Who is the manufacturer of Access hsTnl?

Beckman Coulter, Inc. filed the 510(k) submission for Access hsTnl (K172787).

What is the FDA product code for Access hsTnl?

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 Access hsTnl?

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

What are the predicate devices for Access hsTnl?

Access AccuTnl+3 Reagent (K121214).

Who can help prepare an FDA 510(k) submission like Access hsTnl?

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.

Access hsTnl

K172787 · Beckman Coulter, Inc. · MMI · Jun 14, 2018 · Clinical Chemistry

Device Facts

Record ID	K172787
Device Name	Access hsTnl
Applicant	Beckman Coulter, Inc.
Product Code	MMI · Clinical Chemistry
Decision Date	Jun 14, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1215
Device Class	Class 2

Intended Use

Access hsTnl is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction (MI).

Device Story

Access hsTnI is an in vitro diagnostic immunoassay used on the Access 2 Immunoassay System. It utilizes paramagnetic particles coated with mouse monoclonal anti-human cTnI antibodies and sheep monoclonal anti-human cTnI alkaline phosphatase conjugate. The device performs a chemiluminescent sandwich immunoassay to quantify cTnI levels in human serum or lithium heparin plasma. It is operated by laboratory technicians in clinical settings. The output is a quantitative concentration of cTnI (pg/mL), which clinicians use alongside other diagnostic tests and clinical information to aid in the diagnosis of myocardial infarction. By providing high-sensitivity detection of cardiac troponin, the device assists in the rapid identification of MI, potentially improving patient management and outcomes.

Clinical Evidence

Multicenter prospective study of 1,851 ED patients with chest pain/ischemic symptoms. MI incidence 13%. Diagnostic accuracy evaluated against adjudicated MI status (Universal Definition of MI). Sensitivity and specificity reported at baseline, 1-3h, 3-6h, and 6-9h intervals. Overall sensitivity at 1-3h was 95% (95% CI 90-98%) and specificity 90% (95% CI 89-92%). 99th percentile URL established in 1,089 healthy subjects.

Technological Characteristics

Paramagnetic particle, chemiluminescent sandwich immunoassay. Reagents: Dynabeads paramagnetic particles, mouse monoclonal anti-cTnI, sheep monoclonal anti-cTnI alkaline phosphatase conjugate. Analytical range: 2.0 pg/mL to 27,027 pg/mL. Instrument: Access 2 Immunoassay System. Connectivity: Automated system. Software: Assay Protocol File (APF) without thermal algorithm.

Indications for Use

Indicated for quantitative determination of cardiac troponin I (cTnl) in human serum and plasma to aid in the diagnosis of myocardial infarction (MI) in patients presenting with chest pain or equivalent ischemic symptoms.

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

Access AccuTnl+3 Reagent (K121214)

Related Devices

K172783 — Access hs Tnl · Beckman Coulter, Inc. · Jun 12, 2018
K222881 — Access hsTnI · Beckman Coulter, Inc. · Dec 18, 2023
K242870 — Access hsTnI · Beckman Coulter, Inc. · Jun 16, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal of the Department of Health & Human Services - USA, which features an abstract design of an eagle. To the right of the seal, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font, and the words "U.S. FOOD & DRUG ADMINISTRATION" are in a smaller font. June 14, 2018 Beckman Coulter, Inc. Jennifer Bennett Sr. Analyst, Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, MN 55318 Re: K172787 Trade/Device Name: Access hsTnl Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: May 4, 2018 Received: May 7, 2018 ## Dear Jennifer Bennett: 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. 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. 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ (1-800-638-2041 or 301-796-7100). K172787 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 Sincerely, (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone Kellie B. Kelm -S for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K172787 Device Name Access hsTnI Indications for Use (Describe) Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access 2 Immuoasay Systems to aid in the diagnosis of myocardial infarction (MI). | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| | | | X | 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the company name "BECKMAN COULTER" in bold, black letters. The word "BECKMAN" is stacked on top of the word "COULTER". Immunodiagnostic Development Center 1000 Lake Hazeltine Drive Chaska, Minnesota 55318-1084 ## 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a)(1). The assigned 510(k) number is K172787 ## Submitted By: Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-1142 Fax: (952) 368-7610 ## Contact Person: Jennifer Bennett 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-2040 Fax: (952) 368-7704 Alternate Contact: Angela Kilian (952) 368-1330 (952) 368-7704 (fax) ## Date Prepared: June 12, 2018 ## Device Name: Proprietary / Trade Name: Access hsTnl Common Name: Troponin I Enzyme Immunoassay Classification Name: Immunoassay, Troponin Subunits Classification Regulation: 21 CFR 862.1215 Classification Product Code: MMI {4}------------------------------------------------ #### Predicate Devices: The Access hsTnl claims substantial equivalence to the Access AccuTnl+3 Reagent, FDA 510(k) Number K121214, cleared June 14, 2013. #### Device Description: The Access hsTnl and the Access 2 Immunoassay System compose the Access Immunoassay System for the quantitative determination of cardiac troponin I (cTnl) in human serum and plasma. The Access hsTnI reagent packs contain specific reagents for the in vitro diagnostic measurement of cTnl including: - R1a: Dynabeads* paramagnetic particles coated with mouse . monoclonal anti-human cTnl antibody suspended in TRIS buffered saline, with surfactant, bovine serum albumin (BSA). < 0.1% sodium azide, and 0.1% ProClin** 300. - R1b: 0.1 N NaOH . - R1c: TRIS buffered saline, surfactant, protein (mouse). < 0.1% sodium . azide, and 0.1% ProClin 300. - R1d: Sheep monoclonal anti-human cTnl alkaline phosphatase conjugate diluted in ACES buffered saline, with surfactant, BSA matrix, protein (bovine, sheep, mouse), < 0.1% sodium azide, and 0.25% ProClin 300. *Dynabead® is a registered trademark of Dynal A.S., Osio, Norway **ProClin™ is a trademark of The Dow Chemical Company ("Dow") or an affiliate company of Dow. #### Intended Use: Access hsTnl is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction (MI). #### Comparison to the Predicates: The Access hsTnI and the predicate device, Access AccuTnI+3 Reagent, were compared. The information for the predicate device was derived from the predicate device 510(k) Summary and product labeling. {5}------------------------------------------------ # Comparison of Technological Characteristics to the Predicate (Assay) | Characteristic | Predicate Device Access AccuTnl+3 for Access 2 Immunoassay Systems - k121214 | New Device Access hsTnl on Access 2 Immunoassay System | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use/ Indications for Use | The Access AccuTnl+3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access 2 lmmunoassay System to aid in the diagnosis of myocardial infarction (MI). | Access hsTnl is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access 2 lmmunoassay System to aid in the diagnosis of myocardial infarction (MI) | | Assay Principle | Chemiluminescent sandwich immunoassay | Same | | Test System | Automated immunoassay instrument | Same | | Sample Type | Serum and heparinized plasma | Same | | Reagent Pack configuration | Reagents ready to use and separated in a single reagent pack | Same | | Primary Reagent Materials | Solid phase magnetic particles, anti- cTnl antibodies | Dynabeads* paramagnetic particles coated with mouse monoclonal anti-human cTnl antibody | | Sample Volume | 55μl | Same | | Specific Reagent Materials | Mouse monoclonal anti- human cTnl alkaline phosphatase conjugate, magnetic particles coated with mouse monoclonal anti- human cTnI | Sheep monoclonal anti - human cTnl alkaline phosphatase conjugate diluted in ACES buffered saline, with surfactant, BSA matrix, protein (bovine, sheep, mouse) | | Immunoassay Instrument | Access 2 Immunoassay System | Same | | Analytical Measuring Range | 0.02 ng/mL to 100 ng/mL (20 pg/mL to 100,000 pg/mL) | 2.0 pg/mL to 27,027 pg/mL | | Characteristic | Predicate Device Access AccuTnl+3 for Access 2 Immunoassay Systems – k121214 | New Device Access hsTnl on Access 2 Immunoassay System | | Expected Results (Upper Reference Limit) | 99th percentile of 0.02 with a 95% Confidence Interval (CI) of 0.01- 0.05 ng/mL | 99th percentile of 17.5 pg/ mL with a 95% Confidence Interval (CI) of 12.6 – 20.7 pg/mL for Lithium Heparin Plasma 99th percentile of 18.2 pg/ mL with a 95% Confidence Interval (CI) of 13.1 - 23.1pg/mL for Serum | | Precision | Total CV of ≤8% at concentrations >0.075 ng/mL. SD ≤0.006 at concentrations ≤0.075 ng/mL | ≤ 10% within-laboratory CV for concentrations ≥ 11.5 pg/mL ≤ 1.15 pg/mL within- laboratory SD for concentrations < 11.5 pg/mL | | Open Reagent Pack Stability | Stable at 2 to 10°C for 56 days after initial use | Stable at 2 to 10°C for 64 days after initial use | | Assay Protocol File (APF) | AccuTnI+3 APF with addition of the thermal algorithm | hsTnI APF with no thermal algorithm | {6}------------------------------------------------ {7}------------------------------------------------ ## Summary of Studies 99th percentile URL: A multicenter prospective study was conducted to establish the 99th percentile URL in a population of apparently healthy adults. Serum and lithium heparin plasma samples were evaluated. Subjects ranging from 21 to 99 years of age were enrolled at five qeographically diverse locations throughout the United States. Forty five percent of subjects were ≥ 60 years of age. Subjects were surveyed and were excluded if they met any of the following criteria: - . Disease(s) of/or affecting the cardiovascular system - Currently taking a medication for cardiovascular disease ● - Diabetes ● - Chronic kidney disease ● - Other serious chronic disease(s) (e.g. cancer, COPD, HIV, lupus ● erythematosus, etc.) - Acute bacterial or viral infection ● - Pregnancy ● The 99th percentile URL values determined for lithium heparin plasma (females, males, and overall), and serum (females, and overall) are shown in the following table. All values were determined using the non-parametric statistical method. | Sample Type | Population | N | 99th percentile | 95% CI pg/mL (ng/L) | |------------------------------|------------|------|--------------------|------------------------| | Lithium heparin plasma | Females | 595 | 11.6 | 8.4 - 18.3 | | | Males | 494 | 19.8 | 14.0 - 42.9 | | | Overall | 1089 | 17.5 | 12.6 - 20.7 | | Serum | Females | 595 | 11.8 | 8.7 - 18.7 | | | Males | 493 | 19.7 | 14.3 - 44.3 | | | Overall | 1088 | 18.2 | 13.1 - 23.1 | ## 99th Percentile URL of a Healthy Population Clinical performance: A multicenter prospective study was conducted to evaluate the diagnostic accuracy of the Access hsTnl assay using the established 99th percentile URLs. The study was designed to establish the clinical performance of Access hsTnl as an aid in the diagnosis of MI. The study included 1,851 evaluable subjects from ED patients presenting with chest pain or equivalent ischemic symptoms suggestive of Acute Coronary {8}------------------------------------------------ Syndromes (ACS). A total of 14 geographically diverse, primary care hospital-associated emergency departments participated, reflecting regional, urban, suburban, and rural patient populations. True MI statuses of all subjects were adjudicated by an independent panel of expert physicians using criteria consistent with the Universal Definition of Myocardial Infarction. Adjudicators were blinded to the assay results and the attending physicians' diagnosis. All results presented below were based on the adjudicated diagnoses. The MI incidence was 13% (238/1851). Samples were tested at three independent clinical laboratories on Access 2 systems. Testing was performed using serum and lithium heparin plasma samples. Study results are shown in Table below. Results are presented for the following time intervals between ED presentation and specimen collection: • Time of presentation (baseline), ≥1 - 3 hours, ≥ 3 - 6 hours and ≥ 6 - 9 hours after admission ## Clinical Sensitivity and Specificity Diagnostic sensitivity (% MI correctly diagnosed) and specificity (% Non-MI correctly diagnosed) were calculated per CLSI Guideline I/LA21-A2. Estimates of sensitivity and specificity were determined by dividing the number of patients correctly diagnosed by the Access hsTnl assay (n) by the total number of patients with an adjudicated diagnosis (N). ## Positive Predictive Value (PPV) and Negative Predictive Value (NPV) PPV (probability of MI diagnosis in patients with elevated cTnl) and NPV (probability of non-MI diagnosis in patients with non-elevated cTnl) were calculated per CLSI Guideline I/LA21-A2. Estimates of PPV were determined by dividing the number of patients with elevated cTnl values and adjudicated MI diagnoses (n) by the total number of patients with elevated cTnl values (N). Estimates of NPV were determined by dividing the number of patients with non-elevated cTnl values and adjudicated non-MI diagnoses (n) by the total number of patients with non-elevated cTnl values (N). Predictive value analysis is directly related to the prevalence of disease in the intended use population. The overall MI prevalence of 13% in this study is consistent with literature and public health findings, and indicates that the study population is representative of the intended use population. Since predictive value analysis is prevalence dependent; results will vary by region and facility. {9}------------------------------------------------ ## Clinical Performance of Access hsTnl Using the Calculated 99th Percentile Cutoffs. Presented at Multiple Time Intervals After Admission to the Emergency Department | 99th percentile URL cutoff, pg/mL (ng/L) | Hours After Admission to ED | Sensitivity | | Specificity | | PPV | | NPV | | |---------------------------------------------------------|--------------------------------------|-----------------|-------------|-------------------|------------|-----------------|------------|-------------------|-------------| | | | % (n/N) | 95% CI | % (n/N) | 95% CI | % (n/N) | 95% CI | % (n/N) | 95% CI | | | Lithium heparin plasma | | | | | | | | | | Overall: 17.5 | Baseline | 86 (86/100) | 78-92 | 90 (510/564) | 88-93 | 61 (86/140) | 53-70 | 97 (510/524) | 96 - 99 | | | ≥ 1-3 hour | 95 (128/135) | 90-98 | 90 (985/1090) | 89-92 | 55 (128/233) | 48-61 | 99 (985/992) | 99 - 100 | | | ≥ 3-6 hour | 93 (140/151) | 87-96 | 90 (1045/1161) | 88-92 | 55 (140/256) | 48-61 | 99 (1045/1056) | 98 - 100 | | | ≥ 6-9 hour | 99 (70/71) | 92- 100 | 86 (387/451) | 82-89 | 52 (70/134) | 43-61 | 100 (387/388) | 99 - 100 | | Females: 11.6 | Baseline | 90 (27/30) | 74-98 | 90 (228/254) | 85-93 | 51 (27/53) | 37-65 | 99 (228/231) | 96 - 100 | | | ≥ 1-3 hour | 98 (42/43) | 88- 100 | 90 (482/533) | 88-93 | 45 (42/93) | 35 - 56 | 100 (482/483) | 99 - 100 | | | ≥ 3-6 hour | 98 (48/49) | 89- 100 | 89 (497/557) | 86-92 | 44 (48/108) | 35- 54 | 100 (497/498) | 99 - 100 | | | ≥6-9 hour | 100 (22/22) | 85 - 100 | 84 (188/225) | 78-88 | 37 (22/59) | 25 - 51 | 100 (188/188) | 98 - 100 | | Males: 19.8 | Baseline | 87 (61/70) | 77-94 | 88 (272/310) | 84 - 91 | 62 (61/99) | 51 - 71 | 97 (272/281) | 94- 99 | | | ≥ 1-3 hour | 95 (87/92) | 88-98 | 89 (494/557) | 86 - 91 | 58 (87/150) | 50-66 | 99 (494/499) | 98 - 100 | | | ≥ 3-6 hour | 92 (94/102) | 85-97 | 89 (535/604) | 86 - 91 | 58 (94/163) | 50-65 | 99 (535/543) | 97 - 99 | | | ≥ 6-9 hour | 98 (48/49) | 89- 100 | 83 (188/226) | 78 - 88 | 56 (48/86) | 45 - 67 | 100 (188/189) | 97 - 100 | Note: The Access hsTnl assay is not intended to be used in isolation; results should be interpreted in conjunction with other diagnostic tests and clinical information. {10}------------------------------------------------ | 99th percentile URL cutoff, pg/mL (ng/L) | Hours After Admission to ED | Sensitivity | | Specificity | | PPV | | NPV | | |------------------------------------------------|--------------------------------|-----------------|---------|--------------------|---------|-----------------|---------|-------------------|----------| | Serum | | % (n/N) | 95% CI | % (n/N) | 95% CI | % (n/N) | 95% CI | % (n/N) | 95% CI | | Overall: 18.2 | Baseline | 84 (91/108) | 76 - 91 | 91 (541/595) | 88 – 93 | 63 (91/145) | 54-71 | 97 (541/558) | 95 – 98 | | | ≥ 1-3 hour | 94 (132/141) | 88 – 97 | 91 (1009/1108) | 89 - 93 | 57 (132/231) | 51-64 | 99 (1009/1018) | 98 – 100 | | | ≥ 3-6 hour | 93 (142/152) | 88 - 97 | 90 (1082/1202) | 88 - 92 | 54 (142/262) | 48-60 | 99 (1082/1092) | 98 – 100 | | | ≥ 6-9 hour | 96 (64/67) | 88 - 99 | 86 (403/469) | 82 - 89 | 49 (64/130) | 40 - 58 | 99 (403/406) | 98 – 100 | | Females: 11.8 | Baseline | 86 (25/29) | 68 - 96 | 90 (236/263) | 85 - 93 | 48 (25/52) | 34-62 | 98 (236/240) | 96 – 100 | | | ≥ 1-3 hour | 98 (42/43) | 88-100 | 91 (491/542) | 88 - 93 | 45 (42/93) | 35-56 | 100 (491/492) | 99 – 100 | | | ≥ 3-6 hour | 98 (49/50) | 89-100 | 88 (512/579) | 86 - 91 | 42 (49/116) | 33-52 | 100 (512/513) | 99-100 | | | ≥ 6-9 hour | 100 (20/20) | 83-100 | 83 (196/235) | 78 - 88 | 34 (20/59) | 22-47 | 100 (196/196) | 98- 100 | | Males: 19.7 | Baseline | 86 (68/79) | 77 - 93 | 88.0% (292/332) | 84 - 91 | 63 (68/108) | 53-72 | 96 (292/303) | 94 – 98 | | | ≥ 1-3 hour | 94 (92/98) | 87 - 98 | 89 (501/566) | 86 - 91 | 59 (92/157) | 51-66 | 99 (501/507) | 97 - 100 | | | ≥ 3-6 hour | 93 (95/102) | 86 - 97 | 89 (553/623) | 86 - 91 | 58 (95/165) | 50-65 | 99 (553/560) | 97 - 100 | | | ≥ 6-9 hour | 96 (45/47) | 86-100 | 83 (193/234) | 77 - 87 | 52 (45/86) | 41-63 | 99 (193/195) | 96 - 100 | Clinical Performance of Access hsTnI Using the Calculated 99th Percentile URL Cutoffs. Presented at Multiple Time Intervals After Admission to the Emergency Department Note: The Access hsTnl assay is not intended to be used in isolation: results should be interpreted inconjunction with other diagnostic tests and clinical information. Imprecision: The within-laboratory (total) % CV ranged from 2.6% to 7.4% for hsTnl concentrations ≥ 11.5 pg/mL for lithium heparin plasma and serum. The within-laboratory (total) SD ranged from 0.34 to 0.93 for hsTnl for concentrations < 11.5 pq/mL for lithium heparin plasma and serum. High-dose Hook Effect: The Access hsTnl assay demonstrated no high-dose hook effect up to at least 2,000,000 pg/mL. Linearity: The Access hsTnl assay has demonstrated to be linear across the range of the assay (2.0 to approximately 27,027 pg/mL) in both serum and lithium heparin plasma samples. Dilution Recovery: The Access hsTnl assay has been demonstrated to dilute recover across the range of the assay (2.0 to approximately 27.027 pq/mL) in serum and lithium heparin plasma samples. Samples containing troponin I from approximately 27,027 to 270,270 pg/mL can be diluted 10-fold with an average recovery of 100 ± 10%. {11}------------------------------------------------ Limit of Blank (LoB): The highest measurement result observed with no analyte present in the samples is 0.8 pq/mL. Limit of Detection (LoD): The lowest concentration of analyte in both serum and lithium heparin plasma that can be detected is 2.0 pg/mL. Limit of Quantitation (LoQ): The lowest concentration of analyte in both serum and lithium heparin plasma samples that can be quantitatively determined with within-laboratory imprecision of CV ≤ 10% is 4.1 pg/mL and with within-laboratory imprecision of CV ≤ 20% is 2.0 pq/mL. Analytical Specificity: Potential cross-reactive substances were added to lithium heparin plasma and serum samples at two concentrations of cTnl (approximately 10 pq/mL and one containing approximately 100 pg/mL) Stock solutions of potential cross-reactants were prepared volumetrically using calibrated pipettes and the appropriate solvent. This stock solution was added directly to the lithium heparin plasma and serum samples in no more than 5% (v/v) final concentration. Control samples were prepared in the same manner using the solvent, without the cross-reactant added. Control and test samples were tested on the Access 2 instrument within 24 hours of preparation, using three reagent lots. Of the compounds tested, none were found to cause significant cross-reactivity at the levels listed in the table below, as defined by a shift in concentration greater than ± 2 standard deviation (SD). For sample concentrations > 11.5 pg/mL (ng/L), 2 SD is defined as 10%. For sample concentrations ≤ 11.5 pq/mL (ng/L), 2SD is defined as 2.30 pg/mL (ng/L). Interfering Substances: Potential interferents were tested at one concentration within the reference interval or the therapeutic concentration range as directed by EP7-A2 (Interference Testing in Clinical Chemistry-Approved Guideline, Second Edition). Lithium heparin plasma and serum samples containing cTnl concentrations of approximately, 10 pg/mL (ng/L) and 100 pg/mL (ng/L) were spiked with the substances below and run on a single Access 2 Immunoassay System. Interference was determined by testing controls (no interfering substance added) and matched test samples (with interfering substance added). Of the compounds tested, none were found to cause significant interference at the levels listed in the table below, as defined by a shift in concentration greater than ± 2SD. For sample concentrations > 11.5 pg/mL (ng/L), 2SD is defined as 10%. For sample concentrations ≤ 11.5 pg/mL (ng/L), 2SD is defined as 2.30 pq/mL (nq/L). {12}------------------------------------------------ | Substance | Highest Concentration Added | Substance | Highest Concentration Added | |--------------------------|--------------------------------|---------------------------------------|--------------------------------| | Acetaminophen | 50 mg/dL | Fibrinogen | 1000 mg/dL | | Acetylsalicylic Acid | 65 mg/dL | Furosemide | 40 mg/dL | | Atenolol | 1 mg/dL | Hemoglobin | 4 mg/mL | | Atorvastatin | 20 µg/mL | Human Serum Albumin | 6000 mg/dL | | Bilirubin (conjugated) | 40 mg/dL | Ibuprofen | 50 mg/dL | | Bilirubin (unconjugated) | 20 mg/dL | Intralipid | 3000 mg/dL | | Bivalirudin | 42 µg/mL | Sodium Heparin | 28.8 U/mL | | Caffeine | 10 mg/dL | Methyldopa | 2.5 mg/dL | | Captopril | 5 mg/dL | Nitrofurantoin | 6.4 mg/dL | | Cinnarizine | 40 mg/dL | Nystatin | 2 mg/dL | | Clopidogrel | 75 µg/mL | Phenobarbital | 20 µg/mL | | Cocaine | 2 mg/dL | Rifampicin | 60 µg/mL | | Cyclosporine | 5 µg/mL | Rosuvastatin | 20 µg/mL | | Digoxin | 200 ng/mL | Tissue Plasminogen Activator (TPA) | 2.5 µg/mL | | Dopamine | 65 mg/dL | Verapamil | 16 mg/dL | #### Interfering Substances ## Conclusion: Access hsTnl is equivalent to the currently marketed Access AccuTnl+3 assay. The verification and validation data provided in this submission demonstrates that the safety and efficacy of this device is equivalent to the Access AccuTnl+3 predicate device.