| Device |
capillary blood collection device for alternative site collection |
| Regulation Description |
Blood specimen collection device. |
| Definition |
A capillary blood collection device with or without integrated micro-needles is a blood collection device intended to collect and/or transport capillary whole blood specimens for testing of clinical analytes. |
| Physical State |
Sterile blood collection device which may or may not have micro-needles or other skin puncture mechanism integrated with the device. The device may include an anticoagulant or preservative. |
| Technical Method |
The blood is drawn into the collection device by puncture of capillaries located near the surface of the skin using micro-needles or similar small sharp objects. |
| Target Area |
Capillary whole blood for in vitro diagnostic testing |
| Regulation Medical Specialty |
Clinical Chemistry |
| Review Panel |
Clinical Chemistry |
|---|
| Product Code | PRJ |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Chemistry and Toxicology Devices
(DCTD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
862.1675
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
