IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM)

K133122 · Siemens Healthcare Diagnostics, Inc. · JJX · Oct 30, 2013 · Clinical Chemistry

Device Facts

• Record ID: K133122
• Device Name: IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM)
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Oct 30, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The IMMULITE 2000 3gAllergy Specific IgE Calibration Verification Material (CVM) is intended for in vitro diagnostic use, as a control for calibration verification of the IMMULITE 2000 3gAllergy Specific IgE assay on IMMULITE 2000 systems as indicated in the CVM Package Insert. The IMMULITE 2000 Total IgE Calibration Verification Material (CVM) is intended for in vitro diagnostic use, as a control for calibration verification of the IMMULITE 2000 Total IgE assay on IMMULITE 2000 systems as indicated in the CVM Package Insert.

Device Story

Calibration verification materials (CVM) for IMMULITE 2000 systems; used by clinical laboratories to document calibration verification as required by certification agencies. Supplied as frozen liquid sets of four vials; contains equine serum matrix with sodium azide and preservatives; human IgE positive serum included in levels 2-4. Not a primary calibrator or control. Laboratory personnel process CVMs on IMMULITE 2000 systems; system generates dose values from reference calibrator curves. Healthcare providers compare recovered values against assigned target ranges to verify assay calibration performance. Benefits include ensuring system accuracy and compliance with laboratory certification standards.

Clinical Evidence

No clinical data. Bench testing only. Stability studies validated shelf life (1.5 years for Specific IgE CVM; 3.5 years for Total IgE CVM) at -20°C. Value assignment performed using 27 replicates across 9 runs, 8 systems, and multiple reagent lots. Acceptance criteria based on guideline ranges (±2SD) and dose recovery limits.

Technological Characteristics

Liquid-form calibration verification material; equine serum matrix with 0.098% sodium azide. Four-level set. Traceable to WHO 2nd IRP (75/502). Storage at ≤ -20°C. Designed for use on IMMULITE 2000 systems.

Indications for Use

Indicated for in vitro diagnostic use as a calibration verification control for IMMULITE 2000 3gAllergy Specific IgE and Total IgE assays on IMMULITE 2000 systems. 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) #: k133122

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.