(59 days)
P850048
Not Found
No
The summary describes a standard immunoassay system for measuring PSA levels and does not mention any AI or ML components.
No.
This device is an immunoassay system designed for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum, used as an aid in managing prostate cancer patients. It does not exert any direct therapeutic effect on the patient.
Yes
The device quantitatively determines prostate-specific antigen (PSA) in human serum, which is explicitly stated as being "used as an aid in the management of patients with prostate cancer," fulfilling a diagnostic role.
No
The device description explicitly states that the system comprises both "Immunoassay Reagents" and an "Immunoassay Analyzer," indicating the presence of physical components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of prostate-specific antigen (PSA) in human serum." This involves testing a sample taken from the human body (serum) outside of the body (in vitro).
- Device Description: It describes the "ACCESS® PSA Immunoassay Reagents and the ACCESS® Immunoassay Analyzer" which are used together to perform the test on the human serum sample.
- Performance Studies: The performance studies describe testing on "human serum samples" and "monitoring samples from previously diagnosed prostate cancer patients," further confirming the use of human biological samples.
- Predicate Device: The predicate device listed, "Tandem®-R PSA Immunoradiometric Assay," is also an IVD for measuring PSA in human serum.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
The ACCESS® PSA Immunoassay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of prostate-specific antigen (PSA) in human serum using the ACCESS® Immunoassay System. PSA. measured by the ACCESS® PSA Immunoassay, is intended for use as an aid in the management of patients with prostate cancer.
Product codes (comma separated list FDA assigned to the subject device)
LTJ
Device Description
The ACCESS® PSA Immunoassay Reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of PSA in human serum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Correlation: A comparison of PSA values from 293 samples, ranging from 0.0 to 150.0 ng/ml, run with both the ACCESS® PSA Immunoassay and the Tandem®-R PSA assav demonstrated very good agreement with the following statistical data: r = 0.994; v = 1.01x - 0.96.
Expected Range: In a population of apparently healthy males, 97.5% had PSA values of 4.0 ng/ml or less, with the remaining 2.5% having values in the 4 to 10 ng/ml range.
Monitoring Data: 127 monitoring samples (4 to 6 longitudinal samples per patient) from a total of twenty-nine (29) previously diagnosed prostate cancer patients were compared on the ACCESS® PSA and Tandem®-R PSA assays to verify the intended use claim for monitoring. The data demonstrate that the ACCESS® PSA results were highly concordant to both the Tandem®-R PSA results and the concurrent clinical assessment or predicted the subsequent clinical assessment.
Recovery: Linearity studies performed by diluting human serum samples with ACCESS® PSA Sample Diluent provided an average recovery of 98.4%, with individual recoveries ranging from 94.9 to 105.4%. Recovery of exogenous PSA spiked into serum samples resulted in an average recovery of 99.0%, with individual recoveries ranging from 95.2 to 104%.
Precision: Intra-assay imprecision ranged from 1.29% CV to 2.35% CV. Inter-assay imprecision ranged from 1.33% CV to 3.10% CV. Total impression was less than 5% at PSA levels ranging from 0.32 to 81.58 ng/ml.
Specificity: There was no significant interference from potential sample contaminants (albumin, bilirubin, HAMA, hemoglobin, PAP and triglycerides) or therapeutic drugs (acetamidophenol. acety)salicyclic acid. cisplatin, cyclophosphamide acid, doxorubicin, methotrexate, phenacetin, and vinblastin).
Analytical Sensitivity: The lowest detectable level of PSA distinguishable from zero (ACCESS® PSA Calibrator S0) with 95% confidence is 0.013 ng/ml.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" section for analytical sensitivity and specificity information.
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.
Tandem®-R PSA Immunoradiometric Assay P850048
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.
Not Found
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.
0
i i i 16 16
Summary of Safety and Effectiveness
FEB 20 1998
Prepared December 19, 1997
-
- General Information Device Generic Name:
K974816
- General Information Device Generic Name:
Prostate Specific Antigen (PSA) Immunological Test System for Management of Prostate Cancers
Device Trade Name:
Applicant's Name and Address:
Beckman Instruments, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
ACCESS® PSA Assay
Contact Person:
Ellen Voss. M.S.
2. Predicate Device
Tandem®-R PSA Immunoradiometric Assay Hybritech, Inc. P. O. Box 269006 San Diego, CA 92196-9006
PMA Number: P850048
3. Device Description
The ACCESS® PSA Immunoassay Reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of PSA in human serum.
4. Indications for Use
The ACCESS® PSA Immunoassay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of prostate-specific antigen (PSA) in human serum using the ACCESS® Immunoassay System. PSA. measured by the ACCESS® PSA Immunoassay, is intended for use as an aid in the management of patients with prostate cancer.
5. Comparison of Technological Characteristics
Both the ACCESS® PSA Immunoassay and the Tandem®-R PSA assay quantitatively measure serum PSA by means of simultaneous immunoassays utilizing the binding of PSA to monoclonal antibodies specific to similar epitopes on the PSA molecule. Both systems measure complexed and free forms of PSA equally. Both systems utilize liquid multi-point calibrators.
The ACCESS® PSA Immunoassay Reagents are designed for use on the ACCESS® Immunoassay Analyzer, a fully automated, random access system, while the Tandem®-R PSA assay is a manual method. The ACCESS® Immunoassay Analyzer uses magnetic particle solid phase enzyme immunoassays with chemiluminescent measurement, while the Tandem®-R PSA assay uses a plastic bead solid support with radioactive labeling and detection. The ACCESS® Immunoassay Analyzer stores reagents on board for up to 24 different analytes and has 28 day calibration curve stability, while Tandem®-R PSA assay is an individual analyte reagent kit requiring a new calibration with each assay.
6. Summary of Studies
Correlation: A comparison of PSA values from 293 samples, ranging from 0.0 to 150.0 ng/ml, run with both the ACCESS® PSA Immunoassay and the Tandem®-R PSA assav
1
demonstrated very good agreement with the following statistical data: r = 0.994; v = 1.01x - 0.96.
Expected Range: In a population of apparently healthy males, 97.5% had PSA values of 4.0 ng/ml or less, with the remaining 2.5% having values in the 4 to 10 ng/ml range.
Monitoring Data: 127 monitoring samples (4 to 6 longitudinal samples per patient) from a total of twenty-nine (29) previously diagnosed prostate cancer patients were compared on the ACCESS® PSA and Tandem®-R PSA assays to verify the intended use claim for monitoring. The data demonstrate that the ACCESS® PSA results were highly concordant to both the Tandem®-R PSA results and the concurrent clinical assessment or predicted the subsequent clinical assessment.
Recovery: Linearity studies performed by diluting human serum samples with ACCESS® PSA Sample Diluent provided an average recovery of 98.4%, with individual recoveries ranging from 94.9 to 105.4%. Recovery of exogenous PSA spiked into serum samples resulted in an average recovery of 99.0%, with individual recoveries ranging from 95.2 to 104%.
Precision: Intra-assay imprecision ranged from 1.29% CV to 2.35% CV. Inter-assay imprecision ranged from 1.33% CV to 3.10% CV. Total impression was less than 5% at PSA levels ranging from 0.32 to 81.58 ng/ml.
Specificity: There was no significant interference from potential sample contaminants (albumin, bilirubin, HAMA, hemoglobin, PAP and triglycerides) or therapeutic drugs (acetamidophenol. acety)salicyclic acid. cisplatin, cyclophosphamide acid, doxorubicin, methotrexate, phenacetin, and vinblastin).
Analytical Sensitivity: The lowest detectable level of PSA distinguishable from zero (ACCESS® PSA Calibrator S0) with 95% confidence is 0.013 ng/ml.
7. Conclusion
The ACCESS® PSA Immunoassay Reagents, when used in conjunction with the ACCESS® Immunoassay Analyzer, are substantially equivalent to the Tandem®-R PSA test system. The ACCESS® PSA Immunoassay is appropriate for monitoring patients with prostate cancer.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 20 1998
Ms. Ellen Voss, M.S. Clinical and Regulatory Associate Beckman Instruments, Inc. Immunodiagnostic Development Center 1000 Lake Hazeltine Drive Chaska, Minnesota 55318-1084
Re : K974816 Trade Name: ACCESS® PSA Assay Regulatory Class: II Product Code: LTJ Dated: December 18, 1997 Received: December 23, 1997------
Dear Ms. Voss:
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 aqainst 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 current Good Manufacturing Practice requirement, 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 Reqister. 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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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.
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 Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and : 上一 Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):K974816
Page 1 of 1
Device Name: ACCESS® PSA
Indications For Use:
. "
The Access® PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of prostate-specific antigen (PSA) in human serum using the ACCESS Immunoassay System. PSA measured by the Access PSA Immunoassay, is used as an aid in the management of patients with prostate cancer.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Martin
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)