| Device Type ID | 377 |
| Device Name | Tubes, Vacuum Sample, With Anticoagulant |
| 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 | GIM |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 377 |
| Device | Tubes, Vacuum Sample, With Anticoagulant |
| Product Code | GIM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood Specimen Collection Device. |
| CFR Regulation Number | 862.1675 [🔎] |
| Device Problems | |
|---|---|
Short Fill | 88 |
Volume Accuracy Problem | 52 |
Device Contamination With Chemical Or Other Material | 49 |
Leak / Splash | 48 |
Incorrect Or Inadequate Test Results | 40 |
Coagulation In Device Or Device Ingredient | 17 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 16 |
Material Deformation | 15 |
Device Markings / Labelling Problem | 11 |
Overfill | 4 |
Human-Device Interface Problem | 3 |
Break | 3 |
Device Handling Problem | 3 |
Improper Or Incorrect Procedure Or Method | 2 |
Incorrect Measurement | 1 |
Delivered As Unsterile Product | 1 |
Detachment Of Device Or Device Component | 1 |
Difficult To Insert | 1 |
Fungus In Device Environment | 1 |
| Total Device Problems | 356 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Streck | II | Mar-08-2017 |