(339 days)
K973244/S2
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No
The device description details a standard immunoradiometric assay (IRMA) which is a biochemical method for measuring analyte concentration. There is no mention of AI or ML in the device description, intended use, or performance studies. The performance studies focus on correlation with a predicate device, not on training or testing AI/ML models.
No
This device is an in vitro diagnostic assay used for quantitative measurement of Total PSA in human serum to aid in the management of prostate cancer patients, not for direct therapeutic intervention.
Yes
The Intended Use section explicitly states that the assay is "intended for in vitro diagnostic use."
No
The device is an in vitro diagnostic (IVD) kit that uses chemical reagents and a gamma counter (hardware) to measure PSA levels. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "This assay is intended for in vitro diagnostic use."
- Nature of the Assay: The device description details an "Immunoradiometric Assay (IRMA) Kit" that measures "Total PSA in human serum." This is a laboratory test performed on biological samples (serum) outside of the body, which is the definition of an in vitro diagnostic.
- Intended Use: The intended use is "to aid in the management (monitoring the reoccurrence of prostate cancer) of prostate cancer patients." This is a diagnostic purpose, providing information to healthcare professionals for patient management.
- Intended User / Care Setting: The "in vitro diagnostic use" further reinforces that it's used in a laboratory or clinical setting for diagnostic purposes.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
LTJ
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
Predicate Device(s)
K973244/S2
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows a stylized logo in black. The logo appears to be a combination of the letters 'd' and 't' in a unique, interconnected design. The 'd' is formed by a curved shape with a gap, while the 't' is a simple horizontal line connected to a vertical stroke. The overall design is bold and modern.
K973244j
Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster Texas 77598-4217 USA Tel 281.332.9678 Fax 281.554.4220
Customer Assistance Center Tel 800.231.7970 Fax 281.338.1895 Email mkta@dslabs.com
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: 281-332-9678
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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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that suggest the feathers of the wings and body. The text is in a simple, sans-serif font and is evenly spaced around the circle.
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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Page 2
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 (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). Other 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 (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 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