(261 days)
K100130 PATHFAST® cTnI-II IFU, K 100130
No
The description details a standard chemiluminescent immunoassay process and instrument operation, with no mention of AI or ML for data analysis, interpretation, or decision-making. The conversion of chemiluminescent count to concentration is based on a master calibration curve, which is a traditional method.
No.
This device is an in vitro diagnostic (IVD) test used to measure cardiac Troponin I (cTnI) for diagnostic purposes, not to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "PATHFAST® hs-cTnl-II is an in vitro diagnostic test for the quantitative measurement of cardiac Troponin I (cTnl)...Measurements of cardiac Troponin I are used as an aid in the diagnosis of acute myocardial infarction (AMI)." This clearly indicates its purpose is for diagnosis.
No
The device is an in vitro diagnostic test that is performed on a specific instrument (PATHFAST® instrument) and involves physical reagents and samples (whole blood, plasma, magnetic particles, alkaline phosphatase conjugate, chemiluminescent substrate). This clearly indicates a hardware component is essential to the device's function, making it not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the PATHFAST® hs-cTnl-II is an "in vitro diagnostic test".
- Purpose: It is designed for the quantitative measurement of cardiac Troponin I (cTnl) in biological samples (whole blood and plasma) to aid in the diagnosis of acute myocardial infarction (AMI). This is a classic example of an in vitro diagnostic test, as it analyzes samples taken from the body to provide information about a person's health status.
- Setting: It is intended for use in "clinical laboratory or point of care (POC) settings," which are typical environments for IVD use.
N/A
Intended Use / Indications for Use
PATHFAST® hs-cTnl-II is an in vitro diagnostic test for the quantitative measurement of cardiac Troponin I (cTnl) in heparinized or EDTA whole blood and plasma. Measurements of cardiac Troponin I are used as an aid in the diagnosis of acute myocardial infarction (AMI). PATHFAST® hs-cTnl-II is for use in clinical laboratory or point of care (POC) settings.
Product codes
MMI
Device Description
The PATHFAST® hs-cTnI-II test is a chemiluminescent enzyme immunoassay performed on the PATHFAST® instrument.
Patient samples, whole blood or plasma, are dispensed by the operator into the designated area on the reagent cartridge. The instrument combines the patient sample, the antibody coated magnetic particles, and the alkaline phosphatase conjugate and incubates the mixture for 5 minutes at 37℃. During this incubation, the analyte in the patient sample binds to the antibody on the coated particles, and the alkaline phosphatase conjugate binds to the analyteantibody coated-particle.
After the incubation, the instrument performs Bound/Free (B/F) separation using Magtration® technology to remove any excess unbound reagents. The chemiluminescent substrate is then added. The substrate is catalyzed by the bound alkaline phosphatase, which results in emission of photons.
The photo-multiplier tube in the PATHFAST® instrument detects the photons that are emitted during the reaction. The chemiluminescent count is converted to analyte concentration values by the instrument based on the master calibration curve for the reagent lot.
The PATHFAST® hs-cTnI-II test is supplied in reagent kits. Each kit contains sufficient materials for 60 determinations. The calibrator materials are included with the reagent kit and are also available separately. Calibration kits and diluent kits are also provided separately.
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
clinical laboratory or point of care (POC) settings.
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
Non clinical testing:
Precision, reproducibility, point of care precision reproducibility studies, high dose hook, traceability, stability, expected values, analytical specificity, assay cut-off, comparison studies, matrix studies, clinical sensitivity, clinical specificity, clinical cut-off and reference ranges are reported in K100130 PATHFAST® cTnI-II IFU.
Linearity/Assay Reportable Range:
Linearity studies were conducted on EDTA and lithium heparin whole blood and plasma samples. For the PATHFAST® hs-cTnI-II, the measurement procedure shows linearity for the interval from 4.1 to 50.000 ng/L, with deviations from linearity within +10%.
EDTA whole blood and plasma samples, and lithium heparin whole blood and plasma samples with low and high values were diluted to produce up to 12 dilution levels per each unique series with values ranging from 1 to 64,500 ng/L. Three-dilution series of each sample matrix were tested across three different lots of reagents. Each level was tested in replicates of three. The acceptable coefficient of variation for the replicates was set at
§ 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.
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March 20, 2024
PHC Corporation Helen Landicho, RAC SVP Regulatory Affairs Polymedco, Inc. 510 Furnace Dock Road Cortlandt Manor, New York 10567
Re: K231974
Trade/Device Name: PATHFAST®hs-cTnI-II Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: March 1, 2024 Received: March 4, 2024
Dear Helen Landicho:
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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Paula V. Caposino -S
Paula Caposino, Ph.D. Acting Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name PATHFAST®hs-cTnI-II
Indications for Use (Describe)
PATHFAST® hs-cTnl-II is an in vitro diagnostic test for the quantitative measurement of cardiac Troponin I (cTnl) in heparinized or EDTA whole blood and plasma. Measurements of cardiac Troponin I are used as an aid in the diagnosis of acute myocardial infarction (AMI). PATHFAST® hs-cTnI-II is for use in clinical laboratory or point of care (POC) settings.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY K231974 PATHFAST® hs-cTnI-II High Sensitive Troponin
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Federal Food, Drug, and Cosmetic Act and 21 CFR 807.92.
510(k) Owner:
PHC Corporation 1460-6 Aza-Mitodai, Mito, Tako-machi Katori-gun, Chiba 289-2247, Japan Misato Igarashi Ph.D. 81-3-6400-2115 (Tel) 81-3-5577-0451(Fax
Contact Person: Polymedco, Inc. Helen Landicho, RAC 914.293.1605 (Tel)
Name of the device
Trade name: PATHFAST® hs-cTnI-II Common name: high sensitive Troponin I Classification: 21 CFR 862.1215 Creatine Phosphokinase/creatine kinase or isoenzymes test system Product code: MMI
Legally marketed device claiming equivalence:
PATHFAST® cTnI-II (K100130)
Device description:
The PATHFAST® hs-cTnI-II test is a chemiluminescent enzyme immunoassay performed on the PATHFAST® instrument.
Patient samples, whole blood or plasma, are dispensed by the operator into the designated area on the reagent cartridge. The instrument combines the patient sample, the antibody coated magnetic particles, and the alkaline phosphatase conjugate and incubates the mixture for 5 minutes at 37℃. During this incubation, the analyte in the patient sample binds to the antibody on the coated particles, and the alkaline phosphatase conjugate binds to the analyteantibody coated-particle.
After the incubation, the instrument performs Bound/Free (B/F) separation using Magtration® technology to remove any excess unbound reagents. The chemiluminescent
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510(k) Submission PATHFAST® hs-cTnI-II
substrate is then added. The substrate is catalyzed by the bound alkaline phosphatase, which results in emission of photons.
The photo-multiplier tube in the PATHFAST® instrument detects the photons that are emitted during the reaction. The chemiluminescent count is converted to analyte concentration values by the instrument based on the master calibration curve for the reagent lot.
The PATHFAST® hs-cTnI-II test is supplied in reagent kits. Each kit contains sufficient materials for 60 determinations. The calibrator materials are included with the reagent kit and are also available separately. Calibration kits and diluent kits are also provided separately.
| Component | Quantity |
|---|---|
| Reagent Cartridge | 6 cartridges x 10 trays |
| Calibrator 1 | 2 vials |
| Calibrator 2 | 2 vials |
| Calibrator diluent | 4 vials of 1.0 mL each |
Contents of the PATHFAST® hs-cTnI-II reagent kit
Reagent Cartridge: The reagent cartridge contains 16 wells 1, 6, 8, 9, 10, 12, 14, 15, 16 are empty. The other wells are filled with the following reagents:
| Reagent Description | Volume | Cartridge
Well |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|-------------------|
| Alkaline phosphatase (calf intestine) conjugated anti cTnI
monoclonal antibody (mouse) in MES buffer (pH 6.0) with
0.007% zinc chloride, and 0.06% sodium azide as
preservative | 50 µl | 2 |
| Washing Buffer: Tris buffer (pH 7.5) with 0.05% sodium
azide as preservative | 400 µl | 3, 4, 5 |
| Magnetic particles coated with anti cTnI monoclonal
antibody (mouse) in MOPS buffer | 50 µl | |
| Sample Dilution Buffer: Tris buffer (pH 8.2) with 0.05%
sodium azide as preservative | 25 ul | 11 |
| Chemiluminescent substrate: CDP-Star | 100 µl | 13 |
Contents of the PATHFAST® hs-cTnI-II reagent cartridge
Calibrator 1: Lyophilized preparation containing MES pH 6.0, lactose, and enzyme free human serum. DTT
Calibrator 2: Lyophilized preparation containing cTnI complex, MES pH 6.0, lactose, and enzyme free human serum, DTT
Calibrator diluent: Aqueous solution with 0.05% sodium azide used for reconstituting Calibrators 1 and 2
Calibrator 1 and Calibrator 2 contain human serum obtained from donors who were confirmed negative for anti-HIV-1/2, HbsAg and Anti-HCV.
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Intended use:
PATHFAST® hs-cTnl-II is an in vitro diagnostic test for the quantitative measurement of cardiac Troponin I ( c Tnl) in heparinized or EDTA whole blood and plasma. Measurements of cardiac Troponin I are used as an aid in the diagnosis of acute myocardial infarction (AMI). PATHFAST® hs-cTnl-II is for use in clinical laboratory or point of care (POC) settings.
The indications for use are identical to the predicate assay. The PATHFAST® hs-cTnl-II modified the reporting units from ng/mL to the conventional ng/L and extended the reportable range from 4.1 ng/L to 50,000 ng/L. The modification of the units and reportable range of the device does not affect the diagnostic or clinical utility of the device or the safety and effectiveness of the device when used as labeled.
| Similarities | ||
|---|---|---|
| Item | Candidate Device | |
| PATHFAST hs-cTnI-II | Predicate Device | |
| PATHFAST cTnI-II | ||
| K100130 | ||
| Intended Use | Assist in the diagnosis of | |
| acute myocardial | ||
| infarction. For use in | ||
| clinical laboratory or | ||
| point of care (POC) | ||
| settings. | Same | |
| Storage | 2-8° C | 2-8° C |
| Calibration Levels | 6 | 6 |
| Methodology | Chemiluminescent enzyme | |
| immunoassay | Same | |
| Indications for use | Assist in the diagnosis of | |
| acute myocardial | ||
| infarction. For use in | ||
| clinical laboratory or point | ||
| of care (POC) settings. Not | ||
| for risk stratification | Same | |
| Sample Types | EDTA and Lithium | |
| heparin | ||
| whole blood and plasma | Same | |
| Item | Differences | |
| Candidate Device | ||
| PATHFAST hs-cTnI-II | Predicate Device | |
| PATHFAST cTnI-II | ||
| K100130 | ||
| Reportable range | 4.1 to 50,000 ng/L | 0.019 to 50 ng/mL |
Comparison with the predicate device
Modification of the reporting units from ng/mL to ng/L meets conventional laboratory reporting for troponin.
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Non clinical testing:
Precision, reproducibility, point of care precision reproducibility studies, high dose hook, traceability, stability, expected values, analytical specificity, assay cut-off, comparison studies, matrix studies, clinical sensitivity, clinical specificity, clinical cut-off and reference ranges are reported in K100130 PATHFAST® cTnI-II IFU.
Linearity/assav reportable range:
Linearity studies were conducted on EDTA and lithium heparin whole blood and plasma samples. For the PATHFAST® hs-cTnI-II, the measurement procedure shows linearity for the interval from 4.1 to 50.000 ng/L, with deviations from linearity within +10%.
EDTA whole blood and plasma samples, and lithium heparin whole blood and plasma samples with low and high values were diluted to produce up to 12 dilution levels per each unique series with values ranging from 1 to 64,500 ng/L. Three-dilution series of each sample matrix were tested across three different lots of reagents. Each level was tested in replicates of three. The acceptable coefficient of variation for the replicates was set at