Audit MicroControls Linearity DROP LQ Blood Glucose

K161874 · Aalto Scientific, Ltd. · JJX · Aug 10, 2016 · Clinical Chemistry

Device Facts

• Record ID: K161874
• Device Name: Audit MicroControls Linearity DROP LQ Blood Glucose
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 10, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is intended to simulate human patient samples for use as assayed quality control material, determining linearity, calibration verification, and the verification of reportable range for the glucose analyte. The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is for In Vitro Diagnostic use only.

Device Story

Audit® MicroControls™ Linearity DROP LQ Blood Glucose is an in-vitro diagnostic quality control material; consists of 5 levels (A-E) of liquid human-based serum containing glucose; used by clinical laboratory personnel to verify linearity, calibration, and reportable range of glucose assays; levels B, C, and D are prepared via specific dilution ratios of levels A and E; product is stored at 2-8°C; provides laboratories with target concentration values to assess test method performance; helps ensure accuracy of patient glucose measurements; non-reactive for HbsAg, HIV-1/2, and HCV.

Clinical Evidence

Bench testing only. Stability studies (accelerated and real-time) confirmed 2-year shelf life at 2-8°C and 7-day open-vial stability. Linearity established via dilution scheme (Levels B-D derived from A and E) and verified using Roche Cobas analyzer.

Technological Characteristics

Liquid human-based serum control; 5-level set; glucose analyte; stored at 2-8°C; 2-year shelf life; 7-day open-vial stability; non-sterile; non-reactive for HbsAg, HIV-1/2, and HCV.

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 glucose analyte testing in clinical laboratories.

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) #: k161874

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.