LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3

K130469 · DiaSorin, Inc. · JLW · Apr 5, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130469
• Device Name: LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3
• Applicant: DiaSorin, Inc.
• Product Code: JLW · Clinical Chemistry
• Decision Date: Apr 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

Indications for Use

The DiaSorin LIAISON® TSH assay is an in vitro chemiluminescent immunoassay for the quantitative determination of thyroid stimulating hormone (TSH), also known as thyrotropin and thyrotropic hormone, in human serum. The test has to be performed on the LIAISON® XL Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The DiaSorin LIAISON® Control Thyroid 1, LIAISON® Control Thyroid 2 and LIAISON® Control Thyroid 3 are intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® TSH assay.

Device Story

LIAISON® TSH is a sandwich chemiluminescent immunoassay (CLIA) for quantitative TSH measurement in human serum. Device uses mouse monoclonal antibodies: one coated on magnetic particles (solid phase), one linked to isoluminol derivative (conjugate). Operated on LIAISON® XL Analyzer; system performs all incubation and processing steps. Photomultiplier measures relative light units (RLU), which are inversely proportional to TSH concentration. Results calculated via 2-point calibration against stored master curve. Used in clinical laboratories by trained personnel. Output provides TSH concentration (mIU/L) to assist clinicians in diagnosing thyroid or pituitary dysfunction. Includes three levels of lyophilized quality control samples to monitor assay accuracy and precision.

Clinical Evidence

Bench testing only. Method comparison (n=181) vs. commercial immunoassay showed Passing & Bablok regression y = 1.005x - 0.0030 (R2=0.9748). Precision study (n=160 replicates per sample) demonstrated total CVs between 3.6% and 5.5%. Linearity confirmed 0.02–90 mIU/L. LoB/LoD/LoQ determined as 0.014, 0.02, and 0.02 mIU/L respectively. No significant interference observed for triglycerides, hemoglobin, bilirubin, albumin, or common hormones (LH, FSH, hGH, hCG, HAMA).

Technological Characteristics

Sandwich chemiluminescent immunoassay. Solid phase: magnetic particles coated with mouse monoclonal anti-TSH. Conjugate: isoluminol-antibody conjugate. Energy source: LIAISON® XL Analyzer (photomultiplier detection). Form factor: kit with reagents and calibrators. Connectivity: integrated with LIAISON® XL Analyzer. Traceability: 2nd IRP WHO 80/558 standard.

Indications for Use

Indicated for quantitative determination of TSH in human serum to aid diagnosis of thyroid or pituitary disorders in patients requiring clinical assessment of anterior pituitary function.

Regulatory Classification

Identification

A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

Submission Summary (Full Text)

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

510(k) #: k130469

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.