Clarity Diagnostics, Llc Clarity Diagnostics Urinalysis

The urinalysis systems include two automated analyzer models, both designated for in-vitro diagnostic use in clinical settings:

• Clarity Urocheck 120 Analyzer: Included in the standard kit with five bottles of 10SG strips (10 parameters). This model is both FDA Cleared and CLIA Waived.
• 120C Analyzer: Included in the promotional kit, which features four bottles of 10SG strips and one bottle of specialized Microalbumin/Creatinine strips. This model is CLIA Waived.

These analyzers provide automated reading of the test strips, which ensures enhanced accuracy and streamlines the diagnostic process.

Yes, the Clarity Diagnostics urinalysis systems meet essential regulatory standards for clinical environments, ensuring simplified compliance and reliable operation:

• CLIA Waived Status: Both available analyzer configurations (the Urocheck 120 and the 120C PROMO) are designated as CLIA Waived. This is a significant benefit for clinical facilities, simplifying regulatory requirements for testing.
• FDA Cleared Components: The specific configuration that includes the Clarity Urocheck 120 Analyzer and the (5) Bottles of Clarity 10SG Strips is explicitly noted as being FDA Cleared for diagnostic use.

All components are supplied in factory new condition and are intended for in-vitro diagnostic testing.

The Clarity Diagnostics Urinalysis System is offered in factory-new, comprehensive bundles, each featuring an analyzer and reagent strips for immediate, CLIA Waived diagnostic use. The components vary based on the specific configuration:

1. Standard Urocheck 120 Analyzer Bundle (FDA Cleared)
   • Clarity Urocheck 120 Analyzer
   • Five (5) Bottles of Clarity 10SG Strips
2. Promotional 120C Analyzer Bundle
   • Clarity 120C Analyzer
   • Four (4) Bottles of Clarity 10SG Strips
   • One (1) Bottle of specialized Microalbumin/Creatinine Strips

The 10SG strips provide comprehensive testing for 10 key parameters, including Leukocytes, Nitrite, Protein, Glucose, and pH.

The Clarity Urinalysis system utilizes the standard Clarity 10SG Reagent Strips, which are designed to detect 10 distinct parameters during a single test. This comprehensive analysis is one of the key features of the system, which carries a CLIA Waived status.

Parameters Tested by 10SG Strips

The 10 key parameters tested by the 10SG strips include:

• Leukocytes
• Nitrite
• Urobilinogen
• Protein
• pH
• Blood
• Specific Gravity
• Ketone
• Bilirubin
• Glucose

Certain available configurations also include specialized Microalbumin/Creatinine Strips for expanded diagnostic testing capabilities.

Yes, the Clarity Diagnostics Urinalysis system is designed for in-vitro diagnostic use specifically for clinical purposes. It is ideal for clinical laboratories, medical offices, and healthcare facilities looking to enhance diagnostic accuracy and efficiency in urinalysis testing.

The Clarity Urinalysis system supports comprehensive testing using reagent strips that cover multiple diagnostic parameters, depending on the chosen configuration.

1. Clarity 10SG Strips (Standard 10 Parameters)

These strips are included in all configurations and test for ten essential markers:

• Leukocytes
• Nitrite
• Urobilinogen
• Protein
• pH
• Blood
• Specific Gravity
• Ketone
• Bilirubin
• Glucose

2. Specialized Microalbumin/Creatinine Strips

One specific bundle configuration (the PROMO variant) also includes specialized strips for targeted analysis of:

• Microalbumin
• Creatinine

To ensure reliable diagnostic performance, store your reagent strips at room temperature and always keep them out of direct sunlight. Please remember to replace the cap immediately after each use to protect the integrity of the strips. Once opened, be sure to use the bottle contents within 30 days.

Yes, the system is specifically engineered for a streamlined, high-throughput workflow. The Urocheck 120 Analyzer features a user-friendly interface with a tactile, rubberized keypad and a clear display screen, making it intuitive for staff to navigate and enter data quickly during busy shifts.

Yes, this professional urinalysis system is designed for comprehensive, multi-parameter detection using the Clarity Urocheck Analyzer and specialized reagent strips.

Detection capabilities vary slightly by configuration:

1. Standard 10-Parameter Screening (10SG Strips): This configuration tests for ten essential markers critical for general health screening:
   • Leukocytes
   • Nitrite
   • Urobilinogen
   • Protein
   • pH
   • Blood
   • Specific Gravity
   • Ketone
   • Bilirubin
   • Glucose
2. Specialized Analysis: A promotional configuration is also available that includes strips for Microalbumin and Creatinine testing, offering extended diagnostic value.

This system is ideal for clinical settings as it holds CLIA Waived status, ensuring suitability for low-complexity testing.

Yes, one configuration, the Clarity Urine Analyzer 120C (PROMO), includes one bottle of Microalbumin/Creatinine strips in addition to four bottles of 10SG strips, allowing for specialized testing alongside general urinalysis.