ARCHITECT STAT MYO IMMUNOASSAY

K042924 · Fisher Diagnostics · DDR · Jan 24, 2005 · Immunology

Device Facts

• Record ID: K042924
• Device Name: ARCHITECT STAT MYO IMMUNOASSAY
• Applicant: Fisher Diagnostics
• Product Code: DDR · Immunology
• Decision Date: Jan 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5680
• Device Class: Class 2

Intended Use

ARCHITECT® STAT Myoglobin (MYO) is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of myoglobin in human serum and plasma on the ARCHITECT® i System with STAT protocol capability. Myoglobin values are used to assist in the diagnosis of myocardial infarction (MI). The ARCHITECT® STAT Myoglobin Calibrators are for calibration of the ARCHITECT® i System with STAT protocol capability when used for the quantitative determination of myoglobin in human serum or plasma.

Device Story

ARCHITECT® STAT Myoglobin is a 2-step quantitative chemiluminescent microparticle immunoassay (CMIA) for use on the ARCHITECT® i System. Input: human serum or plasma samples. Process: sample combines with anti-myoglobin coated paramagnetic microparticles; incubation and washing; addition of anti-myoglobin acridinium conjugate; addition of pre-trigger and trigger solutions to induce chemiluminescence. Output: relative light units (RLUs) measured by the system to quantify myoglobin concentration. Used in clinical laboratory settings by trained personnel. Output assists clinicians in diagnosing myocardial infarction. Benefits include rapid, quantitative assessment of myoglobin levels to support timely cardiac diagnostic decision-making.

Clinical Evidence

No clinical studies (sensitivity/specificity) were performed. Evidence consists of bench testing: precision (CV 3.2-6.3%), linearity (80-120% recovery), analytical sensitivity (<1.0 ng/mL), and interference testing (bilirubin, hemoglobin, triglycerides, total protein, HAMA, RF). Method comparison against the predicate (n=238) showed a correlation coefficient of 0.989 and slope of 0.99.

Technological Characteristics

Chemiluminescent Microparticle Immunoassay (CMIA) using Chemiflex technology. Reagents include paramagnetic microparticles coated with mouse monoclonal anti-myoglobin in TRIS buffer. Energy source: ARCHITECT i System optics for RLU detection. Connectivity: ARCHITECT i System. Sterilization: Not specified.

Indications for Use

Indicated for quantitative determination of myoglobin in human serum and plasma to assist in the diagnosis of myocardial infarction (MI). 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

• Abbott AxSYM® myoglobin assay (k983848)

Submission Summary (Full Text)

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K042924

JAN 2 4 2005

#### 7.3 SUMMARY OF SAFETY AND EFFECTIVENESS

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

### Applicant Name:

Josefina Infantas, MSM Sr. Regulatory Affairs Specialist Fisher Diagnostics 8365 Valley Pike P.O. Box 307 Middletown, VA 22645 Phone: [phone] Fax: [phone]

## Establishment Registration Number: 1181121

## ldentification of Device:

Device Name: ARCHITECT® STAT MYO immunoassay Proprietary/Trade Name: ARCHITECT® STAT MYO immunoassay Common Name: MYO test system Device Classification: Class II Governing Regulation: 21 CFR 866.5680 FDA Panel: Clinical Chemistry Product Code: MVE

## Identification of Predicate Device:

Abbott AxSYM® MYO Assay (K983848)

## Intended Use of the Device:

ARCHITECT® STAT MYO is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of MYO in human serim and plasma on the ARCHITECT® i System with STAT protocol capability.

#### Description of the Device:

The ARCHITECT® STAT Myoglobin assay is a two-step immunoassay for the quantitative determination of myoglobin in human serum and plasma using CMA technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample and anti-myoglobin coated paramagnetic microparticles are combined and incubated. Myoglobin present in the sample binds to the anti-myoglobin coated microparticles. After washing, antimyoglobin acridinium labeled conjugate is added in the second step. Following another incubation and wash, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of myoglobin in the sample and the RLUs detected by the ARCHITECT® I* system optics.

* i = immunoassay

T = Immunoadsorbent

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#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: 7.4

The ARCHITECT® STAT MYO and the AxSYM® MYO assays use a microparticle man The ARCHITECT - STAT MTO and and myoglobin (MYO) in human serum or plasma. Anti-microbial agent is used as a presentative for all reagent Serum or plasma. "Anti-microbial" agent "is "assure MYO assay as well as the Both assays have microparticles coated with mouse i ARCHITECT® STAT MYO. monoclonal anti-MYO in TRIS buffer.

Myoglobin is a tightly folded, globular heme-protein located in the cytoplasm of both Myoglobin is a tightly foldod, grobular netio is to store and supply oxygen to muscle The skeetar and cardiac moscie coller to approximately 17,800 daltons."4 The cells. The Tholecular weight of Thyogrooming of storage accounts for the rapid release from damaged muscle cells and ener rises in concentration measured above baseline in blood as compared to other cardiac markers.13.4

In blood as compared to other ourside manceres and infarction (MI), a temporal pattern of in Tischemic Treat Tulogos, Saun athe blood stream is observed. The serum or plasma increased in level will start to show an increase between 2-4 hours after an M1 has myoglobili lever will otal to ately 8-10 hours, and returning to baseline after 24 hours. occurred, peaking at approximated 2-12 hours after an MI can be a good adjunct to Measurement of Thyogoolir Between 2 12 from and early diagnosis of MM. 158 electrocardiography (1507 m therapy.6,7

therapy.
Since myoglobin is present in both cardiac and skeletal muscle, any damage to either of Since myoglobin is proom in belease into the blood stream. Elevated serum levels of these thasse types robations in the following conditions: skeletal muscle damage, Myoglobin have been oboorrou diacolisorders, cardiac bypass surgery, renal failure, strenuous exercise. 2,5,8

stichaous exeralo.
Therefore, serum myoglobin levels should be used in conjunction with other aspects of Therefore, Seram inyoglobin to the diagnosis of an Mi. Myoglobin may also rise the patiers above the reference range in chronic ischemic heart disease (i.e. unstable moderalely above the foremoses, the ARCHITECT® STAT Myoglobin assay results angina). Tor alaghoodio parpossyith other data; e.g., other clinical testing, ECG, symptoms, clinical observations. 8.

#### SUMMARY OF NON-CLINICAL PERFORMANCE: 7.5

The ARCHITECT® STAT MYO assay is substantially equivalent to the Abbott AxSYM® MYO assay in terms of precision, linearity, interferences, and stability as demonstrated in non-clinical performance data in this 510(k) submission.

#### SUMMARY OF CLINICAL PERFORMANCE: 7.6

The ARCHITECT® STAT MYO assay demonstrated substantially equivalent to the AxSYM® MYQ assay. The sample stability study evaluated ARCHITECT® STAT MYO assay using Lithium Heparin and Serum Separator collection tubes. There was no systematic gain or loss of the detectability of MYO in serum or plasma samples under any of the storage conditions evaluated in this study. A method comparison using the any of the storage vonditions evaluate (EP-9A) was also conducted with the ARCHITECT®

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ARCHITECT® STAT MYO Assay Oct. 20, 2004

> STAT MYO and AxSYM® MYO assays and as a result, the two systems demonstrated substantial equivalence as indicated by clinical data in this 510(k) submission.

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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 features a stylized eagle with three bars representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

JAN 2 4 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Josefina Infantas Sr. Regulatory Affairs Specialist Fisher Diagnostics 8365 Valley Pike PO Box 307 Middletown, VA. 22645

Re: k042924

Trade/Device Name: ARCHITECT®STAT Myoglobin Immunoassay Regulation Number: 21 CFR 866.5680 Regulation Name: Myoglobin immunological test system Regulatory Class: Class II Product Code: DDR, JIS Dated: December 22, 2004 Received: January 3, 2005

Dear Ms. Infantas:

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 for are world 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 adulteration.

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 (QS) 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/industry/support/index.html

Sincerely yours,

Carol Benson fer

Jean M. Cooper, MS. D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

| 510(k) Number: | k042924 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | ARCHITECT® STAT Myoglobin Immunoassay |
| Indications For Use: | ARCHITECT STAT MYOGLOBIN is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Myoglobin in human serum and plasma on the ARCHITECT i System with STAT protocol capability. Myoglobin values are used to assist in the diagnosis of myocardial infarction (MI).<br>The ARCHITECT STAT MYOGLIBIN Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of myoglobin in human serum or plasma. |

Over-The-Counter Use Prescription Use × ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol C. Benson
Division Sign-Off

Offro e la vitro Diagnostic Date a Lychuation and Safety

5100: K042924