IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA

K133124 · Siemens Healthcare Diagnostics, Inc. · JJX · Oct 25, 2013 · Clinical Chemistry

Device Facts

• Record ID: K133124
• Device Name: IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Oct 25, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The IMMULITE® Total T3 Calibration Verification Material (CVM) is intended for in vitro diagnostic use in the verification of calibration of the IMMULITE Total T3 assay on the IMMULITE 2000 systems. The IMMULITE® Total T4 Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Total T4 assay on the IMMULITE 2000 systems. The IMMULITE® TBG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE TBG assay on the IMMULITE 2000 systems. The IMMULITE® FSH Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE FSH assay on the IMMULITE 2000 systems. The IMMULITE® Estradiol Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Estradiol assay on the IMMULITE 2000 systems.

Device Story

The IMMULITE 2000 Calibration Verification Materials (CVMs) are multi-level, lyophilized, human or bovine serum-based control materials containing specific analytes (T3, T4, TBG, FSH, or Estradiol). They are used in clinical laboratory settings by technicians to verify the calibration and reportable range of corresponding IMMULITE 2000 assays. The CVMs are processed on the IMMULITE 2000 system as unknown samples. The system measures the analyte concentration, and the resulting values are compared against assigned target ranges to ensure the assay remains within established performance specifications. This verification process helps healthcare providers ensure the accuracy of patient test results, supporting reliable clinical decision-making for thyroid and reproductive hormone assessments.

Clinical Evidence

Bench testing only. Stability studies validated shelf life (3.5 to 5 years at -20°C). Value assignment was validated using commercially available controls and patient samples (n=25-30 per analyte) to confirm recovery within target ranges. No clinical trials were performed.

Technological Characteristics

Lyophilized human or bovine serum matrix with preservatives. Multi-level (4 levels). Storage at -20°C. Single-use. Traceable to internal reference calibrators or WHO standards (e.g., WHO 1st International Standard 88/638 for TBG, WHO 2nd IRP 78/549 for FSH).

Indications for Use

Indicated for in vitro diagnostic use to verify calibration of IMMULITE 2000 Total T3, Total T4, TBG, FSH, and Estradiol 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) #: k133124

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.