IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL

K141444 · Siemens Healthcare Diagnostics, Inc. · JJX · Jul 9, 2014 · Clinical Chemistry

Device Facts

• Record ID: K141444
• Device Name: IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jul 9, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The IMMULITE® Cortisol Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Cortisol assay on the IMMULITE 2000 systems. The IMMULITE® Folic Acid Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Folic Acid assay on the IMMULITE 2000 systems. The IMMULITE® Vitamin B12 Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of the IMMULITE Vitamin B12 assay on the IMMULITE 2000 systems.

Device Story

The IMMULITE 2000 Calibration Verification Materials (CVM) are multi-level, assayed quality control materials used to verify the calibration of specific assays on the IMMULITE 2000 system. The CVMs are provided as liquid (Cortisol) or lyophilized (Folic Acid, Vitamin B12) human serum or albumin-based matrices containing the respective analytes. The device is used in clinical laboratory settings by trained personnel. The healthcare provider runs the CVMs on the IMMULITE 2000 system; the instrument processes the samples and generates dose values based on the reference calibrator curve. The provider compares these recovered values against established target ranges to verify that the assay calibration remains accurate. This verification process ensures the reliability of patient sample testing, allowing for accurate clinical decision-making regarding patient diagnosis and monitoring.

Clinical Evidence

Bench testing only. Stability studies validated real-time shelf life and open-vial stability. Value assignment was validated using commercially available controls and patient serum samples. Acceptance criteria were based on guideline ranges (±2SD) and specific dose recovery limits for each analyte level.

Technological Characteristics

Multi-level (4 levels) calibration verification materials. Matrices: human serum (Cortisol) or human albumin (Folic Acid, Vitamin B12) with preservatives. Form: liquid or lyophilized. Storage: -20°C. Connectivity: used on IMMULITE 2000 systems. Stability: validated per CEN 13640.

Indications for Use

Indicated for in vitro diagnostic use to verify calibration of IMMULITE 2000 Cortisol, Folic Acid, and Vitamin B12 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) #: k141444

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.