Recognition List Number: 011 Publication Date: 09/01/2004
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-104: NCCLS H7-A3, Procedure for Determining Packed Cell Volume by the Microhematocrit Method - Second Edition; Approved Standard - Third Edition. (InVitro Diagnostics)
Date of Standard: 2000. |
| Address of Standards Organization: |
| National Committee for Clinical Laboratory Standards (NCCLS) |
| 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 IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD) |
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| (2) | OFFICE OF COMPLIANCE (OC) |
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| Devices Affected: |
In vitro diagnostic devices for measuring packed cell volume
Whole blood calibration of instrument methods |
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| Processes Affected: |
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| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §864.5600 |
Instrument, Hematocrit, Automated |
Class 2 |
GKF |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §864.6400 |
Device, Hematocrit Measuring |
Class 2 |
JPI |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §864.8165 |
Calibrator For Hemoglobin And Hematocrit Measurement |
Class 2 |
KRZ |
| |
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| Relevant Guidance: |
Points to Consider for Collection of Data in support of In Vitro Device Submissions for 510(k) Clearance
NCCLS M29- Protection of Laboratory Workers from Instruments Biohazards and Infection Disease Transmitted by Blood, Body Fluids and Tissue. |
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| FDA Technical Contact: |
| Paula Stewart |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room 4252 |
| Silver Spring MD 20993 |
| 301/796-6185 |
| Email: paula.stewart@fda.hhs.gov |
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