Equate AQR APO AL/B Duo Control

No FDA recalls on record, checked 5 Oct 2026.

Full name

Equate(Tm) Aqr Apo Al/B Duo Control

510(k) Number

K903122 ↗

FDA Product Code

DFC

Device Class

Class II

Regulation

21 CFR Part 866.5600

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• What is the Equate AQR APO AL/B Duo Control used for?

  This device is a quality control reagent specifically designed for immunology assays. It serves as a reference standard to validate the performance of low-density lipoprotein (LDL) antigen and antiserum tests in clinical laboratories. By providing a controlled sample, it helps ensure the accuracy and consistency of diagnostic results, which is critical for reliable patient testing.

• Is the Equate AQR APO AL/B Duo Control single-use or reusable?

  The Equate AQR APO AL/B Duo Control is supplied as a single-use reagent. This design ensures that each test run uses a fresh, uncontaminated sample, reducing the risk of cross-contamination or degradation over time. Single-use controls are standard in clinical laboratories to maintain precision and reliability in diagnostic assays.

• What regulatory approval does this device hold?

  The Equate AQR APO AL/B Duo Control holds FDA 510(k) clearance under the classification of Lipoprotein, Low-Density, Antigen, Antiserum, Control. It is categorized under product code DFC and falls under Class II medical devices, indicating it has been reviewed and deemed substantially equivalent to a legally marketed device by the FDA.

• How should the Equate AQR APO AL/B Duo Control be stored?

  While specific storage conditions are not detailed in the provided data, standard laboratory practices should be followed for this single-use reagent. This typically includes storing it in a clean, dry environment, protected from extreme temperatures, direct light, and contamination. Always refer to the manufacturer’s instructions for precise storage guidelines to maintain the integrity of the control.

• What immunology advisory committee reviewed this device?

  The Equate AQR APO AL/B Duo Control was reviewed by the Immunology (IM) Advisory Committee as part of its FDA 510(k) clearance process. This committee provides expert input on the safety and effectiveness of immunology-related medical devices, ensuring that products like this meet rigorous standards for clinical use in diagnostic testing.