| Device |
newborn screening specimen collection paper |
| Regulation Description |
Blood specimen collection device. |
| Definition |
Newborn screening specimen collection paper is a blood collection device intended to be used as medium to collect and transport whole blood specimens from newborns to the laboratory for in vitro diagnostic analysis. |
| Physical State |
Newborn screening specimen collection paper is an in vitro diagnostic device that consists of specifically designed filter paper with a uniform surface for the collection of blood spots. The collection paper is in the format of a printed card that incorporates a section for the collection of the patient¿s demographic information. |
| Technical Method |
The blood is applied to the indicated spots on the paper. The specimen is allowed to dry and then sent to a laboratory for in vitro diagnostic analysis. |
| Target Area |
An in vitro diagnostic device used as a medium to collect and transport whole blood specimen spots to a laboratory |
| Regulation Medical Specialty |
Clinical Chemistry |
| Review Panel |
Clinical Chemistry |
|---|
| Product Code | PJC |
|---|
| Premarket Review |
Division of Chemistry and Toxicology Devices
(DCTD)
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 |
