• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device data acquisition software
Regulation Description Instrumentation for clinical multiplex test systems.
Definition Software that integrates a network of sample pooling instruments, and manages the overall blood analysis sample workflow.Software acquires and processes data from various donor screening, diagnostic, multiplex assay instruments.
Physical State Standalone software running on a PC or on a mobile platform.
Technical Method Software accesses various instruments either wirelessly or wired through the communication protocol defined by these instruments. Software retrieves data stored in these instruments and creates a workflow repository of the samples tested.
Target Area Systemic viral infection
Regulation Medical Specialty Clinical Chemistry
Review Panel Microbiology
Product CodePQQ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(K) Exempt
Regulation Number 862.2570
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.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-