Sickle-Chex Solubility Kit

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K023656 ↗

FDA Product Code

GHM

Device Class

Class II

Regulation

21 CFR Part 864.7825

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Streck Laboratories, Inc. →

• What is the Sickle-Chex Solubility Kit used for?

  The Sickle-Chex Solubility Kit is designed for qualitative in vitro testing to detect the presence of sickling hemoglobins in human blood or sickle cell control material. It helps hematology laboratories identify sickle cell traits or disease by assessing abnormal hemoglobin variants that cause sickling under specific conditions. This aids in diagnosing sickle cell disorders through solubility testing.

• How is the Sickle-Chex Solubility Kit supplied and used?

  The kit is supplied as a manual test system, meaning it requires no additional sterilization and is intended for single-use per test. It includes essential components like a solubility test reagent and a whole blood control, making it ready for immediate use in compatibility with methods such as Streck’s SICKLEDEX.

• Is the Sickle-Chex Solubility Kit sterile and reusable?

  No, the Sickle-Chex Solubility Kit is not sterile beyond its single-use design—it is intended for one-time use per test and does not require sterilization. It is a manual test system, so reuse is not applicable or recommended.

• What storage conditions should be followed for the Sickle-Chex Solubility Kit?

  While specific storage conditions are not detailed in regulatory data, typical in vitro diagnostics like this kit are generally stored at controlled room temperature (2–25°C) away from direct light. This ensures stability and maintains the integrity of the test components.

• What regulatory clearance does the Sickle-Chex Solubility Kit hold?

  The Sickle-Chex Solubility Kit holds FDA 510(k) clearance (K023656) under the Hematology advisory committee. This clearance confirms its substantial equivalence to a predicate device and adherence to regulatory standards for diagnostic accuracy and performance in sickle cell testing.