IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material

K143504 · Siemens Healthcare Diagnostics, Inc. · JJX · Jan 14, 2015 · Clinical Chemistry

Device Facts

• Record ID: K143504
• Device Name: IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jan 14, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The IMMULITE® Albumin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Albumin assay on the IMMULITE 2000 systems. The IMMULITE® Myoglobin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Myoglobin assay on the IMMULITE 2000 systems.

Device Story

IMMULITE 2000 Albumin and Myoglobin Calibration Verification Materials (CVM) are lyophilized, multi-level quality control products used to verify assay calibration on IMMULITE 2000 systems. Albumin CVM contains bovine protein and human albumin; Myoglobin CVM contains bovine serum and human cardiac myoglobin. Used by laboratory professionals in clinical settings to ensure system performance remains within established specifications. The device is reconstituted and processed on the IMMULITE 2000 system; the system measures the analyte concentration, and the user compares the recovered values against target ranges to validate the calibration curve. This verification process helps ensure the accuracy of patient sample testing, supporting reliable clinical decision-making for albumin and myoglobin levels.

Clinical Evidence

Bench testing only. Stability studies (shelf-life and open-vial) were conducted to validate performance. Albumin CVM stability validated up to 6 years (unopened) and 2 hours (open). Myoglobin CVM stability validated up to 7 years (unopened) and 8 hours (open). Value assignment was validated using multiple IMMULITE 2000 systems, reagent lots, and replicates, with recovery compared against target means and 95% confidence intervals.

Technological Characteristics

Lyophilized, multi-level (4) calibration verification materials. Albumin CVM: bovine protein matrix with preservatives. Myoglobin CVM: bovine serum matrix with preservatives. Analyte-specific human source material included. Storage: 2-8°C (Albumin) or -20°C (Myoglobin). Traceable to internal standards. Designed for use on IMMULITE 2000 systems.

Indications for Use

Indicated for prescription use only as an in vitro diagnostic quality control material to verify the calibration of IMMULITE Albumin and Myoglobin assays on IMMULITE 2000 systems.

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) #: k143504

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.