VITROS XT Chemistry Products GLU-Ca Slides

K190520 · Ortho-Clinical Diagnostics, Inc. · CGA · Apr 3, 2019 · Clinical Chemistry

Device Facts

• Record ID: K190520
• Device Name: VITROS XT Chemistry Products GLU-Ca Slides
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Apr 3, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GLU test within the VITROS XT Chemistry Products GLU-Ca Slides quantitatively measures glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS XT 7600 Integrated Systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. The Ca test within the VITROS XT Chemistry Products GLU-Ca Slides quantitatively measures calcium (Ca) concentration in serum, plasma, and urine using VITROS XT 7600 Integrated Systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Device Story

VITROS XT Chemistry Products GLU-Ca Slides are single-use analytical elements containing both GLU and Ca test patches separated by a plastic barrier. Used on VITROS XT 7600 Integrated Systems in clinical laboratory settings. For glucose: sample oxidation catalyzed by glucose oxidase produces hydrogen peroxide, leading to oxidative coupling and dye formation; intensity measured by reflected light. For calcium: sample dissociates from binding proteins, complexes with Arsenazo III dye, causing absorption shift; reflection density measured spectrophotometrically. Results generated independently for each analyte. Healthcare providers use quantitative results to diagnose and monitor metabolic, endocrine, and bone-related conditions. Benefits include consolidated testing on a single slide, reducing sample volume requirements and improving laboratory workflow efficiency.

Clinical Evidence

Bench testing only. Method comparison followed CLSI EP09c using patient samples (serum, urine, CSF) comparing VITROS XT 7600 to predicate systems. Correlation coefficients were 1.000 for GLU and 0.999 for Ca. Precision evaluated per CLSI EP05-A3 (80 observations over 20 days); results showed high reproducibility. Linearity verified per CLSI EP06-A. Interference testing performed per CLSI EP07/EP37; specific biases identified for substances like glutathione, hemoglobin, and ascorbic acid. No clinical trials were required.

Technological Characteristics

Multilayered analytical elements on polyester support. GLU assay: glucose oxidase/peroxidase colorimetric. Ca assay: Arsenazo III dye complexometric. Dimensions: single slide frame. Connectivity: integrated with VITROS XT 7600 system. Energy source: optical/spectrophotometric measurement. Sterilization: not specified. Software: embedded system control.

Indications for Use

Indicated for quantitative measurement of glucose in serum, plasma, urine, and CSF, and calcium in serum, plasma, and urine. Used for diagnosis/treatment of carbohydrate metabolism disorders (diabetes, neonatal/idiopathic hypoglycemia), pancreatic islet cell carcinoma, parathyroid disease, bone diseases, chronic renal disease, and tetany. Prescription use only.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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

510(k) Number: k190520

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.