Elution Solution (K812565)

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

Full name

Elution Solution

510(k) Number

K812565 ↗

FDA Product Code

KSG

Device Class

Class II

Regulation

21 CFR Part 864.9600

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Freeze Dried Papain

  Class II

  FDA 510(k) K810803 Active Cleared 21 Jul 1981

• Em-V

  Class II

  FDA 510(k) K781397 Active Cleared 14 Sep 1978

• Hematology Control

  Class II

  FDA 510(k) K760162 Active Cleared 4 Aug 1976

• Freeze Dried Ficin

  Class II

  FDA 510(k) K813404 Active Cleared 10 Feb 1982

• Em-X

  Class II

  FDA 510(k) K812222 Active Cleared 23 Sep 1981

• Recap

  Class II

  FDA 510(k) K780665 Active Cleared 6 Jun 1978

• What is the Biological Elution Solution used for in laboratory diagnostics?

  The Biological Elution Solution is designed specifically for in vitro diagnostic use in sequential multiplex immunohistochemistry. Its primary purpose is to remove residual antibodies from preceding detection layers, thereby preventing crosstalk between sequential staining steps. This ensures specificity and accuracy in detecting antibodies during hematological assays, particularly in complex diagnostic workflows where multiple markers are analyzed.

• How is the Biological Elution Solution supplied and intended for use?

  The solution is supplied as a sterile, single-use reagent, meaning each vial is intended for one-time use in laboratory settings. This format minimizes contamination risks and ensures consistency in diagnostic testing. It adheres to standard laboratory practices for sterile reagents, though specific storage conditions are not detailed beyond general regulatory compliance.

• Is the Biological Elution Solution reusable or meant for single-use only?

  The Biological Elution Solution is explicitly labeled as a single-use reagent. Single-use design reduces the risk of cross-contamination between samples and maintains the integrity of diagnostic results. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and accuracy.

• What regulatory approval does the Biological Elution Solution hold, and how does it classify?

  The Biological Elution Solution holds FDA 510(k) clearance under the product code KSG, classified as a Class II medical device. It was granted clearance through the Hematology advisory committee, with a decision of substantial equivalence (SESE) to a predicate device. The solution is regulated under 21 CFR 864.9600, which governs media and reagents for in vitro diagnostic use.

• Are there specific storage requirements mentioned for the Biological Elution Solution?

  While the device description does not specify exact storage conditions, it emphasizes compliance with standard laboratory practices for sterile reagents. This typically includes protection from light, contamination, and extreme temperatures, though exact parameters (e.g., refrigeration or room temperature) are not detailed. Always follow manufacturer guidelines or local regulatory standards for handling sterile diagnostic reagents.