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 Description

The Access Myoglobin reagent and calibrators, the Access Immunoassay Analyzers comprise the Access Immunoassay Systems for the quantitative determination of cardiac Myoglobin in human serum and plasma.

AI/ML Overview

The provided 510(k) summary focuses on a single performance characteristic: imprecision. The submission is for a modified version of an already cleared device, and the only change noted is to the acceptable imprecision range in the Instructions For Use (IFU).

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (from modified IFU)	Reported Device Performance (Myoglobin)
Total Imprecision (%CV)	≤ 10% across the expected physiological range	7.32% CV to 9.25% CV

The reported device performance (7.32% CV to 9.25% CV) falls within the updated acceptance criteria (≤ 10% CV).

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

Sample Size: Not explicitly stated. The summary mentions "concentrations from approximately 79 to 2405 ng/mL" for imprecision testing, but not the number of individual samples or replicates used.
Data Provenance: Not explicitly stated. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.

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

This information is not applicable to this type of submission. The device is an immunoassay for quantitative determination of myoglobin, and the "ground truth" for evaluating imprecision is determined by statistical analysis of repeat measurements, not by expert interpretation of samples.

4. Adjudication Method for the Test Set

This information is not applicable as it relates to expert consensus for ground truth, which is not relevant for imprecision studies of an immunoassay.

5. 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

This information is not applicable. This submission is for an immunoassay for myoglobin, not an AI-assisted diagnostic imaging device that involves human readers.

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

This information is not applicable. This is a laboratory immunoassay device, not an algorithm, and does not involve human-in-the-loop performance in the same way as an AI-driven image analysis tool. The performance described (imprecision) is inherently "standalone" in the sense that it measures the inherent variability of the assay itself.

7. The Type of Ground Truth Used

The ground truth for imprecision studies is the measured value itself and its statistical distribution. Repeated measurements of the same sample are used to assess the variability (imprecision) of the assay. There isn't an external "truth" in the way there would be for disease diagnosis (e.g., pathology).

8. The Sample Size for the Training Set

This information is not applicable. This device is a biochemical assay and does not involve machine learning models that require a "training set."

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

This information is not applicable as there is no training set for this type of device.

Summary

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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.1000 Lake Hazeltine DriveChaska, MN 55318
Contact person:	Rachelle ParsonsSenior Regulatory Affairs Specialist, RACPhone: 952.368.1227Fax: 952.368.7610
Date prepared:	August 20, 2008
Proprietary name:	Access ® Myoglobin and Access Myoglobin Calibrators onthe 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 AccessImmunoassay Analyzers comprise the Access ImmunoassaySystems for the quantitative determination of cardiacMyoglobin in human serum and plasma.
Intended use:	The Access Myoglobin assay is a paramagnetic particle,chemiluminescent immunoassay for the quantitativedetermination of myoglobin levels in human serum andplasma using the Access Immunoassay Systems.

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Comparison of Technological Characteristics

Attribute	Access Myoglobin	Access Myoglobin(With Modification to IFU)
Intended Use	For the quantitativedetermination of myoglobinlevels in human serum andplasma.	For the quantitativedetermination of myoglobinlevels in human serum andplasma.
Assay principles	A two site immunoenzymatic("sandwich") assay. A sampleis added to a reaction vesselwith mouse monoclonal anti-myoglobin-alkalinephosphatase conjugate, mousemonoclonal anti-myoglobin-biotin conjugate, andparamagnetic particles coatedwith goat anti-biotin	A two site immunoenzymatic("sandwich") assay. A sampleis added to a reaction vesselwith mouse monoclonal anti-myoglobin-alkalinephosphatase conjugate, mousemonoclonal anti-myoglobin-biotin conjugate, andparamagnetic particles coatedwith goat anti-biotin
Solid Support	Paramagnetic particles.	Paramagnetic particles.
Detection System	Chemiluminescent substrate.	Chemiluminescent substrate.
Calibrator	Liquid calibrators (frozen)prepared from buffered bovineserum albumin matrix withhuman cardiac Myoglobin atspecified levels	Liquid calibrators (frozen)prepared from buffered bovineserum albumin matrix withhuman cardiac Myoglobin atspecified levels
Analytical Range	1-4000ng/mL	1-4000ng/mL
Imprecision	This assay exhibits totalimprecision of less than 8%across the expectedphysiological range.	This assay exhibits totalimprecision of ≤ 10% acrossthe expected physiologicalrange.

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

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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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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:

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

Regulation Number and Section

§ 866.5680 Myoglobin immunological test system.

(a)
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.(b)
Classification. Class II (performance standards).