K101574 is an FDA 510(k) clearance for the ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0. This device is classified as a Gabapentin Assay (Class II - Special Controls, product code OTF).
Submitted by ARK Diagnostics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 23, 2010, 169 days after receiving the submission on June 7, 2010.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3350. Test For The Quantitative Determination Of Gabapentin In Human Serum Or Plasma. Gabapentin Concentrations Can Be Used As An Aid In Management Of Patients Treated With Gabapentin..
| 510(k) Number | K101574 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2010 |
| Decision Date | November 23, 2010 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | OTF - Gabapentin Assay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3350 |
| Definition | Test For The Quantitative Determination Of Gabapentin In Human Serum Or Plasma. Gabapentin Concentrations Can Be Used As An Aid In Management Of Patients Treated With Gabapentin. |