(168 days)
No
The device description and performance studies focus on the immunochromatographic assay and fluorescence measurement, with no mention of AI or ML. The calculation of the quantitative reading is based on a ratio of fluorescence values, which is a standard analytical method, not indicative of AI/ML.
No
Explanation: The device is an in vitro diagnostic product that measures cardiac troponin I levels to aid in the rapid diagnosis of acute myocardial infarction (AMI). It provides diagnostic information and is not used for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic product" and "aids in the rapid diagnosis of acute myocardial infarction (AMI)."
No
The device description clearly states it is an "immunochromatographic test" and is used with a "RAMP Clinical Reader" which measures fluorescence. This indicates a physical assay and a hardware reader are integral components, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states, "The RAMP Troponin I Assay is a quantitative immunochromatographic test indicated for use as an in vitro diagnostic product used with the RAMP Clinical Reader to measure cardiac troponin I levels in EDTA whole blood." This directly identifies it as an in vitro diagnostic device.
- Device Description: The description details how the test works by analyzing a biological sample (EDTA whole blood) outside of the body to measure a specific analyte (cardiac troponin I). This is the core function of an in vitro diagnostic.
- Clinical Performance: The clinical performance section describes studies conducted to evaluate the device's performance in diagnosing a medical condition (acute myocardial infarction) using patient samples. This is typical for IVD devices.
- Predicate Devices: The mention of predicate devices (K973126 Triage Cardiac Panel®; Troponin I Assay; K973650 Dimension® RxL Cardiac Troponin-I Flex®) which are known IVD devices, further supports that this device falls into the same category.
N/A
Intended Use / Indications for Use
The RAMP Troponin I Assay is a quantitative immunochromatographic test indicated for use as an in vitro diagnostic product used with the RAMP Clinical Reader to measure cardiac troponin I levels in EDTA whole blood. Measurement of cardiac troponin I aids in the rapid diagnosis of acute myocardial infarction (AMI). The RAMP Troponin I Assay is intended to be used only to prioritize patient management for those suspected of AMI.
Product codes
MMI
Device Description
The RAMP Troponin I Assay is a quantitative immunochromatographic test for the rnic Tric Troponia T-Thous) Do A whole blood. Diluted EDTA whole blood is added to the sample well of the Test Cartridge which houses the immunochromatographic test strip our pro real blood cells are retained in the sample pad, and the separated plasma migrates along the strip. Fluorescent-dyed latex particles coated with anti-Tril antibodies hightion and in the sample. As the sample migrates along the strip, Tnl bound particles are immobilized at the detection zone, and additional particles are immobilized at the internal control zone.
The RAMP Reader then measures the amount of fluorescence emitted by the complexes bound at the detection zone and at the internal control zone. Using a ratio between the two fluorescence values, a quantitative reading is calculated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
PRECISION: The intra-assay and the inter-assay precision of the RAMP Troponin I Assay were determined by one operator assaying duplicates of two standards (1.05 and 5.01 ng/mL Tnl) twice each day over 10 days. The mean, standard deviation and %CV were calculated for the predicted Tnl at each concentration. Within run precision was 8.7% and 8.3% respectively. Total precision was 10.0% and 8.3% respectively. Low end precision was also determined by the same method using Plasma Standards of 0.09, 0.15, 0.22, 0.29, 0.40 and 0.70 ng/mL Tnl. The assay concentration in standards where 10.0% or less CV is achieved was 0.21 ng/mL Tnl and where 20.0% or less CV is achieved was 0.14 ng/mL Tnl for within run precision. The assay concentration in standards where 10.0% or ngmic Yil for within full problem. The as a viere 20.0% or less CV is achieved was 0.15 ng/mL Tnl for total precision. Low end precision of the RAMP Troponin I Assay was 0.15 Ilgmir Thi for total prodision: Low one proclaired assaying 10 replicates of each of also determined in ED World Color assay concentration in blood where 10.0% or less CV is 5 spired ini concentrations. The assure of is achieved was 0.10 ng/mL Tnl.
LINEARITY and PERCENT RECOVERY: Tnl antigen concentrations of 0.86, 1.72, 3.44, 6.88, 13.75, and 27.5 ng/mL were prepared in normal donor EDTA blood. The linearity 0.00, 15.15, and 27.5 hgmd. Were propan assaying five replicates of each concentration and baseline. The mean, standard deviation and %CV were calculated for the predicted and bach concentration. Linear regression analysis of actual Tnl concentration versus expected TnI concentration resulted with an R = 0.997 and a slope of 1.019 with an offset of 0.279. The recovery of spiked Tnl antigen at the five concentrations was 0.82, 1.72, 3.65, 7.65, 15.78, and 27.51 ng/mL. Percent recovery of Tnl ranged from 95 to 115% with an average of 105%.
HOOK EFFECT: There is no high dose hook effect in the RAMP Troponin I Assay up to the highest level tested (500 ng/mL Tnl).
ANALYTICAL SENSITIVITY: The lower limit of detection (LLD) is defined as the analyte concentration corresponding to the mean (n=20) plus 2 standard deviations of the zero. The LLD is 0.03 ng/mL Tnl. Tnl levels in excess of 32 ng/mL are reported as greater than (>) 32 nq/mL.
ANALYTICAL SPECIFICITY: Potentially cross-reactive substances were evaluated by spiking different concentrations into blood. Skeletal Troponin I, Cardiac Troponin T and Cardiac Troponin C appear to have no significant cross-reactivity with the RAMP Troponin I Assay. HAMA, HAGA, HARA and RhF appear to have minimal cross-reactivity with the RAMP Troponin I Assay.
INTERFERENCE: Potentially interfering substances were evaluated by spiking different concentrations of potential interferents into EDTA blood with TnI added. Different blood samples were used for each potential interferent. Interference was evaluated by calculating the Tnl concentration of potential interferent-spiked blood, expressed as a percentage of the Tnl concentration of the unspiked (no potential interferent) blood sample. No evidence of cross-reactivity or interference was observed for hemoglobin, triglyceride, bilirubin, cholesterol, or heparin at levels of very high physiological concentrations, up to 1500 mg/dL, 3000mg/dL, 80 mg/dL, 500 mg/dL, and 66 IU/mL, respectively. No trend was observed in the Tnl predictions as the concentration of potential interferent was increased.
CLINICAL PERFORMANCE - EXPECTED VALUES: Whole blood samples from 180 healthy individuals (84 males and 96 females) were assayed for Troponin I by the three methods, RAMP, Triage, and Dimension. The lower assayed for Troponia 1 by the first normal range were defined as the 5" and 95" percentile values and are presented in Table 4-1. The RAMP Troponin I normal range distribution is presented in Figure 4-1. The normal range of the RAMP Troponin I Assay was found to be 0.00 ng/mL in the normal population. The normal range of the Triage Troponin I Assay was found to be ) 32 nq/mL.
Percent recovery of Tnl ranged from 95 to 115% with an average of 105%.
Within run precision: 8.7% and 8.3% for standards (1.05 and 5.01 ng/mL Tnl).
Total precision: 10.0% and 8.3% for standards (1.05 and 5.01 ng/mL Tnl).
Assay concentration where 10.0% or less CV is achieved (plasma standards): 0.21 ng/mL Tnl (within run), 0.15 ng/mL Tnl (total precision).
Assay concentration where 20.0% or less CV is achieved (plasma standards): 0.14 ng/mL Tnl (within run), 0.15 ng/mL Tnl (total precision).
Assay concentration in blood where 10.0% or less CV is achieved: 0.10 ng/mL Tnl.
Normal range of RAMP Troponin I Assay: 0.00 ng/mL.
Normal range of Triage Troponin I Assay:
§ 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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Image /page/0/Picture/2 description: The image is a black line on a white background. The line is straight and runs horizontally across the image. The line is thin and has a uniform thickness. The white background is plain and has no other features.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 4.0
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K033745
1. Establishment
Response Biomedical Corp. 8081 Lougheed Highway Burnaby, British Columbia Canada, V5A 1W9
Tel: (604) 681-4101 Fax: (604) 412-9830
William J. Radvak Contact: President and CEO
November 27, 2003 Prepared:
2. Regulatory Information
| Trade Name: | Response Biomedical Corp. RAMP® Troponin I Assay |
|---|---|
| Common Name: | Troponin I immunological test system |
| Classification Name: | Troponin I immunological test system |
| Regulation Number: | 862.1215 |
| Product Code: | MMI |
| Panel: | Clinical Chemistry |
3. Predicate Device
| Immunoassay: | Triage Cardiac Panel®; Troponin I Assay (K973126) which is
currently being marketed by Biosite Diagnostics, Inc. |
|--------------|---------------------------------------------------------------------------------------------------------------------|
| Immunoassay: | Dimension® RxL Cardiac Troponin-I Flex®, (K973650) which
is currently being marketed by Dade Behring Inc. |
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4. Description of the Device
The RAMP Troponin I Assay is a quantitative immunochromatographic test for the rnic Tric Troponia T-Thous) Do A whole blood. Diluted EDTA whole blood is added to the sample well of the Test Cartridge which houses the immunochromatographic test strip our pro real blood cells are retained in the sample pad, and the separated plasma migrates along the strip. Fluorescent-dyed latex particles coated with anti-Tril antibodies hightion and in the sample. As the sample migrates along the strip, Tnl bound particles are immobilized at the detection zone, and additional particles are immobilized at the internal control zone.
The RAMP Reader then measures the amount of fluorescence emitted by the complexes bound at the detection zone and at the internal control zone. Using a ratio between the two fluorescence values, a quantitative reading is calculated.
5. Indication for Use
The RAMP Troponin I Assay is a quantitative immunochromatographic test indicated for use as an in vitro diagnostic product used with the RAMP Clinical Reader to measure cardiac troponin I levels in EDTA whole blood. Measurement of cardiac troponin I aids in the rapid diagnosis of acute myocardial infarction (AMI). The RAMP Troponin I Assay is intended to be used only to prioritize patient management for those suspected of AMI.
6. Comparison of Technological Characteristics
The RAMP Troponin I Assay, Triage Cardiac Panel (Triage) Troponin I, and Dade Dimension RxL (Dimension) Cardiac Troponin-I (Troponin I) Flex Assays are for the quantitative measurement of Tnl in human whole blood (RAMP and Triage) or plasma (Triage and Dimension). All three immunoassays utilize the binding of Tnl to specific antibodies and utilize light in their respective detection systems. Both the RAMP and Triage assays measure light production from a fluorescence reaction using a fluorometer while the Dimension measures the amount of colored product produced which is directly proportional to the concentration of Tnl present in the patient sample. Both the RAMP Troponin I and the Triage Troponin I assays are quantitative immunochromatographic tests, whereas the Dimension Troponin I test is a sandwich enzyme immunoassay.
7. Summary of Studies
PERFORMANCE CHARACTERISTICS
PRECISION: The intra-assay and the inter-assay precision of the RAMP Troponin I Assay were determined by one operator assaying duplicates of two standards (1.05 and 5.01 ng/mL Tnl) twice each day over 10 days. The mean, standard deviation and %CV were calculated for the predicted Tnl at each concentration. Within run precision was 8.7% and 8.3% respectively. Total precision was 10.0% and 8.3% respectively. Low end precision was also determined by the same method using Plasma Standards of 0.09, 0.15, 0.22, 0.29, 0.40 and 0.70 ng/mL Tnl. The assay concentration in standards where 10.0% or less CV is achieved was 0.21 ng/mL Tnl and where 20.0% or less CV is achieved was 0.14
2
ng/mL Tnl for within run precision. The assay concentration in standards where 10.0% or ngmic Yil for within full problem. The as a viere 20.0% or less CV is achieved was 0.15 ng/mL Tnl for total precision. Low end precision of the RAMP Troponin I Assay was 0.15 Ilgmir Thi for total prodision: Low one proclaired assaying 10 replicates of each of also determined in ED World Color assay concentration in blood where 10.0% or less CV is 5 spired ini concentrations. The assure of is achieved was 0.10 ng/mL Tnl.
LINEARITY and PERCENT RECOVERY: Tnl antigen concentrations of 0.86, 1.72, 3.44, 6.88, 13.75, and 27.5 ng/mL were prepared in normal donor EDTA blood. The linearity 0.00, 15.15, and 27.5 hgmd. Were propan assaying five replicates of each concentration and baseline. The mean, standard deviation and %CV were calculated for the predicted and bach concentration. Linear regression analysis of actual Tnl concentration versus expected TnI concentration resulted with an R = 0.997 and a slope of 1.019 with an offset of 0.279. The recovery of spiked Tnl antigen at the five concentrations was 0.82, 1.72, 3.65, 7.65, 15.78, and 27.51 ng/mL. Percent recovery of Tnl ranged from 95 to 115% with an average of 105%.
HOOK EFFECT: There is no high dose hook effect in the RAMP Troponin I Assay up to the highest level tested (500 ng/mL Tnl).
ANALYTICAL SENSITIVITY: The lower limit of detection (LLD) is defined as the analyte concentration corresponding to the mean (n=20) plus 2 standard deviations of the zero. The LLD is 0.03 ng/mL Tnl. Tnl levels in excess of 32 ng/mL are reported as greater than (>) 32 nq/mL.
ANALYTICAL SPECIFICITY: Potentially cross-reactive substances were evaluated by spiking different concentrations into blood. Skeletal Troponin I, Cardiac Troponin T and Cardiac Troponin C appear to have no significant cross-reactivity with the RAMP Troponin I Assay. HAMA, HAGA, HARA and RhF appear to have minimal cross-reactivity with the RAMP Troponin I Assay.
INTERFERENCE: Potentially interfering substances were evaluated by spiking different concentrations of potential interferents into EDTA blood with TnI added. Different blood samples were used for each potential interferent. Interference was evaluated by calculating the Tnl concentration of potential interferent-spiked blood, expressed as a percentage of the Tnl concentration of the unspiked (no potential interferent) blood sample. No evidence of cross-reactivity or interference was observed for hemoglobin, triglyceride, bilirubin, cholesterol, or heparin at levels of very high physiological concentrations, up to 1500 mg/dL, 3000mg/dL, 80 mg/dL, 500 mg/dL, and 66 IU/mL, respectively. No trend was observed in the Tnl predictions as the concentration of potential interferent was increased.
CLINICAL PERFORMANCE
EXPECTED VALUES
Whole blood samples from 180 healthy individuals (84 males and 96 females) were assayed for Troponin I by the three methods, RAMP, Triage, and Dimension. The lower assayed for Troponia 1 by the first normal range were defined as the 5" and 95" percentile values and are presented in Table 4-1. The RAMP Troponin I normal range distribution is presented in Figure 4-1.
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The normal range of the RAMP Troponin I Assay was found to be 0.00 ng/mL in the The normal fange of the Triage system reports values less than 0.2 as "0.20, while the left y-axis represents frequency and ranges from 0 to 200. The right y-axis represents cumulative percentage and ranges from 0% to 100%. The graph includes a bar chart representing frequency and a line graph representing cumulative percentage.
PRECISION STUDY
One hundred and eighty-four (184) subjects were enrolled in the Precision Study. Of these, 55 were normal individuals (28 males and 27 females) and 129 were patients suspected of AMI based on the individual hospital criteria (76 males and 53 females). The samples were selected from those obtained during the Method Comparison Study. The samples were stored refrigerated for up to one day between analyses. The data were reviewed and one outlier was removed. Correlation for Troponin I Assay replicate Result 2 vs Result 1 for the RAMP Assay is presented in Table 4-2.
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| Population | n | Slope
y = | Intercept | R |
|---------------------------|-----|--------------|-----------|-------|
| Combined Populations | 183 | 1.086 | -0.153 | 0.989 |
| Patients with suspect AMI | 128 | 1.093 | -0.246 | 0.988 |
Table 4-2: Precision of RAMP Troponin I Assay, Result 1 vs Result 2
METHOD COMPARISON
Three hundred and sixty-five (365) subjects were enrolled in the Method Comparison Study. Of these subjects, 180 were normal individuals (84 males and 96 females) and 185 were suspected of acute myocardial infarct (AMI) based on the individual hospital criteria (115 males and 70 females). EDTA and heparin whole blood samples were obtained for each of these subjects. All normal subjects were consented. Waste samples were used for the subjects suspected of AMI. An aliquot of the whole blood was taken for the RAMP Troponin I Assay and heparinized plasma was prepared for the Triage Troponin I Assay and the Dimension Troponin I Assay. The samples were stored refrigerated for up to one day between analyses for the rapid tests. Heparin samples were frozen and sent to a reference lab for the Dimension testing.
To accommodate the differing reportable ranges of the RAMP and Triage Troponin I Assays, and the Dimension Troponin I Assay, the data were winsorized, and then examined for outliers. The correlation data is presented for both the RAMP and Triage Troponin I Assays versus the Dimension Troponin I Assay in Table 4-3.
| Population | n | Slope (y=) | Intercept | R | |
|---|---|---|---|---|---|
| RAMP Troponin I Assay | Combined Normal and | ||||
| Suspect AMI Subjects | 364 | 0.456 | 0.011 | 0.988 | |
| Suspect AMI Subjects | 184 | 0.456 | 0.025 | 0.986 | |
| Triage Troponin I Assay | Combined Normal and | ||||
| Suspect AMI Subjects | 365 | 0.718 | -0.138 | 0.974 | |
| Suspect AMI Subjects | 185 | 0.729 | -0.563 | 0.972 |
Table 4-3: Correlation of RAMP and Triage vs Dimension
8. Conclusion
The RAMP Troponin I Assay when utilized with the RAMP Reader is substantially equivalent to other assays currently in commercial distribution for the measurement of Thi.
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Image /page/5/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 7 2004
Mr. William J. Radvak President and CEO Response Biomedical Corp. 8081 Lougheed Hwy. Burnaby, British Columbia, Canada V5A 1W9
Re: K033745
Trade/Device Name: RAMP Troponin 1 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: March 15, 2004 Received: March 15, 2004
Dear Mr. Radvak:
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 r ou mays 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CVR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and wyour e FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, If you don't spotition and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, US, DVM.
Jean M. Cooper, MS, D.V.M. 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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Indications for Use
510(k) Number (if known): K033745
RAMP Troponin I Assay Device Name:
The RAMP Troponin I Assay is a quantitative Indications For Use: immunochromatographic test indicated for use as an in vitro diagnostic product used with the RAMP Clinical Reader to measure cardiac troponin I levels in EDTA whole blood. Measurement of cardiac troponin I aids in the rapid diagnosis of acute myocardial infarction (AMI). The RAMP Troponin I Assay is intended to be used only to patient management for those prioritize suspected of AMI.
(Part 21 CFR 801 Subpart D)
$\frac{(VD)}{(D)}$ AND/OR
Prescription Use X (IVD) AND/OR Over-The-Counter Use N/A (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Office of in Vitro Diagnostic Device Evaluation and Safety
510(k)
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