ACTIVE PSA IRMA (DSL-9700)

• K Number: K973244
• Device Name: ACTIVE PSA IRMA (DSL-9700)
• Manufacturer: DIAGNOSTIC SYSTEMS LABORATORIES, INC.
• Date Cleared: 1998-08-03 ( 339 days)
• Product Code: LTJ
• Regulation Number: 866.6010
• Type: Traditional
• Panel: Immunology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The DSL-9700 Active™ PSA Immunoradiometric Assay (IRMA) Kit provides materials for the quantitative measurement of Total PSA in human serum to aid in the management (monitoring the reoccurrence of prostate cancer) of prostate cancer patients. This assay is intended for in vitro diagnostic use.

Device Description

The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the coated tube, the other antibody is radiolabelled for detection. The analyte present is bound by both the antibodies to form a "sandwich" complex. Unbound materials are removed by decanting and washing the tube. The resultant is analyzed in a gamma counter for net counts. The amount of bound PSA is directly proportional to the concentration of the PSA present in the sample.

AI/ML Overview

The provided text describes the DSL 9700 PSA IRMA kit, an immunoradiometric assay for the quantitative measurement of Total PSA in human serum. This device is intended to aid in the management (monitoring the recurrence of prostate cancer) of prostate cancer patients.

Here's an analysis of the acceptance criteria and the study that demonstrates the device meets these criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial equivalence to predicate device (DPC IMMULITE PSA assay) must be demonstrated.	Equivalence Demonstrated: Linear regression analysis of 286 human serum samples tested on both the DSL 9700 PSA IRMA and the DPC IMMULITE PSA assay resulted in the equation Y = 1.25(DPC IMMULITE) + 0.33 with a correlation coefficient (r) = 0.97.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: 286 human serum samples.
• Data Provenance: The document does not explicitly state the country of origin. It can be inferred that these were human serum samples collected for this specific validation, but it doesn't specify if they were retrospective or prospective. Given the context of a 510(k) submission, it's likely they were carefully selected for the purpose of demonstrating equivalence retrospectively.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The study focuses on comparing the new device against a predicate device, not on establishing a ground truth via expert review of patient cases.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The study compares two assays directly using quantitative measurements, not through an adjudication process of expert interpretations.

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

This section is not applicable. The DSL 9700 PSA IRMA kit is an in-vitro diagnostic device (an assay), not an AI-powered diagnostic imaging or interpretation system that would involve human readers or AI assistance. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant to this device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone study was performed. The DSL 9700 PSA IRMA kit is a laboratory assay that provides a quantitative measurement. The performance (measurement of PSA levels) is determined by the assay kit itself, without human interpretation of images or complex decision-making based on algorithm output. The study described is a direct comparison of the numerical outputs of the DSL 9700 PSA IRMA kit and the DPC IMMULITE PSA assay.

7. The Type of Ground Truth Used

The "ground truth" in this context is the quantitative measurement provided by the predicate device, the DPC IMMULITE PSA assay. The goal was to establish substantial equivalence to this already legally marketed device, meaning its measurements are accepted as the standard for comparison. The samples were chosen across a range of expected PSA levels (low, intermediate, high), implying that the actual PSA level in each sample, as determined by the predicate, was the reference point.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or algorithm development. For this type of in-vitro diagnostic device, the "development" or "calibration" might involve internal runs during product development. The provided sample size (n=286) refers to the set used for demonstrating substantial equivalence to the predicate device, which would typically be considered a validation or test set in the context of a regulatory submission.

9. How the Ground Truth for the Training Set Was Established

Given that this is an In-Vitro Diagnostic (IVD) assay and not an AI or imaging device, the concept of "ground truth for a training set" as it relates to expert annotations for AI is not applicable. The development of such assays involves establishing analytical performance characteristics (e.g., sensitivity, specificity, accuracy, precision) against known standards or reference methods. The "ground truth" for calibrating or developing the DSL 9700 PSA IRMA assay would likely have been established through:

• Reference materials with certified PSA concentrations.
• Cross-validation with established, highly accurate laboratory methods or other well-characterized PSA assays.
  The document does not detail these specific developmental steps, as the summary focuses on the comparative study for regulatory clearance.

Summary

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K973244j

Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster Texas 77598-4217 USA Tel [phone] Fax [phone]

Customer Assistance Center Tel [phone] Fax [phone] Email [e-mail]

AUG 3 1998

SUMMARY OF SAFETY AND EFFECTIVENESS

DSL 9700 PSA IRMA Kit Name of Device: Classification Name: Immunoradiometric Assay for PSA Analyte Code and Name: PSA Regulatory Class: 11

Submitter: John Class Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone: [phone]

July 28, 1998 Date:

The DSL 9700 PSA IRMA kit was developed for the quantitative measurement of Total PSA in human serum. The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the coated tube, the other antibody is radiolabelled for detection. The analyte present is bound by both the antibodies to form a "sandwich" complex. Unbound materials are removed by decanting and washing the tube. The resultant is analyzed in a gamma counter for net counts. The amount of bound PSA is directly proportional to the concentration of the PSA present in the sample.

The DSL PSA IRMA assay is intended for the quantitative determination of PSA in human serum to aid in the management (monitoring the reoccurrence of prostate cancer) of prostate cancer patients.

The DSL 9700 PSA IRMA is substantially equivalent to the DPC IMMULITE PSA assay.

To demonstrate substantial equivalence between the two assays, human serum samples (n = 286) were collected and assayed using both methods. Samples were chosen based on expected PSA levels so that samples with low, intermediate and high levels would be evaluated. Linear regression analysis of the results obtained for the comparison gave the equation Y = 1.25(DPC IMMULITE) + 0.33 with a correlation coefficient of (r) = 0.97.

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3 1998 AUG

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. John Class Diaqnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598

K973244/S2 Re : Active™ PSA IRMA (DSL-9700) Trade Name: Regulatory Class: II Product Code: LTJ Dated: June 9, 1998 Received: June 9, 1998

Dear Mr. Class:

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 leqally 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). 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 against 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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: ... General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 regulations.

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This letter will allow you to beqin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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FDATODRH/ODF ADMO

0 3 29 Jul 13

510(k) Number (if known): K973244

Device Name: Active™ PSA IRMA

Indications For Use:

The DSL-9700 Active™ PSA Immunoradiometric Assay (IRMA) Kit provides materials for the quantitative measurement of Total PSA in human serum to aid in the management (monitoring the reoccurrence of prostate cancer) of prostate cancer patients. This assay is intended for in vitro diagnostic use.

(Please DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (QDE)

(Division Sign-Off)
Division of Clinical Laboratory Devices

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

OR

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.