LIAISON 25 TOTAL-D

K132492 · DiaSorin, Inc. · MRG · Sep 5, 2013 · Clinical Chemistry

Device Facts

• Record ID: K132492
• Device Name: LIAISON 25 TOTAL-D
• Applicant: DiaSorin, Inc.
• Product Code: MRG · Clinical Chemistry
• Decision Date: Sep 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1825
• Device Class: Class 2

Indications for Use

The LIAISON® 25 TOTAL-D assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum, EDTA and Lithium heparin plasma. The LIAISON® 25 TOTAL-D assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The DiaSorin LIAISON® 25 TOTAL-D is intended to be used on the LIAISON® XL Analyzer. The DiaSorin LIAISON® 25 TOTAL-D Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® 25 TOTAL-D assay. The DiaSorin LIAISON® 25 TOTAL-D Calibration Verifiers are assayed quality control materials intended for use in the quantitative verification of calibration and reportable range of the LIAISON® 25 TOTAL-D assay when performed on the LIAISON® XL Analyzer.

Device Story

The LIAISON® 25 TOTAL-D is a chemiluminescent immunoassay (CLIA) for the quantitative measurement of 25-hydroxyvitamin D in human serum or plasma. The device uses paramagnetic particles coated with goat anti-25 OH Vitamin D antibody. The assay follows a competitive principle: 25 OH Vitamin D from the sample competes with a vitamin D-isoluminol conjugate for antibody binding sites. After incubation and washing, starter reagents initiate a flash chemiluminescent reaction. A photomultiplier measures the light signal (RLU), which is inversely proportional to the analyte concentration. The device is intended for use on the LIAISON® XL Analyzer in clinical laboratory settings. Healthcare providers use the quantitative output to assess vitamin D sufficiency in adult patients. The system includes controls and calibration verifiers to ensure accuracy and precision.

Clinical Evidence

Bench testing only. Method comparison study (n=403) against predicate showed high correlation (r=0.990, slope 0.99). Matrix comparison (serum, SST, EDTA, Li-heparin) confirmed equivalence. Precision/reproducibility study (n=80 replicates per sample) showed total CVs between 5.0% and 13.6%. LoB/LoD/LoQ were determined to be <2.03 ng/mL, 2.91 ng/mL, and 4.0 ng/mL respectively. Recovery studies averaged 96%. Interference testing showed no significant bias (<10%) for common endogenous substances.

Technological Characteristics

Chemiluminescent immunoassay (CLIA) using paramagnetic particles coated with goat anti-25 OH Vitamin D antibody. Reagents include isoluminol-conjugated vitamin D. Operates on LIAISON® XL Analyzer. Measuring range 4-150 ng/mL. Storage 2-8°C. Automated sample processing.

Indications for Use

Indicated for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum, EDTA, and Lithium heparin plasma to aid in the assessment of vitamin D sufficiency in adults.

Regulatory Classification

Identification

A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.

Special Controls

*Classification.* Class II (special controls). Vitamin D test systems must comply with the following special controls:(1) Labeling in conformance with 21 CFR 809.10 and (2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.

Submission Summary (Full Text)

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

510(k) #: k132492

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.