K152986 is an FDA 510(k) clearance for the StatStrip Xpress 2 Glucose Hospital Meter 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 Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on January 27, 2016, 110 days after receiving the submission on October 9, 2015.
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 | K152986 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2015 |
| Decision Date | January 27, 2016 |
| Days to Decision | 110 days |
| Submission Type | Special |
| 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. |