ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM)

K140267 · Siemens Healthcare Diagnostics, Inc. · JJX · Mar 10, 2014 · Clinical Chemistry

Device Facts

• Record ID: K140267
• Device Name: ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM)
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 10, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The ADVIA Centaur TnI-Ultra Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur TnI-Ultra assay. The ADVIA Centaur Digoxin Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Digoxin assay.

Device Story

ADVIA Centaur Master Curve Materials (MCM) are in vitro diagnostic quality control products used to verify calibration and reportable range of ADVIA Centaur TnI-Ultra and Digoxin assays. TnI-Ultra MCM contains bovine cardiac troponin I in goat serum; Digoxin MCM contains digoxin in defibrinated human plasma. Both are supplied as lyophilized sets (5 levels for TnI-Ultra; 6 levels for Digoxin) requiring reconstitution. Used in clinical laboratories on ADVIA Centaur systems; operated by laboratory technicians. Healthcare providers use MCM results to perform bi-annual calibration verification checks required for hospital accreditation. By confirming assay linearity and calibration, the device ensures accurate patient test results, supporting clinical decision-making for cardiac and therapeutic drug monitoring.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing, including real-time shelf-life stability, in-use (open vial) stability at 2-8°C and -20°C, and on-board stability. Value assignment was performed using reference calibrators traceable to NIST SRM 2921 (TnI-Ultra) or USP standards (Digoxin).

Technological Characteristics

Lyophilized quality control material. TnI-Ultra MCM: bovine cardiac troponin I in goat serum matrix. Digoxin MCM: digoxin in defibrinated human plasma. Energy source: N/A (manual preparation for automated analyzer). Connectivity: Standalone material for use on ADVIA Centaur systems. Stability testing per CEN 13640.

Indications for Use

Indicated for in vitro diagnostic use to verify calibration and reportable range of ADVIA Centaur TnI-Ultra and Digoxin assays on ADVIA Centaur systems. For prescription use only.

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) #: k140267

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.