Lumipulse G CA19-9-N

K200997 · Fujirebio Diagnostics,Inc. · NIG · May 14, 2020 · Immunology

Device Facts

• Record ID: K200997
• Device Name: Lumipulse G CA19-9-N
• Applicant: Fujirebio Diagnostics,Inc.
• Product Code: NIG · Immunology
• Decision Date: May 14, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Indications for Use

Lumipulse® G CA19-9-N is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative measurement of CA 19-9 in human serum or plasma (sodium heparin, lithium heparin, or dipotassium EDTA) on the LUMIPULSE G System. The assay is to be used as an aid in the management of patients diagnosed with cancer of the exocrine pancreas who have detectable levels of CA 19-9 at some point in their disease process. Serial testing for patient CA 19-9 assay values should be used in conjunction with other clinical methods used for monitoring cancer of the exocrine pancreas.

Device Story

Lumipulse G CA19-9-N; in vitro diagnostic immunoassay for quantitative measurement of CA19-9 in human serum and plasma; used by clinical laboratory professionals; modification involves increasing tamoxifen test concentration for interference evaluation from 0.228 mg/dL to 6.0 mg/dL; fundamental scientific technology remains unchanged; device provides quantitative results to aid in clinical management of patients.

Clinical Evidence

Bench testing only. Verification and validation activities performed to assess the impact of the tamoxifen interference concentration change. No clinical data required for this modification.

Technological Characteristics

Chemiluminescent enzyme immunoassay (CLEIA) for use on the Lumipulse G system. Modification: increased tamoxifen interference test concentration to 6.0 mg/dL. Fundamental technology unchanged.

Indications for Use

Indicated for use as a tumor-associated antigen immunological test system for the quantitative measurement of CA19-9 in human serum and plasma.

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.

Predicate Devices

• Lumipulse G CA19-9-N (K191973)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K200997

B Applicant

Fujirebio Diagnostics, Inc.

C Proprietary and Established Names

Lumipulse G CA19-9-N

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NIG | Class II | 21 CFR 866.6010 - Tumor-Associated Antigen Immunological Test System | IM - Immunology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for the test drug concentration used for evaluating interference.

4. The tamoxifen test concentration for interference was changed from 0.228 mg/dL to 6.0 mg/dL.

5. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

6. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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