VITROS XT Chemistry Products ALB-TP Slides

K191316 · Ortho-Clinical Diagnostics, Inc. · CIX · Jun 7, 2019 · Clinical Chemistry

Device Facts

• Record ID: K191316
• Device Name: VITROS XT Chemistry Products ALB-TP Slides
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: CIX · Clinical Chemistry
• Decision Date: Jun 7, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1035
• Device Class: Class 2

Indications for Use

The ALB test within the VITROS XT Chemistry Products ALB-TP Slides quantitatively measures albumin (ALB) concentration in serum and plasma using the VITROS XT 7600 Integrated System. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Device Story

VITROS XT Chemistry Products ALB-TP Slides are single-use analytical slides containing both albumin and total protein tests separated by a plastic barrier. The device is used on the VITROS XT 7600 Integrated System. For albumin measurement, a patient serum or plasma sample is deposited on the slide; a spreading layer distributes the sample to underlying layers. Bromcresol green (BCG) dye diffuses into the reagent layer, binds to albumin, and causes a shift in the reflectance maximum wavelength. The resulting color complex is measured via reflectance spectrophotometry. The amount of albumin-bound dye is proportional to the albumin concentration. The system is operated by laboratory professionals. Results assist clinicians in diagnosing and monitoring liver and kidney diseases. The device provides quantitative diagnostic data to inform clinical decision-making.

Clinical Evidence

Bench testing only. Method comparison (N=127) against the predicate showed a slope of 1.00, intercept of -0.03, and correlation coefficient of 0.999. Precision studies (80 observations over 20 days) demonstrated repeatability %CV between 0.7% and 1.2%. Linearity was verified across 0.5–7.1 g/dL. Interference testing identified bias from Dextran 40 and Hemoglobin at specific concentrations.

Technological Characteristics

Multilayered analytical element on polyester support; colorimetric reflectance spectrophotometry; 4.2 µL sample volume; compatible with VITROS XT 7600 Integrated System. No changes to reagent composition compared to predicate. Assay range 1.0–6.0 g/dL.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratory settings to quantitatively measure albumin concentration in serum and plasma for the diagnosis and treatment of liver or kidney diseases.

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)

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

510(k) Number: k191316

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.