ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS

K080481 · Beckman Coulter, Inc. · DDR · Feb 20, 2009 · Immunology

Device Facts

• Record ID: K080481
• Device Name: ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS
• Applicant: Beckman Coulter, Inc.
• Product Code: DDR · Immunology
• Decision Date: Feb 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5680
• Device Class: Class 2

Intended Use

Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems. Measurement of myoglobin aids in the rapid diagnosis of heart and renal diseases.

Device Story

Access Myoglobin assay is a two-site immunoenzymatic sandwich immunoassay. Input: human serum or plasma samples. Process: sample added to reaction vessel with mouse monoclonal anti-myoglobin-alkaline phosphatase conjugate, mouse monoclonal anti-myoglobin-biotin conjugate, and paramagnetic particles coated with goat anti-biotin; myoglobin binds to biotin conjugate and is immobilized on paramagnetic particles; mouse anti-myoglobin-alkaline phosphatase conjugate binds to a different antigenic site; magnetic field holds bound materials while unbound materials are washed away; chemiluminescent substrate (Lumi-Phos 530) added; light generated is measured by a luminometer. Output: light intensity directly proportional to myoglobin concentration, calculated via stored multi-point calibration curve. Used in clinical laboratory settings on UniCel DxI 800 or Access Immunoassay Systems. Operated by laboratory technicians. Results used by physicians to aid in diagnosis of heart and renal diseases.

Clinical Evidence

Bench testing only. Precision study evaluated within-run and between-run imprecision across concentrations from 79 to 2405 ng/mL. Within-run imprecision ranged from 3.05% to 4.32% CV; between-run ranged from 6.49% to 8.58% CV; total imprecision ranged from 7.32% to 9.25% CV, meeting the ≤ 10% specification.

Technological Characteristics

Two-site immunoenzymatic ("sandwich") assay. Components: mouse monoclonal anti-myoglobin-alkaline phosphatase conjugate, mouse monoclonal anti-myoglobin-biotin conjugate, paramagnetic particles coated with goat anti-biotin. Detection: chemiluminescent substrate. Analytical range: 1-4000 ng/mL. Total imprecision: ≤ 10%. Calibrators: liquid (frozen) buffered bovine serum albumin matrix with human cardiac myoglobin.

Indications for Use

Indicated for the quantitative determination of myoglobin levels in human serum and plasma to aid in the diagnosis of heart and renal diseases. For prescription use only.

Regulatory Classification

Identification

A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

Predicate Devices

• Access Myoglobin Assay (k021229)

Submission Summary (Full Text)

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FEB 2 0 2009

### 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K080481

| Applicant: | Beckman Coulter, Inc.<br>1000 Lake Hazeltine Drive<br>Chaska, MN 55318 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Rachelle Parsons<br>Senior Regulatory Affairs Specialist, RAC<br>Phone: [phone]<br>Fax: [phone] |
| Date prepared: | August 20, 2008 |
| Proprietary name: | Access ^® Myoglobin and Access Myoglobin Calibrators on<br>the Access Immunoassay Systems |
| Common name: | Myoglobin Enzyme Immunoassay |
| Product classification: | Class II |
| Product code: | DDR; JIS |
| Predicate device: | Access Myoglobin Assay - k021229 |
| Device description: | The Access Myoglobin reagent and calibrators, the Access<br>Immunoassay Analyzers comprise the Access Immunoassay<br>Systems for the quantitative determination of cardiac<br>Myoglobin in human serum and plasma. |
| Intended use: | The Access Myoglobin assay is a paramagnetic particle,<br>chemiluminescent immunoassay for the quantitative<br>determination of myoglobin levels in human serum and<br>plasma using the Access Immunoassay Systems. |

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# Comparison of Technological Characteristics

| Attribute | Access Myoglobin | Access Myoglobin<br>(With Modification to IFU) |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the quantitative<br>determination of myoglobin<br>levels in human serum and<br>plasma. | For the quantitative<br>determination of myoglobin<br>levels in human serum and<br>plasma. |
| Assay principles | A two site immunoenzymatic<br>("sandwich") assay. A sample<br>is added to a reaction vessel<br>with mouse monoclonal anti-<br>myoglobin-alkaline<br>phosphatase conjugate, mouse<br>monoclonal anti-myoglobin-<br>biotin conjugate, and<br>paramagnetic particles coated<br>with goat anti-biotin | A two site immunoenzymatic<br>("sandwich") assay. A sample<br>is added to a reaction vessel<br>with mouse monoclonal anti-<br>myoglobin-alkaline<br>phosphatase conjugate, mouse<br>monoclonal anti-myoglobin-<br>biotin conjugate, and<br>paramagnetic particles coated<br>with goat anti-biotin |
| Solid Support | Paramagnetic particles. | Paramagnetic particles. |
| Detection System | Chemiluminescent substrate. | Chemiluminescent substrate. |
| Calibrator | Liquid calibrators (frozen)<br>prepared from buffered bovine<br>serum albumin matrix with<br>human cardiac Myoglobin at<br>specified levels | Liquid calibrators (frozen)<br>prepared from buffered bovine<br>serum albumin matrix with<br>human cardiac Myoglobin at<br>specified levels |
| Analytical Range | 1-4000ng/mL | 1-4000ng/mL |
| Imprecision | This assay exhibits total<br>imprecision of less than 8%<br>across the expected<br>physiological range. | This assay exhibits total<br>imprecision of ≤ 10% across<br>the expected physiological<br>range. |

### Summary of Precision Study

Imprecision: Within-run assay imprecision was tested for concentrations from approximately 79 to 2405 ng/mL. The within-run imprecision ranged from 3.05 % CV to 4.32% CV. Between-run assay imprecision ranged from 6.49% CV to 8.58% CV. Total imprecision ranged from 7.32% CV to 9.25% CV.

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#### Conclusion

Imprecision was the only performance characteristic revised in the Access Myoglobin assay and was not found to impact the safety and efficacy of the device. The modified Access® Myoglobin assay is substantially equivalent to the previously cleared Access® Myoglobin assay. .

. . . . . . .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Beckman Coulter, Inc. c/o Ms. Rachelle Parsons Senior Regulatory Affairs Specialist, RAC 1000 Lake Hazeltine Drive Chaska, MN 55318

FEB 2 0 2009

Re: k080481

> Trade/Device Name: Access® Myoglobin and Access Myoglobin Calibrators on the Access Immunoassay Systems

Regulation Number: 21 CFR §866.5680 Regulation Name: Myoglobin Immunological Test System. Regulatory Class: Class II Product Code: DDR, JIT Dated: February 16, 2009 Received: February 17, 2009

Dear Ms. Parsons:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 adalteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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Page - 2

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act From the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Coy C. H

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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## Indication for Use

510(k) Number (if known): k080481

Device Name:

Access Myoglobin and Access Myoglobin Calibrators on the Access® Immunoassay Systems

Indication For Use:

Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems, . . -- --:

Measurement of myoglobin aids in the rapid diagnosis of heart and renal diseases.

Prescription Use × (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safely (O)VD);

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(K) K 7804