NSI Astra Calcium Reagent Kit NSI Item #7909

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

Full name

Nsi Astra Tm Calcium Reagent Kit Nsi Item # 7909

510(k) Number

K854716 ↗

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 Nobel Scientific Industries, Inc. →

• What is the NSI Astra Calcium Reagent Kit used for in a clinical setting?

  The NSI Astra Calcium Reagent Kit (NSI Item #7909) is designed for the quantitative measurement of calcium levels—both ionized and total—in serum or plasma samples. It uses the cresolphthalein complexone method, a colorimetric assay commonly employed in clinical chemistry laboratories to accurately determine calcium concentrations.

• Is this reagent kit single-use or reusable, and how should it be handled?

  The NSI Astra Calcium Reagent Kit is a single-use, non-sterile reagent system. It must be prepared and used according to standard laboratory protocols, as it is not intended for repeated use or sterilization.

• What regulatory pathway was followed for this device’s clearance in the U.S.?

  The NSI Astra Calcium Reagent Kit received FDA clearance through a 510(k) submission, classified as a Class II medical device under the product code CIC (Clinical Chemistry). The clearance was granted as substantially equivalent (SESE) to a predicate device, with the decision made by the FDA’s Clinical Chemistry (CH) Advisory Committee in 1986.

• Does this kit require any special storage conditions, and is it compatible with automated laboratory systems?

  The device specifications do not explicitly detail storage conditions, but as a chemical reagent kit, it should be stored according to standard laboratory guidelines for chemical stability—typically at room temperature, protected from light and moisture. While the cresolphthalein complexone method is widely used in manual assays, compatibility with automated systems would depend on the specific laboratory equipment and validation protocols in place.