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.

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.

AI/ML Overview

The provided 510(k) summary for the Access® Hybritech® PSA QC describes a quality control material, not a device that directly measures a patient's condition or uses an AI algorithm. Therefore, many of the requested categories in the prompt (e.g., test set, ground truth, experts, MRMC study, standalone algorithm performance, training set) are not applicable to this type of submission.

However, I can extract the relevant information regarding the acceptance criteria and study proving performance as a quality control material.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Precision: Within-run, between-run, and total imprecision of all three levels of the Access Hybritech PSA QC.	Within-run, between-run, and total imprecision of all three levels of the Access Hybritech PSA QC were less than 5% CV.

Study Details (as applicable to a Quality Control Material):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The term "test set" in the context of an algorithm or diagnostic device is not directly applicable here. For a quality control material, the "sample size" refers to the number of replicates or runs performed to assess precision.
- The summary states "Within-run, between-run, and total imprecision of all three levels...". This implies multiple replicates at each of the three control levels, over multiple runs, to calculate the Coefficient of Variation (CV).
- Specific numbers of replicates or runs are not provided.
- Data provenance (country of origin, retrospective/prospective) is not specified, but typically such studies for IVD QC materials are conducted in-house by the manufacturer.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. For a quality control material, the "ground truth" (or target value) for precision is established by the inherent analytical performance of the assay and the stability of the control material itself, not by expert consensus on patient data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for interpretation of complex data (e.g., medical images) where human judgment might vary. For analytical precision, statistical methods are used for calculation.
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 material, not a device intended for human interpretation or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a quality control material used to monitor an immunoassay system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a quality control material, the "ground truth" for evaluating precision is the expected statistical variation (imprecision) of the material when run on the Access Immunoassay System. This is determined through rigorous laboratory testing. The target concentrations (approx. 1 ng/mL, 15 ng/mL, and 90 ng/mL) for the controls would be established by the manufacturer.
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.

Summary

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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

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:

(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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Regulation Number and Section

§ 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.