Alere Technologies AS
NO Last updated 22 Oct 2026
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- Devices
- 3
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Afinion HbA1c Dx Ref K180296
Afinion HbA1c Dx on Afinion 2 Ref K182988
What Alere Technologies AS makes
Alere Technologies AS manufactures point-of-care diagnostic analyzers and tests for hemoglobin A1c (HbA1c) measurement, including the Afinion AS100 Analyzer and its associated HbA1c test kits. These devices provide automated, rapid results for monitoring diabetes management in clinical and near-patient settings.
The company’s HbA1c analyzers and tests are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. The portfolio is listed in the FDA’s 510(k) database, reflecting compliance with U.S. regulatory requirements. The manufacturer is based in the United States.
Frequently asked questions
What types of medical devices does Alere Technologies AS manufacture?
Alere Technologies AS specializes in point-of-care diagnostic devices, specifically automated analyzers and test kits for measuring hemoglobin A1c (HbA1c). HbA1c is a key biomarker used to monitor long-term blood glucose levels in patients with diabetes. Their portfolio includes systems like the Afinion AS100 Analyzer and associated test kits, designed for rapid, automated results in clinical or near-patient settings.
Where is Alere Technologies AS based?
Alere Technologies AS is headquartered in the United States. The company’s U.S. location aligns with its focus on regulatory compliance for devices marketed in North America, including FDA requirements.
How are Alere Technologies AS’s devices classified under U.S. regulations?
Alere Technologies AS’s HbA1c analyzers and test kits fall under Class II medical device classification in the U.S. This classification applies because these devices, while not invasive, involve measurements critical to patient management (e.g., diabetes monitoring) and require performance standards to ensure accuracy and reliability. Class II devices typically undergo 510(k) clearance to demonstrate substantial equivalence to a predicate device.
Are Alere Technologies AS’s devices listed in any regulatory databases?
Yes, Alere Technologies AS’s HbA1c analyzers and test kits are included in the FDA’s 510(k) database. This listing reflects that each device has undergone the 510(k) premarket notification process, where the manufacturer demonstrates compliance with U.S. regulatory requirements for Class II devices. The database serves as a public record of cleared devices, allowing healthcare providers and regulators to verify authorization status.
Why does the classification of Alere’s HbA1c devices matter for healthcare providers?
The Class II classification for Alere’s HbA1c analyzers and tests indicates that these devices are subject to stricter controls than Class I (lower-risk) devices but do not require the rigorous clinical trials of Class III (high-risk) devices. This classification ensures that the devices meet performance standards for accuracy, reliability, and safety in measuring HbA1c—a critical marker for diabetes management. Providers rely on this classification to trust the device’s regulatory scrutiny before use in patient care.
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