FDA Device, Combination Product Authorizations: XW-100 ANALYZER, ABILIFY MYCITE, NSS-2 BRIDGE – Drug and Device Digest

Capture.JPGXW-100 Automated Hematology Analyzer

Sysmex America, Inc.

INTENDED USE:  For use in patients 2 years of age and older who require a whole blood cell count and white blood cell differential.

Test results can be used with other clinical and laboratory findings to provide early alerts of patients with serious conditions such as severe anemia (low red blood cell or hemoglobin count) and agranulocytosis (low white blood cell count), who require additional testing.

Not intended to diagnose or monitor patients with primary and/or secondary hematologic diseases, including oncology and critically ill patients.

REGULATORY PATHWAY: Dual Submission pathway – 510(k)) and CLIA Waiver

  • Original 510(k) clearance (2015) for use at patient’s point-of-care
  • CLIA Waiver: Simple operator instructions and number of hematology parameters reduced to 12
  • Dual clearance based on substantially equivalence to  2015 model + demonstration ease of use and low risk of false results when used by untrained operators
  • Regulation No. 864.5220
  • Product Code: GKZ


  • 15 µL venous blood to provide CBC with three-part differential
  • White Blood Cell Count (WBC), Red Blood Cell Count (RBC), Hemoglobin (HGB),  Hematocrit (HCT), Mean Corpuscular Volume (MCV), Platelet Count (PLT), Neutrophil Count (NEUT#), Lymphocyte Count (LYM#), Other White Blood Cell Count (Other WBC#), Neutrophil Percentage (NEUT%), Lymphocyte Percentage (LYM%), Other White Blood Cell Percentage (Other WBC%)


  • 582 samples collected from patients 2 to 92 years old.
  • Comparison of XW-100 test results: non-medical personnel in CLIA-waived settings  vs. hematology analyzer in accredited clinical laboratory
  • Accurate testing effectively conducted by untrained personnel following manufacturer’s instructions for use

Capture.JPGABILIFY MYCITE (aripiprazole with sensor) tablets

Otsuka Pharmaceuticals, Proteus Digital Health


Drug-device combination product comprised of aripiprazole tablets embedded with Ingestible Event Marker (IEM) sensor to track drug ingestion, is indicated for :
• Treatment of adults with schizophrenia
• Treatment of bipolar I disorder
• Adjunctive treatment of adults with Major Depressive Disorder

Limitations of Use:
• Ability to improve patient compliance not been established
• Use to track drug ingestion in “real-time” or emergency not recommended


  • Being able to track ingestion of medications prescribed for mental illness
  • New technology might benefit patients and prescribers


  • Abilify : NDA first approved in 2002 to treat schizophrenia
  • Ingestible sensor: De Novo order in 2012
  • Required Postmarketing Pediatric Studies:  Human factors usability studies in schizophrenia, bipolar I disorder, irritability associated with autistic disorder


  • Aripiprazole tablet embedded with IEM sensor
  • Patch (wearable sensor) that detects signal from IEM sensor after ingestion and
    transmits data to smartphone
  • APP – to display information for the patient
  • Web-based portal for healthcare professionals and caregivers


  • Safety and efficacy of aripiprazole tablets for the treatment of adults with schizophrenia, acute treatment of adults with manic and mixed episodes associated with Bipolar I disorder, and adjunctive treatment of adults with major depressive disorder  established based on prior adequate and well-controlled trials of aripiprazole tablets
  • Ensuring  compatibility with their specific smartphone and downloading APP; facilitated by the healthcare provider
  • Skin irritation with patch


  • Only select number of health plans and providers
  • Learnings for prescribers, health plans, and Otsuka for implementing broader access


Capture.JPGNSS-2 BRIDGE Neurostimulation System

Innovative Health Solutions, Inc.

INDICATION FOR USE: Percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination


  • Innovative new way to address epidemic of opioid addiction
  • Additional help  to live lives of sobriety with medically assisted treatment

REGULATORY PATHWAY: De Novo Request, to expand use

  • Regulation Number: 21 CFR 882.5896
  • Regulation Name: Percutaneous nerve stimulator for substance use disorders
  • Regulatory Class: Class II
  • Product Code: PZR
  • Prior (2014) clearance of EAD (electro auricular device)for use in acupuncture
GENERIC TYPE OF DEVICE: Percutaneous nerve stimulator for substance use disorders
  • Device that stimulates nerves percutaneously to aid in the reduction of withdrawal symptoms associated with substance use disorders


  • Small electrical nerve stimulator placed behind patient’s ear
  • Battery-powered chip emits electrical pulses to stimulate branches of certain cranial nerves
  • Stimulations may provide relief from opioid withdrawal symptoms


  • Single-arm clinical study, n=73, undergoing opioid physical withdrawal
  • Endpoint: Clinical opiate withdrawal scale (COWS) score
  • COWS reduction of at least 31 %  within 30 minutes of device use
  • Transitioned to medication assisted therapy: 88% after 5 days of device use


  • Adverse tissue reaction – Biocompatibility evaluation, Labeling
  • Electrical, mechanical, or thermal hazards leading to user discomfort or injury –
    Electromagnetic compatibility testing, Electrical, mechanical, and thermal safety testing, Non-clinical performance testing, Software verification, validation and hazard analysis, Labeling
  • Infection Sterility testing- Shelf life testing, Labeling

Image credit: Sysmex, Otsuka, Innovative Health Solutions

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