(36 days)
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No
The document describes a quality control material for an immunoassay system, not a device that processes data or images using AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is a quality control material intended for monitoring the performance of immunoassay systems that measure PSA, not for treating patients.
No
The device is described as a "tri-level control" intended for "monitoring system performance of immunoenzymatic procedures", not for diagnosing a condition in a patient. It is used to verify the performance of a diagnostic test system.
No
The device description clearly states it is a "control material consisting of human PSA in a buffered bovine serum albumin (BSA) matrix with preservatives," indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring system performance of immunoenzymatic procedures for the quantitative measurement of total PSA using the Access® Immunoassay Systems." This indicates it's used in vitro (outside the body) to assess the performance of a diagnostic test.
- Device Description: The description further clarifies that it's a "control material" used for "monitoring system performance" of a quantitative measurement of PSA. Control materials are a key component of IVD testing to ensure accuracy and reliability.
- Nature of the Material: The control material itself is a "human PSA in a buffered bovine serum albumin (BSA) matrix with preservatives," which is a substance used in vitro for testing purposes.
The purpose of this device is to ensure the proper functioning of an immunoassay system that measures PSA, which is a diagnostic test performed on biological samples in vitro. Therefore, it fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access® Hybrttech® PSA QC are tri-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of total PSA using the Access® Immunoassay Systems.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The Access Hybritech PSA QC are controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of Prostate Specific Antigen (PSA) using the Access Immunoassay systems.
The Access Hybritech PSA QC are ready to use tri-level control material consisting of human PSA in a buffered bovine serum albumin (BSA) matrix with preservatives. The controls are targeted to cover the assay range of approximately 0.008 - 150 ng/mL at three levels of approximate PSA concentrations of 1 ng/mL, 15 ng/mL, and 90 ng/mL.
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
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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)
Precision:
Within-run, between-run, and total imprecision of all three levels of the Access Hybritech PSA QC were less than 5% CV.
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.
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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).
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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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510(k) Promarket Notification Confidential
JAN 18 2000
1994200
510(k) Summarv
Prepared January 14, 2000
Applicant's Name and Address
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Contact Person: Michele S. Gust
Device Name
Trade Name - Access® Hybritech® PSA QC on the Access® Immunoassay System Common Name - Access® Hybritech® PSA QC Classification name - Quality control material (assaved and unassayed)
Device Description
The Access Hybritech PSA QC are controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of Prostate Specific Antigen (PSA) using the Access Immunoassay systems.
The Access Hybritech PSA QC are ready to use tri-level control material consisting of human PSA in a buffered bovine serum albumin (BSA) matrix with preservatives. The controls are targeted to cover the assay range of approximately 0.008 - 150 ng/mL at three levels of approximate PSA concentrations of 1 ng/mL, 15 ng/mL, and 90 ng/mL.
Intended Use
Access Hybritech PSA QC are tri-level controls intended for monitoring system performance of Immunoenzymatic procedures for the quantitative measurement of total Prostate Specific Antigen (PSA) using the Access Immunoassay Systems.
Comparison of Technological Characteristics
The Access Hybritech PSA QC and the predicate device are both ready to use quality control materials intended to monitor assay performance.
Summary of Studies
Precision:
Within-run, between-run, and total imprecision of all three levels of the Access Hybritech PSA QC were less than 5% CV.
Conclusion
These data demonstrate the Access Hybritech PSA QC tri-level controls give reproducible results when used as quality control materials with the Access Immunoassay Systems for the quantitative determination of PSA levels. Based on similarity of features and the reproducibility of results, the Access Hybritech PSA QC is substantially equivalent to the predicate device for the monitoring of system performance of the Access Hybritech total PSA immunoassay.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 18 2000
Ms. Michele Gust Senior Regulatory Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, Minnesota 55318-1084
Re: K994200
Trade Name: Access® Hybritech® PSA OC on the Access® Immunoassay System Regulatory Class: I Product Code: JJX Dated: December 10, 1999 Received: December 13, 1999
Dear Ms. Gust:
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 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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" (21CFR 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 Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Access® Hybritech® PSA QC
Indications For Use:
The Access® Hybrttech® PSA QC are tri-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of total PSA using the Access® Immunoassay Systems.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) 00 11 11 ﻢ OR Over-The Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use_ (Per 21 CFR 801.109) (Optional Format 1-2-96)
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