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 Description

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ARCHITECT® STAT CK-MB immunoassay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Substantial Equivalence	To demonstrate substantial equivalence to the predicate device (Abbott AxSYM® CK-MB Assay).	Achieved. The device "demonstrated substantially equivalent to the AxSYM® CK-MB assay" in clinical performance and "is substantially equivalent...in terms of precision, linearity, interferences, and stability" in non-clinical performance.
Precision	Not explicitly stated as a numerical criterion, but evaluated.	Demonstrated substantial equivalence to the predicate.
Linearity	Not explicitly stated as a numerical criterion, but evaluated.	Demonstrated substantial equivalence to the predicate.
Interferences	Not explicitly stated as a numerical criterion, but evaluated.	Demonstrated substantial equivalence to the predicate.
Stability (Sample)	No systematic gain or loss of detectability of CK-MB in serum or plasma samples under various storage conditions.	Achieved. "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."
Stability (Assay)	Not explicitly stated as a numerical criterion, but evaluated.	Demonstrated substantial equivalence to the predicate.
Method Comparison	Demonstrated substantial equivalence to the predicate based on the NCCLS Bias Estimation Standard (EP-9A).	Achieved. "the two systems demonstrated substantial equivalence as indicated by clinical data."

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

Sample Size: The document does not explicitly state the exact sample size for the test set used in the clinical performance study. It mentions a "sample stability study" and a "method comparison using the NCCLS Bias Estimation Standard (EP-9A)" which imply a test set was used, but the number of samples is not provided.
Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the data 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 provided in the document. The study involved a comparison against a predicate device (AxSYM® CK-MB assay), and the "ground truth" for the test samples would have been the results obtained from the predicate device or a clinical outcome implicitly associated with CK-MB levels. There's no mention of a ground truth established by external experts.

4. Adjudication Method for the Test Set

This information is not provided in the document. Since the "ground truth" was based on comparison to a predicate device, an explicit expert adjudication method for the test set is unlikely to have been employed in the traditional sense (e.g., multiple experts reviewing and reaching consensus).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This device is an immunoassay (a lab test), not an AI-assisted diagnostic imaging device or an AI system designed to aid human readers. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is a standalone diagnostic test. The ARCHITECT® STAT CK-MB immunoassay is a device that itself performs the quantitative determination of CK-MB from a sample. It generates a numerical result, which is then interpreted by clinicians. It does not involve a human-in-the-loop performance analysis in the context of an algorithm. Its performance is evaluated compared to a predicate device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The primary "ground truth" used for evaluating the ARCHITECT® STAT CK-MB assay was the results obtained from the predicate device, the Abbott AxSYM® CK-MB Assay. The study aimed to demonstrate substantial equivalence, meaning the new device's measurements correlated well with the established predicate. The clinical utility of CK-MB values (used to assist in the diagnosis of MI) represents the broader clinical "ground truth" for both devices.

8. The Sample Size for the Training Set

This information is not applicable/provided in the context of this device's development. Immunoassays are not "trained" in the same way machine learning models are. Their performance is established through rigorous analytical and clinical validation studies using samples, not through a "training set" for an algorithm.

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

This information is not applicable as there is no "training set" in the context of an immunoassay. The development and validation of an immunoassay rely on established chemical reactions, antibodies, and measurement principles, with performance characterized through analytical studies and comparison to established methods.

Summary

{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: 540-869-8158 Fax: 540-869-8129

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:

Description of the Device:

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 (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,

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

Regulation Number and Section

§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.

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