AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET

K130157 · Aalto Scientific, Ltd. · JJX · Mar 19, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130157
• Device Name: AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains Beta-Hydroxybutyric Acid. These five levels demonstrate a linear relationship to each other for Beta-Hydroxybutyric Acid. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Beta-Hydroxybutyric Acid. 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 Beta-Hydroxybutyric Acid. 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™ Beta-Hydroxybutyric Acid Linearity Set should not be used for calibration or standardization of the Beta-Hydroxybutyric Acid assay. The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is "For In Vitro Diagnostic Use Only".

Device Story

Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set consists of five levels of human-based serum containing Beta-Hydroxybutyric Acid; levels are related by linear dilution. Used in clinical laboratories to verify linearity, calibration, and reportable range of quantitative Beta-Hydroxybutyric Acid assays on specified analyzers. Product serves as quality control material; not for calibration or standardization. Laboratory personnel use the provided target values as guides to establish their own acceptable ranges. Benefits include ensuring instrument accuracy and reliability for patient testing.

Clinical Evidence

Bench testing only. Stability studies were performed to determine open vial stability (40 days at 2-8°C) and shelf life (two years at 2-8°C). No clinical data provided.

Technological Characteristics

Assayed quality control material; human-based serum matrix; liquid form; 5 levels per set; 1 analyte per vial. Storage at 2-8°C. No electronic, software, or mechanical components.

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 Beta-Hydroxybutyric Acid 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)

{0}

# Decision Summary

Statement for the Record, k130157

This 510(k) was reviewed under OIR's 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.