(103 days)
The Access® Hybritech® free PSA QC are bi-level controls intended for use in monitoring system performance of immunoenzymatic procedures for the quantitative measurement of free PSA using the Access® Immunoassay Systems.
The Access Hybritech free PSA QC are controls intended for use in monitoring system performance of immunoenzymatic procedures for the quantitative measurement of free PSA using the Access Immunoassay systems.
The Access Hybritech free PSA QC are ready to use bi-level control material consisting of human free PSA in a buffered bovine serum albumin (BSA) matrix with preservatives. The controls are targeted to cover the assay range of approximately 0.005 – 20 ng/ml at two levels of approximate concentrations of 1ng/mL and 13 ng/mL.
The provided text describes a 510(k) premarket notification for a quality control device, not an AI/ML-driven medical device for diagnosis or prognosis. Therefore, many of the requested fields, such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable to this type of device.
However, I can extract the acceptance criteria and the summary of the study performed to demonstrate the device's performance regarding those criteria.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Precision: Within-run | Less than 5% CV |
| Precision: Between-run | Less than 5% CV |
| Precision: Total | Less than 5% CV |
Study Details:
- Sample size used for the test set and the data provenance: Not applicable. This device is a quality control material, and the study focuses on its precision, not diagnostic accuracy on patient data. No "test set" in the context of patient data for diagnostic classification is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic purposes is not relevant for a quality control material. The study assesses the reproducibility of the control material itself.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication of diagnostic outcomes is involved.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a quality control device, not an AI/ML diagnostic aid.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a quality control device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a quality control material is its expected concentration and the variability around it. The study evaluates the reproducibility of this material.
- The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
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510(k) Premarket Notification Confidential
Access Hybritech free PSA QC
993210
JAN - 5 2000
510(k) Summary
Prepared September 16, 1999
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® free PSA QC on the Access® Immunoassay System Common Name - Access® Hybritech® free PSA QC Classification name - Quality control material (assayed and unassayed)
Device Description
The Access Hybritech free PSA QC are controls intended for use in monitoring system performance of immunoenzymatic procedures for the quantitative measurement of free PSA using the Access Immunoassay systems.
The Access Hybritech free PSA QC are ready to use bi-level control material consisting of human free PSA in a buffered bovine serum albumin (BSA) matrix with preservatives. The controls are targeted to cover the assay range of approximately 0.005 – 20 ng/ml at two levels of approximate concentrations of 1ng/mL and 13 ng/mL.
Intended Use
Access Hybritech free PSA QC are bi-level controls intended for use in monitoring system performance of immunoenzymmatic procedures for the quantitative measurement of free PSA using the Access Immunoassay Systems.
Comparison of Technological Characteristics
The Access Hybritech free PSA QC and the predicate devices are ready to use quality control materials intended to monitor the system performance of immunoassays on Access Immunoassay Systems.
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Summary of Studies
Precision:
Within-run, between-run, and total imprecision of both levels of the Access Hybritech free PSA QC were less than 5% CV.
Conclusion
These data demonstrate that the Access Hybritech free PSA QC bi-level controls give reproducible results when used as quality control materials with the Access Immunoassay Systems for the quantitative determination of free PSA levels. Based on similarity of features and the reproducibility of results, the Access Hybritech free PSA QC is substantially equivalent to the predicate device for the monitoring of system performance of the Access Hybritech free PSA immunoassay.
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JAN - 5 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Michele S. Gust Senior Regulatory Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, Minnesota 55318
K993210 Re:
Trade Name: Access® Hybritech® free PSA QC on the Access® Immunoassay Analyzer Regulatory Class: I Product Code: JJX Dated: December 3, 1999 Received: December 7, 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 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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Page 2
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 (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
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510(k) Number (if known):
Page 1 of 1
Device Name: Access® Hybritech® free PSA QC
Kyg3210
Indications For Use:
The Access® Hybritech® free PSA QC are bi-level controls intended for use in monitoring system performance of immunoenzymatic procedures for the quantitative measurement of free 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)
Peter E. Martin
(Division Sign-Off) Division of Clinical Laboratory Levices 510(k) Number
| Prescription Use | V |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.