Identifiers
- 510(k) Number
- K833772 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 Auto Aic Analyzer System is an assay for glycosylated hemoglobin, classified as a Class II medical device under regulation number 864.7470. It is designed for the quantitative measurement of glycated hemoglobin in blood samples, serving as a tool in hematology for monitoring long-term glucose control.
The system is supplied as a traditional 510(k)-cleared device (K833772) by Helena Laboratories, located in McHenry, Illinois. It is intended for use in clinical laboratory settings and is not described as sterile, single-use, reusable, or MRI-safe in the provided data. No specific sizes, storage conditions, or additional authorizations beyond the FDA 510(k) clearance are detailed in the specifications.
Frequently asked questions
What is the Auto Aic Analyzer System used for?
The Auto Aic Analyzer System is designed for the quantitative measurement of glycated hemoglobin in blood samples, serving as a tool in hematology for monitoring long-term glucose control in patients.
How is the Auto Aic Analyzer System supplied and cleared for use?
The system is supplied as a traditional 510(k)-cleared device (K833772) by Helena Laboratories and is classified as a Class II medical device under regulation number 864.7470, indicating it is substantially equivalent to a legally marketed device.
Is the Auto Aic Analyzer System described as sterile, single-use, or reusable in the provided data?
The provided data does not describe the Auto Aic Analyzer System as sterile, single-use, reusable, or MRI-safe, so no claims about its sterility or reusability can be made based on the information given.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K833772 | Class II | Active |
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Manufacturer
- Manufacturer
- Helena Laboratories
Sources (1)
- FDA 510(k) K833772 24 fields · synced Sep 23, 2026