Elecsys CA 15-3 II

K181492 · Roche Diagnostics · MOI · Jun 22, 2018 · Immunology

Device Facts

• Record ID: K181492
• Device Name: Elecsys CA 15-3 II
• Applicant: Roche Diagnostics
• Product Code: MOI · Immunology
• Decision Date: Jun 22, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Indications for Use

Immunological in vitro assay for quantitative determination of CA 15-3 in human serum, Li-heparin and EDTA plasma to aid in the management of breast cancer patients. In conjunction with other clinical and diagnostic procedures, serial testing with this assay is an aid in the early detection of recurrence in previously treated stage II and III breast cancer patients for monitoring response to therapy in metastatic breast cancer patients. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

Device Story

Elecsys CA 15-3 II is a two-step sandwich immunoassay for quantitative measurement of CA 15-3 antigen in human serum, Li-heparin plasma, and K2-EDTA plasma. Device utilizes streptavidin-coated microparticles and monoclonal antibodies (115D8 and DF3) labeled with a ruthenium complex. Operated on cobas e 801 immunoassay analyzers in clinical laboratory settings by trained personnel. Input samples undergo electrochemiluminescence (ECLIA) detection; results are calculated via a 2-point calibration curve and master curve. Output provides quantitative CA 15-3 levels to clinicians to assist in breast cancer management, specifically recurrence detection and therapy monitoring. Device benefits patients by providing standardized, automated serial testing to track disease progression or treatment efficacy.

Clinical Evidence

No clinical prospective/retrospective studies were performed. Evidence is based on bench testing comparing K2-EDTA plasma to serum samples. A study of 44 paired samples demonstrated analytical equivalence with a correlation coefficient of 0.997, a slope of 0.985 (95% CI: 0.955–1.036), and an intercept of -0.279 (95% CI: -1.143–0.288). All other performance characteristics (precision, sensitivity, hook effect, linearity, interference) were previously established under K171605.

Technological Characteristics

Two-step sandwich immunoassay; uses streptavidin-coated microparticles and ruthenium-labeled monoclonal antibodies (115D8, DF3). Employs electrochemiluminescence (ECLIA) detection. Designed for use on cobas e 801 analyzer. Measuring range: 3–300 U/mL. Standardized against Enzymun-Test CA 15-3 and CA 15-3 RIA. Calibration via 2-point calibration and master curve provided via cobas link.

Indications for Use

Indicated for breast cancer patients, specifically for early detection of recurrence in previously treated stage II and III patients and monitoring therapy response in metastatic patients.

Regulatory Classification

Identification

A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

Special Controls

*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.

Submission Summary (Full Text)

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

510(k) Number: K181492

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.