Identifiers
- 510(k) Number
- K062395 FDA 510(k)
- FDA Product Code
- NBW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1345 FDA 510(k)
- Regulation Number
- 862.1345 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Accu-Chek Smart Pix is a device reader designed as part of a diabetes management system. It serves as the central component that interfaces with various Accu-Chek meters and insulin pumps, containing the electronics and programs necessary to process data and results read from these devices.
The device temporarily stores analyses created from processed data, which can be viewed using an Internet browser. It was cleared through the FDA 510(k) process under k-number K062395, with a traditional clearance type and product code NBW, and is manufactured by Roche Diagnostics Corp. in Indianapolis, Indiana.
Frequently asked questions
What is the purpose of the Accu‑Chek Smart Pix?
The Smart Pix functions as the central data‑processing hub in Roche’s diabetes management system. It receives information from compatible Accu‑Chek glucose meters and insulin pumps, runs the necessary software to interpret the readings, and makes the results available for review, supporting clinicians and patients in managing therapy.
How does the device store and present the processed data?
After the Smart Pix processes incoming measurements, it temporarily holds the analysis in its internal memory. Users can then access these stored results through a standard Internet browser, allowing convenient review without needing specialized software. This temporary storage design ensures data is available for immediate review while maintaining device simplicity.
Is the Smart Pix a single‑use or reusable device?
The Smart Pix is a reusable electronic reader. It contains the electronics and programs needed to interface with multiple meters and pumps over its service life, rather than being disposed after a single use. Reusability aligns with its role as a central data hub in ongoing diabetes management.
What regulatory clearance does the Accu‑Chek Smart Pix have?
The device received traditional FDA 510(k) clearance under K062395, indicating it was found substantially equivalent to a legally marketed predicate. The clearance was reviewed by the Clinical Chemistry advisory committee and recorded with decision code SESE on May 9 2007.
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: ROCHE ACCU-CHEK SMART PIX USER MANUAL Pdf Download, ACCU-CHEK SMART PIX USER MANUAL Pdf Download | ManualsLib, Accu-Chek® Smart Pix Software: Advanced Diabetes Management, Device Reader
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K062395 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA 510(k) K062395 24 fields · synced Sep 27, 2026