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U.S. Department of Health and Human Services

Product Classification

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Device dna-based test for minimal residual disease for hematologic malignancies
Definition A DNA-based test for minimal residual disease is an in vitro diagnostic device that identifies and quantifies specific nucleic acid sequences isolated from human specimens to estimate the percentage of cells that harbor the specific sequence(s). The test is intended to be used as an aid to measure minimal residual disease to monitor the change in burden of disease for patients with a hematological malignancy during and after treatment. The results should be interpreted by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings.
Physical State Test consists of reagents, instrumentation, software and instructions needed to perform the test method. Should not include devices intended to measure or quantify circulating or cell-free nucleic acid sequences isolated from human plasma specimens.
Technical Method This test uses polymerase chain reaction and/or sequencing-based methods to quantify specific nucleic acid sequences for the purpose of measuring minimal residual disease. The test may utilize other technologies and/or quantification methods
Target Area Human bone marrow aspirate and peripheral blood. Excludes circulating DNA in plasma.
Regulation Medical Specialty Pathology
Review Panel Pathology
Product CodeQDC
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type 510(k)
Regulation Number 866.6100
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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