(30 days)
The PSA method for the Dimension® RxL with the heterogeneous immunoassay module is a device used to measure PSA in serum as an aid in the management of prostate cancer patients.
The PSA method is a one-step enzyme immunoassay. Sample is incubated with chromium dioxide particles (CrO2) coated with monoclonal antibodies specific for a binding site on the PSA molecule and conjugate reagent [β-galactosidase (β-gal) labeled monoclonal antibodies specific for a second binding site on the PSA molecule] to form a particle/PSA/conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ß-gal catalyzes the hydrolysis of chlorophenol red-β-d galactopyranoside (CPRG) to chlorophenol red (CPR). The color change measured at 577nm due to the formation of CPR is directly proportional to the concentration of PSA present in the patient sample.
Here's a breakdown of the acceptance criteria and study details for the Dade International Prostate Specific Antigen (PSA) Method, based on the provided document:
Acceptance Criteria and Reported Device Performance
The core of the acceptance criteria for this 510(k) submission is substantial equivalence to the predicate device, the aca® plus PSA Test Kit. This is primarily demonstrated by a strong correlation in performance.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Dimension® RxL PSA vs. aca® plus PSA) |
|---|---|
| High correlation coefficient | 0.994 |
| Slope close to 1 | 1.06 ± 0.01 |
| Intercept close to 0 | -0.07 ± 0.14 ng/mL |
| Consistent results across healthy and disease states | Compared well in all healthy and disease state categories. Data consistent with clinical status. |
Study Details
2. Sample size used for the test set and the data provenance:
- Sample Size: 596 clinical patient samples.
- Data Provenance: The document does not explicitly state the country of origin. It refers to "clinical patient samples," implying real-world patient data. Given the submitter's location (Newark, DE, USA) and the FDA submission, it's highly probable the data is from the USA. The study design is retrospective as it involves "split sample comparison," meaning existing samples were tested on both devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention a number of experts or their qualifications for establishing ground truth. The "ground truth" in this context is implicitly the measurement from the predicate device (
aca® plus PSA Test Kit). The comparative study focuses on the agreement between the new device and the predicate device.
4. Adjudication method for the test set:
- None explicitly stated in the context of expert adjudication. The study is a direct comparison of results between two devices on the same samples.
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:
- No, an MRMC comparative effectiveness study was not done. This is an in vitro diagnostic (IVD) device for quantitative measurement, not an imaging device or one that involves human (reader) interpretation in the same way an AI-assisted diagnostic tool might. The "readers" here are laboratory instruments, and the comparison is between the instrument's output.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance described is a standalone performance study. The device (Dimension® RxL PSA method) directly measures PSA levels. The comparison is between the output of this automated method and the output of the predicate automated method, without any human 'in-the-loop' interpretation influencing the quantitative result.
7. The type of ground truth used:
- The ground truth used for performance comparison is the results obtained from the legally marketed predicate device, the aca® plus PSA Test Kit. This is a common method for demonstrating substantial equivalence for IVDs. The "clinical status of the patient" is mentioned as being consistent with the data, but the primary ground truth for the statistical comparison is the predicate's measurement.
8. The sample size for the training set:
- The document does not mention a separate training set. As this is an immunoassay (chemical detection) method, rather than a machine learning/AI algorithm, the concept of a "training set" for the device itself is not directly applicable in the same way it would be for an AI-based diagnostic. The device's operational parameters and calibration would be established through internal development and validation, but this document focuses on its performance using a clinical test set against a predicate.
9. How the ground truth for the training set was established:
- Not applicable in the context of a "training set" for an AI algorithm. For the development and internal validation of the immunoassay method, the ground truth would typically be established through highly characterized reference materials, spiked samples, and potentially clinical samples with established PSA levels using recognized reference methods or established assays. However, this level of detail is not provided in a 510(k) summary for an immunoassay.
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DADE INTERNATIONAL
Image /page/0/Picture/2 description: The image shows the word "DADE" in bold, black, sans-serif font. The letters are large and take up most of the frame. The background is white, providing a strong contrast with the black letters. The text appears to be a title or heading due to its prominent size and weight.
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SEP 1 8 1997
Chemistry Systems P.O. Box 6101 Newark, DE 19714
Summary of Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's Name: | Rebecca S. AyashDade International Inc.Building 500, Mailbox 514P.O. Box 6101Newark, DE 19714-6101Phone: (302) 451-0276FAX: (302) 451-0299 |
|---|---|
| Date of Preparation: | 8/15/97 |
| Device Name: | Prostate Specific Antigen (PSA) Method |
| Classification Name: | Prostate Specific Antigen for Management ofProstate Cancer |
| Predicate Device: | aca® plus PSA Test Kit |
Device Description: The PSA method is a one-step enzyme immunoassay. Sample is incubated with chromium dioxide particles (CrO2) coated with monoclonal antibodies specific for a binding site on the PSA molecule and conjugate reagent [β-galactosidase (β-gal) labeled monoclonal antibodies specific for a second binding site on the PSA molecule] to form a particle/PSA/conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ß-gal catalyzes the hydrolysis of chlorophenol red-β-d galactopyranoside (CPRG) to chlorophenol red (CPR). The color change measured at 577nm due to the formation of CPR is directly proportional to the concentration of PSA present in the patient sample.
Intended Use: The PSA method is used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to quantitatively measure PSA in human serum and plasma. Measurements of PSA aid in the management of prostate cancer patients.
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Comparison to Predicate Device:
| Item | Dimension® RxL PSA | aca® plus PSA |
|---|---|---|
| Technology | Sandwich formatmonoclonal antibodyimmunoassay | Sandwich formatmonoclonal antibodyimmunoassay |
| Detection | Colorimetric ratemeasurement at 577nmand 700nm | Colorimetric endpointmeasurement at 577nmand 600nm |
| Specimen type | serum | serum |
| Sample Size | 40μL | 100μL |
Comments on Substantial Equivalence: Split sample comparison between the PSA method on the Dimension® RxL clinical chemistry system and the aca® plus PSA Test Kit gave a correlation coefficient of 0.994, slope of 1.06 ± 0.01 and an intercept of -0.07 ± 0.14 ng/mL when tested with 596 clinical patient samples ranging from 0,00 to 99.9 ng/mL. The Dimension® RxL assay compared well with the aca® plus assay in all healthy and disease state categories. Data obtained were consistent with the clinical status of the patient.
Conclusion: The PSA method for the Dimension® RxL system with the heterogeneous immunoassay module is substantially equivalent in principle and performance to the aca® plus PSA Test Kit based on the split sample comparison summarized above.
Rebecca S. Cyphers
Rebecca S. Avash Regulatory Affairs and Compliance Manager Date: 8/15/97
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Rebecca S. Ayash Requlatory Affairs and Compliance Manager Dade International SEP 1 8 1997 Building 500, Mailbox 514 P.Ó. Box 6101 Newark, Delaware 19714-6101 K973101 Re : Trade Name: Prostate Specific Antigen (PSA) Method Requlatory Class: II Product Code: LTJ Dated: August 15, 1997 Received: August 19, 1997
Dear Ms. Ayash:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP requlation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Qther general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications Statement
Device Name: Prostate Specific Antigen (PSA) Method
Indications for Use: The PSA method for the Dimension® RxL with the heterogeneous immunoassay module is a device used to measure PSA in serum as an aid in the management of prostate cancer patients.
Rebecca S. Ayers
Rebecca S. Ayas Regulatory Affairs and Compliance Manager Date: 8/15/97
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Macken
K973101
510(k) Number
Division Sign-Off Office of Device Evaluation
Prescription Use ✓
§ 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.