ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR

K132664 · Siemens Healthcare Diagnostics, Inc. · CJW · Oct 16, 2013 · Clinical Chemistry

Device Facts

• Record ID: K132664
• Device Name: ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: CJW · Clinical Chemistry
• Decision Date: Oct 16, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1035
• Device Class: Class 2

Indications for Use

For in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on ADVIA Chemistry systems. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys. For in vitro diagnostic use in the calibration of the ADVIA Chemistry Albumin BCP Assay (ALBP) on ADVIA Chemistry systems.

Device Story

ADVIA Chemistry Albumin BCP Assay is an in vitro diagnostic reagent for quantitative albumin measurement in human serum or plasma. It utilizes the bromocresol purple (BCP) dye-binding method; serum/plasma albumin binds to BCP to form a complex measured as an endpoint reaction at 596/694 nm. The device is used on automated ADVIA 1650 Chemistry systems in clinical laboratory settings. It includes a lyophilized, human serum-based multi-analyte calibrator. Healthcare providers use the resulting albumin concentration values to assist in the diagnosis and management of liver and kidney diseases. The assay provides a standardized measurement traceable to ERM-DA470k reference material, supporting clinical decision-making regarding patient protein status.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (N=80 per sample, total CV 0.0-1.5%). Linearity assessed across 0.6-8.0 g/dL range (R=1.000). LoB/LoD/LoQ determined per CLSI EP17-A2 (LoQ 0.6 g/dL). Method comparison with predicate (N=69) showed high correlation (r=0.999, slope 0.99). Matrix comparison (plasma vs. serum) showed r=0.993-0.998. Interference testing confirmed no significant bias (>10%) for bilirubin, lipemia, or hemoglobin at tested concentrations.

Technological Characteristics

Liquid, ready-to-use BCP dye-binding reagent. Calibrator is lyophilized human serum-based. Measurement via endpoint spectrophotometry at 596/694 nm. Traceable to ERM-DA470k. Designed for use on automated ADVIA 1650 Chemistry systems. Analytical range 0.6-8.0 g/dL.

Indications for Use

Indicated for quantitative measurement of albumin in human serum or plasma to aid in diagnosis and treatment of liver or kidney diseases. Used for calibration of the ADVIA Chemistry Albumin BCP Assay.

Regulatory Classification

Identification

An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Submission Summary (Full Text)

{0}

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

510(k) #: 132664

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.