Precision Point of Care Blood Glucose Test Strip With True Measure Technology
510(k) K021960
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK021960 | Date16 Aug 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LFR
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Glucose Dehydrogenase, Glucose test strip designed for point-of-care blood glucose measurement. It quantitatively determines D-glucose levels in whole blood samples, including venous, arterial, neonatal, and fingertip capillary blood. The True Measure Technology enhances accuracy and reliability for clinical decision-making in diabetes management and patient monitoring.
The test strip is intended for single-use in vitro diagnostic applications and requires no sterilization beyond manufacturer-provided packaging. It is classified as a Class II device under FDA regulations (product code LFR, regulation number 862.1345) and holds an FDA 510(k) clearance (K021960) for substantial equivalence. Supplied in sterile, individual packaging, it is regulated under the Clinical Chemistry specialty and must be used in accordance with the provided instructions for use.
Other devices from Abbott Laboratories
Questions
AI-generated answers, 1 Oct 2026
What types of blood samples can the Precision Point-of-Care Blood Glucose Test Strip measure?
This test strip is designed to quantitatively determine D-glucose levels in whole blood samples from multiple sources, including venous, arterial, neonatal, and fingertip capillary blood. Its broad compatibility ensures reliable results for diverse patient monitoring needs, particularly in diabetes management.
Is the Precision Point-of-Care Blood Glucose Test Strip reusable or single-use?
The strip is intended for single-use only and is supplied in sterile, individual packaging. Reuse is not recommended, as it could compromise accuracy and introduce contamination risks. Always follow the manufacturer’s instructions for use to maintain reliability.
How is sterility maintained for the Precision Point-of-Care Blood Glucose Test Strip?
Each strip is packaged sterilely by the manufacturer, eliminating the need for additional sterilization procedures before use. The sealed, individual packaging ensures sterility until the first use, reducing the risk of cross-contamination in clinical settings.
What distinguishes the True Measure Technology in this test strip?
True Measure Technology enhances the strip’s accuracy and reliability by improving the precision of glucose measurement in whole blood. This innovation helps clinicians make more confident decisions in diabetes management, particularly in scenarios where blood glucose levels may fluctuate or vary between sample types.
Where can I find the regulatory details for this device?
This test strip holds an FDA 510(k) clearance (K021960) under the Clinical Chemistry specialty, classified as a Class II device (product code LFR, regulation number 862.1345). For full regulatory documentation, refer to the FDA’s OpenFDA database or the manufacturer’s official submission records.