IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL

K132391 · Siemens Helathcare Diagnostics, Inc. · JJX · Sep 20, 2013 · Clinical Chemistry

Device Facts

• Record ID: K132391
• Device Name: IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL
• Applicant: Siemens Helathcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Sep 20, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The IMMULITE® Anti-TG Ab Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Anti-TG Ab assay on the IMMULITE 2000 systems as indicated in the CVM Package Insert. The IMMULITE® Anti-TPO Ab Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Anti-TPO Ab assay on the IMMULITE 2000 systems as indicated in the CVM Package Insert. The IMMULITE® Thyroglobulin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Thyroglobulin assay on the IMMULITE 2000 systems as indicated in the CVM Package Insert.

Device Story

Calibration verification materials (CVM) for IMMULITE 2000 systems; used to verify assay calibration; consists of 4-level lyophilized vials (human or equine serum matrix); used by laboratory technicians; input is CVM sample run on IMMULITE 2000; output is recovered dose value compared against target ranges; assists in ensuring system accuracy and clinical decision-making reliability.

Clinical Evidence

Bench testing only. Stability validated up to 6-9 years. Traceability established to WHO 1st IRP 65/93 (Anti-TG), WHO 1st IRP 66/387 (Anti-TPO), and BCR 457 (Thyroglobulin). Performance validated using 27 replicates across multiple instruments and reagent lots; recovery within ±10-25% of assigned dose.

Technological Characteristics

Lyophilized human or equine serum matrix with preservatives; 4-level concentration; stored at 2-8°C; traceable to international reference materials (WHO/BCR); intended for use on IMMULITE 2000 immunoassay systems.

Indications for Use

Indicated for in vitro diagnostic use to verify calibration of IMMULITE 2000 Anti-TG, Anti-TPO, and Thyroglobulin assays. 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) #: 132391

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.