EMIT Convenience Pack Quinidine Assay/Calibrators

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K904990 ↗

FDA Product Code

LBZ

Device Class

Class II

Regulation

21 CFR Part 862.3320

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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• What is the EMIT Convenience Pack Quinidine Assay/Calibrators used for?

  This device is designed for the quantitative measurement of quinidine levels in biological specimens, such as blood or urine. It uses a homogeneous enzyme-multiplied immunoassay technique (EMIT) to provide rapid and accurate results, making it particularly useful in clinical toxicology settings where quick assessment of quinidine exposure or overdose is critical.

• How is the EMIT Convenience Pack supplied, and is it for single-use?

  The pack is supplied as a convenience kit containing all necessary assay reagents and calibrators. It is explicitly intended for single-use in clinical laboratory settings, ensuring consistency and reducing contamination risks between tests.

• What storage conditions are required for this device?

  Standard laboratory storage conditions apply. The pack should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Since it is a single-use convenience pack, ensure it remains unopened until use to maintain sterility and accuracy of the calibrators and reagents.

• Does this device require any special handling or safety considerations?

  No special MRI safety considerations are noted for this device. However, it must be handled in accordance with standard clinical laboratory protocols for immunoassays. Proper personal protective equipment (PPE) should be used when preparing or processing specimens to prevent exposure to biological materials.

• What regulatory clearance does this device have?

  The EMIT Convenience Pack Quinidine Assay/Calibrators has received FDA 510(k) clearance under product code LBZ, classified as a Class II medical device. This clearance indicates it is deemed substantially equivalent to a predicate device and meets regulatory standards for safety and effectiveness in clinical toxicology applications.