Identifiers
- 510(k) Number
- K141944 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 Home Access AIC Test is an assay for glycosylated hemoglobin (HbA1c) measurement. It is designed for use with blood specimens collected at the patient's home or in a healthcare professional setting.
The test is supplied for use with mail delivery to the laboratory. Measurements obtained are used for monitoring long-term blood sugar control in people with diabetes. It is authorized under FDA 510(k) clearance K141944 and classified as a Class II device under regulation number 864.7470.
Frequently asked questions
What is the Home Access AIC Test used for?
The Home Access AIC Test is an assay designed to measure glycosylated hemoglobin (HbA1c) in blood specimens. It is used to monitor long-term blood sugar control in individuals with diabetes, reflecting average glucose levels over the past two to three months.
How is the Home Access AIC Test supplied and used?
The test is supplied for use with blood specimens collected at home or in a healthcare setting, followed by mail delivery to a laboratory for analysis. Patients collect the sample using the provided kit, which is then sent to a lab where HbA1c levels are measured.
Is the Home Access AIC Test a single-use device?
Yes, the Home Access AIC Test is intended for single-use only. Each kit is designed to process one blood specimen collected from a single patient, and components are not meant to be reused due to the risk of contamination and potential compromise of test accuracy.
What regulatory authorization does the Home Access AIC Test have?
The Home Access AIC Test is authorized under FDA 510(k) clearance K141944 and is classified as a Class II medical device under regulation number 864.7470, which governs in vitro diagnostic devices for glycosylated hemoglobin measurement.
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: HOME ACCESS AIC TEST (K141944) — FDA 510(k) | Innolitics, HOME ACCESS A1C TEST — FDA Class I Medical Device | MedEquip Directory, Zara Home Deutschland | Offizielle Website, HOME ACCESS AIC TEST 510 (k) K141944 - 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 | K141944 | Class II | Active |
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Manufacturer
- Manufacturer
- Home Access Health Corp.
Sources (1)
- FDA 510(k) K141944 24 fields · synced Sep 24, 2026