IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)

K142811 · Siemens Healthcare Diagnostics, Inc. · JJX · Oct 29, 2014 · Clinical Chemistry

Device Facts

• Record ID: K142811
• Device Name: IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Oct 29, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The IMMULITE® 2000 LH Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE LH assay on the IMMULITE 2000 systems. The IMMULITE® 2000 Free T3 Calbration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Free T3 assay on the IMMULITE 2000 systems. The IMMULITE® 2000 Gastrin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Gastrin assay on the IMMULITE 2000 systems.

Device Story

Calibration verification materials (CVM) for IMMULITE 2000 systems; used to verify assay calibration for LH, Free T3, and Gastrin. Each CVM set contains four vials of lyophilized material (bovine serum or human protein matrix) with analyte-specific antigens. Used in clinical laboratories by technicians; processed on IMMULITE 2000 platforms. Output is a recovered dose value compared against assigned target ranges to ensure system accuracy. Helps healthcare providers confirm assay performance within established clinical decision levels; ensures reliable patient test results.

Clinical Evidence

Bench testing only. Stability validated via real-time shelf life and open-vial studies. Value assignment validated using multiple IMMULITE 2000 systems, reagent lots, and replicates. Traceability established to WHO standards (LH) or internal gravimetric standards (Free T3, Gastrin). Acceptance criteria based on target mean and ±2SD ranges.

Technological Characteristics

Lyophilized calibration verification materials; bovine serum or buffered human protein matrix with preservatives. 4-level format. Analyte-specific antigens (LH, Free T3, or Gastrin). Storage at 2-8°C or ≤-20°C. Designed for use on IMMULITE 2000 systems. Traceable to WHO or internal standards. Stability tested per CEN 13640.

Indications for Use

Indicated for in vitro diagnostic use to verify calibration of IMMULITE LH, Free T3, and Gastrin 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)

{0}

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k142811

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.