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U.S. Department of Health and Human Services

Product Classification
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Device mass spectrometric, immunoglobulins (g, a, m, d, e)
Regulation Description Immunoglobulins A, G, M, D, and E immunological test system.
Definition The test system is intended for the (semi-)quantitative or quantitative determination of monoclonal immunoglobulins (M-proteins) and/or the identification of Immunoglobulin isotype of M-proteins in human specimens by mass spectrometric methods.
Physical State In vitro diagnostic (IVD) device
Technical Method Mass spectrometric methods (e.g., matrix-assisted laser desorption and ionization-time of flight, MALDI-TOF; liquid chromatography-mass spectrometry, LC-MS) .
Target Area Human specimens
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeSGG
Premarket Review Division of Immunology and Hematology Devices (DIHD)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5510
Device Class 2
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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