IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL

K140258 · Siemens Healthcare Diagnostics, Inc. · JJX · Mar 5, 2014 · Clinical Chemistry

Device Facts

• Record ID: K140258
• Device Name: IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 5, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The IMMULITE 2000 DHEA-SO4 Calibration Material (CVM) is intended for in vitro diagnostic use in the verification of calibration of the IMMULITE DHEA-SO4 assay on the IMMULITE 2000 systems. The IMMULITE 2000 Third Generation Verification Material (CVM) is intended for in vitro diagnostic use in the verification of calibration of the IMMULITE Third Generation TSH assay on the IMMULITE 2000 systems. The IMMULITE 2000 Intact PTH Calibration Material (CVM) is intended for in vitro diagnostic use in the verification of calibration of the IMMULITE Intact PTH assay on the IMMULITE 2000 systems.

Device Story

Calibration verification materials (CVM) for IMMULITE 2000 systems; used to verify assay calibration for DHEA-SO4, Third Generation TSH, and Intact PTH. CVMs consist of four vials of lyophilized analyte in serum/buffer matrix (human or equine). Reconstituted by laboratory personnel; processed on IMMULITE 2000 systems. Output provides recovered dose values compared against assigned target ranges to ensure system performance and calibration accuracy. Used in clinical laboratory settings; results assist healthcare providers in validating assay reliability for patient sample testing.

Clinical Evidence

Bench testing only. Stability validated via real-time shelf life and open-vial studies. Value assignment validated using multiple replicates across systems and reagent lots. Acceptance criteria based on guideline ranges (±8-16% of assigned dose) and control recovery within 2SD of target. No clinical data.

Technological Characteristics

Lyophilized calibration verification material; 4-level set. Matrix: human serum (DHEA-SO4) or equine serum/buffer (TSH, PTH) with preservatives. Storage: ≤-20°C. Stability: 1.5-7 years unopened; 8 hours post-reconstitution. Connectivity: used on IMMULITE 2000 systems. Traceability: DHEA-SO4 (internal material), TSH (WHO 2nd IRP 80/558), PTH (internal material).

Indications for Use

Indicated for in vitro diagnostic use to verify calibration of DHEA-SO4, Third Generation TSH, and Intact PTH 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) #: k140258

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.