(418 days)
The LOCI CA19-9 method is an in vitro diagnostic test for the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum and lithium heparin and EDTA plasma on the Dimension Vista® System. Measurements of CA 19-9 are indicated for the serial measurement of CA19-9 to aid in managing patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum CA 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort. CA 19-9 values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is determined.
The LOCI 7 CAL is an in vitro diagnostic product for the calibration of the Cancer Antigen 19-9 (CA19-9) method on the Dimension Vista® System.
The CA19-9 method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCl® reagents include two synthetic bead reagents and a biotinylated anti-CA 19-9 monoclonal 1116-NS-19-9 anibody fragment. The first bead reacent (Chemibeads) is coated with an anti-CA 19-9 monoclonal antibody (1116-NS-19-9) and contains a chemilyminescent dye. The second bead reagent (Sensibeads) is coated with and contains a photosensitizer dye. Sample is incubated with biotinylated antibody and Chemibeads to form bead-CA 19-9-biotinylated antibody sandwiches. Sensibeads are added and bind to form bead-pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the CA 19-9 concentration in the sample when measured against a calibration curve.
The LOCI 7 calibrator is a liquid, frozen bovine serum albumin, based product containing CA 19-9 from human cell culture. The kit consists of ten vials, two vials per level (A-E), 2.0 mL per vial.
This document is a 510(k) summary for a diagnostic test, not a study reporting on the device's performance against specific acceptance criteria. A 510(k) is a premarket notification demonstrating that the device is substantially equivalent to a legally marketed predicate device. Therefore, it does not typically include detailed acceptance criteria tables or specific studies proving the device meets those criteria in the way a clinical trial or performance evaluation report would.
However, based on the provided text, I can extract information related to the device's reported specifications and the general nature of the evidence presented for substantial equivalence.
Here's an analysis of the provided text in relation to your request, highlighting what is not available in this specific document:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria and reported device performance in the typical sense of a clinical study. Instead, it offers a "Comparison of Similarities and Differences" table between the new device (LOCI CA 19-9 Flex® Reagent Cartridge and LOCI 7 Calibrator) and its predicate devices. This comparison focuses on features such as intended use, sample type, measuring range, sample size, measurement principle, matrix, preparation, number of calibrator levels, target concentrations, and storage.
The document states: "Comparative testing described in the submission substa[ntiates substantial equivalence]" but does not provide the details of this testing or specific performance metrics with acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available in the provided 510(k) summary. The summary refers to "comparative testing" but does not detail the sample size (number of patients or samples) or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not available in the provided 510(k) summary. Given that this is an in vitro diagnostic test for biomarker measurement, the ground truth would likely refer to the true concentration of CA 19-9, often established by reference methods or gravimetric preparation for calibrators/controls, rather than expert interpretation of images or clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not available in the provided 510(k) summary. Adjudication methods are typically relevant in studies involving human interpretation or subjective assessments, which is not the primary focus of validating an in vitro diagnostic assay like this.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/available. The device is an in vitro diagnostic reagent and calibrator for quantitative measurement of a biomarker, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are irrelevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable/available. The device is a laboratory assay, not an algorithm. Its performance is inherent to the chemical and physical processes of the assay itself when run on the specified instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a quantitative in vitro diagnostic test, the "ground truth" for the test set (clinical samples) would typically be the true concentration of the analyte (CA 19-9) as determined by a highly accurate reference method, or for manufactured calibrators, it would be the gravimetrically prepared target concentration. Specific details are not provided in this summary, but the context implies it relates to accurate measurement of CA 19-9 levels.
For the calibrator (Dimension Vista® LOCI 7 Calibrator), the ground truth for its concentrations are "Target Concentrations: Level 1 (CAL A): 0 U/mL, Level 2 (CAL B): 30 U/mL, Level 3 (CAL C): 131 U/mL, Level 4 (CAL D): 525 U/mL, Level 5 (CAL E): 1050 U/mL". This acts as the "ground truth" for calibration.
8. The sample size for the training set
This information is not available in the provided 510(k) summary. For in vitro diagnostic devices, the concept of "training set" is generally not applied in the same way as for AI models. Assay development involves optimization and validation using various samples, but these are typically not categorized as a distinct "training set" in the context of a 510(k) summary.
9. How the ground truth for the training set was established
This information is not available in the provided 510(k) summary for the above reasons.
Summary Table of Device Specifications (from the "Similarities and Differences" comparison, not "Acceptance Criteria" actively met by a study):
| Feature | LOCI CA 19-9 Flex® Reagent Cartridge (New Device) |
|---|---|
| Intended Use | Quantitative measurement of CA 19-9 in human serum, lithium heparin, and EDTA plasma on Dimension Vista® System. Aid in serial measurement for managing pancreatic cancer patients and monitoring disease status in confirmed cases with elevated CA 19-9. |
| Sample Type | Serum, lithium heparin, and EDTA plasma |
| Measuring Range | 2-1000 U/mL |
| Sample Size | 4 µL |
| Measurement | Chemiluminescent: Homogenous sandwich immunoassay based on LOCI® technology |
| Feature | LOCI 7 Calibrator (New Device) |
|---|---|
| Intended Use | In vitro diagnostic product for the calibration of the Cancer Antigen 19-9 (CA19-9) method on the Dimension Vista® System. |
| Matrix | Bovine serum albumin-based matrix |
| Preparation | Liquid: Provided ready to use. |
| Number of Calibrator Levels | 5 levels |
| Target Concentrations | Level 1 (CAL A): 0 U/mL, Level 2 (CAL B): 30 U/mL, Level 3 (CAL C): 131 U/mL, Level 4 (CAL D): 525 U/mL, Level 5 (CAL E): 1050 U/mL |
| Storage | Store at -15 to -25 °C. |
Study Details Mentioned (Limited):
- Type of Study: The document refers to "Comparative testing" to demonstrate substantial equivalence to the predicate device (ADVIA Centaur CA 19-9 assay, K031393). This implies analytical performance studies (e.g., precision, accuracy, linearity, interference) were performed to show that the new device performs similarly to the predicate. However, specific results or detailed methodologies are not included in this summary.
- Purpose: To demonstrate substantial equivalence to legally marketed predicate devices.
- Conclusion: The LOCI CA 19-9 method and LOCI 7 calibrator are considered substantially equivalent to their respective predicate devices based on the comparative testing described in the full submission.
§ 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.