IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C

K140541 · Siemens Healthcare Diagnostics, Inc. · JJX · Apr 1, 2014 · Clinical Chemistry

Device Facts

• Record ID: K140541
• Device Name: IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 1, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The IMMULITE® C-Peptide Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE C-Peptide assay on the IMMULITE 2000 systems. The IMMULITE® SHBG Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE SHBG assay on the IMMULITE 2000 systems. The IMMULITE® Total Testosterone Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Total Testosterone assay on the IMMULITE 2000 systems.

Device Story

The IMMULITE 2000 CVMs are multi-level, lyophilized or liquid quality control materials used to verify the calibration of specific assays (C-Peptide, SHBG, Total Testosterone) on the IMMULITE 2000 system. The device is used in clinical laboratory settings by trained technicians. The CVMs are value-assigned using reference calibrators and are processed on the IMMULITE 2000 system. The system measures the recovery of the CVMs; healthcare providers use these results to verify that the assay calibration remains within established performance specifications. This verification ensures the accuracy of patient sample testing, supporting clinical decision-making for the respective analytes.

Clinical Evidence

Bench testing only. Stability studies (shelf-life and open-vial) were conducted to validate performance specifications. Value assignment was validated using commercially available controls and patient samples (e.g., 59 samples for C-Peptide, 28 for SHBG, 32 for Total Testosterone). Acceptance criteria were based on dose recovery within defined percentages of assigned values or 2SD of control target values.

Technological Characteristics

Multi-level (4 levels) calibration verification materials. Matrices include buffered human albumin, bovine protein, or processed human serum with sodium azide preservatives. Lyophilized or liquid form. Storage at 2-8°C or -20°C. Traceable to internal gravimetrically prepared materials or WHO standards. Designed for use on IMMULITE 2000 systems.

Indications for Use

Indicated for in vitro diagnostic use in the verification of calibration of the IMMULITE C-Peptide, SHBG, and Total Testosterone assays on the 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) #: k140541

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.