ARCHITECT STAT CK-MB IMMUNOASSAY

K041596 · Fisher Diagnostics · JHX · Jul 21, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041596
• Device Name: ARCHITECT STAT CK-MB IMMUNOASSAY
• Applicant: Fisher Diagnostics
• Product Code: JHX · Clinical Chemistry
• Decision Date: Jul 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

ARCHITECT® STAT CK-MB is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of CK-MB in human serum and plasma on the ARCHITECT i System with STAT capability. CK-MB values are used to assist in the diagnosis of myocardial infarction (MI).

Device Story

ARCHITECT STAT CK-MB is a two-step Chemiluminescent Microparticle Immunoassay (CMIA) used on the ARCHITECT i System. Input: human serum or plasma samples. Process: sample combines with anti-CK-MB coated paramagnetic microparticles; after incubation/wash, anti-CK-MB acridinium conjugate is added; after further incubation/wash, pre-trigger and trigger solutions are added to induce a chemiluminescent reaction. Output: relative light units (RLUs) measured by the ARCHITECT i optical system, which are directly proportional to CK-MB concentration. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing myocardial infarction, estimating infarct size, and assessing reperfusion status.

Clinical Evidence

Clinical performance demonstrated via method comparison study using NCCLS Bias Estimation Standard (EP-9A) against the predicate AxSYM CK-MB assay. Sample stability evaluated using Lithium Heparin and Serum Separator tubes under various storage conditions, showing no systematic gain or loss of CK-MB detectability. No clinical diagnostic sensitivity/specificity metrics provided in the summary.

Technological Characteristics

Chemiluminescent Microparticle Immunoassay (CMIA). Components: paramagnetic microparticles coated with mouse monoclonal anti-CK-MB in TRIS buffer; anti-CK-MB acridinium conjugate. Energy source: optical detection system for chemiluminescence. Connectivity: integrated with ARCHITECT i System. Form factor: reagent kit for automated analyzer. Preservative: anti-microbial agent.

Indications for Use

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

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.

Predicate Devices

• Abbott AxSYM® CK-MB Assay (k935924)

Submission Summary (Full Text)

{0}------------------------------------------------

K041596

## 6.3 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.

JUL 2 1 2004

### 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

#### Identification of Device:

Device Name: ARCHITECT® STAT CK-MB immunoassay Proprietary/Trade Name: ARCHITECT® STAT CK-MB immunoassay Common Name: CK-MB test system Device Classification: Class II Governing Regulation: 21 CFR 862.1215 FDA Panel: Clinical Chemistry Product Code: MMI THIX

#### Identification of Predicate Device:

Abbott AxSYM® CK-MB Assay (K935924)

#### Intended Use of the Device:

ARCHITECT STAT CK-MB is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of CK-MB in human serum and plasma on the ARCHITECT i System with STAT capability. CK-MB values are used to assist in the diagnosis of myocardial infarction (MI).

#### Description of the Device:

The ARCHITECT STAT CK-MB assay is a two-step assay to determine the presence of the MB isoenzyme of creatine kinase (CK-MB) in human serum and plasma using CMA technology with flexible assay protocols, referred to as Chemiflex®

In the first step, sample and anti-CK-MB coated paramagnetic microparticles are combined. After incubation and washing, anti-CK-MB acridinium 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 CK-MB in the sample and the RLUs detected by the ARCHITECT i* optical system.

#### Comparison of Technological Characteristics:

The ARCHITECT® STAT CK-MB and the AxSYM® CK-MB assays use a microparticle immunoassay method for the quantitative determination of creatine kinase (CK-MB) in human serum or plasma. Values obtained are used to assist in the diagnosis of

## Confidential

{1}------------------------------------------------

myocardial infarction. Anti-microbial agent is used as a preservative for all reagent components (microparticles and conjugate) of the AxSYM® CK-MB assay as well as the ARCHITECT STAT CK-MB. Both assays have microparticles coated with mouse monoclonal anti-CK-MB in TRIS buffer.

CK-MB is an 84,000 molecular weight enzyme that represents a significant fraction of the creatine kinase present in myocardial tissue. CK-MB is also present in a variety of other tissues, although at much lower levels. The appearance of CK-MB in serum, in the absence of major muscle trauma, may be indicative of cardiac damage and thus, myocardial infarction (MI). MI is defined as myocardial cell death due to prolonged ischemia. The magnitude and temporal course of CK-MB elevation and decline may clarify the timing of the myocardial insult, allow an estimate of infarct size, and contribute to the non-invasive assessment of reperfusion.

#### Summary of Non-clinical Performance:

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

#### Summary of Clinical Performance:

The ARCHITECT STAT CK-MB assay demonstrated substantially equivalent to the AxSYM® CK-MB assay. The sample stability study evaluated ARCHITECT STAT CK-MB assay using Lithium Heparin and Serum Separator collection tubes. There was no systematic gain or loss of the detectability of CK-MB in serum or plasma samples under any of the storage conditions evaluated in this study. A method comparison using the NCCLS Bias Estimation Standard (EP-9A) was also conducted with the ARCHITECT STAT CK-MB and AxSYM® CK-MB assays and as a result, the two systems demonstrated substantial equivalence as indicated by clinical data in this 510(k) submission.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The logo is black and white.

Public Health Service

JUL 2 1 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

k041596 Re:

Trade/Device Name: ARCHITECT® STAT CK-MB Immunoassay Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: JHX, JIS Dated: June 10, 2004 Received: June 14, 2004

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 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 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).

{3}------------------------------------------------

### 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,

Jean M. Cooper MS, DVM.

Yean 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

{4}------------------------------------------------

ARCHITECT® STAT CK-MB Assay June 9, 2004

# 6.1 Indications for Use

ARCHITECT STAT CK-MB is a Chemiluminescent Micropaticle Immunoassay (CMIA)
Chilian Children Chemical of OK MD in human serum and plasma on the ARCHITECT STAT CK-MB is a Chemilluminesoon masepara and plasma on the may on the first for the quantitative determination of CR-MB in haman occare and provinsity of the same of the Market in the
ARCHITECT i System with STAT capability. CK-MB values are used to diagnosis of myocardial infarction (MI).

510 (k) Number (if known): K041596

Device Name: ARCHITECT® STAT CK-MB Immunoassay

Use Prescription × -AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol Benson
Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K041596

Confidential

Page 74 of 113