IMMULITE 2000 CEA Calibration Verification Material

K143639 · Siemens Healthcare Diagnostics · JJX · Jan 23, 2015 · Clinical Chemistry

Device Facts

• Record ID: K143639
• Device Name: IMMULITE 2000 CEA Calibration Verification Material
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jan 23, 2015
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

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

Device Story

The IMMULITE 2000 CEA Calibration Verification Material (CVM) consists of four levels of lyophilized processed human serum containing preservatives; levels 2-4 contain human CEA. Used in clinical laboratories to verify the calibration of the IMMULITE CEA assay on IMMULITE 2000 systems. The device is reconstituted by the user and processed on the IMMULITE 2000 platform. The system measures the CEA concentration in the CVM samples; the resulting values are compared against target ranges to ensure the assay calibration remains accurate. This verification process helps healthcare providers ensure the reliability of patient CEA test results, which are used in clinical decision-making for cancer management.

Clinical Evidence

Bench testing only. Stability was validated through real-time shelf-life studies and open-vial testing at ambient temperature. Value assignment was validated using 27 replicates across 9 runs, 9 IMMULITE 2000 systems, and 5 reagent lots. Acceptance criteria for stability were based on dose recovery within ±10% (levels 2-3) or ±15% (level 4) of time-zero values. Expected values were established using target means and ±2 SD ranges.

Technological Characteristics

Lyophilized processed human serum matrix with preservatives. Four-level material. Storage at ≤-20°C. Reconstituted with 1.0mL volume. Analyte: CEA. Compatible with IMMULITE 2000 systems. Stability validated per CEN 13640.

Indications for Use

Indicated for in vitro diagnostic use to verify the calibration of the IMMULITE CEA assay 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) #: k143639

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.