Adams A1c HA-8180V Calibrator 80
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K162822 FDA 510(k)
- FDA Product Code
- PDJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1373 FDA 510(k)
- Regulation Number
- 862.1373 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Adams A1c Ha-8180V Calibrator 80 is a Hemoglobin A1c Test System Calibrator, designed for use with point-of-care glucose monitoring devices. It provides standardized calibration solutions to ensure accurate measurement of glycated hemoglobin (HbA1c) levels, a key biomarker for diabetes management and long-term blood glucose control.
This calibrator is supplied as a single-use, non-sterile reagent intended for in vitro diagnostic use in clinical chemistry laboratories or point-of-care settings. It is authorized under FDA 510K, In Vitro Diagnostic Device Directive (IVDD), and In Vitro Diagnostic Regulation (IVDR). The device is classified as Class II and adheres to regulatory requirements under 21 CFR 862.1373. Storage conditions and usage instructions are specified in the accompanying documentation.
Frequently asked questions
What is the primary purpose of the Adams A1c HA-8180V Calibrator 80 in clinical settings?
The Adams A1c HA-8180V Calibrator 80 is designed to provide standardized calibration solutions for point-of-care glucose monitoring devices. It ensures accurate measurement of glycated hemoglobin (HbA1c) levels, which are critical for monitoring diabetes management and assessing long-term blood glucose control. This calibrator helps maintain precision in HbA1c testing, supporting reliable clinical decisions.
Is the Adams A1c HA-8180V Calibrator 80 intended for single-use or repeated use, and what are its sterility specifications?
The Adams A1c HA-8180V Calibrator 80 is explicitly supplied as a single-use reagent. It is non-sterile, meaning it is not intended for sterile procedures or applications requiring aseptic conditions. The device is intended for in vitro diagnostic use in clinical chemistry laboratories or point-of-care settings, where non-sterile reagents are acceptable for calibration purposes.
What regulatory pathways has the Adams A1c HA-8180V Calibrator 80 followed, and how does this affect its use?
The device has been authorized through FDA 510(k), the In Vitro Diagnostic Device Directive (IVDD), and the In Vitro Diagnostic Regulation (IVDR). It is classified as Class II, adhering to regulatory standards under 21 CFR 862.1373. These pathways confirm its compliance with safety, performance, and quality requirements for in vitro diagnostic use, ensuring it meets established benchmarks for calibration accuracy in HbA1c testing.
Where should the Adams A1c HA-8180V Calibrator 80 be stored, and are there specific handling instructions?
Storage conditions and usage instructions for the Adams A1c HA-8180V Calibrator 80 are detailed in the accompanying documentation provided by Arkray Factory, Inc. While the exact storage requirements (e.g., temperature, light exposure) are not specified here, typical calibrators of this type generally require protection from extreme temperatures, moisture, and direct sunlight. Always follow the manufacturer’s guidelines to preserve the calibrator’s stability and accuracy before use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K162822 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ARKRAY Factory, Inc.
Sources (2)
- FDA 510(k) K162822 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026