COBAS C BILIRUBIN TOTAL GEN.3

K131544 · Roche Diagnostics · CIG · Jul 17, 2013 · Clinical Chemistry

Device Facts

• Record ID: K131544
• Device Name: COBAS C BILIRUBIN TOTAL GEN.3
• Applicant: Roche Diagnostics
• Product Code: CIG · Clinical Chemistry
• Decision Date: Jul 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

cobas c Bilirubin Total Gen.3 is an in vitro test for the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems. Measurement of the levels of 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 gall bladder block.

Device Story

The cobas c Bilirubin Total Gen.3 is an in vitro diagnostic reagent for use on Roche/Hitachi cobas c clinical chemistry analyzers. It utilizes a diazo colorimetric method where total bilirubin couples with a 3,5-dichlorophenyl diazonium salt in a strongly acidic medium to form a red azo dye. The intensity of the color, measured photometrically, is directly proportional to the total bilirubin concentration. The device is intended for use in clinical laboratory settings by trained laboratory personnel. Healthcare providers use the quantitative results to assess liver function and diagnose metabolic or hematological disorders. The system supports serum and plasma samples (Li-heparin, K2-EDTA) and provides automated measurement, facilitating clinical decision-making regarding patient hyperbilirubinemia management.

Clinical Evidence

Bench testing only. Performance validated via precision (CLSI EP5-A2), linearity (CLSI EP6-A), and detection limits (CLSI EP17-A2). Precision studies showed CV% < 3.3% across human serum samples. Linearity confirmed for 0.15-35.1 mg/dL. Interference testing evaluated endogenous substances (lipemia, hemolysis, indican) and 15 common drugs. Method comparison with predicate (n=131 adult sera) yielded Passing/Bablok regression y = 0.959x + 0.091, r = 0.9997.

Technological Characteristics

Quantitative colorimetric diazo method. Reagent R1: detergent, buffer, stabilizers (pH 1.0); R2: 3,5-dichlorophenyl diazonium salt (≥ 1.35 mmol/L). Platform: Roche/Hitachi cobas c 501 analyzer. Calibration: linear regression, standardized against Doumas manual reference method. Connectivity: integrated with cobas c systems.

Indications for Use

Indicated for quantitative determination of total bilirubin in serum and plasma of adults and neonates to aid in diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders (e.g., hepatitis, gall bladder block).

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) #: k131544

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.