Audit MicroControls Linearity LQ Cystatin-C

K143571 · Aalto Scientific, Ltd. · JJX · Jan 23, 2015 · Clinical Chemistry

Device Facts

• Record ID: K143571
• Device Name: Audit MicroControls Linearity LQ Cystatin-C
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jan 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Linearity LQ Cystatin-C is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration verification, and the verification of reportable range for the Cystatin-C analyte. The Linearity LQ Cystatin-C is for In Vitro Diagnostic use only.

Device Story

Audit® MicroControls™ Linearity LQ Cystatin-C is a liquid, assayed quality control material consisting of five levels (A-E) of human and bovine-based serum containing the Cystatin-C analyte. Used in clinical laboratories to verify the linearity, calibration, and reportable range of quantitative Cystatin-C assays. The device is intended for in-vitro diagnostic use. Healthcare providers use the output to verify that analytical instruments are performing within established specifications for patient sample testing. The device benefits patients by ensuring the accuracy and reliability of Cystatin-C measurements, which are critical for assessing renal function.

Clinical Evidence

Bench testing only. Stability studies (accelerated and real-time) established a 3-year shelf life at 2-8°C and 30-day open-vial stability. Analyte value assignment was performed on the Beckman Immage analyzer using multiple measurements to establish target concentrations and ranges (±10%).

Technological Characteristics

Liquid quality control material; 5 levels; matrix consists of human and bovine-based serum. Analyte: Cystatin-C. Storage: 2-8°C. Non-sterile. No software or electronic components.

Indications for Use

Indicated for use as an assayed quality control material to simulate human patient samples for determining linearity, calibration verification, and reportable range verification for the Cystatin-C analyte in clinical chemistry assays.

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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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k143571

This 510(k) was reviewed under OIR’s Triage-Quick Review 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.