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

The ARCHITECT STAT Troponin-I Calibrators are for calibration of the ARCHITECT i 2000SR System when used for the quantitative determination of cardiac Troponin-I in human serum or plasma.

Device Description

The ARCHITECT STAT Troponin-I assay is a two-step assay to determine the presence of cardiac troponin-I in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex®.

In the first step, sample, assay diluent and anti-troponin-l antibody-coated paramagnetic microparticles are combined. After incubation and washing, anti-troponin-l 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 chemilyminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of troponin-I in the sample and the RLUs detected by the ARCHITECT i system optics. The concentration of troponin-I is read relative to a standard curve established with calibrators of known troponin-l concentration.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ARCHITECT® STAT Troponin-I Assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in terms of specific performance thresholds for sensitivity, specificity, or other metrics. Instead, it frames the acceptance criteria implicitly as demonstrating "substantial equivalence" to a predicate device.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Precision	Substantially equivalent to the ACCESS® AccuTnl assay	Demonstrated substantial equivalence
Linearity	Substantially equivalent to the ACCESS® AccuTnl assay	Demonstrated substantial equivalence
Interferences	Substantially equivalent to the ACCESS® AccuTnl assay	Demonstrated substantial equivalence
Stability	Substantially equivalent to the ACCESS® AccuTnl assay	Demonstrated substantial equivalence; "no systematic gain or loss of the detectability of troponin-I in serum or plasma samples under any of the storage conditions evaluated"
Sensitivity	Substantially equivalent to the ACCESS® AccuTnl assay at the optimal AMI "cut-off" of 0.30 ng/mL	Demonstrated substantial equivalence
Specificity	Substantially equivalent to the ACCESS® AccuTnl assay at the optimal AMI "cut-off" of 0.30 ng/mL	Demonstrated substantial equivalence
Method Comparison	Two systems (ARCHITECT STAT Troponin-I and ACCESS AccuTnl) demonstrate substantial equivalence.	Demonstrated substantial equivalence

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

The document does not explicitly state the sample size used for the clinical test set. It mentions "clinical data in this 510(k) submission" and a "sample stability study." However, specific numbers for patients or samples are not provided.

The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. It refers to "clinical data" which typically implies human samples.

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

The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set. The comparison is made against a predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This device is an in-vitro diagnostic assay, not an imaging or interpretation system that would typically involve multiple human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is an in-vitro diagnostic (IVD) assay, which by nature operates as a standalone algorithm (the ARCHITECT i System) to determine troponin-I concentration. The performance described (precision, linearity, sensitivity, specificity) is inherent to the assay and the instrument, without a human-in-the-loop performance component in the traditional sense of AI system evaluation. The output is a quantitative value used by clinicians for diagnosis.

7. Type of Ground Truth Used

The ground truth for evaluating the ARCHITECT® STAT Troponin-I assay's performance (specifically sensitivity and specificity for MI diagnosis) is implicitly established by comparison to the ACCESS® AccuTnl Assay as a predicate device, using an "optimal AMI 'cut-off' of 0.30 ng/mL." This suggests that the ground truth for MI diagnosis with respect to troponin-I levels was derived from established clinical criteria and comparison to a legally marketed equivalent device, rather than pathology or long-term outcomes data explicitly.

8. Sample Size for the Training Set

The document does not provide information on the sample size for any training set. This is typical for an IVD assay where development often involves calibration and validation with characterized samples rather than a "training set" in the machine learning sense.

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

Since no "training set" is explicitly mentioned in the context of machine learning, the establishment of its ground truth is not applicable or described in this document. The assay's "ground truth" implicitly refers to the accuracy and reliability of its quantitative measurements of cTnl compared to established methods and its ability to assist in MI diagnosis per clinical standards.

Summary

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ARCHITECT® STAT Troponin- I Assay May 5, 2004

sher Diagnostics A Fisher Scientific Company

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.

AUG 1 2 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 Troponin-I immunoassay Proprietary/Trade Name: ARCHITECT® STAT Troponin-I immunoassay Common Name: Troponin-I test system Device Classification: Class II Governing Regulation: 21 CFR 862.1215 FDA Panel: Clinical Chemistry (75) Product Code: MMI

Identification of Predicate Device:

Access® AccuTnl Assay (K021814)

Intended Use of the Device:

Description of the Device:

Image /page/0/Picture/19 description: The image shows a handwritten alphanumeric string. The string is "K041192". The characters are written in a simple, slightly irregular style, suggesting they were written quickly or by someone without formal calligraphy training. The background is plain white.

A Fisher Scientific Company 8365 Valley Pike P.O. Box 307 Middletown, VA 22645-0307

540-869-3200 Tel: Fax: 540-869-5249

fishersci.com

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ARCHITECT® STAT Troponin- I Assay May 5, 2004

relative to a standard curve established with calibrators of known troponin-l concentration.

Comparison of Technological Characteristics:

The ARCHITECT® STAT Troponin-I and the ACCESS® AccuTnl assays use a The ANOTH EST of CMA trioperimmunoassay (CMIA) method for the quantitative determination of cardiac troponin-I in human serum and plasma. Values obtained are used to assist in the diagnosis of myocardial infarction. Proclin® 300 is a presenvative used all reagent components (microparticles, diluent and conjugate) of the ACCESS ascu an roagent computhe diluent and conjugate of the ARCHITECT STAT Troponin-i contain Proclin® 300 as a preservative. The ARCHITECT STAT Troponin-1 microparticles contain an antimicrobial agent as a preservative. Both assays have microparticles contain an antimorsenal anti-troponin-l in TRIS buffer. The conjugates both contain mouse monoclonal anti-troponin-l.

Summary of Non-clinical Performance:

The ARCHITECT® STAT Troponin-I assay is substantially equivalent to the ACCESS® AccuTnl 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 Troponin-I assay demonstrated sensitivity and specificity that is substantially equivalent to the ACCESS AccuTnl assay, using the optimal AMI "cut-off" of 0.30 ng/mL as indicated by clinical data in this 510(k) submission. The sample stability study evaluated ARCHITECT STAT Troponin-I assay using Lithium Heparin and Serum Separator collection tubes. There was no systematic gain or loss of the detectability of troponin-I in serum or plasma samples under any of the storage conditions evaluated in this study. A method comparison was also conducted with the ARCHITECT STAT Troponin-I and ACCESS AccuTnl assays and as a result, the two systems demonstrated substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a black and white logo. The logo consists of three curved lines that resemble a bird in flight. The lines are arranged in a way that they appear to be overlapping each other. The logo is surrounded by text that is arranged in a circular pattern. The text is difficult to read due to the low resolution of the image.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 2 2004

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

K041192 Re:

Ro Froz ARCHITECT STAT Troponin- I Calibrators Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI, JIT Dated: August 5, 2004 Received: August 5, 2004

Dear Ms. Infantas:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have tevice would four becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to stgms) the enactment date of the Medical Device Amendments, or to conninered pror to May 2017, in accordance with the provisions of the Federal Food, Drug, de nees that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, morelore, manns of the Act include requirements for annual registration, listing of general controls proficies gractice, 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 your device is etablifical controls. Existing major regulations affecting your device It may be subject to such additions controllations (CFR), Parts 800 to 895. In addition, FDA can be found in Title = nouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of advilsed that I Driver device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies. You must or any I cacrates and regaranents, including, but not limited to: registration and listing (21

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ogin mixing of substantial equivalence of your device to a legally premaired notincation: The PDF intembers of 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, If you destions on the promotion and advertising of your device, please contact the Office of or questions on the promotion and Safety at (301) 594-3084. Also, please note the In I the Diaglessed Dorlov by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may ovain other general messans 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,

Jain M. Cooper MS, DVM.

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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6.1 Indications for Use

ARCHITECT STAT Troponin-I is a Chemiluminescent Microparticle AHCHITECT UTAT Troponin' Hopenin' House Mation of cardiac troponin-l Infridnoussay (Owling for the quema on the ARCHITECT i System with STAT (CTTI) in numan oram and I values are used to assist in the diagnosis of myocardial infarction (MI).

The ARCHITECT STAT Troponin-I Calibrators are for calibration of the The ANOHITEOT i 2000SR System when used for the quantitative determination of cardiac Troponin-I in human serum or plasma.

510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: ARCHITECT® STAT Troponin-I Immunoassay

Over-The-Counter Use Use Prescription × (21 CFR 807 Subpart C) -- AND/OR (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

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mo Diogra

510(k) K041192

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.