Total Bilirubin2

K223324 · Abbott Ireland Diagnostics Division · CIG · Dec 29, 2022 · Clinical Chemistry

Device Facts

• Record ID: K223324
• Device Name: Total Bilirubin2
• Applicant: Abbott Ireland Diagnostics Division
• Product Code: CIG · Clinical Chemistry
• Decision Date: Dec 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Total Bilirubin2 assay is used for the quantitation of total bilirubin in human serum or plasma, of adults and neonates, on the ARCHITECT c System. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and disorders of the biliary tract. In newborn infants, the Total Bilirubin2 assay is intended to measure the levels of total bilirubin (conjugated and unconjugated) in serum or plasma to aid in the diagnosis and management of neonatal jaundice and hemolytic disease of the newborn.

Device Story

Total Bilirubin2 is an automated in vitro diagnostic assay for the ARCHITECT c System. It measures total bilirubin (conjugated and unconjugated) in human serum or plasma samples. The device uses a diazo-based chemical reaction where bilirubin couples with a diazo reagent in the presence of a surfactant to form azobilirubin. The resulting increase in absorbance at 548 nm is directly proportional to the total bilirubin concentration. The assay is operated by laboratory technicians in a clinical setting. Healthcare providers use the quantitative results to diagnose and manage liver, hematological, and metabolic disorders, including neonatal jaundice. The device provides an analytical measuring interval of 0.1–25.0 mg/dL, extendable to 125.0 mg/dL via automated or manual dilution, assisting in clinical decision-making for patient treatment and monitoring.

Clinical Evidence

Bench testing only. Performance evaluated on ARCHITECT c8000 system. Precision studies (CLSI EP05-A3) showed within-laboratory CVs of 0.7%–3.4%. Accuracy bias ranged from -0.1% to 3.7% relative to Doumas reference method. Linearity confirmed across 0.1–25.0 mg/dL. Method comparison (CLSI EP09c) against predicate showed correlation coefficient of 1.00 for both serum and neonatal serum samples. Interference testing performed per CLSI EP07.

Technological Characteristics

Automated clinical chemistry assay using diazonium salt methodology. Reagents include 2,4-dichlorobenzenediazonium 1,5-naphthalenedisulfonate hydrate and Brij L23 surfactant. Operates on ARCHITECT c8000 system. Analytical measuring interval 0.1–25.0 mg/dL; reportable up to 125.0 mg/dL. Standardized to Doumas method. Compatible with serum, serum separator, and various heparin/EDTA plasma tubes.

Indications for Use

Indicated for quantitation of total bilirubin in human serum or plasma of adults and neonates to aid in diagnosis/management of liver, hemolytic, hematological, and metabolic disorders (e.g., hepatitis, biliary tract disorders) and neonatal jaundice/hemolytic disease of the newborn.

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) Number: K223324

This 510(k) was reviewed under the OHT7/OHT8 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.

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