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.
| Device Type ID | 661 |
| Device Name | Newborn Screening Specimen Collection Paper |
| 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 In |
| 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 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 | PJC |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 661 |
| Device | Newborn Screening Specimen Collection Paper |
| Product Code | PJC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood Specimen Collection Device. |
| CFR Regulation Number | 862.1675 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Agilent Technologies, Inc. | II | Apr-05-2017 |
| 2 | PerkinElmer Health Sciences, Inc. | III | Jul-24-2017 |