Abacus 3CP
Clinical chemistry analyzer
Device · On PremiseCompany source
Company profile
About Arkray
ARKRAY USA, Inc. is the American subsidiary of ARKRAY, Inc., a global medical device and diagnostics company. The company specializes in diabetes management solutions, clinical diagnostics, and oral wellness products. ARKRAY's diabetes management portfolio includes the GLUCOCARD line of blood glucose meters and test strips (Shine, Expression, and Vital models), along with TechLITE lancets, pen needles, and syringes for consumer healthcare. For professional healthcare settings, ARKRAY offers the Assure product line including blood glucose meters and safety devices. In clinical diagnostics, the company provides HbA1c analyzers (ADAMS A1c HA-8180V), urinalysis systems (AUTION series including ELEVEN, EYE, and MAX models), and dry chemistry analyzers (Abacus 5 and 3CP). ARKRAY emphasizes accuracy that meets FDA requirements while maintaining affordability, particularly in its consumer blood glucose monitoring systems. The company supports healthcare providers with product training, wellness programs, and data management solutions. ARKRAY operates globally with presence across Asia Pacific, Europe, North America, Latin America, Middle East, and Africa, serving consumers with diabetes, healthcare professionals, pharmacies, clinical laboratories, and health systems.
Company description Arkray official website
Primary marketChronic Disease Management & Digital Therapeutics
Commercial modelCommercial information available on request
Company presenceOfficial website
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01 · Operating footprint
Where the Company operates
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Clinical focus
- Chronic kidney disease
- Diabetes
- Urinary tract conditions
Who it serves
- Clinical laboratories
- Consumers with diabetes
- Health systems
- Healthcare professionals
- Pharmacies
Deployment & integration
Embedded · Hybrid · On Premise deployment with recorded integration context.
Geographic context
MarketsAfrica · Asia Pacific (China, India, Indonesia, Japan, Korea, Philippines) · Europe (Benelux, Italy, Netherlands, Portugal, Spain, United Kingdom) · Latin America · Middle East · United States
Company sourceOfficial website
Company milestones
Platform expansion
Address change notification on product labeling (February 2025); EFLM European Urinalysis Guideline webinar (October 2024)
Partnerships
Recorded partners
No partners are currently listed.
02 · Flagship portfolio
Products, workflows, and platform capabilities
Selected source-backed Company products and the available commercial context.
Abacus 5
Clinical chemistry analyzer
Device · On PremiseCompany source
ADAMS A1c HA-8180V
HbA1c analyzer for clinical diagnostics
Device · On PremiseCompany source
ARKRAY Wellness Program
Comprehensive diabetes wellness and management program
Service · HybridCompany source
Assure ID Safety Pen Needles
Safety pen needles for professional healthcare use
Device · On PremiseCompany source
Assure Lance
Professional healthcare lancets
Device · On PremiseCompany source
Assure Lance Plus
Professional healthcare lancets
Device · On PremiseCompany source
Assure Platinum
Professional healthcare blood glucose monitoring system
Device · On PremiseCompany source
Assure Prism multi
Multi-parameter professional healthcare monitoring system
Device · On PremiseCompany source
03 · Research intelligence
Research Intelligence evidence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Evidence position
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Publications & preprints
No linked records are currently available.
Clinical validation
Clinical-trial records
No linked records are currently available.
Regulatory
Regulatory records
AUTION EYE AI-4510 Urine Particle Analysis SystemK232416 · 510k · May 3, 2024
04 · Company-reported outcomes
Outcomes and case studies
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
FDA accuracy compliance
GLUCOCARD Shine systems meet FDA accuracy requirements equivalent to more expensive meters
05 · Leadership
Leadership team
Leadership profiles and professional links from the current Company record.
No active leadership profiles are currently listed.
06 · Company updates
Updates from Arkray
Recent articles published on Arkray's official website.
07 · HAIC coverage
Coverage and analysis
Health AI Central reporting that mentions this Company.
No HAIC coverage is currently linked to this Company.
08 · Official presence
Company sources and channels
Curated official destinations from the active Company record.
09 · Market pathway
Additional Companies in this Market
Other active Companies in the same market, selected alphabetically from the HAIC directory.
Market context
Chronic Disease Management & Digital Therapeutics
Companies using AI and digital health tools to help patients manage chronic conditions through digital therapeutics, gamified health management, and AI-powered coaching. Covers management of all chronic diseases including diabetes, hypertension, COPD, heart disease, and multi-condition platforms. Includes continuous glucose monitoring (CGM) systems with AI analytics and insulin optimization algorithms.
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Pro Research will introduce expanded technical context, linked evidence analysis, and comparative Company research.
Linked research, clinical, and regulatory source pathways.
Expanded product, deployment, integration, and partnership research.
Record-level provenance and review context.