URight Hemoglobin A1c System, FORA A1c System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K142664 FDA 510(k)
- FDA Product Code
- LCP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7470 FDA 510(k)
- Regulation Number
- 864.7470 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The URight Hemoglobin A1c System, FORA A1c System is an assay device designed to quantitatively measure the percentage of glycosylated hemoglobin A1c in capillary finger-stick or venous whole blood. The samples must be collected in EDTA (K2 and K3) or sodium heparin anticoagulants. It is intended for use in both clinical laboratory settings and at the point of care.
The system is supplied as a single-use device and requires storage in a dry environment at room temperature. It is not evaluated for use in magnetic resonance imaging (MRI) environments. The device is regulated under product code LCP and classification 864.7470 for hematology assays, with authorization under the FDA 510(k) premarket notification process.
Frequently asked questions
What type of blood samples can be used with the URight Hemoglobin A1c System?
The system can be used with capillary finger-stick or venous whole blood samples, collected in EDTA (K2 and K3) or sodium heparin anticoagulants.
Is the URight Hemoglobin A1c System a single-use device?
Yes, the system is supplied as a single-use device, requiring storage in a dry environment at room temperature.
What is the intended use of the URight Hemoglobin A1c System?
The system is intended for use in both clinical laboratory settings and at the point of care to quantitatively measure the percentage of glycosylated hemoglobin A1c in blood samples.
Is the URight Hemoglobin A1c System evaluated for use in MRI environments?
No, the device is not evaluated for use in magnetic resonance imaging (MRI) environments.
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. Sources consulted: URight Hemoglobin A1c system, FORA A1c System (K142664) — FDA 510 (k ..., PDF Taidoc Technology Corporation, URight Hemoglobin A1c System, FORA A1c System 510 (k)… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142664 | Class II | Active |
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Manufacturer
- Manufacturer
- Taidoc Technology Corporation
Sources (1)
- FDA 510(k) K142664 24 fields · synced Sep 26, 2026