ATAGO UG-α Digital Urine Specific Gravity Refractometer
| Brand | ATAGO |
|---|---|
| Origin | Japan |
| Model | UG-α |
| Type | Handheld Refractometer |
| Temperature Control | Yes |
| Digital Display | Yes |
| Measurement Range | 1.0000–1.0600 |
| Accuracy | ±0.001 |
| Compliance | ISO 17025 traceable calibration capability (per ATAGO factory standard) |
Overview
The ATAGO UG-α Digital Urine Specific Gravity Refractometer is a precision handheld optical instrument engineered for rapid, field-deployable, and laboratory-grade measurement of urine specific gravity (USG) in clinical, veterinary, and point-of-care settings. It operates on the principle of critical-angle refractometry: incident light passes through a prism-sample interface, and the resulting refraction angle—directly correlated to the solution’s refractive index—is converted into a specific gravity value using a pre-calibrated algorithm optimized for human and animal urine matrices. Unlike hydrometers or dipstick methods, the UG-α eliminates subjective interpretation and operator-dependent variability by delivering direct digital readouts with 0.0001 resolution and ±0.001 accuracy across its clinically relevant range (1.0000–1.0600). Its compact form factor, integrated temperature compensation (ATC), and robust aluminum alloy housing enable consistent performance under ambient fluctuations typical in emergency departments, mobile clinics, and animal shelters.
Key Features
- High-resolution digital LCD display with automatic backlight for low-light environments
- Automatic Temperature Compensation (ATC) spanning 10–40 °C, eliminating manual correction and ensuring metrological consistency per ISO 21748 guidelines
- Optical system featuring high-transmittance sapphire prism and precision-ground glass optics for long-term stability and minimal drift
- Battery-powered operation (2× AAA batteries, >10,000 measurements per set) with auto-power-off after 3 minutes of inactivity
- Ergonomic, non-slip rubberized grip designed for single-handed use and glove-compatible operation
- Calibration verification via ATAGO-certified Brix/USG reference standards (e.g., 1.010 and 1.030 USG solutions), traceable to NIST-traceable reference materials
Sample Compatibility & Compliance
The UG-α is validated for use with fresh, centrifuged, or clarified urine specimens—including those containing moderate levels of protein, glucose, or ketones—without requiring dilution or pretreatment. It is not intended for highly viscous, turbid, or particulate-laden samples without prior filtration (0.45 µm membrane recommended). The instrument complies with essential requirements of IEC 61010-1 for electrical safety and meets the environmental classification IP65 for dust and water resistance. While not an FDA-cleared IVD device, it supports GLP/GMP-aligned workflows when used with documented calibration logs, operator training records, and maintenance schedules. Its measurement uncertainty profile aligns with CLIA-waived testing criteria for USG when operated within specified environmental and procedural controls.
Software & Data Management
The UG-α operates as a standalone instrument with no embedded data logging or Bluetooth connectivity. However, its repeatable output enables seamless integration into existing laboratory information systems (LIS) or electronic health record (EHR) platforms via manual entry or barcode-assisted transcription using optional ATAGO-compatible label printers. For quality assurance purposes, users are advised to maintain calibration records per ISO/IEC 17025:2017 Annex A.3, including date, standard used, operator ID, ambient temperature, and deviation from nominal value. ATAGO provides downloadable calibration certificates and traceability documentation upon request for audit readiness.
Applications
- Clinical assessment of renal concentrating ability and hydration status in outpatient and inpatient settings
- Veterinary diagnostics for evaluating kidney function in dogs, cats, and equines
- Urinalysis workflow optimization in urgent care centers and dialysis units
- Quality control of urine collection protocols in clinical trials (e.g., pharmacokinetic studies requiring standardized USG thresholds)
- Educational use in medical, nursing, and veterinary technician training programs for teaching osmolality–specific gravity relationships
FAQ
What is the recommended calibration frequency?
ATAGO recommends daily calibration before first use and after any significant ambient temperature shift (>5 °C); additional verification is required after cleaning or if readings deviate from expected clinical norms.
Can the UG-α measure other biological fluids?
It is specifically calibrated for urine; use with serum, CSF, or saliva requires independent validation and is not supported by ATAGO’s warranty or regulatory documentation.
Does it meet FDA 21 CFR Part 11 requirements?
No—the UG-α lacks electronic audit trail, user authentication, or secure data storage; however, its outputs may be entered into Part 11–compliant LIS/EHR systems with appropriate procedural controls.
How does temperature compensation work?
An integrated thermistor continuously monitors sample temperature at the prism surface and applies real-time correction based on the Sellmeier equation-derived USG–temperature relationship for aqueous sodium chloride–urea mixtures.
Is the prism replaceable?
The sapphire prism is permanently bonded and not user-replaceable; prism damage voids calibration validity and requires return to an ATAGO-authorized service center.
