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U.S. Department of Health and Human Services

Product Classification

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Device high throughput dna sequence analyzer
Definition A high throughput sequencing technology performing targeted dna sequencing of amplicons from a defined genetic region or a subset of genes in human genomic dna from a clinical sample.
Physical State sequencing instrument and associated software
Technical Method A high throughput DNA sequence analyzer is an automated clinical multiplex instrument system intended to prepare, generate, measure and sort signals in order to analyze DNA molecules of amplicons from a clinical sample such as peripheral whole blood. Signals produced are measured and interpreted by accompanying software into DNA sequence information.
Target Area human genomic DNA from a clinical sample
Regulation Medical Specialty Immunology
Review Panel Toxicology
Product CodePFF
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(K) Exempt
Regulation Number 862.2265
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of Class II (special controls) devices subject to certain limitations, that are now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet a requirement of the Modernization Act.
Third Party Review Not Third Party Eligible
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