(42 days)
Not Found
No
The description details a standard immunometric assay technique and mentions "Intellicheck™" which is likely a quality control or system monitoring feature, not indicative of AI/ML for data analysis or interpretation. There is no mention of AI, ML, deep learning, or related terms, nor is there a description of training or test sets for an AI/ML model.
No
The device aids in diagnosis by measuring Troponin I levels, but does not provide treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "to aid in the diagnosis of myocardial infarction."
No
The device description clearly outlines a chemical assay performed on a physical instrument (Vitros ECi Immunodiagnostic System) using physical reagents (reagent pack, calibrators). This involves hardware and chemical processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the in vitro quantitative measurement of Troponin I (cTnI) in human heparin plasma to aid in the diagnosis of myocardial infarction." The phrase "in vitro" is a key indicator of an IVD, meaning it's used to test samples outside of the body.
- Device Description: The description details the use of "human heparin plasma" and describes an "immunometric technique" involving antibodies and reagents to measure a substance in the sample. This is characteristic of an IVD.
- Performance Studies: The performance studies involve analyzing "human heparin plasma samples" and "chest pain patients," further confirming that the device is used to test biological samples.
The entire description aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes
MMI, JIT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The upper reference limit for normals (URL) was set at 0.08 ng/mL based on a panel of 798 fresh heparin plasma samples from normal blood donors between the ages of 18-89 (61.3% male donors and 38.7% female donors collected across six sites). The observed values for the upper 97.5 percentile and the upper 99.0 percentile were 0.04 ng/mL (90% confidence interval 0.03 - 0.05 ng/mL) and 0.06 ng/mL (90% confidence interval 0.05 - 0.08 ng/mL), respectively. The URL represents the upper 90% confidence interval of the 99.0 percentile.
Data from a total of 458 chest pain patients, 78 of which were diagnosed with AMI were analyzed by Receiver Operator Characteristic (ROC) curve analysis to determine the best diagnostic cut-off for AMI using heparin plasma. The AMI cut-off was set at 0.4 ng/ml, representing a balance between sensitivity (85%) and specificity (91%).
Key Metrics
Correlation Coefficient: 0.949
Regression Equation: Vitros = 0.728 x Dade -0.093 ng/ml
Range of Samples (Vitros Troponin I Values): 0.053 – 66.9 ng/ml
Upper reference limit for normals (URL): 0.08 ng/mL
Upper 97.5 percentile: 0.04 ng/mL (90% confidence interval 0.03 - 0.05 ng/mL)
Upper 99.0 percentile: 0.06 ng/mL (90% confidence interval 0.05 - 0.08 ng/mL)
AMI cut-off: 0.4 ng/ml
Sensitivity (AMI): 85%
Specificity (AMI): 91%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
APR 1 2 2002
Attachment C - Revised 510(k) Summary
GENERAL INFORMATION 1.0
510(k) Summary 1.1
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 KO 20662
1.1.1. Submitter Name, Address, Contact
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (716) 453-4041
Contact Person: Ann M Quinn
1.1.2. Preparation Date
Date 510(k) prepared: February 28, 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 DADE Dimension™ RxL Cardiac Troponin-I (TROP) Method.
1
1.1.5. 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.
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 are substantially equivalent to the DADE Dimension RxL Cardiac Troponin-I (TROP) Method which was cleared by the FDA (K973650) for IVD use.
A comparison of the correlation data previously cleared (K992366) for Vitros Troponin I and modifications which are the subject of this Special 510 (k) are displayed in the table below.
This relationship was determined from a panel of patient samples from a variety of clinical categories.
2
| | Vitros Troponin I
K992366 | Vitros Troponin I
Modification |
|---------------------------------------------------|------------------------------------------|-------------------------------------------|
| Number of Samples | 122 | 198 |
| Correlation Coefficient | 0.983 | 0.949 |
| Regression Equation | $Vitros = 1.04 x$
$Dade -0.151 ng/ml$ | $Vitros = 0.728 x Dade$
$-0.093 ng/ml$ |
| Range of Samples
(Vitros Troponin I
Values) | 0.021 - 99.1 ng/ml | 0.053 – 66.9 ng/ml |
The upper reference limit for normals (URL) was set at 0.08 ng/mL based on a panel of 798 fresh heparin plasma samples from normal blood donors between the ages of 18-89 (61.3% male donors and 38.7% female donors collected across six sites). The observed values for the upper 97.5 percentile and the upper 99.0 percentile were 0.04 ng/mL (90% confidence interval 0.03 - 0.05 ng/mL) and 0.06 ng/mL (90% confidence interval 0.05 - 0.08 ng/mL), respectively. The URL represents the upper 90% confidence interval of the 99.0 percentile.
Data from a total of 458 chest pain patients, 78 of which were diagnosed with AMI were analyzed by Receiver Operator Characteristic (ROC) curve analysis to determine the best diagnostic cut-off for AMI using heparin plasma. The AMI cut-off was set at 0.4 ng/ml, representing a balance between sensitivity (85%) and specificity (91%).
3
A comparison of these limits from the previously cleared 510 (k) -A comparison of these animal I and the modifications which are the subject of this Special 510 (k) are displayed in the table below.
| Upper Reference Limit of Normals
(Non AMI) in ng/ml | Vitros
Troponin I
K992366 | Vitros
Troponin I
Modification |
|--------------------------------------------------------|---------------------------------|--------------------------------------|
| Serum | 0.1 | NA |
| Plasma | 0.08 | 0.08 |
| Higher Decision Limit (AMI cut-off)
in ng/ml | | |
| Serum | 1.0 | NA |
| Plasma | 0.8 | 0.4 |
Conclusions 1.1.8
The intended use as cleared in K992366 is being limited from serum, EDTA and heparin plasma to heparin plasma only. The proposed changes described in this submission provide performance characteristics in line with this specimen type. These revisions provide data that continue to support the safe and effective use of the Vitros Troponin I Reagent Pack and Calibrators for use in quantitatively measuring Troponin I concentration in heparin plasma. Expected Values and Reporting Units.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image contains the logo of the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like extensions, symbolizing care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Ms. Ann M. Quinn, RAC Manager, Regulatory Affairs Ortho Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101
APR 1 2 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K020662
Trade/Device Name: VITROS Immunodiagnostic Products Troponin I Reagent Pack and VITROS Immunodiagnostic Products Troponin I Calibrators
Regulation Number: 21 CFR § 862.1215
Regulation Name: Creatine Phosphokinase/Creatine Kinase or Isoenzymes Test System Regulatory Class: II Product Code: MMI Regulation Number: 21 CFR § 862.1150
Regulation Name: Calibrator Regulatory Class: II
Dated: February 28, 2002 Received: March 1, 2002
Product Code: JIT
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will and in you ding of substantial equivalence of your device to a legally marketed predication. 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 1 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, (201) 59 rttact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or 14.01) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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
6
CONFIDENTIAL AND PROPRIETARY
Statement of Intended Use 1.2
Page 1 of 1
510(k) Number (if known):
Device Name:
Indications for Use:
VITROS Immunodiagnostic Products Troponin I Reagent Pack
VITROS Immunodiagnostic Products Troponin I Calibrators
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.
on Sian-Off Asion of Clinical Laboratory Devices 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)