Audit MicroControls Linearity FD Tumor Markers II

K163629 · Aalto Scientific, Ltd. · JJY · Mar 10, 2017 · Clinical Chemistry

Device Facts

• Record ID: K163629
• Device Name: Audit MicroControls Linearity FD Tumor Markers II
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Audit® MicroControls™ Linearity FD Tumor Markers II 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 HE4 and HER2 analytes. The Audit® MicroControls™ Linearity FD Tumor Markers II is for In Vitro Diagnostic use only.

Device Story

Audit® MicroControls™ Linearity FD Tumor Markers II is a multi-analyte, freeze-dried quality control material derived from human serum; contains HE4 and HER2 analytes. Used in clinical laboratories to verify linearity, calibration, and reportable range of quantitative assays. Device consists of five levels (A-E) prepared via specific dilution schemes. Laboratory personnel use the product by running it on analyzers (e.g., Siemens Centaur XP, Roche Cobas e411) alongside patient samples. Output is a measured concentration value compared against lot-specific target ranges provided by the manufacturer. Discrepancies between measured values and target ranges alert clinicians to potential assay performance issues, ensuring accurate patient test results.

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 and target value assignment were validated using Siemens Centaur XP (HER2) and Roche Cobas e411 (HE4) analyzers. No clinical trials were performed.

Technological Characteristics

Freeze-dried human serum matrix; 5-level set; 1ml fill size. Analytes: HE4, HER2. Storage: 2-8°C. Shelf life: 2 years. Open vial stability: 7 days. Non-reactive for HbsAg, HCV, and HIV-1/2. No electronic components or software algorithms.

Indications for Use

Indicated for use as an assayed quality control material to simulate human patient samples for determining linearity, calibration verification, and verification of reportable range for HE4 and HER2 analytes 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}

1

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

510(k) #: K163629

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.