K | Astoria-Pacific, Inc. | Sep 21, 2001 | SESE |
| DEN990008 | WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 | Wallac, Inc. | Feb 15, 2000 | DENG |
Top Applicants
- Astoria-Pacific, Inc. — 2 clearances
- Perkinelmer, Inc. — 1 clearance
- Wallac OY — 1 clearance
- Wallac, Inc. — 1 clearance
