IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material

K142878 · Siemens Healthcare Diagnostics, Inc. · JJX · Oct 30, 2014 · Clinical Chemistry

Device Facts

• Record ID: K142878
• Device Name: IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Oct 30, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

IMMULITE® 2000 Beta-2 Microglobulin Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Beta-2 Microglobulin assay on the IMMULITE 2000 systems. IMMULITE® 2000 High Sensitivity CRP Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE High Sensitivity CRP assay on the IMMULITE 2000 systems.

Device Story

Calibration verification materials (CVM) for IMMULITE 2000 systems; used by laboratory technicians to verify assay calibration. CVMs consist of multi-level vials (Beta-2 Microglobulin: 4 levels, bovine protein matrix; High Sensitivity CRP: 4 levels, bovine protein/buffer matrix with sodium azide). Input: CVM samples processed on IMMULITE 2000 systems; system measures analyte concentration. Output: recovered dose values compared against target ranges to confirm instrument calibration accuracy. Affects clinical decision-making by ensuring reliability of patient test results. Benefits patient by maintaining diagnostic assay performance.

Clinical Evidence

Bench testing only. Stability studies validated real-time shelf life and open-vial stability. Value assignment validated using patient samples (spiked/neat/diluted) and commercially available controls. Performance met acceptance criteria for dose recovery within established target ranges (±6% to ±20% depending on level).

Technological Characteristics

Multi-level (4) calibration verification materials. Beta-2 Microglobulin CVM: lyophilized, bovine protein buffer matrix, stored at -20°C. High Sensitivity CRP CVM: liquid, bovine protein/buffer matrix with 0.098% sodium azide, stored at 2-8°C. Traceable to internal gravimetric standards or WHO IS 85/506 and CRM 470. Used on IMMULITE 2000 systems.

Indications for Use

Indicated for prescription use only for in vitro diagnostic verification of calibration of IMMULITE 2000 assays (Beta-2 Microglobulin or High Sensitivity CRP) in clinical laboratory settings.

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) #: k142878

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.