FDA Approvals: SENTOSA ZIKV Test, MINIMED 670G SYSTEM – Drug and Device Digest

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FDA BRIEF: Week of September 26, 2016

FDA approved

SENTOSA ZIKV RT-PCR Test

Vela Diagnostics USA, Inc. Fairfield, NJ, USA

Image result for SENTOSA ZIKA test image

INTENDED USE: The Sentosa® SA ZIKV RT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum, EDTA plasma or urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Testing is limited to U.S. laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, and similarly qualified non-U.S. laboratories

REG PATHWAY: Emergency Use Authorization (EUA)

DESCRIPTION: Uses the following materials

  • Enzyme Mix
  • Zika Virus Primer/Probe Mix
  • Extraction Control Primer/Probe Mix
  • Extraction Control
  • Positive Control
  • Negative Control (nuclease free water)

MINIMED 670G SYSTEM

Medtronic MiniMed, Inc., Northridge, CA, USA

Picture of the device.

INDICATION FOR USE:  For continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of Type 1 diabetes mellitus in persons, fourteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 670G System includes SmartGuard technology, which can be programmed to automatically adjust delivery of basal insulin based on Continuous Glucose Monitor sensor glucose values, and can suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values.

UNMET NEED:

  • Need to advance the development of an artificial pancreas device system
  • Automatically monitors blood glucose and provides appropriate insulin doses in people with diabetes who use insulin.

REG PATHWAY: PMA, Device Procode: OZP,

  • Artificial pancreas device system, single hormonal control
  • Priority Review because device is novel technology and availability is in patients’ best interest.
  • Insulin reservoirs and infusion sets used with the 670G System are the same as those currently used with the MiniMed 530G System (P120010)

DEVICE DESCRIPTION: System consists of:

  • MiniMed 670G insulin pump
  • Guardian Link Transmitter
  • Guardian Sensor
  • One-Press Serter
  • Contour NEXT Link 2.4 Glucose Meter

EFFECTIVENESS:

  • Pivotal study: Safety Evaluation of the Hybrid Closed Loop (HCL) System in Type 1 Diabetes
  • Performance Evaluation of the Enlite® 3 Sensor to Support a Full 168 hours (7 Days) of Use
  • Established sensor performance across the claimed measuring range (40 to 400 mg/dL glucose), the precision, and the calibration frequency (calibrate minimally every 12 hours or 3-4 times a day) of the 7 day wear period for the Guardian sensor
  • Established the performance of the alarms and alerts

SAFETY:

  • Risks of the Auto Mode feature
  • Risks of the predictive suspend feature
  • Risks of the pump hardware problems
  • Potential device-related non-serious events : Skin irritation, Infection, Pain, Discomfort, Bruising, Edema, Rash, Induration of skin, Allergic reaction to adhesives, Hematoma, Unnecessary fingersticks, Hyperglycemia, Ketosis, Sensor may break

REVIEW

Published by Drug & Device Advisory Group

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