VITROS XT Chemistry Products TRIG-CHOL Slides

K190490 · Ortho-Clinical Diagnostics, Inc. · CHH · Mar 27, 2019 · Clinical Chemistry

Device Facts

• Record ID: K190490
• Device Name: VITROS XT Chemistry Products TRIG-CHOL Slides
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Mar 27, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Indications for Use

The TRIG test within the VITROS XT Chemistry Products TRIG-CHOL Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. The CHOL test within the VITROS XT Chemistry Products TRIG-CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Device Story

VITROS XT Chemistry Products TRIG-CHOL Slides are multilayered analytical elements on polyester support; contain both TRIG and CHOL tests in a single slide frame. Input: patient serum or plasma sample. Operation: sample deposited on slide; spreading layer distributes sample; Triton X-100 dissociates lipoprotein complexes. TRIG test: lipase hydrolyzes triglycerides to glycerol; glycerol kinase/oxidase/peroxidase reactions produce dye. CHOL test: cholesterol ester hydrolase/oxidase/peroxidase reactions produce dye. Output: dye density measured via reflectance spectrophotometry on VITROS XT 7600 Integrated Systems. Used in clinical laboratories by technicians. Output provides quantitative analyte concentration; aids clinicians in diagnosing/treating lipid-related metabolic and cardiovascular conditions.

Clinical Evidence

Bench testing only. Method comparison (N=148) against predicate devices showed high correlation (r=1.000 for TRIG, r=0.999 for CHOL). Precision evaluated over 20 days (80 observations) with CV% ranging 0.3-1.5% for TRIG and 0.6-2.1% for CHOL. Linearity verified across claimed ranges. Interference testing performed per CLSI EP07-03.

Technological Characteristics

Multilayered analytical elements on polyester support; plastic barrier separates TRIG and CHOL tests. Principle: reflectance spectrophotometry of colorimetric enzymatic reactions. Reagents: lipase, peroxidase, glycerol kinase, cholesterol oxidase, cholesterol ester hydrolase, Triton X-100, leuco dye. Dimensions: single slide frame. Connectivity: integrated with VITROS XT 7600 system. Sterilization: not specified.

Indications for Use

Indicated for in vitro diagnostic use in patients requiring quantitative measurement of triglyceride and cholesterol concentrations in serum and plasma to assist in the diagnosis and treatment of diabetes mellitus, nephrosis, liver diseases, lipid metabolism disorders, endocrine disorders, atherosclerosis, and renal diseases.

Regulatory Classification

Identification

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Submission Summary (Full Text)

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

510(k) Number: K190490

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.