Who is the manufacturer of PATHFAST®hs-cTnI-II?

Phc Corporation filed the 510(k) submission for PATHFAST®hs-cTnI-II (K231974).

What is the FDA product code for PATHFAST®hs-cTnI-II?

MMI. It is classified under 21 CFR 862.1215 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for PATHFAST®hs-cTnI-II?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like PATHFAST®hs-cTnI-II?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PATHFAST®hs-cTnI-II

K231974 · Phc Corporation · MMI · Mar 20, 2024 · Clinical Chemistry

Device Facts

Record ID	K231974
Device Name	PATHFAST®hs-cTnI-II
Applicant	Phc Corporation
Product Code	MMI · Clinical Chemistry
Decision Date	Mar 20, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1215
Device Class	Class 2

Intended Use

PATHFAST®hs-cTnI-II is an in vitro diagnostic test for the quantitative measurement of cardiac Troponin I (cTnI) 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.

Device Story

PATHFAST® hs-cTnI-II is a chemiluminescent enzyme immunoassay for quantitative measurement of cardiac Troponin I (cTnI). Input: heparinized or EDTA whole blood or plasma samples. Operation: operator dispenses sample into reagent cartridge; instrument incubates sample with antibody-coated magnetic particles and alkaline phosphatase conjugate; Magtration® technology performs bound/free separation; chemiluminescent substrate (CDP-Star) added; photomultiplier tube detects emitted photons. Output: analyte concentration values calculated via master calibration curve. Used in clinical laboratories or point-of-care settings by healthcare professionals. Output assists clinicians in diagnosing acute myocardial infarction (AMI). Benefits: provides rapid, quantitative cardiac biomarker assessment to support timely clinical decision-making.

Clinical Evidence

No new clinical trials were conducted. The submission relies on analytical performance data (linearity, LoB, LoD, LoQ) and re-evaluation of clinical data from the predicate device (K100130). Linearity was demonstrated from 4.1 to 50,000 ng/L with deviations <10%. LoQ was established at 4.1 ng/L (CV <20%). The 99th percentile cutoff remains 29 ng/L. Clinical sensitivity and specificity are unchanged from the predicate.

Technological Characteristics

Chemiluminescent enzyme immunoassay; quantitative measurement of cTnI. Reportable range: 4.1 to 50,000 ng/L. Analyzed on PATHFAST Analyzer. Standards: CLSI EP6 (linearity), CLSI EP17-A2 (detection capability).

Indications for Use

Indicated for the quantitative measurement of cardiac Troponin I in heparinized or EDTA whole blood and plasma to aid in the diagnosis of acute myocardial infarction (AMI) in clinical laboratory or point-of-care settings.

Regulatory Classification

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.

Predicate Devices

PATHFAST® cTnI-II (K100130)

Related Devices

K100130 — PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 · Mitsubishi Chemical Medience CO · May 16, 2011
K242870 — Access hsTnI · Beckman Coulter, Inc. · Jun 16, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION". 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" {1}------------------------------------------------ 2 (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 {2}------------------------------------------------ Enclosure {3}------------------------------------------------ #### 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) K231974 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response. including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ## 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 {5}------------------------------------------------ ### 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. {6}------------------------------------------------ ## 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. {7}------------------------------------------------ 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 <20%. The relative concentration, measured values, predicted values, deviations from linearity and percent deviations were analyzed for each sample in a series. The %CV for the replicates was set at <20% and the allowable deviation from linearity was acceptable within +10%. The maximum absolute deviation observed in the linearity study across all sample matrices was 9.7% {8}------------------------------------------------ ## Detection limit: LoB/LoD studies were conducted using EDTA and lithium heparin whole blood and plasma samples. The LoB was determined by testing four lots of reagents, four plasma samples, replicates of two per sample, repeated twice a day for three consecutive business days. Each lot had a total of 24 replicates for a combined number of 96 determinations. The LoD for EDTA and lithium heparin whole blood and plasma was determined by testing 4 low samples, twice a day with four lots of reagent over three days for a total of 96 replicates. The LoQ study was conducted using EDTA and lithium heparin whole blood and plasma samples at the estimated concentration where the coefficient of variation for the replicates was < 20%. Two sets of three samples and two reagent lots; each tested in replicates of four, three runs per day, for a total of 24 replicates per sample. Testing was repeated for each matrix. The coefficient of variations and means were calculated and pooled for each sample per reagent lot. The LoQ for EDTA and lithium heparin whole blood and plasma was determined by averaging the values over two lots. Lowest hs-cTnI concentration of the samples that showed less than 20 % CV. Summary: | | EDTA | | LiHep | | |-----|-------|--------|-------|--------| | | WB | Plasma | WB | Plasma | | LoB | 1.466 | 1.466 | 1.466 | 1.466 | | LoD | 2.991 | 2.958 | 2.942 | 3.002 | | LoQ | 4.1 | 4.1 | 4.1 | 4.1 | LoD = LoB + coSDt, where co =1.645/1-(1/4*(L - J)) C LoQ = minimum cTnI concentration with % CV < 20 % The measuring range of the cTnI-II assay is from 4.1 ng/L to 50,000 ng/L. The analytical information in this premarket notification supports the measuring range of the PATHFAST® hs-cTnI of 4.1 ng/L to 50,000 ng/L ## Clinical performance: The effects of the modification of the LoQ were evaluated on the previously reported clinical claims from the predicate device. During the predicate reference range study used to establish the 99th percentile cutoff all values below 0.019 ng/mL were reported as numerical results. The data set used to non-parametrically calculate the 99th percentile consisted entirely of numerical results. The predicate LoQ was the lowest concentration at which there was an imprecision of 10% CV; the updated LoQ is the lowest concentration at which there was an imprecision of 20% CV, which is 4.1 ng/L. There is no impact on the 99th percentile cutoff of the reference range validated in K 100130 with the updated LoQ of 4.1 ng/L, because the original numerical results for all testing were previously used in the calculation. The PATHFAST® hs-cTnI-II assay continues to meet the criteria that measurable concentrations are above the limit of detection for over 50% of healthy individuals. The 99th percentile cutoff remains at 29 ng/L. {9}------------------------------------------------ ### 510(k) Submission PATHFAST® hs-cTnI-II The clinical sensitivity and specificity of the PATHFAST® hs-cTnI-II assay is not affected by lowering the LoQ to 4.1 ng/L, as all the numerical data was included in the predicate calculations. The clinical sensitivity and specificity remain unchanged when lowering the LoQ to 4.1 ng/L. The evidence supports that the non-parametrically calculated cutoff at the 99th percentile remains at 29 ng/L and the assay continues to meet the criteria that measurable concentrations are above the limit of detection for over 50% of healthy individuals. The clinical sensitivity and specificity of the assay remain unchanged from the predicate device. ### Summary conclusion: The summary includes conclusions drawn from the nonclinical tests that demonstrate that the device is safe, effective and performs as wells as or better than the predicate device. The information provided in this submission is complete and demonstrates that the subject device is substantially equivalent to the predicate device.