(270 days)
Not Found
No
The summary describes a standard immunoassay system and its performance characteristics. There is no mention of AI or ML in the device description, intended use, or performance studies. The analysis focuses on traditional analytical performance metrics and clinical study results.
No
This device is an in vitro diagnostic (IVD) immunoassay system used for the quantitative determination of cardiac troponin I (cTnl) to aid in the diagnosis of myocardial infarction. It does not provide any therapeutic function; it only provides diagnostic information.
Yes
The device is described as an "immunoassay 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 explicitly states its purpose is to assist in diagnosis, which is the definition of a diagnostic device.
No
The device description explicitly details reagent packs containing physical components (paramagnetic particles, antibodies, buffers, etc.) used in an immunoassay system, indicating it is not software-only.
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 describes a test performed on biological samples taken from the body to provide information for diagnosis.
- Device Description: The "Device Description" details the reagents used for the "in vitro diagnostic measurement of cTnl." This confirms that the test is performed outside of the living organism.
- Sample Type: The device is designed to analyze "human serum and plasma," which are biological samples.
- Purpose: The purpose is to "aid in the diagnosis of myocardial infarction (MI)," which is a medical condition.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 UniCel DxI Access Immunoassay Systems to aid in the diagnosis of myocardial infarction (MI).
Product codes (comma separated list FDA assigned to the subject device)
MMI
Device Description
The Access hsTnl and Access UniCel Dxl 800 Immunoassay System comprise the Access Immunoassay System for the quantitative determination of cardiac troponin I (cTnl) in human serum and plasma.
The Access hsTnl 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 pq/mL. For sample concentrations ≤ 11.5 pg/mL, the change in concentration between diluent control and test sample must be within 2SD, where 2SD is defined as 2.30 pg/mL.
Interfering Substances: Of the compounds tested, none were found to cause significant interference, as defined by a shift in concentration within ± 10% for samples > 11.5 pg/mL. For sample concentrations ≤ 11.5 pq/mL, the change in concentration between diluent control and test sample must be within 2SD, where 2SD is defined as 2.30 pg/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall (Lithium Heparin Plasma):
Baseline: Sensitivity: 88%, Specificity: 89%, PPV: 58%, NPV: 98%
≥ 1-3 hour: Sensitivity: 94%, Specificity: 90%, PPV: 54%, NPV: 99%
≥ 3-6 hour: Sensitivity: 94%, Specificity: 90%, PPV: 55%, NPV: 99%
≥ 6-9 hour: Sensitivity: 99%, Specificity: 85%, PPV: 51%, NPV: 100%
Overall (Serum):
Baseline: Sensitivity: 87%, Specificity: 89%, PPV: 60%, NPV: 97%
≥ 1-3 hour: Sensitivity: 95%, Specificity: 90%, PPV: 55%, NPV: 99%
≥ 3-6 hour: Sensitivity: 95%, Specificity: 90%, PPV: 54%, NPV: 99%
≥ 6-9 hour: Sensitivity: 97%, Specificity: 85%, PPV: 49%, NPV: 100%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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June 12, 2018
Beckman Coulter, Inc. Kerrie Oetter Staff Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, MN 55318-1084
Re: K172783
Trade/Device Name: Access hsTnI 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 3, 2018 Received: May 4, 2018
Dear Kerrie Oetter:
We have reviewed vour 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
1
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.
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 medical devices and radiation-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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K172783
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 UniCel DxI Access Immunoassay Systems to aid in the diagnosis of myocardial infarction (MI).
| 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) |
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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 K172783
Submitted By:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-1142 Fax: (952) 368-7610
Contact Person:
Kerrie Oetter 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-7858 Fax: (952) 368-7704
Alternate Contact: Angela Kilian
(952) 368-1330 (952) 368-7704 (fax)
Date Prepared:
June 7, 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 Access UniCel Dxl 800 Immunoassay System comprise the Access Immunoassay System for the quantitative determination of cardiac troponin I (cTnl) in human serum and plasma.
The Access hsTnl 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 6-9 hour | 98
(48/49) | 89-100 | 81
(183/225) | 76-86 | 53
(48/90) | 43-64 | 100
(183/184) | 97-100 |
10
| 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 |
| Serum | | | | | | | | | |
| Overall:
18.1 | Baseline | 87
(96/110) | 80-93 | 89
(534/598) | 87-92 | 60
(96/160) | 52-68 | 97
(534/548) | 96-99 |
| | ≥ 1-3 hour | 95
(134/141) | 90-98 | 90
(999/1110) | 88-92 | 55
(134/245) | 48-61 | 99
(999/1006) | 99-100 |
| | ≥ 3-6 hour | 95
(147/155) | 90-98 | 90
(1074/1200) | 88-91 | 54
(147/273) | 48-60 | 99
(1074/1082) | 99-100 |
| | ≥ 6-9 hour | 97
(66/68) | 90-100 | 85
(398/468) | 82-88 | 49
(66/136) | 40-57 | 100
(398/400) | 98-100 |
| Females:
13.6 | Baseline | 83
(24/29) | 64-94 | 89.4%
(237/265) | 85-93 | 46
(24/52) | 32-61 | 98
(237/242) | 95-99 |
| | ≥ 1-3 hour | 95
(41/43) | 84-99 | 91
(493/543) | 88-93 | 45
(41/91) | 35-56 | 100
(493/495) | 99-100 |
| | ≥ 3-6 hour | 96
(49/51) | 87-100 | 90
(519/579) | 87-92 | 45
(49/109) | 35-55 | 100
(519/521) | 99-100 |
| | ≥ 6-9 hour | 100
(20/20) | 83-100 | 86
(202/235) | 81-90 | 38
(20/53) | 25-52 | 100
(202/202) | 98-100 |
| Males:
19.8 | Baseline | 86
(70/81) | 77-93 | 87.1%
(290/333) | 83-91 | 62
(70/113) | 52-71 | 96
(290/301) | 94-98 |
| | ≥ 1-3 hour | 96
(94/98) | 90-99 | 88
(498/567) | 85-90 | 58
(94/163) | 50-65 | 99
(498/502) | 98-100 |
| | ≥ 3-6 hour | 95
(99/104) | 89-98 | 88
(546/621) | 85-90 | 57
(99/174) | 49-64 | 99
(546/551) | 98-100 |
| | ≥ 6-9 hour | 96
(46/48) | 86-100 | 82
(191/233) | 76-87 | 52
(46/88) | 41-63 | 99
(191/193) | 96-100 |
Clinical Performance of Access hsTnl Using the Calculated 99th Percentile Cutoffs. Presented at Multiple Time Intervals After Admission to the Emergency Department
Imprecision: The within-laboratory (total) % CV ranged from 2.8% to 10% for hsTnl concentrations ≥ 11.5 pg/mL for serum and lithium heparin plasma samples. The within-laboratory (total) SD ranged from 0.22 to 0.75 for hsTnl for concentrations 11.5 pq/mL. For sample concentrations ≤ 11.5 pg/mL, the change in concentration between diluent control and test sample must be within 2SD, where 2SD is defined as 2.30 pg/mL.
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 pq/mL (ng/L) and 100 pq/mL (ng/L) were spiked with the substances below and run on a single Dxl 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, as defined by a shift in concentration within ± 10% for samples > 11.5 pg/mL. For sample concentrations ≤ 11.5 pq/mL, the change in concentration between diluent control and test sample must be within 2SD, where 2SD is defined as 2.30 pg/mL.
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Interfering Substances
| 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 |
Conclusion:
The 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.