Systemate Calcium Test Technicon RA 1000

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K922953 ↗

FDA Product Code

CIL

Device Class

Class II

Regulation

21 CFR Part 862.1160

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Em Diagnostic Systems, Inc. →

• What is the Systemate Calcium Test Technicon RA 1000 used for?

  The Systemate Calcium Test Technicon RA 1000 is used for clinical chemistry testing to measure carbon dioxide levels in patient samples. It employs cresol red colorimetry as its measurement principle, which detects changes in color intensity proportional to CO2 concentration. This method is specific to clinical laboratory settings where blood gas or metabolic assessments are required, providing quantitative data to support diagnostic evaluations of acid-base balance and respiratory function.

• How is the Systemate Calcium Test Technicon RA 1000 supplied and is it sterile or single-use?

  The device data does not specify whether the Systemate Calcium Test Technicon RA 1000 is supplied sterile, single-use, or reusable. No information is provided about its physical form, packaging, or sterility status. As a clinical chemistry analyzer, it likely functions as a benchtop instrument requiring reagent kits or cartridges for operation, but the supplied components, reusability, and sterility cannot be confirmed from the available data. Users should consult the manufacturer’s labeling for detailed handling and use instructions.

• What regulatory pathway was used for the Systemate Calcium Test Technicon RA 1000?

  The Systemate Calcium Test Technicon RA 1000 received FDA clearance through the traditional 510(k) pathway, demonstrating substantial equivalence to a legally marketed predicate device. This is confirmed by its K-number K922953 and decision date of September 9, 1992. The traditional 510(k) route requires a side-by-side comparison of technological characteristics, performance data, and intended use to establish that the new device is as safe and effective as the predicate. This clearance classification places it under FDA regulation 862.1160 for carbon dioxide testing systems.