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.
| Device Type ID | 671 |
| Device Name | Capillary Blood Collection Device For Alternative Site Collection |
| 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 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 | PRJ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 671 |
| Device | Capillary Blood Collection Device For Alternative Site Collection |
| Product Code | PRJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood Specimen Collection Device. |
| CFR Regulation Number | 862.1675 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SEVENTH SENSE BIOSYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |