(218 days)
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No
The summary describes a standard immunoassay kit and analyzer for measuring PSA levels, with no mention of AI or ML in the intended use, device description, or performance studies.
No
Explanation: The device is an in vitro diagnostic immunoassay used for the quantitative measurement of PSA to aid in monitoring prostate cancer patients, not for treating them.
Yes
Explanation: The device is an "in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of prostate specific antigen (PSA) in serum" and "is an adjunctive test used as an aid in the monitoring of prostate cancer patients." This clearly indicates its use in the diagnosis and monitoring of a medical condition.
No
The device is a set of reagents intended for use with an analyzer, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "OPUS PSA is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of prostate specific antigen (PSA) in serum."
The term "in vitro" directly indicates that the test is performed outside of the living body, which is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
OPUS PSA is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of prostate specific antigen (PSA) in serum. OPUS PSA is an adjunctive test used as an aid in the monitoring of prostate cancer patients. OPUS PSA is intended for use with the OPUS analyzers.
Product codes (comma separated list FDA assigned to the subject device)
LTJ
Device Description
OPUS PSA is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of prostate specific antigen (PSA) in human serum.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
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)
Precision:
Intra-assay precision was determined by the evaluation of three levels of control material in replicates of twenty (20) each. %CV ranged from 5.1 to 5.8
Inter-assay precision was determined by the evaluation of three levels of control material in duplicate, assaved over a ten day period to total 40 replicates. %CV ranged from 6.6 to 7.0
Accuracy by Recovery:
Recovery was determined by making four dilutions of an elevated PSA patient sample into a normal human serum pool. The samples were assayed using OPUS PSA in replicates of three. Percent recovery ranged from 97 to 107%
Accuracy by Correlation:
OPUS PSA was compared to a commercially available immunoassay by evaluation of 145 serum samples ranging from 0.443 to 90.7 ng/ml. A correlation coefficient of 0.98 was obtained with a y-intercept value of 0.36 and a slope of 0.94.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Hybritech Tandem-E PSA
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Behring Diagnostics Inc. OPUS® PSA 510(k) Notification
JUN 2 4 1997
510(k) Summary for OPUS PSA
1 . Manufactures Name, Address, Telephone, and contact person, date of preparation:
Manufacturer:
Behring Diagnostics Inc. 151 University Avenue Westwood, MA 02090 617-320-3023 Attn: Kathleen Dray-Lyons
Preparation date:
March 10, 1996
2. Classification: Name/ Device
OPUS PSA: Classification Number: Tumor Associated Antigen Immunological Test class II (classification number has not been assigned)
3 . Identification of the legally marketed device:
Hybritech Tandem-E PSA
4 . Proposed Device Description:
OPUS PSA is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of prostate specific antigen (PSA) in human serum.
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- Proposed Device Intended Use:
OPUS PSA is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of prostate specific antigen (PSA) in serum. OPUS PSA is an adjunctive test used as an aid in the monitoring of prostate cancer patients. OPUS PSA is intended for use with the OPUS analyzers.
- Proposed Device Intended Use:
000275
CONFIDENTIAL
1
Medical device to which equivalence is claimed and comparison 6. information:
The OPUS PSA assay is substantially equivalent in intended use to results obtained using the Hybritech Tandem-E PSA. The Hybritech Tandem-E PSA, like the proposed product, employs the principle of two site or sandwich immunoassay. Both use a labeled antibody for the quantitative measurement of PSA in human serum. The OPUS PSA and the Hybritech Tandem-E PSA are based on a six level calibrator system.
The OPUS PSA differs from the Hybritech Tandem-E PSA in that the enzyme labeled antibody is a mouse monoclonal in the Hybritech Tandem-E PSA, while the enzyme labeled antibody is a goat polyclonal in the OPUS PSA test. Also, the OPUS PSA includes a tri-level control, where as the Hybritech Tandem-E PSA test includes a bi-level control. Also, the Hybritech Tandem-E PSA is intended as an aid in the detection of prostate cancer as well as an aid in management of patients with prostate cancer, while the OPUS PSA is only intended for the management of patients with prostate cancer.
7. Proposed Device Performance Characteristics:
Precision
Intra-assay precision was determined by the evaluation of three levels of control material in replicates of twenty (20) each. %CV ranged from 5.1 to 5.8
Inter-assay precision was determined by the evaluation of three levels of control material in duplicate, assaved over a ten day period to total 40 replicates. %CV ranged from 6.6 to 7.0
Accuracy by Recovery
Recovery was determined by making four dilutions of an elevated PSA patient sample into a normal human serum pool. The samples were assayed using OPUS PSA in replicates of three. Percent recovery ranged from 97 to 107%
Accuracy by Correlation
OPUS PSA was compared to a commercially available immunoassay by evaluation of 145 serum samples ranging from 0.443 to 90.7 ng/ml. A correlation coefficient of 0.98 was obtained with a y-intercept value of 0.36 and a slope of 0.94.
CONFIDENTIAL
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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 features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 4 1997
Kathleen Dray-Lyons Manager, Regulatory Affairs Behring Diagnostics, Inc............. 151 University Avenue Westwood, MA 02090
Re: K964595/S001 Trade Name: OPUS PSA Test Regulatory Class: II Product Code: LTJ Dated: March 25, 1997 Received: March 26, 1997
Dear Ms. Dray-Lyons:
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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
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.
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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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
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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Diagnostics Inc. Behring OPUS® PSA OPUS® For
510(k) Notification
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510(k) Number (if known): K964595
Device Name:_ OPUS PSA Test System
Indications For Use:
an in vitro fluorogenic enzyme OPUS PSA is quantitative for the immunoassay (ELISA) measurement of prostate specific antigen (PSA) in serum. OPUS PSA is an adjunctive test used as an aid in the monitoring of prostate cancer patients. OPUS PSA is intended for use with the OPUS analyzers.
Peter E. Maheri
(Division Sign-Off) Division of Clinical Laboratory Dev 510(k) Number .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109) OR
Over-The Counter Use_
(Optional Format 1-2-96)
CONFIDENTIAL
000172