Calcium Liquid Stable Reagent Set

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

510(k) Number

K855041 ↗

FDA Product Code

CIC

Device Class

Class II

Regulation

21 CFR Part 862.1145

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Medical Analysis Systems, Inc. →

• What is the Calcium Liquid Stable Reagent Set used for?

  This reagent set is designed for the quantitative measurement of calcium levels in serum or plasma samples. It uses a colorimetric assay to produce a stable color complex, enabling precise spectrophotometric analysis. This is particularly useful for clinical diagnosis and monitoring of calcium-related conditions, such as hypercalcemia or hypocalcemia, in patient samples.

• How is the Calcium Liquid Stable Reagent Set supplied and prepared for use?

  The reagent set is supplied as a single, ready-to-use liquid reagent. No additional preparation is required beyond diluting the reagent with sample aliquots. It is intended for single-use only, ensuring consistency and reducing contamination risks in laboratory settings.

• How long does the colorimetric reaction remain stable after preparation?

  The color complex formed by the reagent remains stable for at least eight hours at room temperature (22–28 °C). This stability allows for flexibility in laboratory workflows without compromising result accuracy, provided the assay is completed within the specified timeframe.

• Is the Calcium Liquid Stable Reagent Set sterile and intended for reuse?

  The device is not explicitly described as sterile in the provided data, but it is supplied as a single-use liquid reagent for in vitro diagnostic use. Single-use design minimizes cross-contamination and ensures consistent performance, aligning with best practices for clinical chemistry assays.

• What regulatory pathway does this reagent follow?

  The Calcium Liquid Stable Reagent Set is regulated under FDA 510(k) clearance (K855041) and classified as a Class II medical device. It falls under the Clinical Chemistry specialty and adheres to the Traditional 510(k) review pathway, ensuring compliance with U.S. regulatory standards for in vitro diagnostics.