The Access® AFP QC (serum based) are tri-level controls intended for use in monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprotein (AFP) using the Access Immunoassay System.

Device Description

The Access AFP QC are tri-level controls consisting of human AFP in human serum with preservatives. They are targeted to cover the assay range of approximately 7.0 ng/ml to 1725 ng/ml. with the controls targeted at 7, 80 and 1725 na/ml.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance Study for Access AFP QC

This 510(k) summary describes the Access AFP QC, a quality control product for Alpha-fetoprotein (AFP) immunoassays. The primary goal of the submission is to demonstrate substantial equivalence to a predicate device, the Lyphochek® Immunoassay Control Serum, rather than establishing a de novo set of performance criteria for a new measurement device. Therefore, the "acceptance criteria" here are framed around demonstrating comparable performance and stability to existing standards or expectations for quality control materials.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a quality control product, the acceptance criteria are focused on its stability and precision rather than diagnostic accuracy.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Imprecision (Precision)	Within-run, between-run, and total imprecision	Less than 5% CV for all three levels of Access AFP QC
Stability	Stable for a specified duration under storage conditions	Stable for up to 13 months when stored at 2-8° C
Target Assay Range	Targeted to cover the assay range of approximately	Targeted to cover 7.0 ng/ml to 1725 ng/ml (controls at 7, 80, and 1725 ng/ml)
Material Equivalence	Human AFP in human serum with preservatives	Human AFP in human serum with preservatives
Readiness of Use	Ready to use	Provided ready to use

Note: The core "acceptance criterion" for this 510(k) is substantial equivalence to the predicate device, K891475. The study's purpose is to demonstrate that the Access AFP QC performs comparably to or within acceptable parameters for such a control.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not explicitly state the sample size used for the imprecision (test set) studies. It only mentions "all three levels of the Access AFP QC," implying that the study was conducted across the low, medium, and high control levels.

The data provenance is not specified (e.g., country of origin). Since it's a submission from Beckman Coulter, Inc. located in Chaska, MN, USA, it's highly probable the study was conducted in the USA. The type of study is prospective in nature, as it involves testing the performance of the newly developed Access AFP QC materials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For a quality control material like Access AFP QC, the concept of "ground truth" as established by experts (e.g., radiologists, pathologists) is not applicable in the same way it would be for a diagnostic device.

The "ground truth" for a control material is its expected value or designated target range, which is typically established through a robust formulation and value assignment process by the manufacturer, followed by internal validation. The summary mentions the controls are "targeted at 7, 80 and 1725 ng/ml," which are the assigned target values. The experts involved would likely be biochemists, analytical chemists, and quality control specialists internal to Beckman Coulter, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Since the "ground truth" (target values and expected performance parameters like precision) is established by the manufacturer and the study focuses on quantitative measurements of imprecision and stability, an external "adjudication method" involving independent experts (like 2+1, 3+1 consensus) is not relevant or described in this context. The study data (imprecision, stability) would be analyzed against predefined statistical acceptance limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or needed.

MRMC studies are typically performed for diagnostic imaging or interpretation devices where human readers (e.g., radiologists) are involved in interpreting results and their performance is compared with and without AI assistance. The Access AFP QC is a quality control material for an automated immunoassay system, and human interpretation of control results is standard process, not a "reading" that would be assisted by AI.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in essence, a standalone (algorithm only) performance assessment was done.

The studies described ("Within-run, between-run and total imprecision" and "stability") directly assess the inherent performance characteristics of the control material itself when processed by the Access Immunoassay System. There is no human "in the loop" performing an interpretive step that would alter the control's fundamental performance; the human interaction is typically limited to loading the controls and reviewing the quantitative results generated by the instrument. The "algorithm" here would be the immunoassay system's method for measuring AFP.

7. The Type of Ground Truth Used

The "ground truth" for the Access AFP QC is based on:

Manufacturer's assigned target values: The controls are "targeted at 7, 80 and 1725 ng/ml."
Established analytical performance parameters: The expected precision (%CV) and stability are based on industry standards for quality control materials and internal validation by the manufacturer.

It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

A "training set" is not applicable or described for this device.

The Access AFP QC is a physical control material, not an AI/ML algorithm that requires training data. The immunoassay system itself would have been developed and validated using training/development data, but this submission is about the control material.

9. How the Ground Truth for the Training Set was Established

As noted above, there is no "training set" for this quality control material itself. The ground truth for the control's target values and expected performance is established through rigorous internal manufacturing, formulation, and validation processes by Beckman Coulter.

Summary

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JUN 12 1998

510(k) Summary of Safety and Effectiveness

1. General Information Device Generic Name:

Single (Specified) Analyte Controls, Assayed Control

Device Trade Name:

Applicant's Name and Address:

Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318

Submission Date:

May 26, 1998

Access AFP QC

Predicate Device 2.

Lyphochek@ Immunoassay Control Serum Bio-Rad Laboratories 3726 E. Miraloma Avenue Anaheim, CA 92806

510(k) Number: K891475

3. Device Description

Indications for Use 4.

The Access AFP QC are controls intended for use in monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprotein (AFP) using the Access Immunoassay System.

5. Comparison of Technological Characteristics

The Access AFP QC and the Lyphochek Immunoassay Controls are both tri-level, human serum-based immunoassay controls intended to monitor the system performance of immunoassays for the measurement of AFP in human serum.

The Access AFP QC, intended for use with the Access AFP Reagents on the Access Immunoassay System are provided ready to use with an approximate range of 7.0 to 1725 ng/ml. The Lyphochek Immunoassay Controls, not designed for a specific immunoassay system, have approximate range of 30 to 280 ng/ml, depending on the assay used and require reconstitution.

6. Summary of Studies

Within-run, between-run and total imprecision of all three levels of the Access AFP QC were less than 5% CV. Access AFP QC are stable for up to 13 months when stored at 2-8° C

7. · Conclusion

The Access AFP QC tri-level control materials are substantially equivalent to the Lyphochek Immunoassay Controls for the determination of system performance of AFP immunoassays based on similar features and reproducible results.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the circle. The text is in all caps and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN / 2 1998

Ellen M. Voss, M.S. Regulatory Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, Minnesota 55318-1084

Re : K981864 ACCESS® AFP QC on the ACCESS® Immunoassay Analyzer Regulatory Class: I Product Code: JJX May 26, 1998 Dated: May 27, 1998 Received:

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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ರ್ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 In addition, FDA may publish further announcements action. 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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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/dsmamain.html".

sincerely yours,
Steven Gutman

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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INDICATIONS FOR USE STATEMENT

1 of 1 Page ___

510(k) Number (if known):

Device Name: ACCESS® AFP 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)

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K981864

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.