Olympus LDL Cholesterol Reagent OSR6196/OSR6296; Olympus LDL Cholesterol Calibrator ODC0024

• • Ongoing Z-1135-2026 FDA Class II ·initiated 8 Dec 2025 ·on shared 510(k) K040471

  Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80 mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL).

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K040471 ↗

FDA Product Code

JIT

Models / Variants

Olympus Ldl Cholesterol Reagent, OSR6196/OSR6296

Olympus Ldl Cholesterol Calibrator, ODC0024

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Olympus America, Inc. →

• What is the Olympus LDL cholesterol reagent and calibrator used for?

  The Olympus LDL cholesterol reagent (OSR6196/OSR6296) and calibrator (ODC0024) are designed for the quantitative determination of low-density lipoprotein (LDL) cholesterol in human serum and plasma. This measurement supports clinical assessments of cardiovascular risk by providing accurate LDL levels, which are critical for evaluating patient risk of heart disease.

• How are the LDL cholesterol reagent and calibrator supplied, and do they require sterilization?

  The LDL cholesterol reagent and calibrator are supplied as single-use items, meaning each kit is intended for one-time use only. No additional sterilization is required beyond the manufacturer-provided packaging, which ensures sterility for clinical laboratory use.

• Are the Olympus LDL cholesterol reagent and calibrator reusable, or are they intended for single-use?

  These reagents and calibrator are explicitly designed for single-use only. This ensures consistency, accuracy, and safety in laboratory testing, as reuse could compromise sterility and result integrity.

• What regulatory clearance does the Olympus LDL cholesterol reagent and calibrator hold?

  The Olympus LDL cholesterol reagent and calibrator hold FDA 510(k) clearance under Special Controls (product code JIT) and are classified as Class II devices. This clearance confirms that the device meets FDA requirements for safety and effectiveness as a secondary calibrator and reagent set for LDL cholesterol measurement.

• What is the purpose of the LDL cholesterol calibrator in this set?

  The LDL cholesterol calibrator (ODC0024) ensures traceability and consistency in analytical results across laboratory testing systems. It provides a standardized reference point for the reagent (OSR6196/OSR6296), allowing laboratories to maintain accuracy and reliability in LDL cholesterol measurements over time.