AUDIT MICROCV VITAMIN D LINEARITY SET

K130764 · Aalto Scientific, Ltd. · JJX · Apr 26, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130764
• Device Name: AUDIT MICROCV VITAMIN D LINEARITY SET
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Audit® MicroCV™ Vitamin D Linearity Set is an assayed quality control material consisting of five levels of human and equine based serum. Each level contains Vitamin D. These five levels demonstrate a linear relationship to each other for Vitamin D. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Vitamin D. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for Vitamin D. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroCV™ Vitamin D Linearity Set should not be used for calibration or standardization of the Vitamin D assay. The Audit® MicroCV™ Vitamin D Linearity Set is "For In Vitro Diagnostic Use Only".

Device Story

Audit® MicroCV™ Vitamin D Linearity Set is an assayed quality control material; consists of five levels of human and equine-based serum containing Vitamin D. Levels demonstrate linear relationship via dilution. Used in clinical laboratories to verify linearity, calibration, and reportable range of quantitative Vitamin D assays on specified analyzers. Not for calibration or standardization of assays. Healthcare providers use the product to monitor analytical performance; laboratory establishes own means and acceptable ranges. Benefits include ensuring accuracy and reliability of patient Vitamin D test results.

Clinical Evidence

Bench testing only. Stability studies performed to determine open vial stability (30 days at 2-8°C) and shelf life (two years at 2-8°C).

Technological Characteristics

Liquid quality control material; five levels; human and equine-based serum matrix; contains Vitamin D; stored at 2-8°C; 30-day open vial stability.

Indications for Use

Indicated for use as an assayed quality control material to simulate human patient serum for determining linearity, calibration verification, and reportable range verification of Vitamin D quantitative assays in clinical laboratory settings.

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) #: k130764

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.