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 |