(28 days)
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.
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 µq/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 ℃ or lower. Preservative: sodium azide.
- Enzyme-Labeled Antibody Solution (Liquid, 350 µL/Immunoreaction Cartridge) Contains 0.5 µg/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.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Context: This document describes a Special 510(k) submission for the Lumipulse G CA19-9-N device, specifically addressing a change in the tested concentration of the therapeutic interferent Tamoxifen. The device is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative measurement of CA 19-9, used as an aid in the management of patients with cancer of the exocrine pancreas.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Individual samples must have a percent difference of ± 10% difference from the control. | -2% to 1% (Met acceptance criteria) |
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for the "Supplemental Therapeutic Interference Study." However, the tables comparing the cleared vs. modified device list "Samples (Mean Test Concentrations (U/mL) (n=3))" and "Samples (Mean Control Concentrations (U/mL) (n=3))" for three serum pools. This suggests that for each serum pool, there were likely 3 replicates tested (n=3).
- Data Provenance: Not specified, but given it's an in vitro diagnostic measuring a biomarker, the samples would be human serum/plasma. The document does not mention country of origin or whether the data was retrospective or prospective, though interference studies are typically laboratory-based and prospective using spiked samples or naturally interfering samples.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications: Not applicable. This study is an interference study for an in vitro diagnostic device measuring a quantitative biomarker (CA 19-9). Ground truth is established by the known concentration of the substance being measured (CA 19-9) and the known concentration of the interferent (Tamoxifen). Expert consensus or pathologist review is not relevant for this type of test.
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Adjudication Method for the Test Set: Not applicable. This is an interference study for a quantitative assay, not a subjective diagnostic interpretation.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done: No, an MRMC study was not done. This type of study is typically performed for image-based diagnostics where multiple readers interpret cases with and without AI assistance. This document pertains to an in vitro diagnostic assay.
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If a Standalone Performance Study was done: Yes, a standalone performance study in the form of a "Supplemental Therapeutic Interference Study" was conducted. This study assessed the device's performance (specifically, its susceptibility to Tamoxifen interference) without human interpretation in the loop, by comparing results with and without the interferent to a control.
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The Type of Ground Truth Used: The ground truth for this interference study is established by:
- The known, pre-established concentrations of CA 19-9 in the serum pools used.
- The known concentration of Tamoxifen added to the samples.
- The "control" measurements (samples without Tamoxifen) serve as the reference for determining the "percent difference."
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The Sample Size for the Training Set: Not applicable. This is not a machine learning or AI-based device that requires a training set in the conventional sense. The "training" for such an assay is its analytical development and optimization.
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How the Ground Truth for the Training Set was Established: Not applicable, as there is no training set for this type of in vitro diagnostic device in the context of machine learning. The assay is built on established chemical and immunological principles, with performance characteristics determined through analytical validation studies (like interference studies).
§ 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.