Urine/CSF Albumin, Urine/CSF Albumin Calibrator

K142346 · Beckman Coulter Ireland, Inc. · DCF · Oct 15, 2014 · Immunology

Device Facts

• Record ID: K142346
• Device Name: Urine/CSF Albumin, Urine/CSF Albumin Calibrator
• Applicant: Beckman Coulter Ireland, Inc.
• Product Code: DCF · Immunology
• Decision Date: Oct 15, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5040
• Device Class: Class 2

Indications for Use

The Urine/CSF Albumin reagent is intended to be used for the quantitation of albumin concentration in human urine and cerebrospinal fluid (CSF) on the Beckman Coulter AU clinical chemistry systems as an aid in the diagnosis of kidney diseases. For in vitro diagnostic use only. The Urine/CSF Albumin calibrator is intended to be used to calibrate the Urine/CSF Albumin reagent on the Beckman Coulter AU clinical chemistry systems. For in vitro diagnostic use only.

Device Story

Device consists of liquid, ready-to-use reagents and calibrators for Beckman Coulter AU clinical chemistry analyzers. Input: human urine or CSF samples. Principle: turbidimetric method; anti-human serum albumin antibodies bind to sample albumin, forming immune complexes that scatter light. Output: absorbance measured at 380nm (with 800nm reference) proportional to albumin concentration. Used in clinical laboratories by technicians/pathologists. Output aids clinicians in diagnosing kidney diseases by quantifying albuminuria or CSF albumin levels. Benefits: provides standardized, automated quantitative assessment of albumin, facilitating clinical decision-making regarding renal function.

Clinical Evidence

Bench testing only. Studies included precision (n=80), linearity (11-point panel), sensitivity (LoB, LoD, LoQ), interference testing, and method comparison (n=131 for urine, n=131 for CSF) against commercially available assays. Results showed acceptable precision (CV < 5%), linearity within claimed ranges, and no significant interference from common substances.

Technological Characteristics

Liquid, ready-to-use reagent kit (R1/R2) and calibrator. Turbidimetric sensing principle. Energy source: clinical chemistry analyzer photometric system. Dimensions/form factor: reagent vials for AU analyzers. Connectivity: standalone reagent for AU clinical chemistry systems. Sterilization: N/A (in vitro diagnostic reagent). Software: embedded in AU analyzer system.

Indications for Use

Indicated for the quantitation of albumin concentration in human urine and cerebrospinal fluid (CSF) to aid in the diagnosis of kidney diseases. No specific age or gender contraindications provided.

Regulatory Classification

Identification

An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

Submission Summary (Full Text)

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

510(k) #: k142346

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.