Definition: A Blood Collection Device For DNA Testing Is An In Vitro Diagnostics Device Intended To Collect And Transport Blood Specimens To The Laboratory For Clinical DNA Testing.
| Device Type ID | 663 |
| Device Name | Blood/plasma Collection Device For Dna Testing |
| Physical State | Blood Collection Device |
| Technical Method | The Blood Is Drawn In The Tube To Be Transported To The Laboratory For Clinical DNA Testing. |
| Target Area | Whole Blood/ Plasma For In Vitro Diagnostics |
| Regulation Description | Blood Specimen Collection Device. |
| 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 | 862.1675 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PJE |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 663 |
| Device | Blood/plasma Collection Device For Dna Testing |
| Product Code | PJE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood Specimen Collection Device. |
| CFR Regulation Number | 862.1675 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PREANALYTIX GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect Or Inadequate Test Results | 10 |
Leak / Splash | 6 |
Device Contamination With Chemical Or Other Material | 5 |
Short Fill | 3 |
Volume Accuracy Problem | 3 |
Coagulation In Device Or Device Ingredient | 3 |
Overfill | 1 |
Delamination | 1 |
Material Deformation | 1 |
Material Protrusion / Extrusion | 1 |
| Total Device Problems | 34 |