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.

Device Description

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.

AI/ML Overview

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.

Summary

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K031343

MAY 1 5 2003

Summary of Safety and Effectiveness Information

This safety and effectiveness summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter's Name:	George M. PlummerDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101
Date of Preparation:	April 25, 2003
Name of Product:	TPSA Flex® Reagent Cartridge
FDA Classification Name:	Total Prostate Specific Antigen for the detection andmanagement of prostate cancer
Predicate Device:	Dade Behring TPSA Flex® reagent cartridge (P000021/S2)

Intended Use: 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.

Comparison to Predicate Device:

There are no formulation or design changes associated with this labeling change. The two products are identical and use the same manufacturing processes. When the TPSA Flex® reagent cartridge product (P000021/S2) was approved by the FDA, the insert sheet stated to use the TPSA Calibrator, RC 459, in the US and T/F PSA Calibrator, RC 452, outside the US. Both RC 459 and RC 452 have the same formulation but different packaging and labeling. We created two separate calibrator products at the FDA's request since we did not have approval for the Free PSA FLex® at the time we initiated sale of the Total PSA Flex®. We now have approval for the Free PSA product and intend to revise the Total PSA Flex® insert sheet to remove reference to the TPSA Calibrator, RC459. This latter product will no longer be available for sale.

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Conclusion: The revised PSA Flex® reagent cartridge is substantially equivalent in principle and performance to the current PSA Flex® reagent cartridge.

Jm Plummer

George M. Plummer Regulatory Affairs and Compliance Manager Date: April 25, 2003

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of a human figure with three flowing lines above it, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the graphic.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 5 2003

Mr. George M. Plummer Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, DE 19714

Re: K031343

Trade/Device Name: TPSA Flex® reagent cartridge Regulation Number: 21 CFR 866.6010 Regulation Name: Carcinoembryonic antigen (CEA) immunological test system Regulatory Class: Class II Product Code: LTJ; JIT Dated: April 25, 2003 Received: April 29, 2003

Dear Mr. Plummer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Iisting of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications For Use Statement

KO31343

Device Name: TPSA Flex® reagent cartridge

Indications for Use:

The TPSA method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure 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 exam 1. (DRE) in men 50 years or older. Prostate biopsy is required for diagnosis of cancer
1. as an aid in the management (monitoring) of prostate cancer patients.

George M. Plummer Regulatory Affairs and Compliance Manager

May14, 2003

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CRF 801.109)

Over-The-Counter Use

S.P. Reeves for J. Baptiste

Division of Clinical Laboratory Devices

510(k) Number.

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.