ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL

K140505 · Siemens Healthcare Diagnostics, Inc. · JJX · Mar 31, 2014 · Clinical Chemistry

Device Facts

• Record ID: K140505
• Device Name: ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 31, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The ADVIA Centaur® Vitamin B12 (VB12) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur VB12 assay. The ADVIA Centaur® Total hCG (ThCG) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur ThCG assay. The ADVIA Centaur® Testosterone (TSTO) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Testosterone assay.

Device Story

ADVIA Centaur Master Curve Materials (MCM) are in vitro diagnostic quality control products used to verify calibration and reportable range of specific assays (VB12, ThCG, TSTO) on ADVIA Centaur systems. VB12 MCM contains vitamin B12 in buffered human serum albumin; ThCG MCM contains total hCG in lyophilized equine serum; TSTO MCM contains testosterone in lyophilized human plasma. All include preservatives. Used by laboratory personnel in clinical settings to meet accreditation requirements for bi-annual calibration checks. MCMs are value-assigned using reference calibrators traceable to USP or WHO standards. Healthcare providers use the verification results to ensure assay linearity and accuracy within the reportable range, supporting reliable clinical decision-making for patient diagnosis and monitoring.

Clinical Evidence

Bench testing only. Stability studies (real-time shelf-life and on-board) confirmed performance within specifications. Value assignment protocols utilized nested testing to minimize system/run variation and ensure traceability to USP or WHO reference materials.

Technological Characteristics

MCMs consist of analyte-spiked human serum albumin (VB12), equine serum (ThCG), or human plasma (TSTO). VB12 is liquid; ThCG and TSTO are lyophilized. Connectivity is via the ADVIA Centaur system. Value assignment is traceable to USP or WHO standards. Stability testing follows CEN 13640.

Indications for Use

Indicated for prescription use only for the verification of calibration and reportable range of ADVIA Centaur VB12, Total hCG, and Testosterone 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) #: k140505

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.