(218 days)
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.
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.
Behring Diagnostics Inc. OPUS® PSA 510(k) Notification (K964595)
The Behring Diagnostics Inc. OPUS® PSA is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of prostate specific antigen (PSA) in human serum. It is intended as an adjunctive test to aid in the monitoring of prostate cancer patients.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision (Intra-assay) | Not explicitly stated (implied by acceptable %CV) | %CV ranged from 5.1% to 5.8% |
| Precision (Inter-assay) | Not explicitly stated (implied by acceptable %CV) | %CV ranged from 6.6% to 7.0% |
| Accuracy (by Recovery) | Not explicitly stated (implied by acceptable % recovery) | Percent recovery ranged from 97% to 107% |
| Accuracy (by Correlation) | Not explicitly stated (implied by acceptable correlation coefficient, y-intercept, and slope compared to a legally marketed device) | Correlation coefficient of 0.98, y-intercept of 0.36, and slope of 0.94 (compared to Hybritech Tandem-E PSA) |
2. Sample Size and Data Provenance for Test Set
- Sample Size: 145 serum samples were used for the accuracy by correlation study.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number and Qualifications of Experts for Ground Truth
- The document does not mention the use of experts to establish ground truth for the test set. The accuracy by correlation was performed against a legally marketed predicate device (Hybritech Tandem-E PSA), implying its results served as a comparative reference.
4. Adjudication Method for Test Set
- Not applicable, as the evaluation was based on quantitative measurements against a comparative device, not on subjective expert interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The device is a quantitative immunoassay, not an imaging or diagnostic interpretation tool involving human readers.
6. Standalone Performance Study
- Yes, standalone performance was evaluated through precision, recovery, and correlation studies, demonstrating the algorithm's (immunoassay's) performance characteristics independently. The correlation study compared the OPUS PSA's quantitative results directly against those of the predicate device.
7. Type of Ground Truth Used
- For the accuracy by correlation study, the "ground truth" was established by the results obtained from a legally marketed device, the Hybritech Tandem-E PSA. This effectively uses a comparative reference method as the standard for evaluating the new device's performance. For precision and recovery, the ground truth was inherent to the control materials and spiked samples used.
8. Sample Size for the Training Set
- The document does not explicitly mention a "training set" or its size. As this is a 510(k) for an immunoassay, the development process would likely involve calibration and validation using control materials and patient samples, but the specific term "training set" in the context of machine learning is not used.
9. How the Ground Truth for the Training Set Was Established
- Given the nature of an immunoassay, the "ground truth" for what might be considered calibration or development would typically involve:
- Known concentrations: For calibrators, the PSA concentrations are precisely prepared and known.
- Reference materials: Control materials would have established target ranges.
- Clinical samples with expert-verified PSA levels: Patient samples used during development would likely have their PSA values determined by a reference method or established clinical assays.
The document does not provide specifics on how these "ground truths" were established during the development phase.
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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.
-
- 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
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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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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
| ofar11t |
|---|
| ------------------------- |
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
§ 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.