(482 days)
Not Found
No
The summary describes a standard chemiluminescent immunoassay and instrument for measuring cardiac Troponin I. There is no mention of AI, ML, or any algorithms beyond converting chemiluminescent counts to concentration based on a master calibration curve. The performance studies are standard clinical validation studies, not related to training or testing AI/ML models.
No.
The device is an in vitro diagnostic test used as an aid in diagnosing acute myocardial infarction, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test is an "in vitro diagnostic test" and that measurements are "used as an aid in the diagnosis of acute myocardial infarction."
No
The device description clearly outlines a chemiluminescent enzyme immunoassay performed on a physical instrument (PATHFAST instrument) that involves handling patient samples, reagents, incubation, magnetic separation, and photon detection. This is a hardware-dependent in vitro diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "PATHFAST® cTnl-II test is an in vitro diagnostic test for the quantitative measurement of cardiac Troponin I (cTn!) in heparinized or EDTA whole blood and plasma."
This statement clearly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
PATHFAST® cTnl-II test is an in vitro diagnostic test for the quantitative measurement of cardiac Troponin I (cTn!) 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. This method is for use in clinical laboratory or point of care (POC) settings.
The PATHFAST® cTnl Calibrators are for calibration of the PATHFAST® system when used for the quantitative determination of cardiac Troponin I in human heparinized or EDTA whole blood and plasma.
Product codes
MMI, JIT
Device Description
The PATHFAST cTnl-II assay is for the quantitative measurement of human cardiac troponin I in heparinized or EDTA whole blood or plasma. The assay is designed for use on the PATHFAST instrument.
The PATHFAST cTnl-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°C. 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 analyte-antibody-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.
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
This method is for use in 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
An additional study was performed on prospectively collected banked serial plasma samples (heparin anticoagulant) from 333 consecutively eligible consented patients presenting to the ER with suspicion of myocardial infarction (MI). The study vielded 72 MI patients and 261 non-MI patients. The blood sample collection times were at 0-2 hours, at 2 to 6 hours, and at 6 to 12 hours of presentation to the ER. The clinical diagnosis of MI was performed by an adjudication panel according to ESC/ACCF/AHA/WHF 2007 guidelines. The adjudication panel used existing clinical data including ECG and other clinical information to make the diagnosis, but not the final discharge diagnosis or the PATHFAST cTnl-II Test results. Clinical sensitivity and clinical specificity were calculated by comparing the PATHFAST cTnl-II Test results to clinical diagnosis assigned by the adjudication panel. The calculations were performed with both the 99th percentile cutoff (≥0.029 ng/mL) and the ROC cutoff (≥0.264 ng/mL) of the assay.
Summary of Performance Studies
Study Type: Comparison with predicate device - 57 samples from 0.100 to 43.45 ng/mL.
Key Results: y = 0.947x - 0.005, r = 0.994
Study Type: Diagnosis of AMI – Serial Samples
Sample Size: 333 patients (72 MI patients, 261 non-MI patients)
Key Metrics:
- Cutoff 0.029 ng/mL at 0 to 2 h: Sens 73.6% (53/72), Spec 92.7% (242/261)
- Cutoff 0.029 ng/mL at 2 to 6 h: Sens 93.1% (67/72), Spec 93.1% (243/261)
- Cutoff 0.029 ng/mL at 6 to 12 h: Sens 91.7% (66/72), Spec 91.6% (239/261)
- Cutoff 0.264 ng/mL at 0 to 2 h: Sens 23.6% (17/72), Spec 99.2% (259/261)
- Cutoff 0.264 ng/mL at 2 to 6 h: Sens 62.5% (45/72), Spec 98.1% (256/261)
- Cutoff 0.264 ng/mL at 6 to 12 h: Sens 80.6% (58/72), Spec 97.7% (255/261)
Key Metrics
- Precision (Whole blood across instruments/within lot %CV): from 0.5% to 6.0% with concentrations from 0.096 to 38.5 ng/mL
- Precision (Whole blood across lots/within instrument %CV): from 1.9% to 9.1% with concentrations from 0.096 to 41.3 ng/mL
- Precision (Plasma across instruments/within lot %CV): from 4.3% to 8.0% with concentrations from 0.146 to 30.4 ng/mL
- Precision (Plasma across lots/within instrument %CV): from 1.6% to 10.8% with concentrations from 0.157 to 29.7 ng/mL
- Plasma cutoff within-run %CV from 3.7% to 6.2% and total %CV from 3.9% to 7.1% with concentrations from 0.022 to 0.251 ng/mL
- Limit of blank: 0.004 ng/mL
- 99th percentile = 0.029 ng/mL (from 490 heparinized plasma samples from apparently healthy individuals)
- Clinical Sensitivity and Specificity based on serial samples and two cutoffs (0.029 ng/mL and 0.264 ng/mL), as detailed in 'Summary of Performance Studies'.
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.
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Image /page/0/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix intertwined around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Mitsubishi Chemical Medience Co. c/o Ms. Judi Smith, LLC Principal PO Box 103 Baldwin. MD 21013
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
MAY 1 6 2011
K100130 Re:
Trade Name: PATHFAST® cTnI-II test; PATHFAST cTnI Calibrators Regulation Number: 21 CFR §862.1215 Regulation Name: Creatine Phosphokinase/creatine kinase or isoenzymes test svstem Regulatory Class: Class II Product Codes: MMI, JIT Dated: May 5, 2011 Received: May 11, 2011
Dear Ms. Smith:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
CJC.
Courtney Harper, 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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Indication for Use
510(k) Number (if known): K100130
Device Name: PATHFAST® cTnl-II test
Indication For Use:
PATHFAST® cTnl-II test is an in vitro diagnostic test for the quantitative measurement of cardiac Troponin I (cTn!) 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. This method is for use in clinical laboratory or point of care (POC) settings.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K100130
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Indication for Use
510(k) Number (if known): K100130
Device Name: PATHFAST® cTnl Calibrators ·
Indication For Use:
The PATHFAST® cTnl Calibrators are for calibration of the PATHFAST® system when used for the quantitative determination of cardiac Troponin I in human heparinized or EDTA whole blood and plasma.
Prescription Use _ × (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carl C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K.100/3D
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Image /page/4/Picture/0 description: The image is a logo for Precision for Medicine. The logo has a blue square, a lighter blue square, and a gold square on the left side. To the right of the squares is the text "PRECISION FOR MEDICINE" in blue. Below the text is the phrase "ACCELERATING VALUE. IMPROVING OUTCOMES."
VIA FEDERAL EXPRESS AND ELECTRONIC TRANSMISSION
January 29, 2015
U.S. Food and Drug Administration Center for Devices and Radiological Health Document Mail Center - WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
- ATTN: Courtney H. Lias, PhD, Director, Division of Chemistry and Toxicology Devices
- 510(k) Add-To-File for Revised 510(k) Summary and Product Insert Re: PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 (K100130) LSI Medience Corporation
Dear Dr. Lias,
This submission is in reqards to the above referenced 510(k) Premarket Notification, PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 (K100130), cleared May 16, 2011.
We are requesting FDA replace the 510(k) Summary on file for K100130 with the attached 510(k) Summary due to two typographical errors found on page 4 of the 510(k) Summary originally provided to FDA. Specifically, in the section entitled, "Diagnosis of AMI-Serial Samples," in the first table describing the results for the 0.029 ng/mL Cutoff, the 95% confidence intervals for Clinical Sensitivity for the 2 to 6 hour and the 6 to 12 hour collection times were incorrectly reported. These errors have been corrected in the attached revised 510(k) Summary. The following table shows the corrections highlighted in yellow.
| # / TOTAL | 95% CI | |||
|---|---|---|---|---|
| Cutoff | ||||
| 0.029 ng/mL | 0 to 2 h | Sens | 73.6% (53/72) | (61.9% - 83.3%) |
| Spec | 92.7% (242/261) | (88.9% - 95.6%) | ||
| 2 to 6 h | Sens | 93.1% (67/72) | (84.5% - 97.7%) | |
| Spec | 93.1% (243/261) | (89.3% - 95.9%) | ||
| 6 to 12 h | Sens | 91.7% (66/72) | (82.7% - 96.9%) | |
| Spec | 91.6% (239/261) | (87.5% - 94.6%) |
Revised 510(k) Summary Table for Diagnosis of AMI - Serial Samples
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Please note that all information included within the original 510(k) submission that was reviewed and cleared by FDA was accurate and correctly reported. Thank you for your assistance in this matter.
This 510(k) Add-to-File is being provided in duplicate, via one hard copy and one eCopy. The eCopy is an exact duplicate of the paper copy.
Confidentiality
We request that this 510(k) Add-to-File, including commercial information, be maintained by FDA in confidence pursuant to 21 CFR 807.95 for the maximum period allowed by 21 CFR 807.95(b) and (c), and including the maximum postdetermination period specified in 21 CFR 807.95(e). Please notify me directly of any request for release of information pertaining to this 510(k) prior to public disclosure of such information.
Please contact the undersigned at (240) 316-3377 or Judi.Smith@precisionformedicine.com if any additional information is required.
Respectfully Submitted,
Judi Sans
Judi Smith, MS, MT (ASCP) Vice President, In Vitro Diagnostics and Quality Precision for Medicine
For: LSI Medience Corporation
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510(k) SUMMARY
CONTACT:
Judi Smith Precision for Medicine 2 Bethesda Metro Center, Suite 850 Bethesda, MD 20814
NAME OF DEVICE:
| Trade Name: | PATHFAST® cTnI-II Test, PATHFAST® Calibrators, PATHFAST® Sample Diluent 2 cTnl |
|---|---|
| Common Names/Descriptions: | Cardiac troponin immunoassay |
| Classification Name: | Immunoassay method, troponin subunit |
PREDICATE DEVICE:
Siemens Stratus CS Acute Care Troponin I Testpak
DEVICE DESCRIPTION:
INTENDED USE:
PATHFAST cTnl-II test 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. This method is for use in clinical laboratory or point of care (POC) settings.
The PATHFAST cTnl Calibrators are for calibration of the PATHFAST system when used for the quantitative determination of cardiac Troponin I in human heparinized or EDTA whole blood and plasma.
PATHFAST SAMPLE DILUENT 2 is an in vitro diagnostic product used to dilute samples when PATHFAST assay values exceed the reportable assay range.
DESCRIPTION:
The PATHFAST cTnl-II assay is for the quantitative measurement of human cardiac troponin I in heparinized or EDTA whole blood or plasma. The assay is designed for use on the PATHFAST instrument.
The PATHFAST cTnl-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°C. During this incubation, the analyte in the patient sample binds to the antibody on the
7
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.
SUBSTANTIAL EQUIVALENCE:
The PATHFAST cTnl-II assay is substantially equivalent to the Stratus CS cTnl TestPak (predicate device - K033487). The following table summarizes the similarities and differences.
| Comparison between PATHFAST cTnI-II and predicate device |
|---|
| PATHFAST cTnI-II |
| PATHFAST cTnI-II | Stratus CS cTnI TestPak | |
|---|---|---|
| Intended Use | An in vitro diagnostic test for the quantitative measurement of cardiac Troponin I (cTnI) in heparinized or EDTA whole blood and plasma. |
The PATHFAST cTnl Calibrators are for calibration for the PATHFAST system when used for the quantitative determination of cardiac Troponin I in human heparinized or EDTA whole blood and plasma. | An in vitro diagnostic test for the measurement cardiac Troponin I in heparinized plasma. |
| Indications for Use | PATHFAST 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. This method is for use in clinical laboratory or point of care (POC) settings. | The Stratus® CS Acute Care™ Troponin I method is an in vitro diagnostic test for the measurement of cardiac Troponin I in heparinized plasma. Cardiac Troponin I measurements can be used as an aid in the diagnosis of myocardial infarction. Cardiac Troponin I can also be used as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. |
| Sample type | Plasma, Whole blood | Plasma |
| Anticoagulant | Heparin, EDTA | Heparin |
| Calibration | Reagent lot: Initially by master calibration code, then by user with enclosed calibrators. Recalibration required every four weeks | Reagent lot: Initially by master calibration code, then by user with recommended calibrators.
Recalibration recommended every 60 days |
| Controls | Recommended | Recommended |
| Storage | 2 - 8°C | 2 - 8°C |
| Test Methodology | Chemiluminescent enzyme immunoassay | Sandwich-type immunofluorometric assay |
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| PATHFAST cTnI-II | Stratus CS cTnI TestPak | |
|---|---|---|
| Reportable range | 0.019 – 50 ng/mL | 0 – 50 ng/mL |
| Precision | Whole blood across instruments/within lot %CV from 0.5% to 6.0% with concentrations from 0.096 to 38.5 ng/mL and across lots/within instrument %CV from 1.9% to 9.1% with concentrations from 0.096 to 41.3 ng/mL | |
| Plasma across instruments/within lot %CV from 4.3% to 8.0% with concentrations from 0.146 to 30.4 ng/mL and across lots/within instrument %CV from 1.6% to 10.8% with concentrations from 0.157 to 29.7 ng/mL | ||
| Plasma cutoff within-run %CV from 3.7% to 6.2% and total %CV from 3.9% to 7.1% with concentrations from 0.022 to 0.251 ng/mL | Within run %CV from 2.7% to 4.3% and total %CV from 3.4% to 5.1% with concentrations from 0.64 to 6.48 ng/mL | |
| Limit of blank | 0.004 ng/mL |