VITROS XT Chemistry Products UREA-CREA Slides

K190326 · Ortho-Clinical Diagnostics, Inc. · CDN · Mar 14, 2019 · Clinical Chemistry

Device Facts

• Record ID: K190326
• Device Name: VITROS XT Chemistry Products UREA-CREA Slides
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: CDN · Clinical Chemistry
• Decision Date: Mar 14, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1770
• Device Class: Class 2

Intended Use

Rx Only For in vitro diagnostic use only The UREA test within the VITROS XT Chemistry Products UREA-CREA Slides quantitatively measures urea concentration, reported either as urea nitrogen or as urea (UREA), in serum, plasma, and urine using VITROS XT 7600 Integrated Systems. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. The CREA test within the VITROS XT Chemistry Products UREA-CREA Slides quantitatively measures creatinine (CREA) concentration in serum, plasma, and urine using VITROS XT 7600 Integrated Systems. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Device Story

VITROS XT Chemistry Products UREA-CREA Slides are multilayered analytical elements on polyester support; contain both UREA and CREA tests in a single slide frame. Used on VITROS XT 7600 Integrated System. UREA test: sample deposited on slide; urease reaction generates ammonia; ammonia reacts with indicator in color-forming layer; reflection density measured. CREA test: sample deposited; creatinine hydrolyzed to creatine; creatine converted to sarcosine and urea; sarcosine oxidized to hydrogen peroxide; peroxidase-catalyzed oxidation of leuco dye produces color; reflection density measured at 2 time points. Used in clinical laboratories by trained personnel. Output is quantitative concentration of urea and creatinine. Results assist clinicians in diagnosing/treating renal and metabolic diseases and monitoring dialysis.

Clinical Evidence

Bench testing only. Method comparison (CLSI EP09-A3) using 116-130 patient samples showed high correlation (r=0.998-1.000) with predicate devices. Precision (CLSI EP05-A3) evaluated over 20 days with 80 observations per fluid; CV% ranged from 0.6% to 8.7%. Linearity (CLSI EP06-A) verified measuring ranges. Interference testing (CLSI EP07-A3) characterized bias for endogenous substances and drugs.

Technological Characteristics

Multilayered analytical element on polyester support. UREA: Urease-based colorimetric assay. CREA: Enzymatic (creatinine amidohydrolase, creatine amidinohydrolase, sarcosine oxidase, peroxidase) colorimetric assay. Dimensions: single slide frame. Connectivity: Integrated with VITROS XT 7600 System. Software: Embedded firmware for system operation and data processing.

Indications for Use

Indicated for quantitative measurement of urea and creatinine in serum, plasma, and urine for the diagnosis and treatment of renal and metabolic diseases and monitoring of renal dialysis. For prescription use only.

Regulatory Classification

Identification

A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Submission Summary (Full Text)

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

510(k) Number: k190326

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.