For the in vitro quantitative measurement of Troponin I (cTnI) in human serum or plasma (EDTA or heparin), 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 serum and plasma (EDTA or heparin).

Device Description

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: 1. The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products Troponin I Reagent Pack, VITROS Immunodiagnostic Products Troponin I Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the ... VITROS Troponin I assay, and VITROS Immunodiagnostic Products High Sample Diluent B). Note: High sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total B-hCG Reagent Pack and VITROS Immunodiagnostic Products Total B-hCG Calibrators 510(k) premarket notification (K970894). 2. The VITROS Immunodiagnostic System - instrumentation. which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919). 3. Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310). The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

AI/ML Overview

The provided text details the 510(k) summary for the VITROS Immunodiagnostic Products Troponin I Reagent Pack and Calibrators. This document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a full study report with detailed acceptance criteria and performance against those criteria as would be found in a clinical trial.

Based on the provided information, a complete table of acceptance criteria and reported device performance with numerical metrics cannot be fully constructed for independent standalone performance (i.e. algorithm only without human-in-the loop performance). However, I can extract the information related to the comparison study.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance (as much as can be extracted):

Characteristic	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (VITROS Troponin I assay)
Correlation to Predicate Device	Substantially equivalent performance to the DADE Dimension™ RxL Cardiac Troponin-I (TROP) Method. This implies a strong linear relationship and good agreement in measurements.	VITROS Troponin I assay = 1.05 x X - 0.151 (ng/mL), where X is DADE Dimension RxL Cardiac Troponin-I assay. Spearman rank correlation coefficient of 0.983.
Calibration Range	Expected to be comparable or better than the predicate device.	0-100 ng/mL
Basic Principle	Solid phase immunoassay with enzyme-labeled tracer and mouse monoclonal anti-Troponin I antibody.	Matches the predicate device: Solid phase immunoassay with enzyme-labeled tracer and mouse monoclonal anti-Troponin I antibody (Biotinylated antibody reagent), with goat polyclonal anti-Troponin I antibody (HRP-Conjugate reagent).
Sample Type	Serum and plasma (heparin).	Serum and plasma (EDTA or heparin). (Wider range of sample types than predicate)
Sample Volume	60 μL	50 μL (Lower volume than predicate)
Incubation Time and Temperature	5.4 minutes at 37°C	8 minutes at 37°C
Intended Use	Aid in the diagnosis of myocardial infarction through quantitative measurement of Troponin I.	Matches the predicate device.

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

Sample Size: The document states that the relationship between the VITROS Troponin I assay and the DADE Dimension RxL Cardiac Troponin-I assay was determined from a "panel of patient samples from a variety of clinical categories." However, the specific number of samples (sample size) used for this correlation study is not provided.
Data Provenance: The text does not explicitly state the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, though the use of "patient samples" for a correlation study often implies retrospective analysis of collected samples.

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

Not Applicable / Not Provided: For this type of in vitro diagnostic device (immunoassay for cardiac markers), the "ground truth" is typically established by the quantitative measurement of Troponin I itself, often through the predicate device or a reference method. It does not involve human expert interpretation (e.g., radiologists assessing images). Therefore, there is no mention of experts establishing a ground truth for a test set in the context of human interpretation.

4. Adjudication Method for the Test Set:

Not Applicable / Not Provided: As the "ground truth" for this device is based on quantitative chemical measurement, adjudication methods like 2+1 or 3+1 (common in image interpretation studies) are not relevant or discussed. The primary "adjudication" is the chemical measurement itself, and the comparison is statistical.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable: This device is an in vitro diagnostic assay (a laboratory test kit), not an AI-powered diagnostic tool for interpretation by human readers. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, this is an inherently standalone device. The VITROS Immunodiagnostic System, using the VITROS Troponin I assay, performs the quantitative measurement of Troponin I. This is an automated process without human intervention in the actual measurement or interpretation of the raw signal to produce the Troponin I concentration. The device itself provides the final quantitative result. The study of substantial equivalence directly assessed the performance of this device (algorithm/system) against the predicate device.

7. The type of ground truth used:

The ground truth for demonstrating equivalence was the quantitative measurement results obtained from the predicate device (DADE Dimension™ RxL Cardiac Troponin-I (TROP) Method). The VITROS Troponin I assay's measurements were compared against these predicate measurements.

8. The Sample Size for the Training Set:

Not Provided / Not Applicable (in the traditional machine learning sense): As this is an immunoassay device, the concept of a "training set" in the context of machine learning (where an algorithm learns from data) does not directly apply. The device's performance characteristics (calibration range, precision, analytical sensitivity, specificity) are established through analytical validation studies during its development, not by training an algorithm on a dataset in the way an AI would be. The document mentions "currently commercially available reagents" and patient samples for the correlation study, which serves as a validation set.

9. How the Ground Truth for the Training Set was Established:

Not Applicable (as per point 8): Since there isn't a "training set" in the machine learning sense, the establishment of its ground truth is not applicable. The assay's analytical characteristics are determined through standard laboratory procedures and reference materials.

Summary

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Chapter 1 - Summary Information

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.

The assigned 510(k) number is: 1993300.

1: - Submitter --------------------------------------------------------------------------------------------------------------------------------------------------------------name, 100 Indigo Creek Drive address. Rochester, New York 14626-5101 contact (716) 453-4041

Contact Person: Marlene Shulman

Date 510(k) prepared: 14th July 1999 2. Preparation date
Trade or Proprietary Name: 3. Device VITROS Immunodiagnostic Products Troponin I Reagent Pack name VITROS Immunodiagnostic Products Troponin I Calibrators

Common Name : TROPONIN I assay Classification Name: Immunoassay Method, Troponin Subunit

The VITROS Immunodiagnostic Products Troponin I Reagent Pack and 4. Predicate device VITROS Immunodiagnostic Products Troponin I Calibrators are substantially equivalent to the DADE Dimension™ RxL Cardiac Troponin-I (TROP) Method.

Continued on next page

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510(k) Summary. Continued

The VITROS Immunodiagnostic System uses luminescence as the signal in 5. Device description the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: 1. The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products Troponin I Reagent Pack, VITROS Immunodiagnostic Products Troponin I Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the ... VITROS Troponin I assay, and VITROS Immunodiagnostic Products High Sample Diluent B). Note: High sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total B-hCG Reagent Pack and VITROS Immunodiagnostic Products Total B-hCG Calibrators 510(k) premarket notification (K970894). 2. The VITROS Immunodiagnostic System - instrumentation. which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919). 3. Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k)
Continued on next page

premarket notification (K964310).

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510(k) Summary, Continued

5. Devicedescription,Continued		The VITROS System and common reagents are dedicated specifically for useonly with the VITROS Immunodiagnostic Products range of immunoassavproducts.
6.	Deviceintendeduse	The VITROS Troponin I assay is intended for the in vitro quantitativemeasurement of Troponin I (cTnI) in human serum or plasma (EDTA orheparin), to aid in the diagnosis of myocardial infarction.
7.	Comparisonto predicatedevice	The VITROS Immunodiagnostic Products Troponin I Reagent Pack andVITROS Immunodiagnostic Products Troponin I Calibrators aresubstantially equivalent to the DADE Dimension RxL Cardiac Troponin-I(TROP) Method which was cleared by the FDA (K973650) for IVD use.
		The relationship between the VITROS Troponin I assay and the DADEDimension RxL Cardiac Troponin-I assay, determined by Passing andBablok Regression, is:
		VITROS Troponin I assay = 1.05 x X - 0.151 (ng/mL),with a Spearman rank correlation coefficient of 0.983,where X is DADE Dimension RxL Cardiac Troponin-I assay.
		This relationship was determined from a panel of patient samples from avariety of clinical categories.
		In addition to the above mentioned correlation study, studies were performedto determine the precision, analytical sensitivity, specificity and expectedvalues of the VITROS Troponin I assay, (refer to the VITROS Troponin IReagent Pack package insert for summaries of the results of these studies).
		Table 1 lists the characteristics of the assays performed using the VITROSTroponin I assay and the DADE Dimension RxL Cardiac Troponin-I Assay.
Device	VITROS Troponin I	DADE Dimension RxL
Characteristic	assay	Cardiac Troponin-I
Calibration range	0-100 ng/mL	0-50 ng/mL
Basic principle	Solid phase immunoassay	Solid phase immunoassay
Tracer	Enzyme labeled	Enzyme labeled
Antibody	Mouse monoclonal anti-Troponin I antibody(Biotinylated antibodyreagent).Goat polyclonal anti-Troponin I antibody(HRP-Conjugate reagent).	Mouse monoclonal anti-Troponin I antibody (inAntibody Tablets andConjugate).
Instrumentation	VITROSImmunodiagnosticSystem	DADE Dimension RxLclinical chemistry system
Sample type	Serum and plasma(EDTA or heparin).	Serum and plasma(heparin).
Sample volume	50μL	60μL
Incubation time andtemperature	8 minutes at 37°C	5.4 minutes at 37°C

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

Continued on next page

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510(k) Summary, Continued

の 2007年 10月 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時

1. Comparison Table 1 to predicate device, Continued
  .

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

Continued on next page

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510(k) Summary, Continued

The data presented in the pre-market notification demonstrate that the 8. Conclusions performance of the VITROS Troponin I assay is substantially equivalent to the cleared predicate device.

Equivalence was demonstrated using currently commercially available reagents along with patient samples covering a variety of clinical categories.

The data presented in the premarket notification provide a reasonable assurance that the VITROS Troponin I assay is safe and effective for the stated intended use.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 8 1999

Ms. Marlene A. Shulman Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester, New York 14626-5101

Re: K992366

· Trade Name: VITROS Immunodiagnostic Products Froponin I Reagent Packs VITROS Immunodiagnostic Products Troponin I Calibrators Regulatory Class: II Product Code: MMI Dated: September 22, 1999 Received: September 23, 1999

Dear Ms. Shulman:

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 reguirements 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 additionally 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 Putman

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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Statement of Intended Use

K992366

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 serum or plasma (EDTA or heparin), 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 serum and plasma (EDTA or heparin).

Jan Cooper

(Division Sign-Off) (Division of Clinical Laboratory Devices 2 9 9236 510(k) Number -

(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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Troponin I Reagent Pack
6

VITROS Immunodiagnostic Products Troponin I Calibrators

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.