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U.S. Department of Health and Human Services

Product Classification

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Device device, automated cell locating, bone marrow
Definition An automated cell-locating device for bone marrow aspirate is an in vitro diagnostic device intended for prescription use that automatically locates and presents images of hematopoietic cells on a bone marrow aspirate smear obtained from patients being evaluated for hematologic diseases. The device assists operators to identify and classify each cell according to type.
Physical State The device consists of a digital scanner, computer with display (processing unit), and software to analyze and present the images to the operator.
Technical Method The device enables scanning all the relevant parts of a slide. A high-resolution camera captures multiple images of the bone marrow aspirate smear, and the device presents the scanned images to operator.
Target Area Bone marrow aspiration smears
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeSAL
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 864.5261
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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