← [Clinical Chemistry](/submissions/CH) · Product Code NAK # NAK · System, Test, Biotinidase _Clinical Chemistry · 21 CFR 862.1118 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NAK ## Overview - **Product Code:** NAK - **Device Name:** System, Test, Biotinidase - **Regulation:** 21 CFR 862.1118 - **Device Class:** 2 - **Review Panel:** [Clinical Chemistry](/submissions/CH) - **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. ## Cleared Devices (5) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K131284](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NAK/K131284.md) | GSP NEONATAL BIOTINIDASE KIT | Wallac OY | Nov 14, 2013 | SESE | | [K090123](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NAK/K090123.md) | NEONATAL BIOTINIDASE KIT, MODEL 3018 | Perkinelmer, Inc. | Mar 5, 2010 | SESE | | [K080294](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NAK/K080294.md) | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT | Astoria-Pacific, Inc. | Nov 4, 2008 | SESE | | [K010844](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NAK/K010844.md) | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K | Astoria-Pacific, Inc. | Sep 21, 2001 | SESE | | [DEN990008](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NAK/DEN990008.md) | WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 | Wallac, Inc. | Feb 15, 2000 | DENG | ## Top Applicants - Astoria-Pacific, Inc. — 2 clearances - Wallac, Inc. — 1 clearance - Wallac OY — 1 clearance - Perkinelmer, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NAK](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NAK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NAK