| CLSI NBS01-A6 (Replaces LA04-A5) Blood Collection on Filter Paper for Newborn Screening Programs: Approved Standard - Sixth Edition |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 7-244 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | Kellie Kelm FDA/OMPT/CDRH/OIR/DCTD/ 301-796-6145 kellie.kelm@fda.hhs.gov |
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This document highlights specimen collection methods, discusses acceptable techniques for applying blood drops or aliquots to the filter paper segment of the specimen collection device, and provides instructions on proper specimen handling and transport to ensure quality specimens are consistently obtained for newborn screening analysis.
| Regulation Number | Device Name | Device Class | Product Code |
| §862.1675 | Tubes, Vials, Systems, Serum Separators, Blood Collection | Class 2 | JKA |
| Points to Consider for Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance, Issued September 1994. |