(437 days)
The LOCI CA15-3 method is an in vitro diagnostic test for the quantitative measurement of CA 15-3 in human serum and lithium heparin and EDTA plasma on the Dimension Vista® System. When used in conjunction with other clinical and diagnostic procedures, serial testing with the LOCI CA 15-3 assay may be used as an aid in the management of previously treated stage II and III breast cancer patients and for monitoring response to therapy in metastatic breast cancer patients.
The LOCI 7 CAL is an in vitro diagnostic product for the calibration of Cancer Antigen 15-3 (CA 15-3) and Cancer Antigen 19-9 (CA 19-9) methods on the Dimension Vista® system.
The LOCI CA 15-3 (CA 15-3) method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI® technology. The LOCI® reagents include two synthetic bead reagents and a biotinylated anti-CA 15-3 monoclonal antibody (DF3) fragment. The first bead reagent (Chemibeads) is coated with an anti-CA15-3 monoclonal antibody (115DB) and contains a chemiluminescent dye. The second bead reagent (Sensibeads) is coated with streptavidin and contains a photosensitizer dye. Sample is incubated with biotinylated antibody and Chemibeads to form bead-CA 15-3-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 15-3 concentration in the sample.
The LOCI 7 calibrator is a liguid, frozen, bovine serum albumin, based product containing CA 15-3 from human cell culture. The kit consists of ten vials two vials per level (A-E), 2.0 mL per vial. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.
The provided document is a 510(k) summary for an in vitro diagnostic device (IVDD), the LOCI CA 15-3 Flex® Reagent Cartridge, and its associated calibrator. IVDDs, particularly those for tumor markers, are typically evaluated through analytical performance studies rather than clinical studies with patient outcomes as endpoints, which are more common for AI/ML devices or therapeutic interventions.
The document does not contain the information requested in the prompt regarding acceptance criteria and performance data from a "study that proves the device meets the acceptance criteria." Specifically, it lacks:
- A table of acceptance criteria and reported device performance: The document compares the intended use, sample type, measuring range, sample size, and measurement method of the new device to its predicate, but these are not "acceptance criteria" in the sense of performance metrics (like sensitivity, specificity, accuracy, precision, etc.) and their corresponding measured values.
- Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size, and how training ground truth was established: These details are typical for studies involving diagnostic algorithms, particularly those using AI/ML, and are not found in this 510(k) summary for a traditional immunoassay and calibrator.
Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed devices, as is standard for 510(k) submissions. The substantial equivalence is argued based on similarities in intended use, technology, and analytical characteristics (though specific performance metrics are not detailed here beyond measuring range).
Therefore, I cannot fulfill the request to provide acceptance criteria and study details based on the provided text.
The document primarily states:
- The LOCI CA 15-3 method is a quantitative measurement of CA 15-3 using a homogeneous, sandwich chemiluminescent immunoassay.
- Its intended use is as an aid in the management of previously treated stage II and III breast cancer patients and for monitoring response to therapy in metastatic breast cancer patients, in conjunction with other clinical and diagnostic procedures.
- The LOCI 7 CAL is for the calibration of CA 15-3 and CA 19-9 methods.
- Substantial equivalence is claimed against the ADVIA Centaur CA 15-3 assay (K012357) for the reagent cartridge and the Access® BR Monitor Assay (K072612) for the calibrator.
To obtain the detailed performance data (e.g., precision, accuracy, linearity, analytical sensitivity, etc.) and acceptance criteria that were likely part of the original 510(k) submission, one would need to access the full 510(k) submission packet, which is generally not publicly available in its entirety beyond the summary.
§ 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.