(272 days)
No
The summary describes a standard immunoassay system for measuring cardiac troponin I levels. There is no mention of AI, ML, or any computational analysis beyond standard statistical methods for calculating performance metrics.
No.
The device is an in vitro diagnostic (IVD) immunoassay system intended to aid in the diagnosis of myocardial infarction (MI) by measuring cTnI levels, not for treating or preventing a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used "to aid in the diagnosis of myocardial infarction (MI)". This clearly indicates its diagnostic purpose.
No
The device description clearly outlines physical reagent packs containing various chemical components (paramagnetic particles, antibodies, buffers, etc.) used in an immunoassay system. This indicates a significant hardware and chemical component, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is for the "quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma... to aid in the diagnosis of myocardial infarction (MI)." This clearly indicates that the device is intended for use in vitro (outside the body) to analyze a human sample (serum and plasma) for diagnostic purposes (aiding in the diagnosis of MI).
- Device Description: The "Device Description" section describes the components of the reagent packs as being for the "in vitro diagnostic measurement of cTnl".
- Reagent Components: The description of the reagent components (R1a, R1b, R1c, R1d) details the specific chemical and biological materials used in the assay, which are typical of in vitro diagnostic tests.
- Performance Studies: The document describes various performance studies (99th percentile URL, Clinical performance, Imprecision, Linearity, etc.) which are standard evaluations for IVD devices to demonstrate their analytical and clinical performance.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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).
Product codes
MMI
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). 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. 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Sensitivity and Specificity: Diagnostic sensitivity (% MI correctly diagnosed) and specificity (% Non-MI correctly diagnosed) were calculated per CLSI Guideline I/LA21-A2.
Example key results:
Lithium heparin plasma:
- Overall: 17.5 pg/mL cutoff, Baseline: Sensitivity 86% (86/100), Specificity 90% (510/564).
- Overall: 17.5 pg/mL cutoff, ≥ 1-3 hour: Sensitivity 95% (128/135), Specificity 90% (985/1090).
- Overall: 17.5 pg/mL cutoff, ≥ 3-6 hour: Sensitivity 93% (140/151), Specificity 90% (1045/1161).
- Overall: 17.5 pg/mL cutoff, ≥ 6-9 hour: Sensitivity 99% (70/71), Specificity 86% (387/451).
Serum: - Overall: 18.2 pg/mL cutoff, Baseline: Sensitivity 84% (91/108), Specificity 91% (541/595).
- Overall: 18.2 pg/mL cutoff, ≥ 1-3 hour: Sensitivity 94% (132/141), Specificity 91% (1009/1108).
- Overall: 18.2 pg/mL cutoff, ≥ 3-6 hour: Sensitivity 93% (142/152), Specificity 90% (1082/1202).
- Overall: 18.2 pg/mL cutoff, ≥ 6-9 hour: Sensitivity 96% (64/67), Specificity 86% (403/469).
Positive Predictive Value (PPV) and Negative Predictive Value (NPV): Calculated per CLSI Guideline I/LA21-A2.
Example key results:
Lithium heparin plasma:
- Overall: 17.5 pg/mL cutoff, Baseline: PPV 61% (86/140), NPV 97% (510/524).
- Overall: 17.5 pg/mL cutoff, ≥ 1-3 hour: PPV 55% (128/233), NPV 99% (985/992).
- Overall: 17.5 pg/mL cutoff, ≥ 3-6 hour: PPV 55% (140/256), NPV 99% (1045/1056).
- Overall: 17.5 pg/mL cutoff, ≥ 6-9 hour: PPV 52% (70/134), NPV 100% (387/388).
Serum: - Overall: 18.2 pg/mL cutoff, Baseline: PPV 63% (91/145), NPV 97% (541/558).
- Overall: 18.2 pg/mL cutoff, ≥ 1-3 hour: PPV 57% (132/231), NPV 99% (1009/1018).
- Overall: 18.2 pg/mL cutoff, ≥ 3-6 hour: PPV 54% (142/262), NPV 99% (1082/1092).
- Overall: 18.2 pg/mL cutoff, ≥ 6-9 hour: PPV 49% (64/130), NPV 99% (403/406).
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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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).
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
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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)
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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
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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). 0.075
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 (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).
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| 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.