IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material

K143352 · Siemens Healthcare Diagnostics, Inc. · JJX · Dec 24, 2014 · Clinical Chemistry

Device Facts

• Record ID: K143352
• Device Name: IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Dec 24, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The IMMULITE® Ferritin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Ferritin assay on the IMMULITE 2000 systems. The IMMULITE® IGFBP-3 Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE IGFBP-3 assay on the IMMULITE 2000 systems.

Device Story

Calibration verification materials (CVM) for IMMULITE 2000 immunoassay systems; used to verify assay calibration. Ferritin CVM consists of four liquid vials (human serum albumin matrix); IGFBP-3 CVM consists of four liquid vials (bovine protein buffer matrix). Used in clinical laboratory settings by trained personnel. CVMs are run on the IMMULITE 2000 system; results compared against assigned target values to ensure system performance remains within established specifications. Helps ensure accuracy of patient sample testing; supports clinical decision-making by validating assay reliability.

Clinical Evidence

Bench testing only. Stability validated via real-time shelf life and open-vial studies. Value assignment validated using reference calibrators traceable to WHO standards (WHO 2nd IS 80/578 for Ferritin; WHO NIBSC 93/560 for IGFBP-3). Performance verified across multiple systems, reagent lots, and runs to establish target means and SDs. Acceptance criteria based on % difference from assigned dose.

Technological Characteristics

Liquid-form calibration verification materials. Ferritin CVM: human serum albumin matrix with preservatives. IGFBP-3 CVM: bovine protein buffer matrix with preservatives. 4-level configuration. Storage: 2-8°C (Ferritin) or -20°C (IGFBP-3). Traceable to WHO international standards. Designed for use on IMMULITE 2000 automated immunoassay platforms.

Indications for Use

Indicated for in vitro diagnostic use to verify calibration of IMMULITE Ferritin and IGFBP-3 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) #: k143352

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.