(172 days)
No
The description details a standard immunochromatographic assay read by a fluorometer, with calculations based on fluorescence ratios. There is no mention of AI/ML terms, image processing, or training/test data sets typically associated with AI/ML algorithms.
No
The device is used for diagnostic purposes by quantitative determination of myoglobin, not for treatment or therapy.
Yes
Explanation: The device is used for the quantitative determination of myoglobin in human EDTA whole blood, which is a clinical measurement used for diagnostic purposes, such as in suspected acute myocardial infarct (AMI).
No
The device description explicitly states it uses a "RAMP Reader," which is described as a "general use fluorometer." This is a hardware component used to analyze the results of the immunoassay. The device is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the RAMP Myoglobin Assay is for the "quantitative determination of myoglobin in human EDTA whole blood". This is a test performed in vitro (outside the body) on a biological sample (whole blood) to provide information about a patient's health status (myoglobin levels).
- Device Description: The description details a process of analyzing a biological sample (diluted EDTA whole blood) using an immunochromatographic test. This is a common method used in IVD devices.
- Performance Characteristics: The document includes sections on "PERFORMANCE CHARACTERISTICS" and "CLINICAL PERFORMANCE," which are standard requirements for demonstrating the analytical and clinical validity of an IVD device. These sections describe studies performed on biological samples (standards, bovine calf serum, healthy individuals, patients suspected of AMI).
- Predicate Devices: The mention of predicate devices (K973126 Triage Cardiac Panel®; Myoglobin Assay; K000196 ACCESS® Myoglobin Assay) which are known IVD devices, further supports that this device falls under the IVD category.
The RAMP Reader itself is described as a "general use fluorometer," but its use in conjunction with the RAMP Myoglobin Assay, as described, makes the system (RAMP Reader + RAMP Myoglobin Assay) function as an IVD.
N/A
Intended Use / Indications for Use
The RAMP Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm.
The RAMP™ Myoglobin Assay is an immunochromatographic test for the quantitative determination of myoglobin in human EDTA whole blood, using the RAMP Reader.
Product codes (comma separated list FDA assigned to the subject device)
DDR, KHO
Device Description
The RAMP Myoglobin Assay is an immunochromatographic test for the quantitative determination of myoglobin in human EDTA whole blood, using the RAMP Reader.
Diluted EDTA whole blood is applied into the sample well of the Test Cartridge. The red blood cells are retained in the sample pad, and the separated plasma migrates along a strip, through a contact zone where it interacts with fluorescent latex particles. Latex (test) particles, coated with mouse monoclonal anti-myoglobin antibodies bind to myoglobin in the sample.
The sample moves by capillary action towards the end of the strip. As the sample migrates to the detection zone, myoglobin anti-myoglobin 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
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Anatomical Site
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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)
PERFORMANCE CHARACTERISTICS
PRECISION: The intra-assay and the inter-assay precision of the RAMP Myoglobin Assay were determined by one operator assaying duplicates of each standard (50, 100 and 200 ng/mL myoglobin standards) twice each day over 10 days. The mean, standard deviation and % CV were calculated for the predicted myoglobin at each concentration. Within run precision ranged between 13.0 to 6.5%. Between run precision ranged from 9.1 to 13.8%. Total precision ranged from 10.6 to 14.3%.
LINEARITY: Discrete myoglobin antigen concentrations of 10, 50, 75, 100, 150, 200 and 350 ng/mL were prepared in bovine calf serum. The linearity is determined by assaying five replicates of each standard. The mean, standard deviation and % CV were calculated for the predicted myoglobin at each concentration. Linear regression analysis of expected myoglobin concentration versus actual myoglobin concentration results with an R = 0.998 and a slope of 1.07 with an offset of 1.143.
HOOK EFFECT: There is no high dose hook effect in the RAMP Myoglobin Assay up to the highest level tested (8000 ng/mL myoglobin).
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 2.36 na/mL myoalobin levels in excess of 400 ng/mL are reported as greater than (>) 400 ng/mL.
ANALYTICAL SPECIFICITY: Samples containing rheumatoid factor at levels greater than 1300 Rf IU/mL may interfere with the test and cause erroneous results. If this occurs, another specimen should be obtained and tested by an alternate method.
INTERFERENCE: Potentially interfering substances were evaluated by spiking different concentrations of interferents in blood with 100 ng/mL of myoglobin added. Different blood samples were used for each interferent. Interference was evaluated by calculating the myoglobin concentration of interferent-spiked blood, expressed as a percentage of the myoglobin concentration of the unspiked (no interferent) blood sample. No evidence of crossreactivity or interference was observed for hemoglobin (Hb), triglyceride, bilirubin, cholesterol, or coumidin at levels exceeding the highest expected physiological concentration of up to 2000 mg/dL, 3000mg/dL, 60 mg/dL, 2000 mg/dL, and 200 ug/mL, respectively. No trend was observed in the myoglobin predictions as the concentration of interferent was increased.
CLINICAL PERFORMANCE
EXPECTED VALUES: Whole blood samples from 196 healthy individuals, (92 males and 104 females) were assayed. The lower (LLN) and upper (ULN) limits for normal range were defined as the 5" and 95" percentile values, respectively. The normal range of the RAMP Myoglobin Assay was found to be from 19.15 ng/mL to 99.3 ng/mL in the normal population studied. Each laboratory should establish its own expected values.
PRECISION STUDY: Of 179 subjects tested in duplicate, 77 were normal individuals (40 males and 37 females) and 102 were suspected of acute myocardial infarct (AMI) based on the individual hospital criteria (63 males and 39 females). The samples were selected randomly from those obtained during the Method Comparison Study. The samples were stored refrigerated for up to five days between analyses. Data were winsorized (ACCESS values>400) to adjust for differing reportable ranges between the methods and two outliers excluded.
Table 1-1:
Population: Patients with suspect AMI, n: 102, Slope (y =): 0.9750x, Intercept: 1.9026, r: .986
Population: Normal Individuals, n: 77, Slope (y =): 0.9013x, Intercept: 3.7143, r: .967
Population: Combined Populations, n: 179, Slope (y =): 0.9702x, Intercept: 0.9349, r: .968
METHOD COMPARISON: Of the 415 subjects compared. 196 were normal individuals (92 males and 104 females) and 219 were patients suspected of AMI based on the individual hospital criteria (131 males and 88 females). An EDTA whole blood sample was obtained for each of these subjects. These samples were tested in RAMP Myoglobin Assay and results compared to those obtained with the Beckman ACCESS Myoglobin Assay. Data were winsorized (ACCESS results >400) to adjust for differing reportable ranges between the methods and three outliers excluded. These results are comparable to correlations of the Biosite Triage Myoglobin Assay verses other clinical analyzers, (N=112) 1.25x+38.8; = 943 and (N=108) 1.31x+17.0; r=.877.
Table 1-2:
Population: Patients with suspect AMI, n: 219, Slope (y =): 1.0059x, Intercept: 29.576, r: .928
Population: Normal Individuals, n: 196, Slope (y =): 1.3831x, Intercept: 15.609, r: .889
Population: Combined Populations, n: 415, Slope (y =): 1.0309x, Intercept: 25.905, r: .932
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
§ 866.5680 Myoglobin immunological test system.
(a)
Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.(b)
Classification. Class II (performance standards).
0
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 1.0
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.
(012040 The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
1. Establishment:
Response Biomedical Corp. 8855 Northbrook Court Burnaby, British Columbia V5J5J1 Canada
Tel: (604) 681-4101 Fax: (604) 412-9830
Contact: William J. Radvak President and CEO
June 27, 2001 Prepared:
-
- Trade Name: Response Biomedical Corp. RAMP™ Myoglobin Assay Common Name: Myoglobin immunological test system Classification Name: Myoglobin immunological test system
3. Predicate Device:
| Immunoassay: | Triage Cardiac Panel®; Myoglobin Assay (K973126) which is
currently being marketed by Biosite Diagnostics, Inc. |
|--------------|--------------------------------------------------------------------------------------------------------------------|
| Immunoassay: | ACCESS® Myoglobin Assay (K000196) which is currently being
marketed by Beckman Coulter, Inc. |
4. Description of the Device:
The RAMP Myoglobin Assay is an immunochromatographic test for the quantitative determination of myoglobin in human EDTA whole blood, using the RAMP Reader.
Diluted EDTA whole blood is applied into the sample well of the Test Cartridge. The red blood cells are retained in the sample pad, and the separated plasma migrates along a strip, through a contact zone where it interacts with fluorescent latex particles. Latex (test) particles, coated with mouse monoclonal anti-myoglobin antibodies bind to myoglobin in the sample.
The sample moves by capillary action towards the end of the strip. As the sample migrates to the detection zone, myoglobin anti-myoglobin 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.
1
Comparison of Technological Characteristics ട്.
The RAMP Myoglobin Assay, Triage Cardiac Panel - Myoglobin; and ACCESS Myoglobin Assay are for the quantitative measurement of myoglobin in human whole blood (RAMP and Triage) or plasma (Triage and ACCESS). All three immunoassays utilize the binding of myoglobin 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 ACCESS Test measures light production from a chemiluminescent reaction using a luminometer. Both the RAMP Myoglobin and the Triage Cardiac Panel -Myoglobin are quantitative immunochromatographic tests, whereas the ACCESS Myoglobin test is an enzyme immunoassay.
Summary of Studies 6.
PERFORMANCE CHARACTERISTICS
PRECISION : The intra-assay and the inter-assay precision of the RAMP Myoglobin Assay were determined by one operator assaying duplicates of each standard (50, 100 and 200 ng/mL myoglobin standards) twice each day over 10 days. The mean, standard deviation and % CV were calculated for the predicted myoglobin at each concentration. Within run precision ranged between 13.0 to 6.5%. Between run precision ranged from 9.1 to 13.8%. Total precision ranged from 10.6 to 14.3%.
LINEARITY: Discrete myoglobin antigen concentrations of 10, 50, 75, 100, 150, 200 and 350 ng/mL were prepared in bovine calf serum. The linearity is determined by assaying five replicates of each standard. The mean, standard deviation and % CV were calculated for the predicted myoglobin at each concentration. Linear regression analysis of expected myoglobin concentration versus actual myoglobin concentration results with an R = 0.998 and a slope of 1.07 with an offset of 1.143.
HOOK EFFECT: There is no high dose hook effect in the RAMP Myoglobin Assay up to the highest level tested (8000 ng/mL myoglobin).
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 2.36 na/mL myoalobin levels in excess of 400 ng/mL are reported as greater than (>) 400 ng/mL.
ANALYTICAL SPECIFICITY: Samples containing rheumatoid factor at levels greater than 1300 Rf IU/mL may interfere with the test and cause erroneous results. If this occurs, another specimen should be obtained and tested by an alternate method.
INTERFERENCE: Potentially interfering substances were evaluated by spiking different concentrations of interferents in blood with 100 ng/mL of myoglobin added. Different blood samples were used for each interferent. Interference was evaluated by calculating the myoglobin concentration of interferent-spiked blood, expressed as a percentage of the myoglobin concentration of the unspiked (no interferent) blood sample. No evidence of crossreactivity or interference was observed for hemoglobin (Hb), triglyceride, bilirubin, cholesterol, or coumidin at levels exceeding the highest expected physiological concentration of up to 2000 mg/dL, 3000mg/dL, 60 mg/dL, 2000 mg/dL, and 200 ug/mL, respectively. No trend was observed in the myoglobin predictions as the concentration of interferent was increased.
2
CLINICAL PERFORMANCE
EXPECTED VALUES
Whole blood samples from 196 healthy individuals, (92 males and 104 females) were assayed. The lower (LLN) and upper (ULN) limits for normal range were defined as the 5" and 95" percentile values, respectively. The normal range of the RAMP Myoglobin Assay was found to be from 19.15 ng/mL to 99.3 ng/mL in the normal population studied. Each laboratory should establish its own expected values.
PRECISION STUDY
Of 179 subjects tested in duplicate, 77 were normal individuals (40 males and 37 females) and 102 were suspected of acute myocardial infarct (AMI) based on the individual hospital criteria (63 males and 39 females). The samples were selected randomly from those obtained during the Method Comparison Study. The samples were stored refrigerated for up to five days between analyses. Data were winsorized (ACCESS values>400) to adjust for differing reportable ranges between the methods and two outliers excluded. Data are presented below.
Table 1-1
| Population | n | Slope (y =) | Intercept | r |
|---|---|---|---|---|
| Patients with suspect AMI | 102 | 0.9750x | 1.9026 | .986 |
| Normal Individuals | 77 | 0.9013x | 3.7143 | .967 |
| Combined Populations | 179 | 0.9702x | 0.9349 | .968 |
METHOD COMPARISON
Of the 415 subjects compared. 196 were normal individuals (92 males and 104 females) and 219 were patients suspected of AMI based on the individual hospital criteria (131 males and 88 females). An EDTA whole blood sample was obtained for each of these subjects. These samples were tested in RAMP Myoglobin Assay and results compared to those obtained with the Beckman ACCESS Myoglobin Assay. Data were winsorized (ACCESS results >400) to adjust for differing reportable ranges between the methods and three outliers excluded. Data are presented in Table 4-2 below. These results are comparable to correlations of the Biosite Triage Myoglobin Assay verses other clinical analyzers, (N=112) 1.25x+38.8; = 943 and (N=108) 1.31x+17.0; r=.877.
Table 1-2
| Population | n | Slope (y =) | Intercept | r |
|---|---|---|---|---|
| Patients with suspect AMI | 219 | 1.0059x | 29.576 | .928 |
| Normal Individuals | 196 | 1.3831x | 15.609 | .889 |
| Combined Populations | 415 | 1.0309x | 25.905 | .932 |
7. Conclusion
The RAMP Myoglobin Assay when utilized with the RAMP Reader are substantially equivalent to other assays currently in commercial distribution for the measurement of myoglobin.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes forming its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 8 2001
Mr. William Radvak President and CEO Response Biomedical Corp. 8855 Northbrook Court Burnaby, B.C. V5J 5J1
K012040 Re:
Trade/Device Name: RAMPTM Myoglobin Assay; RAMP Reader Regulation Number: 21 CFR 866. 5680; 21 CFR 862.2560 Regulation Name: Myoglobin immunological test system; Fluorometer for clinical use Regulatory Class: Class II; Class I Product Code: DDR; KHO Dated: October 30, 2001 Received: October 31, 2001
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 general controls 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 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); 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.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
STATEMENT OF INDICATIONS FOR USE 2.0
K012040 510(k) Number (if known):
Indications for Use:
The RAMP Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm.
The RAMP™ Myoglobin Assay is an immunochromatographic test for the quantitative determination of myoglobin in human EDTA whole blood, using the RAMP Reader.
Nora O'Neill & Jean Cooper
(Division Sign-Off) Division of Clinical Labora. יווי וינטנג Koj 2040 510(k) Number.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)