K221349 is an FDA 510(k) clearance for the XPER Technology PREMIUM Pro Blood Glucose Monitoring System. This device is classified as a Prescription Use Blood Glucose Meter For Near-patient Testing (Class II - Special Controls, product code PZI).
Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on November 19, 2024, 925 days after receiving the submission on May 9, 2022.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345. Intended For Use In Near-patient Testing Settings For In Vitro Diagnostic, Multiple-patient Use For The Quantitative Determination Of Glucose Throughout All Hospital And All Professional Healthcare Settings For Use In Determining Dysglycemia..
| 510(k) Number | K221349 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2022 |
| Decision Date | November 19, 2024 |
| Days to Decision | 925 days |
| Submission Type | Dual Track |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | PZI — Prescription Use Blood Glucose Meter For Near-patient Testing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |
| Definition | Intended For Use In Near-patient Testing Settings For In Vitro Diagnostic, Multiple-patient Use For The Quantitative Determination Of Glucose Throughout All Hospital And All Professional Healthcare Settings For Use In Determining Dysglycemia. |