IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL

K141772 · Siemens Healthcare Diagnostics, Inc. · JJX · Aug 19, 2014 · Clinical Chemistry

Device Facts

• Record ID: K141772
• Device Name: IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 19, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The IMMULITE® Rubella Quantitative IgG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Rubella Quantitative IgG assay on the IMMULITE 2000 systems. The IMMULITE® H. pylori IgG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE H. pylori IgG assay on the IMMULITE 2000 systems. The IMMULITE® Toxoplasma Quantitative IgG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Toxoplasma Quantitative IgG assay on the IMMULITE 2000 systems.

Device Story

Calibration verification materials (CVM) for IMMULITE 2000 immunoassay systems; used to verify assay calibration. CVMs consist of liquid human serum with bovine protein matrix and preservatives; provided in multi-level sets (Rubella/Toxoplasma) or single-level (H. pylori). Operated by laboratory technicians on IMMULITE 2000 platforms. Device inputs are CVM samples processed via standard assay protocols; outputs are recovered dose values compared against assigned target ranges. Used by healthcare providers to ensure system accuracy and performance within established clinical ranges; supports reliable diagnostic testing for Rubella, H. pylori, and Toxoplasma IgG.

Clinical Evidence

Bench testing only. Stability studies validated real-time shelf life and open-vial stability. Value assignment validated using reference calibrators, commercially available controls, and patient serum samples (e.g., 42 samples for Rubella, 24 for H. pylori, 63 for Toxoplasma). Performance met acceptance criteria for dose recovery (±10-24% depending on level) and precision (within 2SD of target).

Technological Characteristics

Liquid-form calibration verification material; human serum base with bovine protein matrix and preservatives. Analyte-specific IgG. Storage ≤-20°C. Traceable to WHO standards (Rubella: 1st IS RUBI-1-94; Toxoplasma: 3rd IS for Anti-Toxoplasma Serum) or internal gravimetric standards (H. pylori).

Indications for Use

Indicated for in vitro diagnostic use as calibration verification material for the IMMULITE 2000 systems to verify calibration of Rubella Quantitative IgG, H. pylori IgG, and Toxoplasma Quantitative IgG assays. 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) #: k141772

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.