K180209 is an FDA 510(k) clearance for the Diazyme 1,5-AG Assay. This device is classified as a Assay, 1,5-anhydroglucitol (15ag) (Class II - Special Controls, product code NOZ).
Submitted by Diazyme Laboratories, Inc. (Poway, US). The FDA issued a Cleared decision on October 4, 2018, 253 days after receiving the submission on January 24, 2018.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7470. The Test Provides Quantitative Measurement Of 1,5-anhydroglucitol (15ag) In Patient's Blood. The Test Is For Professional Use, And Is Indicated For The Monitoring Of Glycemic Control In People With Diabetes..
| 510(k) Number | K180209 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2018 |
| Decision Date | October 04, 2018 |
| Days to Decision | 253 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NOZ — Assay, 1,5-anhydroglucitol (15ag) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7470 |
| Definition | The Test Provides Quantitative Measurement Of 1,5-anhydroglucitol (15ag) In Patient's Blood. The Test Is For Professional Use, And Is Indicated For The Monitoring Of Glycemic Control In People With Diabetes. |