ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM)

K142864 · Siemens Healthcare Diagnostics, Inc. · JJX · Oct 29, 2014 · Clinical Chemistry

Device Facts

• Record ID: K142864
• Device Name: ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM)
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Oct 29, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The ADVIA Centaur® C-peptide (CpS) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur C-peptide assay. The ADVIA Centaur® Insulin (IRI) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur insulin assay.

Device Story

ADVIA Centaur Master Curve Materials (MCM) are liquid, multi-level quality control products used to verify calibration and reportable ranges of C-peptide and Insulin assays on ADVIA Centaur systems. The C-peptide MCM consists of C-peptide spiked in citric acid buffer with casein and preservatives; the Insulin MCM consists of insulin in buffered saline with casein, potassium thiocyanate, and sodium azide. Both sets contain ten levels (MCM1-10). The device is used by laboratory personnel in clinical settings to perform bi-annual calibration verification checks required by accreditation bodies. By comparing measured dose recoveries of the MCMs against assigned target values, clinicians verify the linearity and accuracy of the assay across its reportable range, ensuring reliable patient test results for insulin and C-peptide levels.

Clinical Evidence

Bench testing only. Stability studies (real-time shelf-life and on-board) confirmed performance within established specifications. Value assignment was performed using reference standards traceable to WHO IS 84/510 (C-peptide) and WHO 1st IRP 66/304 (Insulin). Acceptance criteria for dose recovery were met.

Technological Characteristics

Liquid, multi-level (10 levels) quality control material. C-peptide MCM: citric acid buffer, casein, preservatives. Insulin MCM: buffered saline, casein, potassium thiocyanate, sodium azide. Storage: 2-8°C. Analyte-free matrix for MCM1. Traceable to WHO reference materials. Used on ADVIA Centaur systems.

Indications for Use

Indicated for prescription use as an in vitro diagnostic quality control material for the verification of calibration and reportable range of the ADVIA Centaur C-peptide and Insulin assays on ADVIA Centaur systems.

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) #: k142864

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.