Hospital Continuous Glucose Monitoring System
Device Code: 676
Product Code(s):
PYV Definition: Intended For The Continuous, Quantitative Measurement Of Glucose In Whole Blood In A Hospital Setting.
Device Classification Information
| Device Type ID | 676 |
| Device Name | Hospital Continuous Glucose Monitoring System |
| Physical State | The Device System Is Comprised Of A Cartridge And An Instrument That Measures And Displays The Result. |
| Technical Method | The Operator Connects The Device To The Blood Source Of The Patient And Activates The Assay. |
| 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 | PYV |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 676 |
| Device | Hospital Continuous Glucose Monitoring System |
| Product Code | PYV |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Glucose Test System. |
| CFR Regulation Number | 862.1345 [🔎] |
| Device Problems |
|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
| Total Device Problems | 2 |
TPLC Last Update: 2019-04-02 19:38:29