ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306

K994439 · Beckman Coulter, Inc. · JHX · Jan 14, 2000 · Clinical Chemistry

Device Facts

• Record ID: K994439
• Device Name: ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306
• Applicant: Beckman Coulter, Inc.
• Product Code: JHX · Clinical Chemistry
• Decision Date: Jan 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

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 System. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction.

Device Story

Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay; performs quantitative determination of CK-MB levels in human serum or plasma. Used with Access Immunoassay Analyzer in clinical laboratory settings. System utilizes reagent packs, calibrators, controls, substrate, and wash buffer. Principle involves solid phase of particles and labeled antibody conjugated to alkaline phosphatase. Healthcare providers use output (CK-MB concentration) to assist in diagnosis and treatment of myocardial infarction.

Clinical Evidence

Bench testing only. Precision: within-run, between-run, and total imprecision <10% CV. Linearity: average recovery 95.7%. Correlation: n=356, r=0.984 vs predicate; n=48, r=0.998 for serum vs EDTA plasma; n=84, r=0.999 for serum vs heparin plasma. Analytical sensitivity: 0.3 ng/ml (lowest detectable level distinguishable from zero with 95% confidence).

Technological Characteristics

Paramagnetic particle, chemiluminescent immunoassay. Components: reagent packs, calibrators, controls, substrate, wash buffer. Detection principle: alkaline phosphatase-conjugated antibody. Analyte: human CK-MB. System: Access Immunoassay Analyzer.

Indications for Use

Indicated for the quantitative determination of CK-MB levels in human serum or plasma to aid in the diagnosis and treatment of myocardial infarction.

Regulatory Classification

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.

Submission Summary (Full Text)

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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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## 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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:

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.

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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)

OR

Over-The Counter Use_