ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM)

K143194 · Siemens Healthcare Diagnostics, Inc. · JJX · Dec 5, 2014 · Clinical Chemistry

Device Facts

• Record ID: K143194
• Device Name: ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM)
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Dec 5, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The ADVIA Centaur® Prolactin (PRL) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Prolactin assay. The ADVIA Centaur® Cortisol (COR) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Cortisol assay.

Device Story

ADVIA Centaur Master Curve Materials (MCM) are quality control products used to verify calibration and reportable range of ADVIA Centaur Prolactin and Cortisol assays. Prolactin MCM consists of prolactin spiked in lyophilized equine serum; Cortisol MCM consists of cortisol in lyophilized human plasma. Both contain preservatives. The device is used by laboratory technicians on ADVIA Centaur systems. The user runs the MCM levels as samples; the system measures the analyte concentration. The provider compares observed dose recoveries against assigned values to verify assay linearity and calibration. This process ensures the accuracy of patient test results, supporting clinical decision-making for endocrine disorders.

Clinical Evidence

Bench testing only. Studies included real-time shelf-life stability (unopened), in-use open vial (reconstituted) stability, and on-board stability on the ADVIA Centaur XP system. Acceptance criteria for dose recovery were met for all stability time points. Value assignment was performed using reference calibrators traceable to WHO 3rd IRP (Prolactin) or GCMS (Cortisol).

Technological Characteristics

Lyophilized quality control material. Prolactin MCM: equine serum matrix with sodium azide and amphotericin B. Cortisol MCM: human plasma matrix with sodium azide. Analyte levels: 10 (Prolactin) and 7 (Cortisol). Storage: 2-8°C. Connectivity: Used on ADVIA Centaur systems. Value assignment via nested testing protocol to remove system/run variation.

Indications for Use

Indicated for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Prolactin and Cortisol assays on ADVIA Centaur systems. Intended for professional use 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) #: k143194

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.