(200 days)
Not Found
No
The device description and performance studies focus on a traditional immunoassay technology (LOCI®) and standard analytical performance metrics. There is no mention of AI/ML algorithms for data analysis, interpretation, or diagnosis.
No.
Explanation: The device is an in vitro diagnostic (IVD) assay used to measure cardiac troponin I levels in human plasma, which aids in the diagnosis of acute myocardial infarction (AMI). It provides diagnostic information but does not directly treat or prevent a disease, injury, or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Dimension Vista® High-Sensitivity Troponin I (TNIH) assay is for in vitro diagnostic use..." and "The assay can be used to aid in the diagnosis of acute myocardial infarction (AMI)." These phrases clearly indicate its function as a diagnostic device.
No
The device is an in vitro diagnostic assay that measures cardiac troponin I in human plasma using a specific system (Dimension Vista system) and reagents. This involves physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The very first sentence explicitly states: "The Dimension Vista® High-Sensitivity Troponin I (TNIH) assay is for in vitro diagnostic use..."
- Purpose: The assay is designed to measure cardiac troponin I in human plasma to aid in the diagnosis of acute myocardial infarction (AMI). This is a diagnostic purpose performed outside of the living body (in vitro).
- Sample Type: It uses human plasma, which is a biological sample collected from a patient.
- Technology: The description details a laboratory-based immunoassay technology (LOCI®) used to analyze the sample.
- Performance Studies: The document describes various analytical and clinical performance studies (precision, linearity, interference, clinical concordance, etc.) which are standard for IVD devices to demonstrate their accuracy and reliability for diagnostic purposes.
- Intended User/Care Setting: It is indicated for "in vitro diagnostic use," reinforcing its classification as an IVD.
All of these factors clearly indicate that the Dimension Vista® High-Sensitivity Troponin I (TNIH) assay is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Dimension Vista® High-Sensitivity Troponin I (TNIH) assay is for in vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma using the Dimension Vista system. The assay can be used to aid in the diagnosis of acute myocardial infarction (AMI).
Product codes (comma separated list FDA assigned to the subject device)
MMI
Device Description
The Dimension Vista® TNIH assay is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI® technology. The LOCI reagents include two synthetic bead reagents and two biotinylated anti-cardiac troponin I monoclonal antibody fragments. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitizer dye. The second bead reagent (Chemibeads) is coated with a third anticardiac troponin I monoclonal antibody and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibodies to form bead-cardiac troponin Ibiotinylated antibody sandwiches. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the cardiac troponin I concentration in the sample
Lithium heparin plasma specimens may be used. The reagent is stored unopened at 2 – 8 °C, is stable sealed on system for 30 days and opened on the system for 7 days. Calibration is performed every 30 days for a 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
The 99th percentile values were determined using the non-parametric statistical method described in CLSI Guidance EP28-A3c. Sample type, gender, and age had no statistically significant effect on the 99th percentile.
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Detection Limit Study:
- Study Type: Evaluation of Limit of Blank (LoB) and Limit of Detection (LoD) in accordance with CLSI EP17-A2 Protocols.
- Sample Size:
- LoB: 5 samples with no analyte (calibrator Level 1), tested N=4 for 3 days, one run per day, 3 reagent lots (total 60 replicates).
- LoD: At least 5 low analyte samples, tested N=4 for 3 days for native lithium heparin plasma, one run per day, 3 reagent lots.
- Key Results:
- LoB: 1.0 pg/mL
- LoD: 0.7 - 1.9 pg/mL (consistent with 2.0 pg/mL)
Limit of Quantitation (LoQ) Study:
- Study Type: Determination of LoQ as the analyte level with a within-lab CV of less than or equal to 20.0%, in accordance with CLSI EP5-A3.
- Sample Size: Testing completed two times a day (n=2) for at least 20 days for a total of 80 replicates with at least 6 native lithium heparin plasma pools on one instrument.
- Key Results: The LoQ for Dimension Vista TNIH was determined to be 3.0 pg/mL.
10% CV Limit Study:
- Study Type: Determination of the analyte level with a within-lab CV of less than or equal to 10.0%, in accordance with CLSI EP5-A3.
- Sample Size: Testing completed two times a day (n=2) for at least 20 days for a total of 80 replicates with at least 6 native lithium heparin plasma pools on one instrument.
- Key Results: The 10% CV limit for Dimension Vista TNIH of 10.0 pg/mL is consistent with the data.
Precision Studies:
- Study Type: Evaluation of Precision Performance in accordance with CLSI EP05-A3.
- Sample Size: n = 2 replicates, two times a day for at least 20 days for a total of 80 replicates with controls and plasma pools on one instrument.
- Key Results: All precision goals were met.
- Plasma 1 (Mean 48.9 pg/mL): Repeatability SD 1.12 pg/mL (2.3% CV), Within-Lab SD 3.05 pg/mL (6.2% CV)
- Plasma 2 (Mean 157.7 pg/mL): Repeatability SD 1.55 pg/mL (1.0% CV), Within-Lab SD 2.60 pg/mL (1.6% CV)
- QC (Mean 8088.5 pg/mL): Repeatability SD 99.54 pg/mL (1.2% CV), Within-Lab SD 200.36 pg/mL (2.5% CV)
Linearity Study:
- Study Type: Evaluation of the Linearity of Quantitative Measurement Procedure (EP06-A).
- Sample Size: 16 lithium heparin plasma samples spanning the assay measuring interval. At least five replicates measured for each sample.
- Key Results: The testing confirmed linearity from 3.0 - 25,000.0 pg/mL.
Interferences Study:
- Study Type: Interference testing following CLSI EP7-A2 using a "paired difference scenario" approach.
- Key Results: No interference was detected (bias =9-24 hrs) to 92.5% (0-=9-24 hrs)
- NPV ranging from 96.9% (0-
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 4, 2019
Siemens Healthcare Diagnostics, Inc. Laura Duggan Sr. Mgr. Regulatory Affairs 500 GBC Drive. M/S 514 Newark, DE 19714
Re: K182225
Trade/Device Name: Dimension Vista High-Sensitivity Troponin I (TNIH) Assay Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: January 24, 2019 Received: January 25, 2019
Dear Laura Duggan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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) K182225
Device Name
Dimension Vista High-Sensitivity Troponin I (TNIH) assay
Indications for Use (Describe)
The Dimension Vista® High-Sensitivity Troponin I (TNIH) assay is for in vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma using the Dimension Vista system. The assay can be used to aid in the diagnosis of acute myocardial infarction (AMI).
| 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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3
SECTION 7: 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
ASSIGNED 510(K) NUMBER
The assigned 510(k) number is K182225.
APPLICANT AND DATE
Laura J. Duggan, Ph. D., RAC Siemens Healthcare Diagnostics Inc. 500 GBC Drive, M/S 514 Newark, DE 19714-6101 Email: laura.j.duggan@siemens-healthineers.com Phone: 302-631-7654 Fax: 302-631-0493
January 24, 2018
MANUFACTURER
Siemens Healthcare Diagnostics Inc. 500 GBC Drive Newark, DE 19714-6101
Registration Number: 2517506
REGULATORY INFORMATION
Regulatory Submission for the Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
| Device: | Immunoassay method, troponin subunit |
|---|---|
| Regulation Description: | Creatine phosphokinase/creatine kinase or isoenzymes test system |
| Proprietary Name: | Dimension Vista High-Sensitivity Troponin I (TNIH) Assay |
| Regulation Number: | 21CFR862.1215 |
| Classification: | Class II |
4
| Product Code: | MMI |
|---|---|
| Panel: | Clinical Chemistry |
| Predicate Device: | Elecsys Troponin T Gen 5 STAT |
| (K162895) |
DEVICE DESCRIPTION
DIMENSION VISTA HIGH-SENSITIVITY TROPONIN I (TNIH) ASSAY
The Dimension Vista® TNIH assay is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI® technology. The LOCI reagents include two synthetic bead reagents and two biotinylated anti-cardiac troponin I monoclonal antibody fragments. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitizer dye. The second bead reagent (Chemibeads) is coated with a third anticardiac troponin I monoclonal antibody and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibodies to form bead-cardiac troponin Ibiotinylated antibody sandwiches. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the cardiac troponin I concentration in the sample
Lithium heparin plasma specimens may be used. The reagent is stored unopened at 2 – 8 °C, is stable sealed on system for 30 days and opened on the system for 7 days. Calibration is performed every 30 days for a reagent lot.
INTENDED USE/INDICATIONS FOR USE
DIMENSION VISTA HIGH-SENSITIVITY TROPONIN I (TNIH) ASSAY
The Dimension Vista High-Sensitivity Troponin I (TNIH) assay is for in vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma using the Dimension Vista® system. The assay can be used to aid in the diagnosis of acute myocardial infarction (AMI).
SUBSTANTIAL EQUIVALENCE COMPARISON
Below is a substantial equivalence comparison for the Dimension Vista High-Sensitivity Troponin I (TNIH) Assay vs. the Elecsys Troponin T Gen 5 STAT (K162895) device.
5
| Feature | Predicate Device:
Elecsys Troponin T Gen 5
STAT (K162895) | New Device:
DIMENSION VISTA HIGH-
SENSITIVITY TROPONIN I
(TNIH) ASSAY |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use : | Immunoassay for the in vitro
quantitative determination of
cardiac troponin T (cTnT) in
lithium heparin plasma. | The High-Sensitivity Troponin
I (TNIH) assay is for in vitro
diagnostic use in the
quantitative measurement of
cardiac troponin I in human
plasma using the Dimension
Vista® system. |
| Indications for Use: | The immunoassay is
intended to aid in the
diagnosis of myocardial
infarction. | The assay can be used to aid
in the diagnosis of acute
myocardial infarction (AMI). |
| Device Technology: | Electrochemiluminescence
immunoassay | Homogeneous immunoassay |
| Sample Type: | Lithium Heparin Plasma | Lithium Heparin plasma |
| Expected Values: | 99th percentile
were determined to be:
• 19 ng/L for both
• 14 ng/L for females
• 22 ng/L for males | 99th percentile determined for
plasma
58.9 pg/mL overall
female 53.7 pg/mL plasma
male 78.5 pg/mL plasma |
| Calibration
Frequency: | after 12 weeks when using
the same reagent lot | 30 days for any one lot |
| Analytical Measuring
Interval: | 6-10,000 ng/L | 3.0 – 25,000.0 pg/mL [ng/L] |
| Interferences: | No interference in plasma at:
Hemoglobin - 100 mg/dL
Bilirubin 25 mg/dL
Lipemia (Intralipid®) — 1500
mg/dL | No interferences in plasma at
approximately 40 pg/mL and
approximately 1350 pg/mL of
cardiac troponin I from:
Hemoglobin - 400 mg/dL
Bilirubin (Unconjugated) – 40
mg/dL |
| | | Bilirubin (Conjugated) – 30
md/dL
Lipemia (Intralipid®) - 3000
mg/dL |
| Calibrators: | Elecsys Troponin T Gen 5
STAT calibrators (CalSet
Troponin T Gen 5 STAT) | High-Sensitivity Troponin I
Calibrator (TNIH Cal), Cat.
No. KC627 |
6
SUMMARY OF PERFORMANCE TESTING
Assay performance results for the Dimension Vista High-Sensitivity Troponin I (TNIH) assay was determined by processing the appropriate body fluids. Summary statistics for each are provided. The following data represent typical assay performance. All data were collected on the Dimension Vista 1500 Analyzer.
DETECTION LIMIT
The Limit of Blank (LoB) and Limit of Detection (LoD) were evaluated in accordance with CLSI EP17-A2 Protocols for Determination of Limits of Detection and Limits of Quantitation: Approved Guideline.
Assessment of LoB was the 95th percentile of all values (sorted from lowest to highest), using non-parametric approach. LoB Rank Position = 0.5 +0.95*B, where B=total reps=60; Rank = 57.5
The nonparametric approach described in EP17-A2 was followed to determine the Limit of Detection. LoD was tested separately for lithium heparin specimens.
| Dimension Vista High-Sensitivity Troponin I (TNIH) - Limit of Detection Results | ||
|---|---|---|
| Limit | Protocol | Result |
| LoB | 5 samples with no analyte (calibrator Level 1) | |
| were tested (N=4) for 3 days, one run per day, 3 | ||
| reagent lots | 1.0 pg/mL | |
| LoD | At least 5 low analyte samples were tested (N=4) | |
| for 3 days for native lithium heparin plasma, one | ||
| run per day, 3 reagent lots | 0.7 - 1.9 | |
| pg/mL |
Results are consistent with a LoB of 1.0 pg/mL and a LoD of 2.0 pg/mL
7
The Limit of Quantitation (LoQ) for plasma was determined as the analyte level with a within-lab CV of less than or equal to 20.0%. Testing was completed two times a day (n=2) for at least 20 days for a total of 80 replicates with at least 6 native lithium heparin plasma pools on one instrument.
LoQ Lot Summary
| Reagent Lot | Lot-1 | Lot-2 | Lot-3 |
|---|---|---|---|
| Lithium Heparin Plasma 20% CV (pg/mL) | 1.2 | 2.4 | 2.2 |
The LoQ for Dimension Vista TNIH was determined to be 3.0 pg/mL.
For lithium heparin plasma the analyte level with a within-lab CV of less than or equal to 10.0% was determined using CLSI EP5-A3, Evaluation of Precision Performance of Quantitative Measurement Methods: Approved Guideline - Third Edition. Testing was completed two times a day (n=2) for at least 20 days for a total of 80 replicates with at least 6 native lithium heparin plasma pools on one instrument.
10% CV Lot Summary
| Reagent Lot | Lot-1 | Lot-2 | Lot-3 |
|---|---|---|---|
| Lithium Heparin Plasma 10% CV (pg/mL) | 2.7 | 5.7 | 5.4 |
The 10% CV limit for Dimension Vista TNIH of 10.0 pg/mL is consistent with the data.
PRECISION STUDIES
Precision testing was performed in accordance with CLSI EP05-A3 Evaluation of Precision Performance of Quantitative Measurement Methods: Approved Guideline -Third Edition. Precision was tested n = 2 replicates, two times a day for at least 20 days for a total of 80 replicates with controls and plasma pools on one instrument. Analysis of variance (ANOVA) was used to evaluate the data consistent with the recommendations of EP05-A3. The data are summarized in the following table. All precision goals were met.
| Repeatability | Within-Lab | ||||
|---|---|---|---|---|---|
| Material | Mean pg/mL | SDa pg/mL | %CVb | SD pg/mL | %CV |
| Plasma 1 | 48.9 | 1.12 | 2.3 | 3.05 | 6.2 |
| Plasma 2 | 157.7 | 1.55 | 1.0 | 2.60 | 1.6 |
| QC | 8088.5 | 99.54 | 1.2 | 200.36 | 2.5 |
aSD = standard deviation
8
b CV = coefficient of variation
LINEARITY STUDY
Linearity was evaluated with 16 lithium heparin plasma samples which spanned the assay measuring interval. Each was prepared by mixing high and low concentration samples across the measurement interval as described in CLSI Evaluation of the Linearity of Quantitative Measurement Procedure (EP06-A). The high samples and the low samples for lithium heparin plasma were native. At least five replicates were measured for each sample. The mean of these replicates was used for the calculations.
The assay was considered linear across the measuring interval if the p values of nonlinear terms in the quadratic and cubic fit equations are nonsignificant (p ≤ 0.05). If the p-value is > 0.05, then the allowable bias is ≤ 10% or 3 pg/mL, whichever is greater.
The testing confirmed linearity from 3.0 - 25,000.0 pg/mL.
INTERFERENCES
CLSI EP7-A2 was followed for the interference testing. The interference study was conducted using a "paired difference scenario" approach where these compounds were spiked into fresh sample pools containing either low or high levels of troponin in lithium heparin troponin I pools. All exogeneous compounds were spiked into the troponin control pools at two levels. Endogeneous compounds were only tested at elevated levels as they are natively found in specimen samples.
Bias is the difference in the results between the control sample (without the interferent) and the test sample (contains the interferent) expressed in percent. Bias exceeding 10% is considered interference. Dilution studies were conducted to determine the level at which the spiked substance no longer displayed significant interference. Dilution studies were conducted at two analyte concentrations, if both sample pools show significant interference.
| Substance Tested | Substance concentration | Bias (%) |
|---|---|---|
| Hemoglobin hemolysate (monomer) | 400 mg/dL [0.25 mmol/L] | 24 |
Table 2: Results for females based on time from presentation to the emergency department
Results for males based on time of presentation to the emergency department, calculated using the male-specific 99th percentile of 78.5 pg/mL for plasma are summarized in Table 3.
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| | Sensitivity | | | Specificity | | | Positive Predictive
Value | | | Negative Predictive
Value | | |
|---------------------------------------|-------------|-------|------------|-------------|-------|------------|------------------------------|-------|------------|------------------------------|-------|------------|
| Time since
presentation
(hours) | n | % | 95% Cl | n | % | 95% Cl | n | % | 95% Cl | n | % | 95% Cl |
| 0 -