RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3

K121588 · Randox Laboratories, Ltd. · JJX · Jun 20, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121588
• Device Name: RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3
• Applicant: Randox Laboratories, Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jun 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Randox Cystatin C Controls Levels 2 and 3 are intended for in vitro diagnostic use as assayed quality control material for monitoring the precision and accuracy of the quantitative determination of human Cystatin C by immunoturbidimetric Assays.

Device Story

Randox Cystatin C Controls (Levels 2 and 3) are human serum-derived, single-analyte quality control materials. Used in clinical laboratory settings by professionals to monitor the precision and accuracy of immunoturbidimetric assays for human Cystatin C. Provided in liquid, ready-to-use form. Healthcare providers use the control results to verify the performance of their diagnostic testing systems, ensuring reliable patient test results.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Human serum matrix; preserved with sodium azide; liquid form; ready-to-use; stable at 2-8°C. No software or electronic components.

Indications for Use

Indicated for use as assayed quality control material for monitoring precision and accuracy of quantitative human Cystatin C immunoturbidimetric assays. Intended for professional, prescription use only.

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

Statement for the Record, k121588

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.