Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-221: CLSI H01-A6, Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition. (InVitro Diagnostics)
Date of Standard: 2010. |
| Address of Standards Organization: |
| Clinical Laboratory Standards Institute (CLSI) |
| 950 West Valley Road |
| Suite 2500 |
| Wayne, PA 19087 |
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) | | DIVISION OF CHEMISTRY AND TOXICOLOGY DEVICES (DCTD) |
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| (2) | OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) | | DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD) |
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| (3) | OFFICE OF COMPLIANCE (OC) |
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| Devices Affected: |
| In vitro diagnostic devices (evacuated tubes and related additives) for collection of venous whole blood, plasma and serum specimens for chemistry, hematology, and immunology laboratory procedures. |
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| Processes Affected: |
| 510(K), HDE, IDE, PDP, PMA |
|
| Type of Standard: |
| National, Horizontal |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §862.1675 |
Tubes, Vacuum Sample, With Anticoagulant |
Class 2 |
GIM |
| §862.1675 |
Tubes, Vials, Systems, Serum Separators, Blood Collection |
Class 2 |
JKA |
| |
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| Relevant Guidance: |
| Points to Consider for Collection of Data in Support of In Vitro Device Submissions for 510(k) Clearance |
|
| FDA Technical Contact: |
| Yung Chan |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room 5630 |
| Silver Spring MD 20993 |
| 301/796-6138 |
| Email: yung.chan@fda.hhs.gov |
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