(119 days)
Not Found
No
The document describes a standard ELISA assay and its performance characteristics. There is no mention of AI, ML, or any computational analysis beyond standard statistical calculations for performance metrics.
No
Explanation: This device is an in vitro diagnostic test for detecting West Nile virus antibodies. It does not provide any treatment or therapy for a disease or condition.
Yes
The device is intended for "qualitatively detecting IgM antibodies to West Nile virus in human serum" and is indicated "as an aid in the presumptive laboratory diagnosis of West Nile virus infection," which directly states its diagnostic purpose.
No
The device is described as an "Indirect Enzyme-linked immunosorbent assay," which is a laboratory test method involving physical reagents and processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for "qualitatively detecting IgM antibodies to West Nile virus in human serum." This is a diagnostic test performed on a biological sample (serum) outside of the body (in vitro).
- Device Description: The description confirms it is an "Indirect Enzyme-linked immunosorbent assay for qualitatively detecting human serum IgM antibodies to West Nile virus." This describes a laboratory test method.
- Indications for Use: It is indicated as an "aid in the presumptive laboratory diagnosis of West Nile virus infection" in persons with symptoms. This clearly points to a diagnostic purpose.
- Intended User / Care Setting: The intended user is a "Clinical laboratory," which is where in vitro diagnostic tests are performed.
The information provided aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Focus Technologies West Nile Virus IgM Capture ELISA is intended for qualitatively detecting IgM antibodies to West Nile virus in human serum. In conjunction with the Focus Technologies West Nile Virus ELISA IgG, the test is indicated for testing persons having symptoms of meningioencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection. Positive results must be confirmed by neutralization test, or by using the current CDC guidelines for diagnosing West Nile encephalitis. This test is not intended for self-testing, and this test is not FDA cleared nor approved for testing blood or plasma donors. Assay performance characteristics have not been established for automated instruments.
Product codes (comma separated list FDA assigned to the subject device)
NOP
Device Description
Indirect Enzyme-linked immunosorbent assay for qualitatively detecting human serum IgM antibodies to West Nile virus.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Expected Values: Prevalence of West Nile antibodies varies by age, geographic location, and testing method. A serosurvey in New York in 2000 found 0.2% (5/2433) had antibodies indicating recent West Nile infection. In 1999 and 2000, NYC serosurveys showed approximately 1 in 150 infections (
§ 866.3940 West Nile virus serological reagents.
(a)
Identification. West Nile virus serological reagents are devices that consist of antigens and antisera for the detection of anti-West Nile virus IgM antibodies, in human serum, from individuals who have signs and symptoms consistent with viral meningitis/encephalitis. The detection aids in the clinical laboratory diagnosis of viral meningitis/encephalitis caused by West Nile virus.(b)
Classification. Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus.” See § 866.1(e) for the availability of this guidance document.
0
OCT 2 2 2003
Image /page/0/Picture/1 description: The image shows the logo for Focus Technologies. The logo consists of the word "FOCUS" in a bold, sans-serif font, with two crescent moon shapes forming the letter "O". Below the word "FOCUS" is the word "technologies" in a smaller, sans-serif font. The logo is black and white.
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| Applicant | Focus Technologies, Inc.
10703 Progress Way
Cypress, California 90630
USA |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration
No. | 2023365 |
| Contact Person | Michael J. Wagner, Esq.
tel (714) 220-1900
fax (714) 995-6921
mwagner@focustechnologies.com |
| Summary Date | October 17, 2003 |
| Proprietary Name | West Nile Virus IgM Capture ELISA |
| Generic Name | West Nile Virus IgM Capture ELISA |
| Classification | West Nile Virus Serological Reagents
21 CFR §866.3940
Class II |
| Predicate Device | Focus Technologies Arbovirus IFA IgM (K913618)
Focus Technologies HSV-2 ELISA (K993724)
CDC West Nile Virus IgM Capture ELISA
West Nile Virus Plaque Reduction Neutralization Test |
Device Description
Indirect Enzyme-linked immunosorbent assay for qualitatively detecting human serum IgM antibodies to West Nile virus.
Intended Use
The Focus Technologies West Nile Virus IgM Capture ELISA is intended for qualitatively detecting IgM antibodies to West Nile virus in human serum. In conjunction with the Focus Technologies West Nile Virus ELISA IgG, the test is indicated for testing persons having symptoms of meningioencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection. Positive results must be confirmed by neutralization test, or by using the current CDC guidelines for diagnosing West Nile encephalitis. This test is not intended for self-testing, and this test is not FDA cleared nor approved for testing blood or plasma donors. Assay performance characteristics have not been established for automated instruments.
Test Principle
In the Focus Technologies West Nile Virus IgM Capture ELISA, the polystyrene microwells are coated with anti-human antibody specific for IgM (u-chain). Diluted serum samples and controls are incubated in the wells, and IgM present in the sample binds to the anti-human antibody (IgM specific reactants are removed by washing. Recombinant WNV antigen is then added to the wells and incubated; and, if anti-WNV IgM is present in the sample, the WNV antigen binds to the anti-WNV in the well. Unbound WNV antigen is then removed by washing the well. Mouse anti-flavivirus conjugated with horseradish peroxidase (HRPO) is then added to the wells and incubated; and, if WNV antigen has been retained in the well by the anti-flavivirus in the sample, the mouse anti-flavivirus: HRPO binds to the WNV antigen in the wells. Excess conjugate is removed by washing. Enzyme substrate and chromogen are added, and the color is allowed to develop. After adding the Stop Reagent, the resultant color change is quantified by a spectrophotometric reading of optical density (OD) that is directly proportional to the amount of antigen-specific IgM present in the sample. Sample optical density readings are compared with reference cut-off OD readings to determine results.
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K031952 510(k) Summary of Safety and Effectiveness West Nile Virus IgM Capture ELISA Catalog No. EL0300M Prepared October 17, 2003 Page 2 of 6
Expected Values
The prevalence of West Nile antibodies varies depending age, geographic location, testing method used, and other factors. A community based serosurvey for West Nile infection conducted in New York in 2000 found that 0.2% (5/2433) of persons tested overall had antibodies indicating recent West Nile infection, and that 1.1% (2/176) of persons reporting a recent headache and fever had antiboding a recent West Nile infection. Two serosurveys conducted in New York City (NYC) in 1999 and 2000 showed that approximately 1 in 150 infections ( Trade/Device Name: West Nile Virus IgM Capture ELISA Regulation Number: 21 CFR 866.3940 Regulation Name: West Nile Virus Serological Reagents Regulatory Class: Class II Product Code: NOP Dated: October 17, 2003 Received: October 20, 2003
Dear Mr. Wagner:
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 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR 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) 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 information about the application of labeling requirements to your device, or questions on the promotion 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). 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K031952
West Nile Virus IgM Capture ELISA Device Name:
The Focus Technologies West Nile Virus IgM Capture ELISA is Indications for Use: intended for qualitatively detecting IgM antibodies to West Nile virus in human serum. In conjunction with the Focus Technologies West Nile Virus ELISA IgG, the test is indicated for testing persons having symptoms of meningioencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection. Positive results must be confirmed by neutralization test, or by using the current CDC guidelines for diagnosing West Nile encephalitis. This test is not intended for self-testing, and this test is not FDA cleared nor approved for testing blood or plasma donors. Assay performance characteristics have not been established for automated instruments.
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Saqattar
Division Sign-Off 10/21/03
Office of In Vitro Diagnostic Device Evaluation and Safety
(Optional Format 3-10-98)
510(k)K031952
/
Abersons
OTC