Audit MicroControls Linearity FD Tumor Markers II

K143573 · Aalto Scientific, Ltd. · JJY · Jan 16, 2015 · Clinical Chemistry

Device Facts

• Record ID: K143573
• Device Name: Audit MicroControls Linearity FD Tumor Markers II
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Linearity FD Tumor Markers II 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: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), Prostate-specific antigen-total (PSA), Carbonic Anhydrase-125 (CA-125), Carbonic Anhydrase 19-9 (CA19-9), Carbonic Anhydrase 27-29 (CA27-29)(BR), free-PSA (fPSA), and Carbonic Anhydrase 15-3 (CA15-3). The Linearity FD Tumor Markers II is for In Vitro Diagnostic use only.

Device Story

Audit® MicroControls™ Linearity FD Tumor Markers II is an in-vitro diagnostic quality control material; consists of two sets of five levels (A-E) of freeze-dried human/bovine serum-based material. Used by clinical laboratory professionals to verify linearity, calibration, and reportable range of tumor marker assays (AFP, CEA, PSA, CA-125, CA19-9, CA27-29, fPSA, CA15-3). Device functions as a reference material; samples are processed on clinical chemistry analyzers (e.g., Siemens Advia Centaur, Abbott Architect i1000SR). Output is a measured concentration value compared against established target ranges (±20%). Helps ensure accuracy and reliability of patient test results; aids in identifying potential instrument or reagent performance issues.

Clinical Evidence

Bench testing only. Stability studies (accelerated and real-time) confirmed shelf life of 2 years at 2-8°C and 14-day reconstituted stability at 2-8°C. Value assignment performed on Siemens Advia Centaur and Abbott Architect i1000SR platforms using multiple measurements to establish target concentrations and ranges (±20%). No clinical patient data included.

Technological Characteristics

Freeze-dried human and bovine serum-based matrix. Five-level linearity set. Storage 2-8°C. Analyte-specific value assignment via clinical chemistry analyzers. 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 of specific tumor marker 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)

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

510(k) #: k143573

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.