(339 days)
K/DEN: Not Found
Not Found
No
The device description details a standard ELISA assay, which is a biochemical method for measuring substances. There is no mention of AI, ML, or any computational analysis beyond basic spectrophotometry and linear regression for performance comparison.
No.
This device is an in vitro diagnostic (IVD) test used to measure Total PSA in human serum to aid in monitoring prostate cancer recurrence. It provides diagnostic information but does not treat or manage a disease directly in a therapeutic manner.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "This assay is intended for in vitro diagnostic use."
No
The device is an in vitro diagnostic (IVD) kit, which is a hardware-based medical device used to perform laboratory tests. It involves physical components like microtiter plates, antibodies, and enzymes, and requires a spectrophotometer for analysis.
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 Device: The device is an ELISA kit designed to measure a substance (Total PSA) in a biological sample (human serum) outside of the body. This is the fundamental definition of an in vitro diagnostic device.
- Purpose: The purpose is to "aid in the management (monitoring the reoccurrence of prostate cancer) of prostate cancer patients," which is a diagnostic and monitoring function performed on a sample taken from the patient.
N/A
Intended Use / Indications for Use
The DSL-9700 Active™ PSA Enzyme-Linked Immunosorbent Assay (ELISA) 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 10-9700 PSA ELISA kit was developed for the quantitative measurement of Total PSA in human serum. The ELISA 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 microtiter plate wells, the other antibody is coniugated the the enzyme horseradish peroxidase 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 microtiter plate. The resultant is analyzed in a spectrophotometer for absorbance. The amount of bound PSA is directly proportional to the concentration of the PSA present in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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 = 193) 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 = 1.11[DPC IMMULITE] + 0.77 with a correlation coefficient of (r) = 0.96.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The DSL 10-9700 PSA ELISA is substantially equivalent to the DPC IMMULITE PSA assay.
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 logo on the left and the text "AUG 3" on the right. The logo is a stylized design, possibly representing initials or a company symbol. The text "AUG 3" likely refers to a date, specifically August 3rd.
K97324
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
SUMMARY OF SAFETY AND EFFECTIVENESS
DSL 10-9700 PSA ELISA Kit Name of Device: Classification Name: Enzyme-linked Immunosorbent Assay for PSA Analyte Code and Name: Prostate Specific Antigen 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 10-9700 PSA ELISA kit was developed for the quantitative measurement of Total PSA in human serum. The ELISA 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 microtiter plate wells, the other antibody is coniugated the the enzyme horseradish peroxidase 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 microtiter plate. The resultant is analyzed in a spectrophotometer for absorbance. The amount of bound PSA is directly proportional to the concentration of the PSA present in the sample.
The DSL PSA ELISA assay is intended for the quantitative determination of Total PSA in human serum to aid in the management (monitoring the reoccurrence of prostate cancer) of prostate cancer patients.
The DSL 10-9700 PSA ELISA is substantially equivalent to the DPC IMMULITE PSA assay.
To demonstrate substantial equivalence between the two assays, human serum samples (n = 193) 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 = 1.11[DPC IMMULITE] + 0.77 with a correlation coefficient of (r) = 0.96.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
3 1998 AUG
Mr. John Class Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598
K973243/S2 Re : Active™ PSA ELISA (DSL-10-9700) 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 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). 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 reqistration, 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 to 895. A substantially equivalent determination assumes compliance 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 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 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 Toutman
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
3
FDA/CDRH/ODE/DMG
29 Jul 93 0 0
510(k) Number (if known): K973243
Device Name: Active™ PSA ELISA
Indications For Use:
The DSL-9700 Active™ PSA Enzyme-Linked Immunosorbent Assay (ELISA) 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)
Peter E. Maison
(Division Sign-Off)
(División Sign-Olm)
Division of Clinical Laboratory Devices K973243
510(k) Number
Image /page/3/Picture/10 description: The image shows the words "Prescription Use" with a check mark above the words. Underneath the words is the text "(Per 21 CFR 801.109)". The text is black and the background is white. The image appears to be a label or part of a document.
OR
Over-The-Counter Use