Calibration Solution 1, Model A943-837; Calibration Solution 2, Model A943-839; Rinse Solution Kit, Model A943-838

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

510(k) Number

K001484 ↗

FDA Product Code

JIX

Models / Variants

Calibration Solution 1, Model A943-837

Calibration Solution 2, Model A943-839

Rinse Solution Kit, Model A943-838

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What are the primary uses of the Calibration Solution 1 (Model A943-837) and Calibration Solution 2 (Model A943-839) in a clinical chemistry lab?

  These calibration solutions are designed to establish standardized reference points for quantitative measurement in clinical chemistry test systems. They ensure accurate and consistent analytical results when analyzing human specimens by calibrating instruments used in laboratory settings. Essentially, they help maintain the precision of tests like glucose, electrolytes, or enzymes by providing a reliable baseline for comparison.

• Are the Calibration Solution 1 and Calibration Solution 2 intended for reuse, or are they single-use only?

  The Calibration Solution 1 (Model A943-837) and Calibration Solution 2 (Model A943-839) are explicitly labeled as single-use solutions. This means each vial is intended for one calibration procedure only, after which it should be discarded to prevent contamination or degradation of results. Single-use design aligns with standard laboratory practices for maintaining sterility and accuracy.

• What is the purpose of the Rinse Solution Kit (Model A943-838), and how does it fit into the calibration process?

  The Rinse Solution Kit (Model A943-838) is provided to clean the instrument between calibrations. Residual calibration solution or specimen remnants can interfere with subsequent measurements, so rinsing ensures the next calibration or test is performed on a clean, uncontaminated system. This step is critical for maintaining the integrity of results and extending the lifespan of the test system.

• How should these calibration solutions be stored, and what precautions should be taken?

  The calibration solutions are supplied as sterile liquid reagents, so they should be stored following standard laboratory protocols for chemical reagents. This typically includes keeping them in a cool, dry place (e.g., refrigerator or room temperature as specified on the label), protected from light, and away from direct sunlight or extreme temperatures. Proper storage ensures stability and prevents degradation, which could compromise accuracy. Always refer to the manufacturer’s instructions for specific storage conditions.

• What regulatory pathway was followed for the FDA clearance of these calibration solutions?

  The Calibration Solution 1, Calibration Solution 2, and Rinse Solution Kit were cleared through the FDA’s 510(k) process, specifically under the Traditional pathway. The submission was reviewed by the Clinical Chemistry (CH) Advisory Committee and determined to be *substantially equivalent* to a predicate device. The clearance (K001484) falls under regulation 862.1150 and classifies these devices as Class II, indicating they pose moderate risk and require special controls to ensure safety and effectiveness.