ADVIA Centaur IgE Master Curve Material

K143680 · Siemens Healthcare Diagnostics, Inc. · JJX · Jan 27, 2015 · Clinical Chemistry

Device Facts

• Record ID: K143680
• Device Name: ADVIA Centaur IgE Master Curve Material
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jan 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The ADVIA Centaur® IgE Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Total IgE assay.

Device Story

ADVIA Centaur IgE Master Curve Material (MCM) consists of seven levels of lyophilized human plasma spiked with IgE, sodium azide, and preservatives; used for bi-annual calibration verification and linearity checks of ADVIA Centaur Total IgE assays. Operated by laboratory technicians on ADVIA Centaur systems. Device provides target values (0.0 to 3150 IU/mL) for comparison against system-generated results. Discrepancies between observed and target values indicate need for recalibration or maintenance. Benefits include ensuring assay accuracy and compliance with accreditation requirements.

Clinical Evidence

Bench testing only. Stability studies (real-time shelf-life, open-vial, and on-board) confirmed performance within specifications. Value assignment was validated using reference calibrators traceable to WHO 75/502 standard.

Technological Characteristics

Lyophilized human plasma matrix with 0.1% sodium azide. Seven-level set (MCM1-7). Traceable to WHO 75/502 reference material. Designed for use on ADVIA Centaur systems. Stability: 8 months unopened at 2-8°C; 28 days reconstituted at 2-8°C; 4 hours on-board.

Indications for Use

Indicated for use as a quality control material to verify calibration and reportable range of the ADVIA Centaur Total IgE assay in a clinical laboratory setting.

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 MEMORANDUM

510(k) #: k143680

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.