K220272 is an FDA 510(k) clearance for the cobas pulse 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 Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on April 26, 2024, 816 days after receiving the submission on January 31, 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 | K220272 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2022 |
| Decision Date | April 26, 2024 |
| Days to Decision | 816 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. |