RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)

K121746 · Randox Laboratories, Ltd. · JJX · Jul 11, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121746
• Device Name: RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)
• Applicant: Randox Laboratories, Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jul 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Randox Microalbumin controls are designed for in vitro diagnostic use as assayed quality control materials for the quantitative determination of albumin in human urine. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.

Device Story

Randox Microalbumin Control Level 1 and Level 2 are liquid, human serum-based quality control materials; used in clinical laboratories to monitor the precision of quantitative albumin determination in human urine. Controls are supplied in two levels with target values of 30 mg/L and 150 mg/L. Laboratory professionals use these controls to validate analytical runs on clinical chemistry analyzers (e.g., Hitachi 717, Cobas Mira, RX Daytona, Dimension). By comparing measured values against assigned target ranges, clinicians ensure the accuracy and reliability of patient urine albumin testing. This process supports the clinical decision-making related to renal function monitoring and disease management.

Clinical Evidence

Bench testing only. Value assignment was performed by running 10 replicates on four different analyzer platforms (Hitachi 717, Cobas Mira, RX Daytona, and Dimension). Target values were established based on the average of results across these platforms, with an acceptable manufacturing range of +/- 20%. Performance metrics included CV% ≤ 5% and % recovery error ≤ 5%.

Technological Characteristics

Liquid, human serum-based control material. Analyte: Microalbumin. Supplied in 6x1ml vials. Storage: +2°C to +8°C. Stability: 28 days opened (refrigerated), stable to expiry unopened. No electronic or software components.

Indications for Use

Indicated for use as assayed quality control materials for the quantitative determination of albumin in human urine by professional laboratory personnel in a clinical setting.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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Decision Summary, k121746

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.