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.
| Device Type ID | 677 |
| Device Name | Prescription Use Blood Glucose Meter For Near-patient Testing |
| Physical State | The Device Is Comprised Of Glucose Test Strips And A Meter That Measures And Displays The Result. |
| Technical Method | The User Obtains A Blood Sample And Applies It To A Test Strip That Contains An Enzyme That Reacts With The Glucose On The Test Strip. The Test Strip Is Inserted In The Meter, Which Measures The Amount Of Glucose In The Blood Sample. |
| Target Area | Whole Blood |
| Regulation Description | Glucose Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1345 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PZI |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 677 |
| Device | Prescription Use Blood Glucose Meter For Near-patient Testing |
| Product Code | PZI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Glucose Test System. |
| CFR Regulation Number | 862.1345 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
NOVA | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
NOVA BIOMEDICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |