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.

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 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.

AI/ML Overview

Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The core purpose of the PATHFAST® cTnI-II test is to aid in the diagnosis of acute myocardial infarction (AMI) by quantitatively measuring cardiac Troponin I (cTnI). The acceptance criteria are implicitly defined by the clinical sensitivity and specificity targets presented in the study.

Table of Acceptance Criteria and Reported Device Performance

The device performance is evaluated at two different cutoffs: the 99th percentile cutoff (0.029 ng/mL) and an ROC cutoff (0.264 ng/mL). The study describes the performance across three time intervals for sample collection relative to presentation at the Emergency Room (ER): 0-2 hours, 2-6 hours, and 6-12 hours.

Cutoff	Time Interval	Metric	Acceptance Criteria (Implied)	Reported Device Performance
0.029 ng/mL	0 to 2 h	Clinical Sensitivity	(Not explicitly stated, but generally high for AMI diagnosis)	73.6% (95% CI: 61.9% - 83.3%)
		Clinical Specificity	(Not explicitly stated, but generally high for AMI diagnosis)	92.7% (95% CI: 88.9% - 95.6%)
	2 to 6 h	Clinical Sensitivity	(Not explicitly stated, but generally high for AMI diagnosis)	93.1% (95% CI: 84.5% - 97.7%)
		Clinical Specificity	(Not explicitly stated, but generally high for AMI diagnosis)	93.1% (95% CI: 89.3% - 95.9%)
	6 to 12 h	Clinical Sensitivity	(Not explicitly stated, but generally high for AMI diagnosis)	91.7% (95% CI: 82.7% - 96.9%)
		Clinical Specificity	(Not explicitly stated, but generally high for AMI diagnosis)	91.6% (95% CI: 87.5% - 94.6%)
0.264 ng/mL	0 to 2 h	Clinical Sensitivity	(Not explicitly stated, but generally high for AMI diagnosis)	23.6% (95% CI: 14.4% - 35.1%)
		Clinical Specificity	(Not explicitly stated, but generally high for AMI diagnosis)	99.2% (95% CI: 97.3% - 99.9%)
	2 to 6 h	Clinical Sensitivity	(Not explicitly stated, but generally high for AMI diagnosis)	62.5% (95% CI: 50.3% - 73.6%)
		Clinical Specificity	(Not explicitly stated, but generally high for AMI diagnosis)	98.1% (95% CI: 95.6% - 99.4%)
	6 to 12 h	Clinical Sensitivity	(Not explicitly stated, but generally high for AMI diagnosis)	80.6% (95% CI: 69.5% - 88.9%)
		Clinical Specificity	(Not explicitly stated, but generally high for AMI diagnosis)	97.7% (95% CI: 95.1% - 99.2%)

Note on "Acceptance Criteria (Implied)": The document doesn't explicitly state numerical acceptance thresholds for sensitivity and specificity. Instead, it presents the device's performance, implying these are acceptable for the intended use as an aid in AMI diagnosis. The fact that the device was cleared suggests these performance metrics met the FDA's requirements for substantial equivalence.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 333 consecutively eligible consented patients.
  - 72 patients diagnosed with MI
  - 261 patients diagnosed as non-MI
- Data Provenance: Prospectively collected banked serial plasma samples (heparin anticoagulant). The country of origin is not explicitly stated in the provided text.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: An "adjudication panel" was used. The exact number of experts is not specified.
- Qualifications of those experts: The qualifications are not explicitly stated, but the panel followed "ESC/ACCF/AHA/WHF 2007 guidelines" for diagnosing MI, implying expertise in cardiology and clinical diagnosis of MI.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: "The clinical diagnosis of MI was performed by an adjudication panel according to ESC/ACCF/AHA/WHF 2007 guidelines." This indicates a consensus-based approach guided by established clinical guidelines. Specific voting rules (like 2+1) are not detailed.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study with human readers and AI assistance was not described. This study focuses on the standalone performance of the PATHFAST® cTnI-II test.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone study was done. The reported clinical sensitivity and specificity describe the performance of the PATHFAST® cTnI-II test (algorithm/device only) in distinguishing MI from non-MI based on cTnI levels, without human interpretation of the test results themselves as part of the primary analysis. The ground truth, however, was human-adjudicated.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth Type: Expert consensus based on "existing clinical data including ECG and other clinical information" and adherence to "ESC/ACCF/AHA/WHF 2007 guidelines." Notably, the panel explicitly "did not use the final discharge diagnosis or the PATHFAST cTnI-II Test results" to avoid bias. This is a form of expert consensus based on comprehensive clinical information.
The sample size for the training set:
- The document primarily describes a clinical validation study and does not explicitly state a separate "training set" for the clinical performance evaluation of the PATHFAST® cTnI-II test in the context of MI diagnosis. The device's internal calibration and analytical performance were likely developed using other sample sets, but these are not detailed as "training sets" for the clinical sensitivity/specificity study. The data referenced for the 99th percentile cutoff (0.029 ng/mL) was derived from "490 heparinized plasma samples from apparently healthy individuals," which could be considered a reference sample set used in establishing normative values rather than a "training set" for a diagnostic algorithm.
How the ground truth for the training set was established:
- As no explicit "training set" for the clinical performance study (diagnosis of AMI - serial samples) is detailed, the method for establishing its ground truth is not applicable in this context. For the 99th percentile reference interval determination, the ground truth was "apparently healthy individuals," implying a healthy cohort without MI.

Summary

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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:

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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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
Cutoff0.029 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.

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coated particles, and the alkaline phosphatase conjugate binds to the analyteantibody-coated particle.

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/mLPlasma 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/mLPlasma 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	<0.03 ng/mL (analytical sensitivity)
Interfering substances	No interference observed with Bilirubin-conjugated and free (60 mg/dL); Hemoglobin (1000 mg/dL); Triglyceride (1000 mg/dL); Rheumatoid factor (500 IU/mL)	No interference observed with Bilirubin-icterus (60 mg/dl); Hemoglobin (1000 mg/dl); Triglyceride (3000 mg/dl)
Cross reactivity	No significant cross reactivity with cTnT (0.08%); cTnC (0.08%); skTnl (0.09%)	No significant cross reactivity with cTnT (1000 ng/mL); cTnC (1000 ng/mL); skTnl (280 ng/mL)
Reference interval	490 heparinized plasma samples from apparently healthy individuals.	101 heparinized plasma samples from apparently healthy individuals.
	99th percentile = 0.029 ng/mL	99th percentile = 0.00 – 0.07 ng/mL(With Stratus CS STAT cardiac Troponin I Assay) 168 samples from 0.00 to 34.38 ng/mL.
Comparison with predicate	Comparison with predicate device57 samples from 0.100 to 43.45 ng/mL.$y = 0.947x - 0.005, r = 0.994$	$y = 0.96x - 0.11, r = 0.99$

Diagnosis of AMI – Serial Samples

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.

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		#/TOTAL	95% CI
Cutoff0.029 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%)
			#/TOTAL	95% Cl*
Cutoff0.264 ng/mL	0 to 2 h	Sens	23.6% (17/72)	(14.4% - 35.1%)
		Spec	99.2% (259/261)	(97.3% - 99.9%)
	2 to 6 h	Sens	62.5% (45/72)	(50.3% - 73.6%)
		Spec	98.1% (256/261)	(95.6% - 99.4%)
	6 to 12 h	Sens	80.6% (58/72)	(69.5% - 88.9%)
		Spec	97.7% (255/261)	(95.1% - 99.2%)

Limitations of procedure

1. The instrument reporting system contains error codes to warn the operator of specific malfunctions. Any reports slip containing such error codes should be kept for follow-up. See the PATHFAST operator's manual.
1. When using the 99th percentile cutoff, the PATHFAST cTnl-II Test should be interpreted with at least 2 serial samples. When using the ROC cutoff, the test should be interpreted with 3 serial samples. When samples are collected in the early hours, it is not advisable to use the higher cutoff.
1. Patient samples may contain heterophilic antibodies that could react in immunoassays to give a falsely high or low result. This assay has been designed to minimize interference from heterophilic antibodies. Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed. A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution.

Regulation Number and Section

§ 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.