DIRECT LDL/HDL CHOLESTEROL CALIBRATOR

K122126 · Randox Laboratories Limited · JIS · Aug 14, 2012 · Clinical Chemistry

Device Facts

• Record ID: K122126
• Device Name: DIRECT LDL/HDL CHOLESTEROL CALIBRATOR
• Applicant: Randox Laboratories Limited
• Product Code: JIS · Clinical Chemistry
• Decision Date: Aug 14, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The Randox Direct LDL/HDL Cholesterol Calibrator is intended for in vitro diagnostic use in the calibration of Randox HDL and LDL Cholesterol methods. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.

Device Story

Randox Direct LDL/HDL Cholesterol Calibrator is a lyophilized human serum-based calibrator containing LDL and HDL lipoproteins. Used in clinical laboratories by professionals to calibrate Randox HDL and LDL cholesterol assay methods. The calibrator is supplied in 3x1ml vials; requires reconstitution before use. Assigned values are established on multiple analyzers (e.g., Abbott Architect, Beckman Coulter AU, Hitachi, Randox RX series, Siemens Advia) relative to a master lot. Provides standardized reference points for clinical chemistry analyzers to ensure accurate patient sample quantification. Benefits patient care by ensuring the accuracy and reliability of cholesterol testing, which is critical for lipid profile assessment and cardiovascular risk management.

Clinical Evidence

Bench testing only. Stability studies confirmed performance of the calibrator under specified storage conditions (unopened at 2-8°C; reconstituted at 2-8°C for 5 days or -20°C for 1 month). Value assignment was validated across multiple clinical analyzer platforms.

Technological Characteristics

Lyophilized human serum matrix containing LDL and HDL lipoproteins. Form factor: 3x1ml vials. Storage: 2-8°C. Stability: 5 days post-reconstitution at 2-8°C. No electronic components, software, or energy sources.

Indications for Use

Indicated for use by professionals in clinical settings to calibrate Randox HDL and LDL cholesterol diagnostic methods. No specific patient population or disease state contraindications provided.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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Decision Summary, k122126

This 510(k) was reviewed under OIVD’s Pilot Triage Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.

OIVD, 4/2/12, v1.1