UniStrip1 Blood Glucose Test Strips
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K162430 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 UniStrip1 Blood Glucose Test Strips are disposable, single-use diagnostic devices classified as blood glucose monitoring systems. They are designed to measure glucose levels in whole capillary blood, providing quantitative results for diabetes management.
These test strips are intended for use with specific LifeScan meters—including the OneTouch Ultra², OneTouch UltraMini, and OneTouch UltraSmart—purchased before April 2016, when configured with calibration code 49. Supplied in sterile, single-use packaging, they require no sterilisation beyond manufacturer-provided conditions. The device holds an FDA 510(k) clearance under product code NBW, with no MRI safety or reusable components specified.
Frequently asked questions
Are these test strips compatible with newer LifeScan meters released after April 2016, and if not, why not?
No, these UniStrip1 test strips are only designed for use with LifeScan meters purchased before April 2016 that are configured with calibration code 49. The compatibility is explicitly tied to the meter’s calibration settings, which were updated after that date to support newer strip models. Always verify your meter’s calibration code before use.
How should I store these test strips to maintain their sterility and accuracy?
The UniStrip1 strips come in sterile, single-use packaging, so they should remain unopened until use. Store them in a cool, dry place, away from direct sunlight and moisture, to preserve their integrity. Avoid refrigeration unless specified by the manufacturer’s instructions (not mentioned here), as extreme temperatures could affect performance. Once opened, use immediately and discard any unused strips.
Can these test strips be reused, or are they intended for single-use only?
These are explicitly labeled as disposable and single-use diagnostic devices. Reusing them could compromise accuracy, introduce contamination, or pose safety risks. Each strip is designed for one measurement only, aligning with standard blood glucose monitoring practices to ensure reliable results.
What regulatory pathway was followed for FDA clearance, and what does that mean for users?
The UniStrip1 strips received FDA 510(k) clearance under product code NBW (Blood Glucose Monitoring Systems) via a Traditional 510(k) review, determined to be *substantially equivalent* to a predicate device. This means the FDA evaluated them against existing, cleared blood glucose test strips to confirm safety and performance. For users, this clearance indicates the strips meet U.S. regulatory standards for accuracy and reliability in measuring glucose levels for diabetes management.
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: UniStrip1 Generic Blood Glucose Test Strips by OK BIOTECH CO., LTD ..., UniStrip1 Generic Blood Glucose Test Strips (K162430) — FDA 510(k ..., UniStrip1 Generic Blood Glucose Test Strips (K160038) — FDA 510(k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162430 | Class II | Active |
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Manufacturer
- Manufacturer
- Ok Biotech Co., Ltd.
Sources (1)
- FDA 510(k) K162430 24 fields · synced Sep 19, 2026