Total Bilirubin

K150510 · Abbott Laboratories · CIG · Apr 2, 2015 · Clinical Chemistry

Device Facts

• Record ID: K150510
• Device Name: Total Bilirubin
• Applicant: Abbott Laboratories
• Product Code: CIG · Clinical Chemistry
• Decision Date: Apr 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma of adults and neonates on the ARCHITECT c8000 System. Measurement of total bilirubin, an organic compound formed during the normal destruction of red blood cells, is used in the diagnosis and treatment of liver, hematological and metabolic disorders, including hepatitis and gall bladder block. A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

Device Story

Device is an in vitro diagnostic reagent kit for quantitative analysis of total bilirubin in human serum or plasma; used on ARCHITECT c8000 System. Principle: total bilirubin couples with diazo reagent in presence of surfactant to form azobilirubin; increase in absorbance at 548 nm is directly proportional to total bilirubin concentration. Operated by laboratory personnel in clinical settings. Output is a numerical concentration value (mg/dL). Healthcare providers use results to diagnose and monitor liver, hematological, and metabolic disorders; in neonates, results aid in assessing risk of bilirubin encephalopathy. Benefits include rapid, automated assessment of bilirubin levels to guide clinical management of jaundice and related conditions.

Clinical Evidence

Bench testing only. Performance validated via LoB/LoD/LoQ (LoQ 0.174 mg/dL), linearity (0.3-25.0 mg/dL), and 20-day precision studies. Method comparison (N=124 adults, N=64 neonates) against predicate showed high correlation (r=0.9994 for adults, r=0.9982 for neonates). Interference testing evaluated hemoglobin, Intralipid, and indican. Matrix equivalence confirmed for various tube types (serum, SST, EDTA, heparin).

Technological Characteristics

In vitro diagnostic reagent kit. Principle: End-point colorimetric diazo reaction. Reagents: R1 (surfactants, HCl), R2 (2,4-dichloroaniline, HCl, sodium nitrite, surfactant). Form factor: Liquid reagents for automated analyzer (ARCHITECT c8000). Detection: Absorbance at 548 nm. Connectivity: Integrated with ARCHITECT c8000 system.

Indications for Use

Indicated for quantitation of total bilirubin in human serum or plasma of adults and neonates. Used to diagnose/treat liver, hemolytic, hematological, and metabolic disorders (e.g., hepatitis, gall bladder block). In neonates, used to measure bilirubin levels to aid in assessing risk of bilirubin encephalopathy (kernicterus).

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) #: k150510

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.