(16 days)
The TPSA method for the Dimension® clinical chemistry system with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure total prostate specific antigen (PSA) in human serum and plasma:
- as an aid in the detection of prostate cancer when used in conjunction with digital rectal 1. exam (DRE) in men 50 years or older. Prostate biopsy is required for diagnosis of cancer
- as an aid in management (monitoring) of prostate cancer patients. 2.
The TPSA Flex® reagent cartridge with the labeling revision referenced in this submission is substantially equivalent in intended use, principle and performance to the current Dade Behring Total Prostate Specific Antigen assay (P000021/S2). Both assays are in vitro immunoassays with intended uses for the measurement of Prostate Specific Antigen in serum and plasma. There are no formulation or design changes associated with this labeling change. The two products are identical and use the same manufacturing processes.
This 510(k) submission (K031343) is for a labeling change to the TPSA Flex® Reagent Cartridge, not a new device or a design change. Therefore, it primarily focuses on demonstrating that the revised labeling does not alter the substantial equivalence of the device to its predicate. As a result, the document does not contain the typical detailed performance study information that would be present for a novel device or a device with significant design modifications.
Here's a breakdown based on the provided text, highlighting what is not applicable or not provided for this specific type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in this submission. The submission states: "There are no formulation or design changes associated with this labeling change. The two products are identical and use the same manufacturing processes." The core of the acceptance criteria here is "substantial equivalence" based on the absence of change impacting performance, rather than new performance data against specific metrics.
2. Sample size used for the test set and the data provenance
Not provided. Since there are no new performance studies involving a test set, this information is not relevant to this submission. The device itself (TPSA Flex® Reagent Cartridge) was previously approved (P000021/S2); performance data for that original approval would have been submitted at that time.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new test set requiring expert ground truth was evaluated in this submission.
4. Adjudication method for the test set
Not applicable. No new test set requiring adjudication was evaluated in this submission.
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 device is an in vitro diagnostic reagent cartridge for measuring PSA, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an in vitro diagnostic reagent cartridge, not an algorithm.
7. The type of ground truth used
Not applicable. No new performance studies requiring a ground truth were conducted for this submission.
8. The sample size for the training set
Not applicable. This submission is for a labeling change to an existing device, not for the development or training of an algorithm.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study and Acceptance Criteria for K031343:
Acceptance Criteria for K031343 (Labeling Change):
The primary acceptance criterion for this 510(k) submission was to demonstrate substantial equivalence to the predicate device (Dade Behring TPSA Flex® reagent cartridge, P000021/S2) despite a revision to the labeling. This means proving that the change in labeling would not alter the fundamental safety or effectiveness of the device.
Reported Device Performance (as per this submission):
The substance of this submission is that there is no change in device performance because there is no underlying change to the device itself.
- Intended Use: Identical to the predicate.
- Principle: Identical to the predicate.
- Performance: Identical to the predicate, as "there are no formulation or design changes associated with this labeling change. The two products are identical and use the same manufacturing processes."
Study that Proves the Device Meets Acceptance Criteria:
The "study" in this context is the comparison document itself, which asserts and provides justification for the substantial equivalence.
- Evidence Presented: The submitter highlighted that the proposed change was solely a labeling revision related to the availability of a specific calibrator (removing reference to TPSA Calibrator, RC459, which would no longer be available for sale, and now having approval for the Free PSA product).
- Key Argument: The core of the argument is that the two previously referenced calibrators (RC 459 and RC 452) had the "same formulation but different packaging and labeling." The decision to keep them separate was based on a prior FDA request related to the Free PSA Flex® product, which has now received approval. Therefore, consolidating the calibrator instruction in the Total PSA Flex® insert by removing RC459 is deemed a change without impact on performance.
- Conclusion: The submitter concludes, and the FDA concurs, that "The revised PSA Flex® reagent cartridge is substantially equivalent in principle and performance to the current PSA Flex® reagent cartridge."
In essence, for this specific 510(k) for a labeling change, the "study" is the explicit declaration and justification provided by the manufacturer that the device itself remains unchanged and thus its performance remains identical to the already-approved predicate device. Performance data from the original approval (P000021/S2) would implicitly support the underlying performance characteristics of the unchanged device.
§ 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.