Reflotron Potassium Test Tabs

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K904033 ↗

FDA Product Code

CEJ

Device Class

Class II

Regulation

21 CFR Part 862.1600

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What clinical setting or specialty is the Reflotron Potassium Test Tabs designed for use in?

  The Reflotron Potassium Test Tabs are specifically designed for clinical chemistry applications, meaning they are intended for use in laboratory settings where electrolyte levels—particularly potassium—are measured in serum or plasma. This aligns with their classification under the Clinical Chemistry advisory committee and their role in diagnostic testing for electrolyte imbalances.

• Are the Reflotron Potassium Test Tabs meant for single-use or repeated use, and what does this imply for handling?

  The Reflotron Potassium Test Tabs are intended for single-use only, as explicitly stated in the device description. This means each tab is designed to be used once per test, after which it should be discarded. Single-use ensures accuracy and avoids cross-contamination, requiring proper disposal following standard laboratory protocols for in vitro diagnostic devices.

• How are these test tabs supplied, and do they require special sterility measures beyond routine lab practices?

  The Reflotron Potassium Test Tabs are supplied as part of the Reflotron system, which is intended for use in laboratory environments. While they do not require special sterility beyond standard aseptic handling (e.g., clean work surfaces, gloves), they must be stored and used according to the accompanying documentation to maintain accuracy and reliability. This aligns with typical practices for in vitro diagnostic devices.

• What method does the Reflotron Potassium Test Tabs use to measure potassium levels, and how does this differ from traditional lab techniques?

  The Reflotron Potassium Test Tabs use a colorimetric analysis with tetraphenyl borate to quantitatively determine potassium levels in serum or plasma. Unlike traditional lab techniques that may rely on flame photometry or ion-selective electrodes, this method provides a rapid, point-of-care-like result directly from the test tab, making it convenient for clinical chemistry workflows without requiring specialized instrumentation beyond the Reflotron system.

• What regulatory pathway was followed for the FDA clearance of the Reflotron Potassium Test Tabs, and what does this classification imply for users?

  The Reflotron Potassium Test Tabs were cleared through the FDA 510(k) process under the Traditional pathway, with a decision code of SESE (Substantially Equivalent). This classification places them in FDA Class II, meaning they are subject to general controls and special controls (e.g., performance standards) to ensure safety and effectiveness. Users should confirm compliance with the accompanying documentation and follow clinical chemistry protocols, as the device is regulated under Regulation 862.1600 for tetraphenyl borate-based colorimetric tests.