True Focus
True Focus is a glucose monitoring system IVD (FDA Class II) made by Trividia Health, Inc., cleared under FDA 510(k) K131013 on 17 Oct 2013 and listed in FDA GUDID since 21 Jun 2017 (UDI-DI 00021292008956), active as of 19 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00021292008956 | Date21 Jun 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK131013 | Date17 Oct 2013 | StatusActive |
Official records
- AccessGUDID record 00021292008956
- FDA 510(k) database K131013
Across registries
- FDA 510(k) K131013 decided 17 Oct 2013 Active
- FDA GUDID UDI-DI 00021292008956 listed 21 Jun 2017 Listed
Timeline
- Cleared FDA 510(k) K131013
- Listed FDA GUDID 00021292008956
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Glucose monitoring system IVD, home-use
- Model / reference
- TRUE FOCUS Self Monitoring Test Strip - 50ct
- Primary DI / UDI-DI
- 00021292008956
- 510(k) Number
- FDA product code
- LFR, NBW, JJX
- GMDN term
- Glucose monitoring system IVD, home-use
- Device class
- Class II
- Regulation number
- 862.1345, 862.1660
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under FDA product code LFR (Glucose Dehydrogenase, Glucose).
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