System, Test, Biotinidase
The Biotinidase Test System is a clinical chemistry in vitro diagnostic device used to screen for biotinidase deficiency, an inherited metabolic disorder in which the body cannot recycle the vitamin biotin, leading to neurological complications if untreated. It is commonly used in newborn screening programs. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 862.1118 (Clinical Chemistry specialty). This device is eligible for third-party 510(k) review.
Basic Information
- Product Code
- NAK
- Device Class
- FDA class 2
- Regulation Number
- 862.1118
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K131284 | GSP NEONATAL BIOTINIDASE KIT | Nov 14, 2013 | Substantially Equivalent | WALLAC OY |
| K090123 | NEONATAL BIOTINIDASE KIT, MODEL 3018 | Mar 05, 2010 | Substantially Equivalent | PERKINELMER, INC. |
| K080294 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT | Nov 04, 2008 | Substantially Equivalent | ASTORIA-PACIFIC,INC. |
| K010844 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K | Sep 21, 2001 | Substantially Equivalent | ASTORIA-PACIFIC,INC. |
| DEN990008 | WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 | Feb 15, 2000 | Unknown | WALLAC, INC. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.