The Troponin I (cTn) assay for the Opus™ Immunoassay System is used to quantitatively measure cardiac troponin I in serum and heparinized plasma to aid in the diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

Device Description

The Opus™ Troponin I (cTn) assay is a two-site or sandwich fluorogenic enzyme linked immunoassay. Dendrimer linked monoclonal antibody is precoated onto a piece of glass fiber paper in the cTn Test Module. This antibody recognizes a distinct antigenic site on the cardiac troponin I molecule.

The OpusTM System pipettes patient sample from a sample cup and dispenses it onto the glass fiber paper where it reacts with immobilized antibody. After a short incubation, a conjugate consisting of enzyme-labeled monoclonal antibody directed against a distinct antigenic site on the cardiac troponin I molecule is pipetted from a sealed well within the test module, onto the reaction zone of the paper. During a second incubation period, enzyme-labeled antibody reacts with the bound cardiac troponin I, forming an antibodyantigen-labeled antibody sandwich. A substrate wash solution is pipetted from a second sealed well on the test module, to the wash port. Unbound labeled antibody is eluted away from the optical read window of the Opus™ System through lateral capillary action. The substrate, 4-methylumbelliferyl phosphate is included within the wash solution allowing simultaneous substrate conversion with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of cardiac troponin I in the sample. The reaction rate can then be measured by the instrument's optical system.

AI/ML Overview

The provided document is a 510(k) premarket notification for an in vitro diagnostic device, the Opus™ Troponin I (cTn) Test Modules. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or threshold format. Instead, it uses a substantial equivalence approach, comparing the performance of the new device to a legally marketed predicate device. The primary performance metric reported is a correlation between the two devices.

Metric	Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (Opus™ Troponin I vs. Dimension® RxL Troponin I)
Correlation Coefficient (r)	High correlation (close to 1)	0.9856
Slope	Close to 1.0	1.01
Intercept	Close to 0 ng/mL	0.1516 ng/mL
Principle of procedure	Similar to predicate	Sandwich format monoclonal antibody immunoassay
Monoclonal Antibodies (Tag)	Identical to predicate	2B1.92F6.6
Type of measurement	Similar function (quantitative)	Fluorogenic (Predicate: Colorimetric)
Solid Support	Similar function (platform)	Glass fiber paper (Predicate: Chromium Oxide)
Specimen type	Identical to predicate	serum or heparinized plasma
Sample Size	Appropriate for method	25µL (Predicate: 60µL)
Intended Use	Identical to predicate	Same stated intended use
Indications for Use	Identical to predicate	Same stated indications for use

Note: The acceptance criteria are "implied" because the document states the device is "substantially equivalent in principle and performance" based on the comparison metrics. A correlation coefficient of 0.9856, a slope of 1.01, and an intercept of 0.1516 ng/mL between the two methods are considered strong evidence for substantial equivalence in the context of clinical immunoassay comparisons.

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

Sample Size for Test Set: 132 clinical patient samples.
Data Provenance:
- Country of Origin: Not explicitly stated.
- Retrospective or Prospective: Not explicitly stated, but the phrase "clinical patient samples ranging from 0.16 - 45.95 ng/mL" suggests real-world samples, the collection method (retrospective or prospective) is not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of information is not applicable to this submission. The study is a method comparison study (split sample comparison) comparing a new device (Opus™) to a predicate device (Dimension® RxL Troponin I). The "ground truth" for the test set is effectively the result provided by the predicate device, or a reference method if the predicate was also being validated against one. There is no mention of human experts interpreting results or establishing a "ground truth" classification for the samples in this context.

4. Adjudication Method for the Test Set

Not applicable. As this is a method comparison study between two analytical devices, rather than a diagnostic interpretation study involving human readers, there is no expert adjudication process described.

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

No, a MRMC study was not done. This document describes the analytical performance of an in vitro diagnostic device, not the interpretive performance of human readers, with or without AI assistance. Therefore, there is no discussion of human reader improvement with AI.

6. Standalone Performance Study

Yes, a form of standalone performance was implicitly done. The "split sample comparison" tests the Opus™ device in its intended operational mode, providing quantitative results directly comparable to the predicate device. The results (correlation, slope, intercept) demonstrate the analytical standalone performance characteristics of the Opus™ device when analyzing patient samples.

7. Type of Ground Truth Used

The "ground truth" in this context is established by the predicate device, the Dimension® RxL Troponin I assay. The study implicitly assumes the predicate device provides accurate measurements of cardiac troponin I, and the goal of the Opus™ device is to provide quantitatively similar results.

8. Sample Size for the Training Set

Not applicable. This device is an immunoassay system, not an AI/ML-based diagnostic algorithm that requires a "training set." The system's performance is based on its chemical and optical principles, not on learned patterns from a training dataset.

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the described device.

Summary

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JUL - 1 1999

K 991177

DADE BEHRING

DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714

. . . . . . . . . . . . . .

Summary of Safety and Effectiveness Information

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.

Submitter's Name:

Rebecca S. Ayash Dade Behring Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark, DE 19714-6101 Phone: (302) 631-6276 FAX: (302) 631-6299

Date of Preparation: 4/6/99

Device Name: Opus™ Troponin I (cTn) Test Modules

Classification Name: Immunoassay Method, Troponin Subunit

Predicate Device: Dimension® RxL Troponin I Flex™ Reagent Cartridge

Device Description: The Opus™ Troponin I (cTn) assay is a two-site or sandwich fluorogenic enzyme linked immunoassay. Dendrimer linked monoclonal antibody is precoated onto a piece of glass fiber paper in the cTn Test Module. This antibody recognizes a distinct antigenic site on the cardiac troponin I molecule.

Intended Use: The Troponin I (cTn) assay for the Opus™ Immunoassay System is used to quantitatively measure cardiac troponin I in serum and heparinized plasma to aid in the

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diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

Item	Opus™ Troponin I	Dimension® RxL Troponin I
Principle of procedure	Sandwich format monoclonal antibody immunoassay	Sandwich format monoclonal antibody immunoassay
Monoclonal Antibodies
TagCapture	2B1.92F6.6	2B1.92F6.6
Type of measurement	Fluorogenic	Colorimetric
Solid Support	Glass fiber paper	Chromium Oxide
Specimen type	serum or heparinized plasma	serum or heparinized plasma
Sample Size	25µL	60µL
Intended Use	For the quantitative determination of cardiac troponin-I levels in serum and heparinized plasma	For the quantitative determination of cardiac troponin-I levels in serum and heparinized plasma
Indications for Use	To aid in diagnosis of myocardial infarction and to aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality	To aid in diagnosis of myocardial infarction and to aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality

Comparison to Predicate Device:

Comments on Substantial Equivalence: Split sample comparison between the Opus™ c Tn assay and the Dimension® RxL Troponin I assay gave a correlation coefficient of 0.9856, slope of 1.01 and an intercept of 0.1516 ng/mL when tested with 132 clinical patient samples ranging from 0.16 - 45.95 ng/mL.

Conclusion: The Opus™ Troponin assay is substantially equivalent in principle and performance to the Dimension® RxL Troponin I assay based on the split sample comparison summarized on the previous page.

Rebecca S. Aypsh

Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 4/6/99

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Image /page/2/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 human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL - 1 1999

Ms. Rebecca S. Avash Regulatory Affairs and Compliance Manager DADE BEHRING INC. Glasgow Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714

Re: K991177

Trade Name: Opus™ Troponin I (cTn) Test Modules Regulatory Class: II Product Code: MMI Dated: June 15, 1999 Received: June 17, 1999

Dear Ms. Ayash:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and addition ally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Steven Gutman

Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications Statement

Device Name: Opus™ Troponin I (cTn) Test Modules

Indications for Use: The Troponin I (cTn) assay for the Opus™ Immunoassay System is a device used to measure cardiac troponin I in serum and heparinized plasma to aid in the diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K-991171

Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 4/6/99

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K991177

510(k) Number

eantoos

Division Sign-Off Office of Device Evaluation

Prescription Use

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.