(90 days)
Not Found
No
The summary describes a standard immunoassay for measuring a biomarker and does not mention any AI or ML components in the device description, intended use, or performance studies.
No.
This device is an in vitro diagnostic (IVD) device used for the quantitative measurement of CA19-9, which aids in the management of patients with exocrine pancreatic cancer. It does not directly treat or prevent a disease, which is the primary function of a therapeutic device.
Yes
The device is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative measurement of CA19-9, which is used as an aid in the management of patients diagnosed with cancer of the exocrine pancreas. This function directly aligns with the definition of a diagnostic device as it provides information for medical diagnosis or monitoring of a disease.
No
The device description clearly outlines physical components (Immunoreaction Cartridges containing solutions) and the intended use is for a laboratory immunoassay system (LUMIPULSE G System), indicating it is a hardware-based diagnostic device with associated reagents.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "quantitative measurement of CA19-9 in human serum or plasma". This involves testing biological samples in vitro (outside the body).
- Device Description: The device consists of "Immunoreaction Cartridges" containing reagents (antibody-coated particles and enzyme-labeled antibody solution) designed to react with components in the patient's sample. This is characteristic of an in vitro diagnostic assay.
- Clinical Studies: The performance studies include "Analytical Performance" and "Clinical Studies" involving testing patient samples to assess the device's ability to aid in the management of patients.
- Predicate Device: The mention of a "Predicate Device" (ARCHITECT® CA 19-9TM xR Assay) which is also an IVD, further supports the classification of this device as an IVD.
The entire description points to a device designed to perform tests on biological samples in a laboratory setting to provide information for clinical use.
N/A
Intended Use / Indications for Use
Lumipulse G CA19-9-N is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative measurement of CA19-9 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 CA19-9 at some point in their disease process. Serial testing for patient CA19-9 assay values should be used in conjunction with other clinical methods used for monitoring cancer of the exocrine pancreas.
WARNING: The concentration of CA19-9 in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the assay for CA19-9 used. Values obtained with different assay methods cannot be used interchangeably. If, in the course of monitoring a patient, the assay method used for determining serial levels of CA 19-9 is changed, the laboratory must perform additional serial testing to confirm baseline values. Prior to changing assays, the laboratory MUST confirm baseline values for patients being serially monitored. Lumipulse & CA19-9-N should not be used for cancer screening or diagnosis.
WARNING: Patients known to be genotypically negative for the Lewis blood group antigen will be unable to produce the CA19-9 antigen even in the presence of malignant tissue. Phenotyping for the Lewis antigen may be insufficient to detect true Lewis antigen negative individuals. Even patients who are genotypically positive for the Lewis antigen may produce varying levels of CA19-9 based on gene dosage effect.
Product codes (comma separated list FDA assigned to the subject device)
NIG
Device Description
The Lumipulse G CA19-9-N Immunoreaction Cartridges (cat. # 235126) consists of 3 x 14 tests. Each kit contains the following:
-
- Antibody-Coated Particle Solution (Liquid when used, 250 µL/Immunoreaction Cartridge) Contains 150 µg/mL anti-CA19-9 monoclonal antibody (mouse)-coated particles, protein stabilizers (bovine and mouse) and chemical stabilizers in 0.15 M sodium chloride/Tris buffer. This solution contains gelatin and turns into gel at 15 °C or lower. Preservative: sodium azide.
-
- Enzyme-Labeled Antibody Solution (Liquid, 350 µL/Immunoreaction Cartridge) Contains 0.5 µq/mL alkaline phosphatase (ALP: calf)-labeled anti-CA19-9 monoclonal antibody (mouse), protein stabilizers (bovine, calf, and mouse) and chemical stabilizers in 0.05 M sodium chloride/Bis-Tris buffer. Preservative: sodium azide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pancreas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Laboratory / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
20-Day Precision:
- Study type: Single-site precision study according to CLSI EP05-A3.
- Sample size: Six native human serum-based panels. Replicates of two separate times of the day for 20 non-consecutive days (n=80 for each sample).
- Key results: Precision = 15% increase) correlated with disease progression in 65% (45/70) of patient samples. No significant change correlated with no progression in 61% (184/304) of patient serial samples. Total concordance was 61% (229/374).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Monitoring of Disease State in Patients Diagnosed with Pancreatic Cancer:
- Sensitivity: 64.29%
- Specificity: 60.53%
- Total Concordance: 61.23%
- PPV: 27.27%
- NPV: 88.04%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ARCHITECT® CA 19-9TM xR, K052000
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration" in a larger font size.
October 22, 2019
Fujirebio Diagnostics, Inc. Kristin Maddaloni Regulatory Affairs Specialist 201 Great Valley Parkway Malvern, Pennsylvania 19355
Re: K191973
Trade/Device Name: Lumipulse G CA19-9-N Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: Class II Product Code: NIG Dated: July 22, 2019 Received: July 24, 2019
Dear Kristin Maddaloni:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Douglas Jeffery, Ph.D. Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191973
Device Name Lumipulse G CA19-9-N
Indications for Use (Describe)
Lumipulse G CA19-9-N is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative measurement of CA19-9 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 CA19-9 at some point in their disease process. Serial testing for patient CA19-9 assay values should be used in conjunction with other clinical methods used for monitoring cancer of the exocrine pancreas.
WARNING: The concentration of CA19-9 in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the assay for CA19-9 used. Values obtained with different assay methods cannot be used interchangeably. If, in the course of monitoring a patient, the assay method used for determining serial levels of CA 19-9 is changed, the laboratory must perform additional serial testing to confirm baseline values. Prior to changing assays, the laboratory MUST confirm baseline values for patients being serially monitored. Lumipulse & CA19-9-N should not be used for cancer screening or diagnosis.
WARNING: Patients known to be genotypically negative for the Lewis blood group antigen will be unable to produce the CA19-9 antigen even in the presence of malignant tissue. Phenotyping for the Lewis antigen may be insufficient to detect true Lewis antigen negative individuals. Even patients who are genotypically positive for the Lewis antigen may produce varying levels of CA19-9 based on gene dosage effect.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------- | ---------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
2
3
Image /page/3/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a stylized blue and white graphic on the left, followed by the company name in blue text. The word "FUJIREBIO" is in a larger, bolder font than "Diagnostics, Inc.", which is placed below it. The logo is clean and professional, with a focus on the company name.
Section 5 510(k) SUMMARY
A. GENERAL INFORMATION
Submission Date: July 22, 2019
Submitter Information:
Submitted By:
Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355
Contact Person:
Kristin Maddaloni Regulatory Affairs Specialist Fujirebio Diagnostics, Inc. 201 Great Valley Pkwy Malvern, PA 19355 Office: 484-395-2126 maddalonik@fdi.com
B. PURPOSE FOR SUBMISSION
To obtain a substantial equivalence determination for the Lumipulse G CA19-9-N.
C. MEASURAND
CA 19-9
D. TYPE OF TEST
Quantitative, Chemiluminescent Immunoassay
E. APPLICANT
Fujirebio Diagnostics, Inc.
F. PROPRIETARY AND ESTABLISHED NAMES
Lumipulse® G CA 19-9-N Lumipulse® G CA19-9-N Immunoreaction Cartridges
G. REGULATORY INFORMATION
Trade Name: Lumipulse G CA19-9-N Classification: Class II Regulation: 21 CFR 866.6010
Lumipulse G CA19-9-N
4
Image /page/4/Picture/1 description: The image contains the logo for Fujirebio Diagnostics, Inc. The logo features a stylized graphic element on the left, consisting of blue and green shapes. To the right of the graphic is the company name, "FUJIREBIO," in a bold, blue sans-serif font, with the registered trademark symbol next to it. Below the company name is the text "Diagnostics, Inc." in a smaller, black sans-serif font.
Requlation Name: Tumor-Associated Antigen Immunological Test System Product Code: NIG - System, Test. Carbohydrate antigen (CA 19-9) for monitoring and management of pancreatic cancer Panel: 82, Immunology
H. INTENDED USE / INDICATIONS FOR USE
-
- Intended Use / 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.
- Intended Use / Indications for use
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.
-
- Warning statements:
The concentration of CA 19-9 in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the assay for CA 19-9 used. Values obtained with different assay methods cannot be used interchangeably. If, in the course of monitoring a patient, the assay method used for determining serial levels of CA 19-9 is changed, the laboratory must perform additional serial testing to confirm baseline values. Prior to changing assays, the laboratory MUST confirm baseline values for patients being serially monitored. Lumipulse G CA19-9-N should not be used for cancer screening or diagnosis.
- Warning statements:
Patients known to be genotypically negative for Lewis blood group antigen are unable to produce the CA 19-9 antigen even in the presence of malignant tissue. Phenotyping for the presence of the Lewis blood group antigen may be insufficient to detect true Lewis antigen negative individuals. Even patients who are genotype positive for the Lewis antigen may produce varying levels of CA 19-9 as the result of gene dosage effect.
-
- Special instrument requirements: Lumipulse G System
l. INDICATIONS FOR USE
Indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the pancreas. Serial testing with Lumipulse® G CA19-9-N for CA 19-9 patient values is used in conjunction with other clinical methods in the management of pancreatic cancer patients.
5
Image /page/5/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a stylized graphic on the left and the company name on the right. The graphic is a combination of blue and green shapes, while the company name is written in blue and black. The word "FUJIREBIO" is in blue, and the words "Diagnostics, Inc." are in black.
J. DEVICE DESCRIPTION
Reagents
The Lumipulse G CA19-9-N Immunoreaction Cartridges (cat. # 235126) consists of 3 x 14 tests. Each kit contains the following:
-
- Antibody-Coated Particle Solution (Liquid when used, 250 µL/Immunoreaction Cartridge) Contains 150 µg/mL anti-CA19-9 monoclonal antibody (mouse)-coated particles, protein stabilizers (bovine and mouse) and chemical stabilizers in 0.15 M sodium chloride/Tris buffer. This solution contains gelatin and turns into gel at 15 °C or lower. Preservative: sodium azide.
-
- Enzyme-Labeled Antibody Solution (Liquid, 350 µL/Immunoreaction Cartridge) Contains 0.5 µq/mL alkaline phosphatase (ALP: calf)-labeled anti-CA19-9 monoclonal antibody (mouse), protein stabilizers (bovine, calf, and mouse) and chemical stabilizers in 0.05 M sodium chloride/Bis-Tris buffer. Preservative: sodium azide.
K. SUBSTANTIAL EQUIVALENCE INFORMATION
-
- Predicate device name(s): ARCHITECT® CA 19-9TM xR Assay
-
- Predicate 510(k) number(s): K052000
-
- Comparison with predicate:
| | Lumipulse® G CA19-9-N | ARCHITECT® CA 19-9TM XR
(K052000) (Predicate) |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assay Intended 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
CA19-9 assay values should be
used in conjunction with other
clinical methods used for | The ARCHITECT® CA 19-9TM assay is
a Chemiluminescent Microparticle
Immunoassay (CMIA) for the
quantitative determination of 1116-NS-
19-9 reactive determinants in human
serum and plasma on the ARCHITECT
iSystem.
The ARCHITECT® CA 19-9TM assay is
to be used as an aid in the management
of pancreatic cancer patients with a
detectable level of Ca 19-9 at some
point in their disease process and in
conjunction with other clinical methods. |
6
Image /page/6/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a stylized graphic on the left and the company name on the right. The graphic is a combination of blue and green shapes, with a white teardrop shape in the center. The company name is written in blue, with "FUJIREBIO" in a larger font size than "Diagnostics, Inc."
| | Lumipulse® G CA19-9-N | ARCHITECT® CA 19-9TM XR
(K052000) (Predicate) |
|-----------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | monitoring cancer of the exocrine | |
| | pancreas. | |
| SIMILARITIES | | |
| Classification | Class II | Same |
| Product Code | NIG | Same |
| Regulation | 21 CFR 866.6010 | Same |
| Antibody Type and
Source | monoclonal antibody (mouse) | Same |
| Sample Type | human serum and plasma | Same |
| Reagent Storage | Store at 2-10°C | Store at 2-8°C |
| Sample Size | 100 μL | 50000.0 | 7.1,
50000.0 |