The AccEss® CK-MB assay is a paramagnetic-particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum or plasma, using the Access Immunoassay System. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction.

Device Description

The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum or plasma, using the Access Immunoassay Systems. The Access CK-MB reagents consist of reagent packs, calibrators, controls substrate and wash buffer. The Access CK-MB assay, CK-MB calibrators, CK-MB QC along with the Access System Wash Buffer and Substrate are designed for use with the Access Immunoassay Analyzer in a clinical laboratory setting.

AI/ML Overview

The provided document describes the Access® CK-MB Reagents on the Access® Immunoassay System, an in vitro diagnostic device for quantitative determination of CK-MB levels. The studies presented focus on the device's analytical performance rather than a comparative effectiveness study with human readers or a standalone clinical performance study.

Here's an analysis of the acceptance criteria and study findings based on the provided text:

Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Precision	CV < 10%	Within-run, between-run, and total imprecision were less than 10% CV.
Spiking & Dilution Recovery	Recovery ~90-110%	Average recovery of 95.7%.
Correlation (vs. Predicate Device)	High correlation (e.g., r > 0.95) and acceptable slope/intercept for equivalence	n=356, r=0.984, y=0.836x + 0.662
Correlation (Serum vs. Plasma - EDTA)	High correlation (e.g., r > 0.95) and acceptable slope/intercept for equivalence	n=48, r=0.998, y=1.009x + 1.119
Correlation (Serum vs. Plasma - Heparin)	High correlation (e.g., r > 0.95) and acceptable slope/intercept for equivalence	n=84, r=0.999, y=1.015x - 0.631
Analytical Sensitivity	Lowest detectable level for zero with 95% confidence	0.3 ng/ml

Study Details

Sample Sizes and Data Provenance:
- Precision: Not explicitly stated, but typically involves repeated measurements of control samples.
- Spiking and Dilution Recovery: One human sample containing CK-MB was used.
- Correlation (Predicate Device): n=356 samples. Provenance (country of origin, retrospective/prospective) is not specified.
- Correlation (Serum vs. Plasma - EDTA): n=48 paired samples. Provenance is not specified.
- Correlation (Serum vs. Plasma - Heparin): n=84 paired samples. Provenance is not specified.
- Analytical Sensitivity: Not explicitly stated, but uses the CK-MB S0 calibrator.
Number of Experts and Qualifications for Ground Truth: Not applicable. This study focuses on analytical performance of an in vitro diagnostic device, not on interpretation by human experts.
Adjudication Method: Not applicable. This study involves quantitative measurements by an automated system, not subjective interpretation requiring adjudication.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. The document does not describe human readers or AI assistance.
Standalone (Algorithm Only) Performance: Yes, the described studies represent the standalone performance of the Access® CK-MB assay when used on the Access® Immunoassay Analyzer. The studies evaluate the analytical capabilities of the device itself.
Type of Ground Truth Used:
- For Precision, Spiking, Dilution Recovery, and Analytical Sensitivity, the "ground truth" is based on the known or expected values of the control materials, spiked samples, and calibrators used in the analytical tests.
- For Correlation studies, the "ground truth" is the measurements obtained from the predicate device (for the comparison with predicate) or the matched serum/plasma samples (for the plasma comparison).
Sample Size for the Training Set: Not applicable. This document describes the validation of a laboratory assay, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves internal calibration and quality control procedures performed during manufacturing and prior to use.
How Ground Truth for the Training Set Was Established: Not applicable, as there's no "training set" in the context of an AI/ML algorithm. For an IVD, the closest equivalent to "establishing ground truth for training" would be the rigorous characterization and validation of the calibrators, controls, and reagents used by the system as part of its development and manufacturing process. These are typically established through primary reference methods, certified reference materials, and extensive in-house validation.

Summary

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JAN 1 4 2000

K994439

5101k) Summarv January 11, 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® CK-MB Reagents on the Access® Immunoassay System Common Name - Access® CK-MB Classification name - Fluorometric Method, CPK or Isoenzymes

Device Description

The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum or plasma, using the Access Immunoassay Systems.

The Access CK-MB reagents consist of reagent packs, calibrators, controls substrate and wash buffer. The Access CK-MB assay, CK-MB calibrators, CK-MB QC along with the Access System Wash Buffer and Substrate are designed for use with the Access Immunoassay Analyzer in a clinical laboratory setting.

Intended Use

The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum or plasma, using the Access Immunoassay Systems.

Comparison of Technological Characteristics

The Access CK-MB assay and the predicate device are contain a solid phase of particles and use a labeted antibody conjugated to alkaline phosphatase. The calibrators consist of 6 levels in which the analyte is human CK-MB. Both of these devices are intended to measure CK-MB in human serum and plasma.

Summary of Studies

Precision:

Within-run, between-run, and total imprecision were less than 10% CV. Spiking and Dilution Recovery:

Linearity studies performed by diluting one human sample containing CK-MB with CK-MB Calibrator S0 yields an average recovery of 95.7%.

Correlation:

A comparison of the Access CK-MB assay and the predicate device gives the following statistical data-n=356, r=0.984, y=0.836x + 0.662.

A comparison of CK-MB values of paired serum and plasma( EDTA) run in the Access CK-MB assay gives the following statistical data-n=48, r=0.998, y=1.009x + 1.119. A comparison of CK-MB values of palred serum and plasma (heparin) run in the Access CK-MB assay gives the following statistical data-n=84, r=0.999, y=1.015x - 0.631. Analytical Sensitivity:

The lowest detectable level of CK-MB distinguishable for zero (CK-MB S0 calibrator) with 95% confidence is 0.3 ng/ml.

Conclusion

The Access CK-MB reagents when used with the Access Immunoassay Analyzer are substantially equivalent to another test currently in commercial distribution for the measurement of CK-MB.

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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 eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 4 2000

Ms. Michele S. Gust Senior Regulatory Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, Minnesota 55318-1084

Re: K994439

Trade Name: Access® CK-MB Assay on the Access® Immunoassay Analyzer Regulatory Class: II Product Code: JHX Dated: December 22, 1999 Received: December 23, 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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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 Putman

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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Beckman Coulter, Inc.

510(k) Premarket Notification Confidential

Page of 1

510(k) Number (if known):

Device Name: Access® CK-MB-Reagent&Assay on the Access Immunoassay Analyzer

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Han Cooper
(Division Sign-Off)

Division of Clinical Labor
510(k) Number: 499439

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use_

Regulation Number and Section

§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.

(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.