For use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) in human heparin plasma.

Device Description

The Vitros Troponin I assay is performed using the Vitros Troponin I Reagent Pack and Vitros Immunodiagnostic Products Troponin I Calibrators on the Vitros ECi Immunodiagnostic System with Intellicheck ™ . An immunometric technique is used. Cardiac Troponin I present in the sample reacts simultaneously with a biotinylated antibody (mouse monoclonal anti-cTnI) and a horseradish peroxidase (HRP)-labeled antibody conjugate (affinity purified goat polyclonal anti-cTnI). The antigen-antibody complex is captured by streptavidin on the wells. Unbound materials are removed by washing. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent (a substituted acetanilide) is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The light signals are read by the Vitros ECi System. The amount of HRP conjugate bound is directly proportional to the concentration of cTnI present in the sample.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary, which often focuses on substantial equivalence rather than detailed performance studies and acceptance criteria as might be found in a full efficacy report. Therefore, some of the requested information (like specific effect sizes for MRMC, sample sizes for test sets, and detailed expert qualifications) is not present in this type of document. I will extract what is available and indicate when information is missing.

Acceptance Criteria and Device Performance Study

The provided document describes the Vitros Troponin I assay, intended for the in vitro quantitative measurement of Troponin I (cTnI) in human heparin plasma to aid in the diagnosis of myocardial infarction. A key focus of this submission is a modification to the assay's interpretation of results, specifically introducing a repeat testing algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria in a quantitative table. Instead, it describes a "modification to the interpretation of results" which aims to "minimize the likelihood of an end user obtaining an occasional falsely elevated non repeatable result." The implicit performance objective is to reduce false positives, particularly those that are non-repeatable.

Acceptance Criteria (Implied)	Reported Device Performance
Reduction of false elevated non-repeatable results.	The introduction of a repeat testing algorithm "minimizes the likelihood of an end user obtaining an occasional falsely elevated non repeatable result." This ensures "non-biased results."
Assurance of reporting non-biased results.	The new algorithm provides "further assurance of reporting non biased results."
Addressing concern for diagnostic decisions based on single results above URL (0.08 ug/ml).	Addresses concern "in cases where a diagnostic decision... is based on a single result obtained on a patient above the URL of 0.08 ug/ml."

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

The document does not provide specific details on the sample size used for a test set to evaluate the modified algorithm, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective nature) for this particular study. The submission focuses on the modification of interpretation for an already cleared device.

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 document primarily discusses an analytical modification to an in vitro diagnostic device, not a diagnostic imaging or algorithmic interpretation task that would typically rely on expert ground truth for a test set in the same manner.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

An MRMC study was not done as this is an in vitro diagnostic assay and the modification concerns an algorithm for interpreting results, not human reader performance with or without AI assistance. This type of study is not applicable to the device described.

6. If a Standalone Study Was Done

The modification described is inherently standalone in its nature, as it's an algorithm applied to the device's output to "interpret results" before they are reported. The modification itself is the algorithm "without human-in-the-loop performance" for its direct application. However, the document does not detail a specific "standalone study" with quantifiable metrics for this new algorithm beyond the statement of its intended effect. The original performance characteristics of the assay itself would have been established in the previous K020662 submission, but those details are not provided here.

7. The Type of Ground Truth Used

Given that this is an in vitro diagnostic assay for cardiac Troponin I (cTnI) to aid in the diagnosis of myocardial infarction, the ground truth for establishing the original assay's performance would likely have involved:

Clinical Diagnosis: Patients with a confirmed diagnosis of myocardial infarction (based on clinical presentation, ECG changes, other cardiac biomarkers, and potentially imaging).
Reference Methods: Comparison against established and validated laboratory methods for measuring cTnI, if applicable, or against a detailed clinical "truth" ascertained by a panel of clinicians.

For the modification described in this 510(k), which pertains to minimizing "falsely elevated non repeatable results," the implicit ground truth would involve:

Repeatability/Precision Studies: Assays of the same sample run multiple times to assess repeatability. A result would be "false elevated non-repeatable" if an initial elevated reading could not be consistently replicated in subsequent tests of the same sample, and the patient's clinical status did not support an actual elevation.

The document does not explicitly state the ground truth methodology for this specific modification study.

8. The Sample Size for the Training Set

The document does not contain information regarding a training set sample size. This type of information is typically associated with machine learning models. The modification described appears to be an algorithmic rule for interpretation rather than a learned model.

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

Since there is no mention of a training set, this information is not applicable from the provided text.

Summary

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GENERAL INFORMATION 1.0

FEB 2 1 ZUO3

1.1 510(k) Summary

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.

K024193

The assigned 510(k) number is

1.1.1. Submitter Name, Address, Contact

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (585) 453-4152

Contact Person: Ann M Quinn

1.1.2. Preparation Date

Date 510(k) prepared: December 19, 2002

1.1.3. Device Name

Trade or Proprietary Name: VITROS Immunodiagnostic Products Troponin I Reagent Pack VITROS Immunodiagnostic Products Troponin I Calibrators

: TROPONIN I assay Common Name Classification Name: Troponin I (cTnI) Test System

1.1.4. Predicate Device

The VITROS Immunodiagnostic Products Troponin I Reagent Pack and VITROS Immunodiagnostic Products Troponin I Calibrators are substantially equivalent to the The VITROS Immunodiagnostic Products Troponin I Reagent Pack and VITROS Immunodiagnostic Products Troponin I Calibrators (K020662).

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1.1.5. Device Description

1.1.6. Device Intended Use

The VITROS Troponin I assay is intended for the in vitro quantitative measurement of Troponin I (cTnI) in human heparin plasma to aid in the diagnosis of myocardial infarction.

1.1.7. Comparison to Predicate Device

The VITROS Immunodiagnostic Products Troponin I Reagent Pack and VITROS Immunodiagnostic Products Troponin I Calibrators as modified, are substantially equivalent to the VITROS Immunodiagnostic Products Troponin I Reagent Pack and VITROS Immunodiagnostic Products Troponin I Calibrators which was cleared by the FDA (K020662) for IVD use.

A modification to the interpretation of results for the assay is being provided to give users further assurance of reporting non biased results.

1.1.8 Conclusions

Introducing a repeat testing algorithm for the VITROS Troponin I Assay minimizes the likelihood of an end user obtaining an occasional falsely elevated non repeatable result. This may be of particular concern in cases where a diagnostic decision resulting in medical intervention is based on a single result obtained on a patient above the URL of 0.08 ug/ml.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a bird or dove with three wavy lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird image.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 2 1 2003

Ms. Ann M. Quinn, RAC Manager, Regulatory Affairs Ortho Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626-5101

Re: K024193

Trade/Device Name: VITROS Immunodiagnostic Products Troponin I Reagent Pack VITROS Immunodiagnostic Products 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; JIS Dated: December 19, 2002 Received: December 20, 2002

Dear Ms. Quinn:

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).

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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 (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.

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Statement of Intended Use 1.2

K024193

Page 1 of 1

510(k) Number (if known):

Device Name:

VITROS Immunodiagnostic Products Troponin I Reagent Pack

VITROS Immunodiagnostic Products Troponin I Calibrators

Indications for Use:

For the in vitro quantitative measurement of Troponin I (cTnI) in human heparin plasma to aid in the diagnosis of myocardial infarction.

For use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) in human heparin plasma.

Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K024193

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _

(Optional Format 1-2-96)

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.