Cardiolipin G EIA Test System

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

510(k) Number

K946215 ↗

FDA Product Code

MID

Device Class

Class II

Regulation

21 CFR Part 866.5660

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K941762 Active Cleared 22 Feb 1995

• I.m Probes

  Class I

  FDA 510(k) K802951 Active Cleared 17 Dec 1980

• Cardiolipin a Eia Test System

  Class II

  FDA 510(k) K946216 Active Cleared 24 Jan 1996

• Redfield Infrared Coagulator

  Class II

  FDA 510(k) K950836 Active Cleared 24 Mar 1995

• Coopersurgical Infrared Coagulator

  Class II

  FDA 510(k) K974168 Active Cleared 23 Jan 1998

• Trocars, Trocar Sleeves and Reduction Sleeves

  Class II

  FDA 510(k) K942389 Active Cleared 16 Feb 1996

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• What types of samples can the Cardiolipin G EIA Test System analyze, and how should they be prepared before testing?

  The Cardiolipin G EIA Test System is designed to measure anticardiolipin antibodies in serum and other body fluids. While the exact preparation instructions are detailed in the kit’s accompanying documentation, standard laboratory protocols for handling and processing samples should be followed. This typically includes centrifugation to separate serum or plasma from whole blood and ensuring the sample is free of clots or contaminants before testing.

• Is the Cardiolipin G EIA Test System intended for single-use only, and if so, what happens to leftover reagents after opening?

  Yes, the Cardiolipin G EIA Test System is explicitly supplied as a single-use kit. Once opened, any unused reagents should be discarded according to laboratory biohazard protocols, as reuse is not permitted. This ensures accuracy and prevents cross-contamination between tests.

• What storage conditions are required for the Cardiolipin G EIA Test System before and after opening?

  The kit must be stored under conditions specified in the manufacturer’s instructions, though the provided data does not detail exact temperature or humidity requirements. Generally, such immunoassay kits are stored refrigerated (typically 2–8°C) before opening. After opening, any unused components should be handled per the kit’s guidelines, often requiring refrigeration until use or immediate disposal if not used promptly.

• How is the regulatory status of this device defined, and what does the FDA 510(k) clearance indicate about its risk classification?

  The Cardiolipin G EIA Test System received FDA 510(k) clearance under the Moderate-Risk Device (MID) classification in immunology. This means it is classified as a Class II device, requiring premarket notification (510(k)) to demonstrate substantial equivalence to a legally marketed predicate device. The clearance does not imply its intended clinical use but confirms it meets FDA safety and effectiveness standards for diagnostic testing.