IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION

K133128 · Siemens Healthcare Diagnostics, Inc. · JJX · Oct 22, 2013 · Clinical Chemistry

Device Facts

• Record ID: K133128
• Device Name: IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Oct 22, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The IMMULITE® HCG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE HCG assay on the IMMULITE 2000 systems. The IMMULITE® Insulin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Insulin assay on the IMMULITE 2000 systems. The IMMULITE® Pyrilinks-D Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Pyrilinks-D assay on the IMMULITE 2000 systems. The IMMULITE® Homocysteine Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Homocysteine assay on the IMMULITE 2000 systems. The IMMULITE® Growth Hormone Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Growth Hormone assay on the IMMULITE 2000 systems.

Device Story

The IMMULITE 2000 Calibration Verification Materials (CVMs) are multi-level, analyte-specific control materials used to verify the calibration and reportable range of corresponding IMMULITE 2000 assays. The CVMs are prepared by spiking specific analytes (HCG, Insulin, Pyrilinks-D, Homocysteine, or Growth Hormone) into various matrices (human serum, equine serum, or phosphoric acid/sodium chloride). The device is used in clinical laboratory settings by trained personnel. The healthcare provider runs the CVMs on the IMMULITE 2000 system; the system generates dose values based on the reference calibrator curve. The provider compares these recovered values against established target ranges to verify assay calibration. If results fall within acceptable limits, the assay is considered calibrated; otherwise, corrective action is required. This process ensures the accuracy and reliability of patient sample testing, supporting clinical decision-making.

Clinical Evidence

Bench testing only. Stability studies validated shelf life (up to 6 years depending on analyte) and performance against acceptance criteria (±8% to ±15% of assigned dose). Value assignment was validated using 15-27 replicates across multiple systems and reagent lots, comparing recovered values to target means and 2SD ranges. No clinical patient outcome data provided.

Technological Characteristics

Multi-level (4 levels) liquid or lyophilized control materials. Matrices include human serum, equine serum, or phosphoric acid/sodium chloride with preservatives. Analyte-specific. Storage conditions vary (≤-20°C or 2-8°C). Traceable to WHO International Standards or internal gravimetric standards. Designed for use on IMMULITE 2000 immunoassay systems.

Indications for Use

Indicated for in vitro diagnostic use to verify calibration of specific IMMULITE 2000 assays (HCG, Insulin, Pyrilinks-D, Homocysteine, Growth Hormone) 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) #: k133128

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.