(264 days)
P910053
Not Found
No
The device description details a standard ELISA immunoassay process, which is a biochemical method for detecting and quantifying substances. There is no mention of algorithms, machine learning models, or any computational analysis beyond standard data interpolation from a standard curve. The performance studies describe statistical analysis of the immunoassay results compared to clinical outcomes, not the performance of an AI/ML model.
No
The device is an in vitro diagnostic immunoassay used to measure a protein in human serum, which aids in monitoring disease progression. It does not directly treat or alleviate any medical condition.
Yes
The document explicitly states that the device is "for IN VITRO DIAGNOSTIC USE ONLY" and is used as "an aid in monitoring the disease progression".
No
The device description clearly outlines a physical immunoassay kit utilizing microtiter plates, antibodies, and reagents, which are hardware components. The process involves physical steps like washing and reading absorbance in a microplate reader.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The AMDL-ELISA DR-70® (FDP) immunoassay is designed for IN VITRO DIAGNOSTIC USE ONLY". This is the most direct confirmation.
- Device Description: The description details a laboratory-based assay (ELISA) that analyzes a human sample (serum) to measure a specific substance (DR-70® (FDP)). This is characteristic of an in vitro diagnostic test.
- Clinical Context: The intended use describes how the results are used in a clinical setting ("aid in monitoring the disease progression in patients who have been diagnosed previously with colorectal cancer"). This further supports its role as a diagnostic tool.
N/A
Intended Use / Indications for Use
"The AMDL-ELISA DR-70® (FDP) immunoassay is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of DR-70® (FDP) in human serum. Serial testing using the AMDL- ELISA DR-70® (FDP) is to be used as an aid in monitoring the disease progression in patients who have been diagnosed previously with colorectal cancer. Results of DR-70® (FDP) testing should be used in conjunction with other clinical modalities that are standard of care for monitoring disease progression in these patients."
Product codes
NTY
Device Description
The AMDL, Inc. DR-70® (FDP) assay is an ELISA based assay utilizing removable strips in a 96 micro titer plate well format. The wells are coated with affinity purified rabbit anti-DR-70® (FDP) antibodies. The DR-70® (FDP) in diluted sera (1:200) is captured from the sera by these antibodies immobilized on the well of a micro titer plate. After a wash step, anti-DR-70® (FDP) antibodies conjugated to horseradish peroxidase are added to the wells. If the DR-70® (FDP) antigen is present, the anti-human fibrinogen peroxidase complex will bind to the captured tumor marker to form an immunological sandwich with the immobilized antibodies.
After a second wash step, the enzyme substrate 3,3',5'-tetramethylbenzidine (TMB) is added to the well. The end point is read in a micro plate reader at 450 nm once the reaction is stopped with 0.1N HCl. The intensity of the color formed is proportional to the amount of DR-70® (FDP) in the serum. The amount is quantified by interpolation from a standard curve using the calibrators provided with the kit.
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
Not Found
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
Clinical Study: AMDL has conducted an extensive clinical testing on the DR-70 which demonstrates its effectiveness in monitoring patients with colorectal cancer including: Normal Healthy Individuals, Benign diseases, Malignant disease, Serial monitoring with colorectal cancer.
Distribution in percent of DR-70® (FDP) values within the Normal, Benign and Malignant disease cohorts: The StatXact® software was utilized during this analysis to establish the exact 95% confidence intervals for the statistics.
- Normal: 420 subjects
- Benign: 326 subjects
- Malignant: 439 subjects
Statistical Analysis of DR-70® (FDP) Immunoassay as an Informative Test for Monitoring Disease Progression in Colon Cancer Patients: Serial samples were taken from 112 colon cancer patients resulting in 446 paired observations in which a DR-70 reading and a determination of disease progression were obtained. A determination was made that a meaningful increase to determine evidence of progression was 15% increase or more. Thus, if the ratio was 1.15 or higher, the DR-70 test was deemed to be positive, otherwise it was deemed to be negative and this determination was paired with the finding at that visit of progression or not.
The resulting 335 paired observations from the post baseline sampling were evaluated in two ways:
- Initial analysis presenting estimates directly from the data: For the per visit analysis, there were 135 visits for sensitivity and 198 visits for specificity.
- Bootstrap sample for each patient: A second analysis was done on a per patient basis in which the number of progressions across all visits for a given patient were used to compute a patient level sensitivity. This resulted in a sample of 112 patients with at least one sensitivity, specificity, or both. This resulted in 70 estimates of per patient sensitivity and 86 estimates of per patient specificity.
Key Results: These data and analyses demonstrate that the DR-70 test when taken as a 15% or greater change from the previous visit, yields informative data regarding colon cancer progression. The DR-70® (FDP) immunoassay results must be used in conjunction with standard of care procedures for monitoring colorectal cancer patients.
Key Metrics
Per visit analysis (from 335 evaluations):
- sensitivity: 65.19% with standard deviation (SD) 2.58
- specificity: 67.34% with SD= 2.94
- sum of sensitivity and specificity: 132.53% with SD = 3.91
- PPV: 57.52% with SD = 1.63
- NPV: 74.03% with SD = 2.44
Per patient analysis (from 112 evaluations):
- sensitivity: 66.21%
- specificity: 68.18%
- sum of sensitivity and specificity: 134.39%
- PPV: 53.44%
- NPV: 69.58%
Predicate Device(s)
P910053
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
0
Image /page/0/Picture/1 description: The image shows the number K072901 at the top. Below the number is a logo for AMDL. The logo is a semi-circle with a circle inside of it. The letters AMDL are below the logo.
According to the requirements of 21 CFR 807.92, the following information summarizes the safety and effectiveness if the test and is the basis for the determination of substantial equivalence.
The assigned 510(k) number is:
Submitter's Name and Address:
JUL -1 2008
AMDL Inc. 2492 Walnut Avenue, Suite 100 Tustin, CA 92780 Telephone: (714) 505-4460 Fax: (714) 505-4464 Contact: Gary Dreher
Date prepared: May 7, 2008
Device Names:
| Proprietary Name: | AMDL-ELISA DR-70® (FDP) |
|---|---|
| ------------------- | ------------------------- |
Common/Usual Name: Immunoassay for DR-70® (FDP)
- Classification: System, Test, Tumor Marker, Monitoring Regulation #: 866.6010 Intended Use: MONITORING AND MANAGEMENT OF COLORECTAL CANCER
Equivalency:
The AMDL DR-70 is substantially equivalent to TOSOH BioScience's AIA-PACK™ CEA (P910053).
Device Description:
For the quantitative analysis of DR-70® (FDP) in human serum for purposes of monitoring disease progression in patients previously diagnosed with colorectal cancer.
vou========================================================================================================================================================================= Page 1 of 9
AMDL, Inc.
2492 Walnut Ave., Suite 100, Tustin, CA 92780 Phone 714.505.4460 Web site: http://www.amdl.com E-mail address: info@amdl.com
1
Image /page/1/Picture/1 description: The image shows the logo for AMD, which consists of a stylized crescent shape above the letters "AMDL". The crescent is black and appears to be partially obscured, giving it a modern and abstract look. The letters "AMDL" are in a simple, sans-serif font and are positioned directly below the crescent shape.
INTENDED USE 1.0
The DR-70® (FDP) ELISA is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of DR-70® (FDP) in human serum. Serial testing using the AMDL- ELISA DR-70® (FDP) is to be used as an aid in monitoring the disease progression in patients who have been diagnosed previously with colorectal cancer. Results of DR-70® (FDP) testing should be used in conjunction with other clinical modalities that are standard of care for monitoring disease progression in these patients.
SUBSTANTIAL EQUIVALENCE STATEMENT 2.0
AMDL Inc. is submitting this Pre-market Notification, 510(K), to convey its intention to manufacture for commercial distribution the AMDL-ELISA DR-70® (FDP). This assay is intended for the in vitro quantitative measurement of DR-70® (FDP) in human serum and is substantially equivalent to the TOSOH BioScience AIA-PACK™ CEA Assay (P910053) which was a PMA approved test prior to the down classification of the tumor markers used for colorectal cancer patients. The intended use of this product is as an aid in monitoring the disease status in patients who have been diagnosed previously with colorectal cancer.
AMDL-ELISA DR-70® (FDP) is substantially equivalent to the previously cleared TOSOH BioScience AIA-PACK™ CEA Assay (P910053) since both assays are equivalent in their intended uses, methodology, and their performance characteristics.
See Table 1 below for a comparison of the salient characteristics of the AMDL-ELISA DR-70® (FDP) to the currently marketed TOSOH BioScience AIA-PACK™ CEA (P910053).
| AMDL-ELISA DR-70® (FDP) | AIA-PACK™ CEA | |
|---|---|---|
| Intended Use | Quantitative analysis of DR-70 (FDP) in | |
| human serum for purposes of monitoring | ||
| disease progression in patients previously | ||
| diagnosed with colorectal cancer | Quantitative analysis of CEA in | |
| human serum for purposes of | ||
| monitoring status of patients | ||
| previously diagnosed with colorectal | ||
| cancer | ||
| Methodology | Immunoassay | Immunoassay |
| Assay Sample | Human serum | Human serum |
| Analyte | Fibrin/ogen Degradation Products | Carcinoembryonic Antigen |
| Antibody Types | Polyclonal (rabbit) | Monoclonal (mouse) |
| Assay Type | Sandwich Assay | Sandwich Assay |
| Reagent Form | Antibody-coated microwells | Antibody-coated mag beads |
| Sample Volume | 10uL | 100uL |
| Precision (Interassay) | 5.0 µg/ml | |
| Normal | 420 | 94.5 |
| (91.9, 96.5) | ||
| 65 years | 83 | 86.8 |
| (77.5, 93.2) | ||
| Benign | 326 | 75.5 |
| (70.4, 80.0) | ||
| GU Disease | 94 | 94.7 |
| (88.0, 98.3) | ||
| GI Disease | 61 | 90.2 |
| (79.8, 96.3) | ||
| Pancreas | 84 | 60.7 |
| (49.5, 71.2) | ||
| Heart | ||
| Disease | 87 | 58.6 |
| (47.6, 69.1) | ||
| Malignant | 439 | 44.0 |
| (39.3, 48.8) | ||
| Colon | 187 | 55.6 |
| (48.2, 62.9) | ||
| Lung | 44 | 34.1 |
| (20.5, 49.9) | ||
| Liver | 44 | 31.8 |
| (18.6, 47.6) | ||
| Breast | 31 | 54.8 |
TABLE 1. Distribution of percent of DR-70® (FDP) values
Page 7 of 9
AMDL, Inc.
2492 Walnut Ave., Suite 100, Tustin, CA 92780 Phone 714.505.4460 Web site: http://www.amdl.com E-mail address: info@amdl.com
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Image /page/7/Picture/1 description: The image shows a logo with the letters "AMDL" in a sans-serif font. Above the letters is a circular graphic that is partially filled in, resembling a crescent shape or a stylized letter "C". The logo appears to be simple and modern in design.
| (36.0, 72.7) | (11.9, 44.6) | (3.6, 29.8) | (0.8, 21.4) | ||
|---|---|---|---|---|---|
| Ovarian | 31 | 25.8 | 6.5 | 32.3 | 35.5 |
| (11.9, 44.6) | (0.8, 21.4) | (16.7, 51.4) | (19.2, 54.6) | ||
| Cervical | 28 | 50.0 | 28.6 | 7.1 | 14.3 |
| (30.7, 69.4) | (13.2, 48.7) | (0.9, 23.5) | (4.0, 32.7) | ||
| Gall Bladder | 19 | 42.1 | 26.3 | 31.6 | 0.0 |
| (20.3, 66.5) | (9.2, 51.2) | (12.6, 56.6) | (0.0, 17.7) | ||
| Pancreas | 28 | 25.0 | 17.9 | 35.7 | 21.4 |
| (10.7, 44.9) | (6.1, 36.9) | (18.6, 55.9) | (8.3, 41.0) | ||
| Gastric/ Other | 27 | 22.2 | 33.3 | 29.6 | 14.8 |
| (8.6, 42.3) | (16.5, 54.0) | (13.8, 50.2) | (4.2, 33.7) |
*Exact binomial confidence limits.
. .
6.2 Statistical Analysis of DR-70® (FDP) Immunoassay as an Informative Test for Monitoring Disease Progression in Colon Cancer Patients.
The DR-70® (FDP) immunoassay was evaluated as an informative test for monitoring disease progression in colorectal cancer patients. An informative test must provide evidence to show that its performance is greater than the clinical diagnoses based on chance alone. There are many measures that can be used to quantify the value of cancer markers including the receiver operating characteristic (ROC) curve, sensitivity, specificity, predictive value positive value negative. While the most useful measures for the clinician are the predictive values, these are rarely used because of their reliance on the prevalence of disease. Measures independent of the prevalence of disease such as ROC, sensitivity and specificity are most frequently studied. Furthermore, the predictive values are functions of sensitivity, specificity, and prevalence.
Serial samples were taken from 112 colon cancer patients resulting in 446 paired observations in which a DR-70 reading and a determination of disease progression were obtained. Since several patients had signs of progression even at the first examination, it was decided to attempt to determine the relationship between DR-70 and progression at successive visits. Thus from the data, a variable was derived by taking the ratio of a subsequent DR-70 reading and the previous reading. This measure is intended to determine the increase from a previous reading as a means of providing information on progression. A determination was made that a meaningful increase to determine evidence of progression was 15% increase or more. Thus, if the ratio was 1.15 or higher, the DR-70 test was deemed to be positive, otherwise it was deemed to be negative and this determination was paired with the finding at that visit of progression or not.
The resulting 335 paired observations from the post baseline sampling were evaluated in two ways. The initial analysis presents estimates directly from the data. This analysis is followed by a bootstrap sample for each patient by randomly sampling one
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AMDL, Inc.
2492 Walnut Ave., Suite 100, Tustin, CA 92780 Phone 714.505.4460 Web site: http://www.amdl.com E-mail address: info@amdl.com
8
510(k) summary:
AMDL-ELISA DR-70® (FDP)
Image /page/8/Picture/2 description: The image shows the logo for AMD, which is a stylized lettermark. The logo consists of the letters "AMDL" stacked vertically, with a crescent shape above the letters. The crescent shape is black, and the letters are in a simple, sans-serif font. The logo is simple and modern.
visit at for each sample and recording the sensitivity or specificity for that visit. Note that if there was a progression and the sensitivity would be 1 if the DR-70 increased from the previous visit by 15% or more and 0 if it did not. If there were no progression at that visit, then there would be no sensitivity reported at that visit, but the specificity would be reported as a 1 if the DR-70 value was below a 15% increase for that visit and 0 otherwise. For the per visit analysis, there were 135 visits for sensitivity and 198 visits for specificity.
A second analysis was done on a per patient basis in which the number of progressions across all visits for a given patient were used to compute a patient level sensitivity by taking the number visits that DR-70 increase by at least 15% among the number of visits that there was a progression. Similarly, the number of visits at which DR-70 had a lower than 15% increase divided by the number of visits in which there was a non-progression allowed the computation of a per patient specificity. Recall that if a patient had all progressions there would be no specificity for that patient and if a patient had all non-progressions, there would be no sensitivity for that patient. This resulted in a sample of 112 patients with at least one sensitivity, specificity, or both. This resulted in 70 estimates of per patient sensitivity and 86 estimates of per patient specificity.
The computed per visit sensitivity from the 335 per visit evaluations was 10088/135= 65.19 with standard deviation (SD) 2.58, the specificity was 100134/199= 67.34 with SD= 2.94, the sum of sensitivity and specificity was 132.53 with SD = 3.91, the PPV was 10088/153= 57.52 with SD = 1.63. and the NPV was 100134/181= 74.03 with SD = 2.44.
For the per patient analysis, the computed per visit sensitivity from the 112 per patient evaluations was 10045.68/69 = 66.21, the specificity was 10058.63/86= 68.18, the sum of sensitivity and specificity was 134.39, the PPV was 10051.83/97= 53.44, and the NPV was 10071.67/103= 69.58. There is no method to obtain variance estimates from this process, so the confidence intervals are obtained from the bootstrap evaluations below.
These data and analyses demonstrate that the DR-70 test when taken as a 15% or greater change from the previous visit, vields informative data regarding colon cancer progression. The DR-70® (FDP) immunoassay results must be used in conjunction with standard of care procedures for monitoring colorectal cancer patients.
7.0 General Conclusions from the 510(k) submission
The data demonstrates that the proposed DR-70® (FDP) immunoassay has the same intended use as legally marketed predicate device, similar technological characteristics as a legally marketed predicate device, and that DR-70® (FDP) immunoassay does not raise new questions of safety or effectiveness. As such, the data provided in the submission support a finding of substantial equivalence.
============================================================================================================================================================================== Page 9 of 9 AMDL. Inc. 2492 Walnut Ave., Suite 100, Tustin, CA 92780 Phone 714.505.4460 Web site: http://www.amdl.com E-mail address: info@amdl.com
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Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and head. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL - 1 2008
AMDL, Inc. c/o Mr. Gary Dreher President and CEO 2492 Walnut Ave., Suite 100 Tustin, CA 92780-7039
Re: K072901
Trade/Device Name: AMDL ELISA DR-70® (FDP) Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: Class II Product Code: NTY Dated: May 12, 2008 Received: May 13, 2008
Dear Mr. Dreher:
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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The
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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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation cntitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Move M Clan
Maria M. Chan, Ph.D. Acting Division Director Division of Immunology and Hematology Devices 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): K072901
Device Name: AMDL-ELISA DR-70® (FDP) .
Indications For Use: "The AMDL-ELISA DR-70® (FDP) immunoassay is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of DR-70® (FDP) in human serum. Serial testing using the AMDL- ELISA DR-70® (FDP) is to be used as an aid in monitoring the disease progression in patients who have been diagnosed previously with colorectal cancer. Results of DR-70® (FDP) testing should be used in conjunction with other clinical modalities that are standard of care for monitoring disease progression in these patients."
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mana mchan
Division Sign-Off
്ivision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
s1000 K072901
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