THERMO SCIENTIFIC MAS OMNI-CARDIO

K122291 · Microgenics Corporation · JJY · Aug 31, 2012 · Clinical Chemistry

Device Facts

• Record ID: K122291
• Device Name: THERMO SCIENTIFIC MAS OMNI-CARDIO
• Applicant: Microgenics Corporation
• Product Code: JJY · Clinical Chemistry
• Decision Date: Aug 31, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Thermo Scientific MAS® Omni•CARDIO™ is intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions related to cardiac and associated critical marker determinations.

Device Story

MAS® Omni•CARDIO is an assayed control serum used in clinical laboratories to monitor the performance of cardiac and critical marker assays. The device consists of human serum-based liquid control levels (UL, L, 1, 2, 3) containing various analytes including BNP, CK-MB, D-Dimer, Digitoxin, Homocysteine, hsCRP, MPO, Myoglobin, NT-proBNP, Procalcitonin, β-HCG, Total CK, Troponin I, and Troponin T. The control is stored frozen at -20°C and thawed for use. Laboratory technicians use the control by running it alongside patient samples on clinical analyzer platforms. The resulting values are compared against established target ranges to verify the accuracy and precision of the analyzer's performance. By ensuring the assay is functioning correctly, the device helps clinicians obtain reliable diagnostic results for cardiac conditions, thereby supporting appropriate clinical decision-making.

Clinical Evidence

Bench testing only. Stability testing (accelerated and real-time) supported a 36-month shelf life at -20°C. Open and closed vial stability at 2-8°C was validated for 15 days for most analytes, with 10-day or 5-day limits for specific analytes (Myoglobin, NT-ProBNP, Homocysteine). Value assignment was performed across multiple analyzer platforms over 5 days in duplicate to establish grand means and target ranges (+/- 20%).

Technological Characteristics

Human serum-based liquid control; stored frozen at -20°C. Analyte constituents include cardiac markers (Troponins, BNP, CK-MB, etc.) and critical markers. Packaged in amber glass bottles with sterile caps. No electronic components, software, or energy sources. Stability validated via linear regression analysis of analyte recovery over time.

Indications for Use

Indicated for use in clinical laboratories as an assayed control serum to monitor assay conditions for cardiac and critical marker determinations. No specific patient population or contraindications described as it is an in vitro diagnostic control material.

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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Decision Summary, k122291

This 510(k) was reviewed under OIVD’s Pilot 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.