Audit MicroControls Linearity LQ Special Diabetes

K142978 · Aalto Scientific, Ltd. · JJY · Nov 20, 2014 · Clinical Chemistry

Device Facts

• Record ID: K142978
• Device Name: Audit MicroControls Linearity LQ Special Diabetes
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Nov 20, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Linearity LQ Special Diabetes 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 following analytes: fructosamine, insulin, and C-peptide. Linearity LQ Special Diabetes is for In Vitro Diagnostic use only.

Device Story

Linearity LQ Special Diabetes is an in-vitro diagnostic quality control material; consists of five levels of liquid human-serum-based matrix containing fructosamine, insulin, and C-peptide. Used by laboratory professionals to verify linearity, calibration, and reportable range of quantitative clinical chemistry assays. Device does not perform analysis; rather, it serves as a reference sample with assigned target values. Healthcare providers compare analyzer results against these target values to ensure instrument accuracy and performance. Benefits include improved confidence in patient test results and regulatory compliance for laboratory quality control.

Clinical Evidence

Bench testing only. Stability studies (accelerated and real-time) confirmed shelf life of 18 months at 2-8°C and open-vial stability of 14 days. Value assignment performed on Roche Modular P and Roche Cobas e411 analyzers; target ranges established as +/-15% of target mean values.

Technological Characteristics

Liquid, human-serum-based matrix; 5 levels per set; 2ml per vial. Analytes: fructosamine, insulin, C-peptide. 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 fructosamine, insulin, and C-peptide 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 MEMORANDUM

510(k) #: k142978

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.