S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN

K131217 · Hitachi Chemical Diagnostics, Inc. · CIG · Jun 7, 2013 · Clinical Chemistry

Device Facts

• Record ID: K131217
• Device Name: S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN
• Applicant: Hitachi Chemical Diagnostics, Inc.
• Product Code: CIG · Clinical Chemistry
• Decision Date: Jun 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2

Indications for Use

The S TEST Reagent Cartridge Total Bilirubin (T-BIL) is intended for the quantitative determination of total bilirubin in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma using the Hitachi Clinical Analyzer E40. The S TEST Reagent Cartridge Total Bilirubin is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Total bilirubin measurements are used in the diagnosis and treatment of disorders of the liver.

Device Story

The S TEST Reagent Cartridge Total Bilirubin is a single-use plastic cartridge containing two reagents (R1, R2) and a reaction cell. Used with the Hitachi Clinical Analyzer E40, a bench-top, automated wet chemistry system. The analyzer pipettes patient samples (serum/plasma) and reagents into the cartridge, mixes them, and incubates. The system uses the nitrous acid method (pH 3.7) to oxidize total bilirubin to biliverdin. A multi-wavelength photometer measures the decrease in absorbance at 450 nm. The analyzer calculates analyte concentration based on absorbance. Results are available in approximately 15 minutes. The device is operated by laboratory personnel or clinicians in clinical or physician office labs. Output is a quantitative total bilirubin value used by healthcare providers to diagnose and manage liver disorders.

Clinical Evidence

Clinical performance was evaluated at three external physician office laboratory (POL) sites. Precision studies (n=30 replicates per level) showed total %CVs ranging from 1.5% to 5.7%. Method comparison studies (n=~50 specimens per site) against a reference method demonstrated strong correlation (r=0.988 to 0.995) across a dynamic range of 0.4 to 38.1 mg/dL. Nonclinical data included analytical sensitivity (LoD 0.2 mg/dL), linearity (0.1 to 42.1 mg/dL), and interference testing (no interference up to 50 mg/dL ascorbic acid, 1,000 mg/dL hemoglobin, and 580 mg/dL triglycerides).

Technological Characteristics

Plastic reagent cartridges (13.5mm x 28mm x 20.2mm) with dot code labels for chemistry parameters. Sensing principle: multi-wavelength photometry (450/546 nm). Energy source: Hitachi Clinical Analyzer E40 (bench-top, automated). Chemistry: Nitrous acid oxidation method. Connectivity: Standalone analyzer with operations screen and printer. Software: Embedded firmware for instrument control and calculation.

Indications for Use

Indicated for quantitative determination of total bilirubin in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma to aid in the diagnosis and treatment of liver disorders. For use in clinical laboratories or physician office laboratories.

Regulatory Classification

Identification

A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Submission Summary (Full Text)

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

510(k) #: k131217

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.