(90 days)
The CELLTRACKS® AUTOPREP® System is a laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. The CELLTRACKS ANALYZER II® may be used for cell identification and enumeration. The system is for in vitro diagnostic use.
The CELLTRACKS® AUTOPREP® System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. The CELLTRACKS® AUTOPREP® System processes up to 8 samples in a batch, performing all required process steps, including red cell detection, plasma aspiration and final transfer to the analysis cartridge. The user is prompted to perform various pre-processing operations such as dilution and centrifugation. Cell analyzers such as the CELLTRACKS ANALYZER II® may be used for cell identification and enumeration following processing. The CELLTRACKS® AUTOPREP® system uses a series of immunomagnetic separation procedures to isolate the cells of interest and to stain the cells with fluorescence-labeled monoclonal antibodies.
This is a 510(k) summary for the CELLTRACKS® AUTOPREP® System, a medical device for in vitro diagnostic use. The purpose of this submission is to demonstrate substantial equivalence to a predicate device (CELLTRACKS® AUTOPREP® System (current - K110406)). The only change is a modification to the pipetting probe to reduce potential carryover and a corresponding label change.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary does not explicitly state numerical acceptance criteria for carryover. Instead, it focuses on demonstrating equivalence to the predicate device and characterization of the new probe's performance regarding carryover.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| New reagent probe assay performance equivalent to current probe. | Equivalence demonstrated through non-clinical functional testing. |
| Reduced potential for carryover compared to predicate device. | CTC spike level characterization of the new probe (tumor cell carryover and control cell carryover) was performed. |
| Run to Run carryover characterization was performed. | |
| Device is safe and effective as the predicate device. | Demonstrated through non-clinical functional testing for the modified device. |
| Reliability/Life testing requirements are met. | Reliability/Life testing was performed. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set in terms of the number of patient samples. It mentions "up to 8 samples in a batch" for processing but this refers to the operational capacity of the instrument, not the sample size of the study for performance validation.
- Test Set Sample Size: Not explicitly stated for each test, but "up to 8 samples in a batch" is mentioned for processing.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The testing is described as "Non-clinical functional testing," implying laboratory-based testing rather than patient data collection in a clinical setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an automated instrument for processing and enriching cells. The evaluation appears to be based on analytical performance metrics (e.g., carryover levels, assay performance equivalence) rather than expert interpretation of images or patient data. Therefore, there's no mention of experts establishing ground truth for the test set in this context.
4. Adjudication method for the test set
Not applicable, as there are no human interpretations or classifications that would require adjudication. The testing is focused on the device's functional performance.
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
Not applicable. This is not an AI-assisted diagnostic device that involves human readers. It's an automated sample preparation system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a standalone product. The CELLTRACKS® AUTOPREP® System is a standalone instrument for sample preparation. The performance evaluation described is of the instrument's functional characteristics (e.g., pipetting, carryover), which is inherently "standalone" in its operation relative to the manual methods it automates. The "algorithm" in this context would be the automated processing steps of the instrument.
7. The type of ground truth used
The "ground truth" for this device would be defined by the expected analytical performance. For example:
- Known Cell Spikes: For CTC spike level characterization, a known number of tumor cells would be "spiked" into samples, and the device's ability to recover them, and the level of carryover from these known spikes, would be measured.
- Control Cells: For control cell carryover, known control cells would be used.
- Reference Methods: The "new reagent probe versus current reagent probe assay performance equivalence" would imply comparison to assays run with the predicate device's probe, where the "truth" is the established performance of the predicate.
- Engineering Specifications: Reliability/Life testing would be against pre-defined engineering specifications for durability and performance over time.
Therefore, the ground truth is based on analytical standards, known input concentrations (e.g., spiked cells), and comparison to a well-characterized predicate device's performance.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a "training set." It's an automated instrument where the "learning" is incorporated during its design and engineering phases, not through a data-driven training process.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 866.6020 Immunomagnetic circulating cancer cell selection and enumeration system.
(a)
Identification. An immunomagnetic circulating cancer cell selection and enumeration system is a device that consists of biological probes, fluorochromes, and other reagents; preservation and preparation devices; and a semiautomated analytical instrument to select and count circulating cancer cells in a prepared sample of whole blood. This device is intended for adjunctive use in monitoring or predicting cancer disease progression, response to therapy, and for the detection of recurrent disease.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System.” See § 866.1(e) for availability of this guidance document.