Bio Set Substrate Calibrators

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

Full name

Bio Set Tm Substrate Calibrators

510(k) Number

K810963 ↗

FDA Product Code

JIS

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the Bio Set™ Substrate Calibrators in a clinical chemistry lab?

  The Bio Set™ Substrate Calibrators are designed as primary calibrators to provide standardized reference materials for clinical chemistry assays. Their purpose is to ensure accurate measurement and calibration of biochemical substrates, which helps maintain the reliability of diagnostic test results in laboratory settings.

• Are the Bio Set™ Substrate Calibrators intended for single-use or reusable applications?

  The Bio Set™ Substrate Calibrators are explicitly labeled as single-use reagents, meaning each unit is meant for one-time use in calibration procedures. This design minimizes contamination risks and ensures consistent performance.

• How are these calibrators regulated, and what does that mean for purchasing or use?

  These calibrators are regulated under FDA 510(k) clearance (K810963) and fall under class II (862.1150) as primary calibrators. This means they have undergone a premarket review to demonstrate substantial equivalence to a predicate device, ensuring they meet safety and effectiveness standards for clinical chemistry applications. No third-party review was required, and they are not indicated for MRI use.

• What types of biochemical substrates are these calibrators intended to standardize?

  While the exact substrates aren’t detailed in the regulatory data, the Bio Set™ Substrate Calibrators are broadly designed for clinical chemistry assays, which commonly measure substrates like glucose, lipids, enzymes (e.g., ALT, AST), electrolytes, or other biochemical markers. Their role is to provide a standardized reference for accurate calibration across these assays.