(136 days)
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No
The summary describes an ELISA assay, which is a laboratory test based on antigen-antibody reactions, and there is no mention of AI or ML in the provided text.
No
The device is described as an ELISA kit for detecting WNV antibodies, which is a diagnostic tool, not a therapeutic intervention.
Yes
The West Nile Detect IgM Capture ELISA is intended for the "qualitative detection of IgM antibodies... for the presumptive clinical laboratory diagnosis of West Nile virus infection." This explicitly states its purpose in diagnosing a disease.
No
The device is described as an ELISA kit, which is a laboratory assay involving physical reagents and procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of IgM antibodies to WNV recombinant antigens (WNRA) in serum for the presumptive clinical laboratory diagnosis of West Nile virus infection". This involves testing a sample (serum) taken from the human body in vitro (outside the body) to provide information for diagnosis.
- Device Description: The device is described as an "ELISA" (Enzyme-Linked Immunosorbent Assay), which is a common laboratory technique used for in vitro diagnostic testing.
The core function of the device is to analyze a biological sample in vitro to aid in the diagnosis of a disease, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The West Nile Detect IgM Capture ELISA is for the qualitative detection of IgM antibodies to WNV recombinant antigens (WNRA) in serum for the presumptive clinical laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with West Nile virus meningoencephalitis. Positive results must be confirmed by Plaque Reduction Neutralization Test (PRNT), or by using the current CDC guidelines for diagnosis of this disease. Assay performance characteristics have not been established for testing cord blood, CSF, or for screening without symptoms of neonate, prenatal screening, general population screening, or automated instruments. This assay is not FDA cleared or approved for testing blood or plasma donors.
Product codes
NOP
Device Description
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Mentions image processing
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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)
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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.
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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).
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§ 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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus, indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and formal nature.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 9 2004
Ms. Estela I. Raychaudhuri President InBios International, Inc. 562 1st Ave. South, Suite 600 Seattle, WA 98104
Re: K041817
Trade/Device Name: West Nile Detect IgM Capture ELISA Regulation Number: 21 CFR 866.3940 Regulation Name: West Nile Virus Serological Reagents Regulatory Class: Class II Product Code: NOP Dated: November 16, 2004 Received: November 17, 2004
Dear Ms. Raychaudhuri:
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). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Saartys
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): ___K041817
Device Name: West Nile Detect IgM Capture ELISA
Indications For Use: The West Nile Detect IgM Capture ELISA is for the qualitative
Indications For Use: 1144 Capt and is antigans (WNRA) in serum for the Indications For Use: The West Nile Detoon Nin Santino Library (WNRA) in serum for the detection of ight antibodies to WNV Tooombinant shiles infection in patients with
presumptive clinical laboratory diagnosis of West Niles results must he presumptive cimical laboratory thagnoin of results . Positive results must be clinical symptoms consistent with methilization Test (PRNT), or by using the current
confirmed by Plaque Reduction Neutralization Test (PRNT), or by using the current CDC guidelines for diagnosis of this disease.
Assay performance characteristics have not been established for testing cord blood, the of Assay performance Characteristics nave not books creening without symptoms of neonate, prenatal screening, general population of conney.
meningoencephalitis or automated instruments. This assay is not FDA cleared or approved for testing blood or plasma donors.
Prescription Use _X (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)
Sagatt
Division sign-off
Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of 1 __
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