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Calcium Scal, Nortrol, Abtrol

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K073355

by Thermofisher Scientific OY

Identifiers

510(k) Number
K073355 FDA 510(k)
FDA Product Code
CJY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1145 FDA 510(k)
Regulation Number
862.1145 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is an Azo Dye, Calcium reagent set, classified under Clinical Chemistry. It is designed for the quantitative determination of calcium in serum or plasma samples using colorimetric methods, enabling accurate biochemical analysis in laboratory settings.

The Calcium Scal, Nortrol, Abtrol is supplied as a multi-component reagent kit for in vitro diagnostic use. It is intended for single-use only and requires no special storage conditions beyond those specified in the accompanying instructions. The device is authorised under FDA 510K clearance (K073355), IVDD, and IVDR compliance, adhering to regulatory standards for in vitro diagnostics.

Frequently asked questions

What is the primary purpose of this Calcium reagent set in a clinical lab setting?

This Calcium reagent set (Scal, Nortrol, Abtrol) is designed for the quantitative determination of calcium levels in serum or plasma samples using a colorimetric method. It enables precise biochemical analysis, which is essential for diagnosing conditions related to calcium metabolism, such as hypercalcemia or hypocalcemia, and monitoring patient treatment.

Is this reagent kit intended for single-use or repeated use, and what storage requirements apply?

The Calcium reagent set is intended for single-use only, meaning each kit should not be reused after opening. While no special storage conditions are explicitly mentioned beyond standard laboratory practices, the manufacturer’s instructions (not provided here) should be followed to ensure reagent stability and accuracy.

What regulatory pathways does this device follow, and which standards does it comply with?

This product is authorized under FDA 510K clearance (K073355), classified as substantially equivalent under the Traditional 510(k) pathway for Clinical Chemistry applications. It also complies with In Vitro Diagnostic Device Directives (IVDD) and In Vitro Diagnostic Regulation (IVDR), meeting EU regulatory standards for in vitro diagnostics.

Are there multiple versions or sizes of this reagent kit, and how would I identify the correct one for my lab?

The provided data lists multiple FEI numbers (e.g., 3006716639, 1000305841) and registration numbers, which may correspond to different lot codes, expiry batches, or regional variants of the kit. While exact sizes or model distinctions aren’t detailed here, the product code (CJY) and accompanying instructions should clarify compatibility with your lab’s instrumentation. Always verify the label or documentation for the correct version.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

European Union Active

IVDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Thermofisher Scientific OY

Sources (2)

  • FDA 510(k) K073355 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026