Reticulocyte Method

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

510(k) Number

K954607 ↗

FDA Product Code

GKL

Device Class

Class II

Regulation

21 CFR Part 864.5200

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What is the Bayer Reticulocyte Method Automated Cell Counter used for?

  The Bayer Reticulocyte Method Automated Cell Counter is designed to quantify reticulocytes—immature red blood cells—in peripheral blood samples. These measurements help clinicians assess bone marrow activity and erythropoietic response, which are critical for diagnosing and monitoring conditions like anemia and evaluating bone marrow function. It provides precise reticulocyte counts, often alongside hemoglobin and hematocrit measurements, to support accurate hematological evaluations.

• How is the Bayer Reticulocyte Method Automated Cell Counter supplied and intended for use?

  The device is supplied as a Class II medical instrument regulated under 21 CFR 864.5200 and is intended for in vitro diagnostic use in clinical hematology laboratories. While the regulatory data does not explicitly state whether it is single-use or reusable, automated cell counters like this typically require single-use consumables for blood sample analysis. Proper calibration and maintenance, as outlined by the manufacturer, are essential for accurate performance.

• Is sterility a requirement for the Bayer Reticulocyte Method Automated Cell Counter?

  The regulatory data for the Bayer Reticulocyte Method Automated Cell Counter does not specify sterility requirements. However, since it is used in clinical hematology laboratories for diagnostic purposes, it is designed to operate in controlled environments where contamination risks are minimized. Standard laboratory practices for instrument hygiene and sample handling should be followed to ensure reliable results.

• What regulatory pathway was used for the FDA clearance of this device?

  The Bayer Reticulocyte Method Automated Cell Counter was cleared via the FDA 510(k) Traditional pathway, with the clearance number K954607. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, meeting FDA requirements for safety and effectiveness. The device falls under the product code GKL and is classified as a Class II medical instrument.

• Does the Bayer Reticulocyte Method Automated Cell Counter require specific maintenance or calibration?

  Yes, the Bayer Reticulocyte Method Automated Cell Counter requires proper calibration and maintenance as specified by the manufacturer’s instructions. Accurate reticulocyte counts depend on the device’s performance, so regular upkeep ensures reliable diagnostic results. Laboratories should follow Bayer’s guidelines to maintain the instrument’s precision and validity for clinical use.