VITROS XT Chemistry Products TBIL-ALKP Slides

K190807 · Ortho-Clinical Diagnostics, Inc. · CIG · Apr 26, 2019 · Clinical Chemistry

Device Facts

• Record ID: K190807
• Device Name: VITROS XT Chemistry Products TBIL-ALKP Slides
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: CIG · Clinical Chemistry
• Decision Date: Apr 26, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2

Intended Use

The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Measurements of the levels of bilirubin, an organic compound formed during the normal destruction of red blood cells, are used in the diagnosis and treatment of liver, hematological and metabolic disorders, including hepatitis and gall bladder block. The ALKP test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma using VITROS XT 7600 Integrated Systems. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Device Story

VITROS XT Chemistry Products TBIL-ALKP Slides are multi-test slides for use on VITROS XT 7600 Integrated Systems; designed for quantitative in vitro diagnostic measurement of total bilirubin (TBIL) and alkaline phosphatase (ALKP) in serum and plasma. Slides utilize thin-film technology to perform chemical reactions; system measures resulting colorimetric changes via reflectance spectrophotometry. Used in clinical laboratory settings by trained laboratory personnel. Output provides quantitative concentration/activity levels to clinicians for diagnosis and management of liver, bone, metabolic, and hematological conditions. Benefits include simultaneous testing on a single slide, improving laboratory efficiency and diagnostic throughput.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing and analytical performance validation comparing the XT slide performance to predicate VITROS slide performance.

Technological Characteristics

Thin-film multilayer slide technology; colorimetric reflectance spectrophotometry; integrated system platform. Materials and sensing principles are consistent with established VITROS chemistry slide technology. No specific ASTM standards cited. Standalone slide consumable for use with VITROS XT 7600 Integrated System.

Indications for Use

Indicated for in vitro diagnostic use in serum and plasma for quantitative measurement of total bilirubin and alkaline phosphatase activity to aid in diagnosis and treatment of liver, hematological, metabolic, bone, parathyroid, and intestinal disorders. Prescription use only.

Regulatory Classification

Identification

A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Submission Summary (Full Text)

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

510(k) Number: k190807

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.