IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C

K140818 · Siemens Healthcare Diagnostics, Inc. · JJX · May 1, 2014 · Clinical Chemistry

Device Facts

• Record ID: K140818
• Device Name: IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: May 1, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The IMMULITE® Free T4 Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Free T4 assay on the IMMULITE 2000 systems. The IMMULITE® IGF-1 Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE IGF-1 assay on the IMMULITE 2000 systems. The IMMULITE® Prolactin Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Prolactin assay on the IMMULITE 2000 systems.

Device Story

The IMMULITE 2000 Calibration Verification Materials (CVM) are multi-level, processed serum/buffer-based materials used to verify the calibration of specific assays (Free T4, IGF-1, Prolactin) on the IMMULITE 2000 system. The device consists of four vials at varying analyte concentrations. The CVMs are processed by the IMMULITE 2000 instrument; the system compares recovered values against assigned target ranges to confirm assay calibration accuracy. Used in clinical laboratories by trained technicians. The output provides a verification of the instrument's calibration curve, ensuring the accuracy of patient sample testing. This allows healthcare providers to rely on assay results for clinical decision-making, benefiting patients by ensuring diagnostic test reliability.

Clinical Evidence

No clinical data. Bench testing only. Stability validated via shelf-life studies at -20°C or 2-8°C. Value assignment validated using 27 replicates across multiple runs, reagent lots, and IMMULITE 2000 systems. Acceptance criteria require recovery within ±10% (or ±15% for specific levels) of assigned dose.

Technological Characteristics

Multi-level (4) lyophilized or liquid materials. Matrices: processed human serum, bovine protein/buffer, or equine serum with sodium azide/preservatives. Sensing principle: immunoassay-based calibration verification on IMMULITE 2000 platform. Storage: -20°C or 2-8°C. Traceability: internal gravimetric standards or 3rd IS 84/500.

Indications for Use

Indicated for in vitro diagnostic use to verify calibration of IMMULITE 2000 Free T4, IGF-1, and Prolactin 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) #: k140818

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.