(89 days)
No
The document describes an immunoassay system and reagents for measuring cardiac Troponin I. There is no mention of AI or ML in the intended use, device description, or performance metrics. The system appears to be a standard automated immunoassay platform.
No
This device is for in vitro diagnostic use only, measuring cardiac Troponin I to aid in the assessment of myocardial damage and risk stratification, not directly to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" for the Troponin I ES Reagent Pack, Calibrators, and Range Verifiers. Additionally, the purpose of measuring cardiac Troponin I is "to aid in the assessment of myocardial damage and risk stratification" and "aids in the diagnosis of acute myocardial infarction," which are diagnostic purposes.
No
The device description clearly outlines hardware components (VITROS Immunodiagnostic System instrumentation) and reagent packs, indicating it is not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section for all three components (Reagent Pack, Calibrators, and Range Verifiers) explicitly states "For in vitro diagnostic use only."
- Purpose: The device is intended for the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma. This is a laboratory test performed outside of the body to provide information about a patient's health status.
- Clinical Application: The results of the test are used to "aid in the assessment of myocardial damage and risk stratification," and "aids in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST-segment elevation acute coronary syndromes." These are clear diagnostic and prognostic applications.
- Components: The device includes reagents, calibrators, and range verifiers, which are all typical components of an in vitro diagnostic assay.
- System: While the VITROS Immunodiagnostic System is the instrument used to perform the assay, the reagents, calibrators, and verifiers are the core diagnostic components that interact with the patient sample.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITROS® Troponin I ES Reagent Pack:
For in vitro diagnostic use only. For the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA) using the VITROS Immunodiagnostic System, to aid in the assessment of myocardial damage and risk stratification.
Cardiac Troponin I measurement aids in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST-segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures.
VITROS® Troponin I ES Calibrators:
For in vitro diagnostic use only. For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA).
VITROS® Troponin I ES Range Verifiers:
For in vitro diagnostic use only. For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of cardiac Troponin I (cTnI).
Product codes (comma separated list FDA assigned to the subject device)
MMI, JIT, JJX
Device Description
- The VITROS Immunodiagnostic Products range of immunoassav products: VITROS Immunodiagnostic Products Troponin I ES Reagent Pack, the VITROS Immunodiagnostic Products Troponin I ES Calibrators and the VITROS Immunodiagnostic Products Troponin I ES Range Verifiers, (which are combined by the VITROS Immunodiagnostic System to perform the VITROS Troponin I ES assay), and VITROS Immunodiagnostic Products High Sample Diluent B.
- 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).
- 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).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
AMI Cut off: 0.120 ng/mL (95% sens., 93% spec.)
Spec.& Sens over time (0 to 24 hrs.): Sens. Range 69-90%, Spec. Range 94-96%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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.
Ko 62838 The assigned 510(k) number is
Submitter Name, Address, Contact 1.
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (585) 453-3730
Contact Person: Charlotte Baker
Preparation Date 2.
Date 510(k) prepared: September 20, 2006
3. Device Name
Trade or Proprietary Names: VITROS® Immunodiagnostic Products Troponin I ES Reagent Pack VITROS® Immunodiagnostic Products Troponin I ES Calibrators VITROS® Immunodiagnostic Products Troponin I ES Range Verifiers
Common Name: Troponin I assay and controls
Classification Names: Immunoassay Method, Troponin Subunit, (862.1215), Class II
Calibrator, multi-analyte mixture, (862.1150), Class II
Quality control material, (assayed and unassayed), (862.1660), Class I
1
Predicate Device 4.
The VITROS® Immunodiagnostic Products Troponin I ES Reagent Pack and Calibrators (the VITROS Troponin I ES assay) are substantially equivalent to the BECKMAN Access® AccuTnI Troponin I assay (K974075).
The VITROS® Immunodiagnostic Products Troponin I ES Range Verifiers are substantially equivalent to the VITROS Troponin I Range Verifiers (K992349).
ક. Device Description
-
- The VITROS Immunodiagnostic Products range of immunoassav products: VITROS Immunodiagnostic Products Troponin I ES Reagent Pack, the VITROS Immunodiagnostic Products Troponin I ES Calibrators and the VITROS Immunodiagnostic Products Troponin I ES Range Verifiers, (which are combined by the VITROS Immunodiagnostic System to perform the VITROS Troponin I ES assay), and VITROS Immunodiagnostic Products High Sample Diluent B.
-
- 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).
-
- 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).
Note: High Sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total ß-hCG Reagent Pack and VITROS Immunodiagnostic Products Total ß-hCG Calibrators 510(k) premarket notification (K970894).
The VITROS Immunodiagnostic System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.
Ortho-Clinical Diagnostics, Inc.
2
Device Intended Use 6.
VITROS Troponin I ES Reagent Pack:
For in vitro diagnostic use only.
For the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA) using the VITROS Immunodiagnostic System, to aid in the assessment of myocardial damage and risk stratification.
Cardiac Troponin I measurement aids in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST-segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures.
VITROS Troponin I ES Calibrators:
For in vitro diagnostic use only.
For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA).
VITROS Troponin I ES Range Verifiers:
For in vitro diagnostic use only.
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of cardiac Troponin I (cTnI).
7. Comparison to Predicate Device
The VITROS® Immunodiagnostic Products Troponin I ES Reagent Pack and Calibrators are substantially equivalent to the BECKMAN Access® AccuTnI Troponin I Reagent Pack and Calibrators (K974075).
The VITROS® Immunodiagnostic Products Troponin I ES Range Verifiers are substantially equivalent to the VITROS Troponin I Range Verifiers (K992349).
Table 1 (page 4) presents the similarities and differences of both assays.
Table 2 (page 5) presents the similarities and differences of both calibrators
Table 3 (page 5) presents the similarities and differences of both range verifiers.
3
| Similarities | ||
|---|---|---|
| Device | ||
| Characteristic | New Device-VITROS® Troponin I ES | |
| assay | Predicate Device-BECKMAN Access® | |
| AccuTnI Troponin I assay | ||
| Intended Use | For the in vitro quantitative measurement of | |
| cardiac Troponin I (cTnI) in human serum | ||
| and plasma (heparin and EDTA) using the | ||
| VITROS Immunodiagnostic System, to aid in | ||
| the assessment of myocardial damage and | ||
| risk stratification. | For the in vitro quantitative determination | |
| of cardiac troponin I (cTnI) levels in | ||
| human serum and plasma using the | ||
| Access Immunoassay Systems to aid in | ||
| the diagnosis and treatment of | ||
| myocardial infarction and cardiac muscle | ||
| damage. | ||
| Cardiac Troponin I measurement aids in the | ||
| diagnosis of acute myocardial infarction and | ||
| in the risk stratification of patients with non- | ||
| ST-segment elevation acute coronary | ||
| syndromes with respect to relative risk of | ||
| mortality, myocardial infarction (MI) or | ||
| increased probability of ischemic events | ||
| requiring urgent revascularization procedures. | Cardiac troponin I determination aids in | |
| the risk stratification of patients with | ||
| unstable angina or non-ST segment | ||
| elevation acute coronary syndromes with | ||
| respect to relative risk of mortality, | ||
| myocardial infarction, or increased | ||
| probability of ischemic events requiring | ||
| urgent revascularization procedures. | ||
| Basic Principal | Chemiluminescence Immunoassay | Chemiluminescence Immunoassay |
| Tracer | Enzyme labeled | Enzyme labeled |
| Instrumentation | Automated Immunoassay System | Automated Immunoassay System |
| Antibody | Mouse monoclonal | Mouse monoclonal |
| Sample type | Serum and plasma (heparin and EDTA) | Serum and plasma (EDTA and heparin) |
| Organizations | ||
| used/referenced | NACB, ESC/ACC/AHA, WHO | NACB, ESC/ACC/AHA, WHO |
| Lower Limit of | ||
| Detection | 0.012ng/mL | Not applicable |
| Differences | ||
| Basic principle | Solid phase immunoassay | 2-site immunoenzymatic assay |
| Sample volume | 80µL | 40µL |
| Measuring range | 0.012-80.0 ng/mL | 0.01-100 ng/mL |
| Analytical Sensitivity | Trade/Device Name: VITROS Immunodiagnostic Products Troponin I ES Reagent Pack VITROS Immunodiagnostic Products Troponin I ES Calibrator VITROS Immunodiagnostic Products Troponin I ES Range Verifier |
Regulation Number: 21 CFR§ 862.1215
21 CFR§ 862.1150 21 CFR8 862.1660
Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI, JIT, JJX Dated: September 21, 2006 Received: September 26, 2006
Dear Ms. Baker:
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. Iisting 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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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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours.
Alberto Gutierrez
Alberto Gutierrez, Ph.D. 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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Statement of Intended Use
| 510(k) Number (if known): |