Cordisnhyperion Hemoglobin A1 Test Sys
by Cordis Corp.
510(k) K812242
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK812242 | Date9 Sep 1981 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LCP
- Device class
- Class II
- Regulation
- 21 CFR Part 864.7470
- Advisory committee
- Hematology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Cordis Hyperion Hemoglobin A1 Test System is an assay device designed to measure glycosylated hemoglobin (HbA1c) levels in blood samples. HbA1c testing provides a long-term indicator of blood glucose control, aiding in the diagnosis and management of diabetes. This system quantifies the proportion of hemoglobin bound to glucose, reflecting average blood sugar levels over the preceding two to three months. It is classified as a Class II medical device under FDA regulations, ensuring compliance with stringent performance and safety standards.
This system is intended for use in clinical laboratories and healthcare settings by trained personnel. It operates as a single-use diagnostic tool, requiring no sterilization between tests. The device is regulated under FDA 510(k) clearance (K812242) and falls under the Assay, Glycosylated Hemoglobin product code (LCP). Supplied as a ready-to-use kit, it adheres to regulatory requirements outlined in 21 CFR 864.7470. No MRI safety or reusable components are specified in the device data.
Other devices from Cordis US Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Cordis Hyperion Hemoglobin A1 Test System used for?
The Cordis Hyperion Hemoglobin A1 Test System measures glycosylated hemoglobin (HbA1c) levels in blood samples. HbA1c provides a long-term average of blood glucose control over the preceding two to three months, which is critical for diagnosing and managing diabetes. This helps clinicians assess how well a patient’s blood sugar has been controlled over time, guiding treatment adjustments.
How is the Cordis Hyperion HbA1c Test System supplied?
The system is supplied as a ready-to-use kit, designed for single-use only. Each kit contains all necessary components for performing one HbA1c test, eliminating the need for sterilization or preparation between uses. This ensures consistency and reduces the risk of cross-contamination in clinical settings.
Is the Cordis Hyperion HbA1c Test System reusable or single-use?
The Cordis Hyperion HbA1c Test System is explicitly designed for single-use only. This design choice simplifies workflows in clinical laboratories by removing the need for cleaning, sterilization, or reprocessing between tests. Single-use devices also help maintain accuracy and reliability, as they are not subject to wear or degradation from repeated use.
What regulatory approval does the Cordis Hyperion HbA1c Test System hold?
The Cordis Hyperion Hemoglobin A1 Test System holds FDA 510(k) clearance under the product code LCP (Assay, Glycosylated Hemoglobin). It is classified as a Class II medical device, adhering to stringent regulatory standards for performance, safety, and accuracy. The clearance number is K812242, and it complies with regulatory requirements outlined in 21 CFR 864.7470.
Does the Cordis Hyperion HbA1c Test System require any special storage conditions?
While the device data does not specify exact storage conditions, most single-use assay systems like this are typically stored in a clean, dry environment protected from extreme temperatures and direct light. It is essential to follow the manufacturer’s instructions provided in the kit for optimal performance and shelf life. Proper storage ensures the accuracy and reliability of the test results.