(266 days)
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No
The summary describes a serological test system for detecting antibodies and does not mention any AI/ML components or image processing.
No.
The device is an in-vitro diagnostic test system for detecting antibodies to aid in the diagnosis of EBV-associated infectious mononucleosis and diseases caused by the EBV virus. It is not used for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section states that the test system is intended "to aid in the laboratory diagnosis of EBV-associated infectious mononucleosis and diseases caused by EBV virus." This directly indicates a diagnostic purpose.
No
The summary describes a "Test System" intended for the qualitative detection of antibodies using specific EBV antigens. This strongly implies a physical laboratory test kit or system involving reagents and potentially instrumentation, not solely software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is for the "qualitative detection of IgG class antibody to three separate EBV Antigens... to aid in the laboratory diagnosis of EBV-associated infectious mononucleosis and diseases caused by EBV virus." This describes a test performed in vitro (outside the body) on biological samples (presumably blood or serum, as it's detecting antibodies) to provide diagnostic information.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K042116) strongly suggests that this device has gone through the FDA's 510(k) clearance process, which is the regulatory pathway for many IVD devices.
Therefore, the intended use and the regulatory context (implied by the predicate device) clearly indicate that this is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Zeus Scientific, Inc. AtheNA Multi-Lyte EBV IgG Test System is intended for the qualitative detection of IgG class antibody to three separate EBV Antigens (EBV-VCA gp125, EBV-EA total and Recombinant EBNA-1) through the AtheNA Multi-Lyte System. The test system is intended to be used with these EBV IgG markers along with anti-EBV VCA IgM to aid in the laboratory diagnosis of EBV-associated infectious mononucleosis and other EBV virus related diseases caused by EBV virus.
Product codes (comma separated list FDA assigned to the subject device)
JRY
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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§ 866.3235 Epstein-Barr virus serological reagents.
(a)
Identification. Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 9 2005
Mr. Mark J. Kopnitsky Vice President, Research and Development Zeus Scientific, Inc. P.O. Box 38 Raritan, NJ 08869
K042118 Re:
K042116
Trade/Device Name: AtheNA Multi-Lyte® EBV IgG Test System Regulation Number: 21 CFR 866.3235 Regulation Name: Epstein-Barr virus serological reagents Regulatory Class: Class I Product Code: JRY Dated: March 22, 2005 Received: March 24, 2005
Dear Mr. Kopnitsky:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector b r (x), pe device is substantially equivalent (for the indications felerenced above and nave ustommed are are are and a sevices marketed in interstate for use stated in the encrosule) to regarly manatinent date of the Medical Device American Council Food. Days commerce prior to May 28, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that to not require subject to the general controls provisions of the Act. The You may, therefore, manset the act include requirements for annual registration, listing of general controls provisions of the rest labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (360 a00 v) incl . Existing major regulations affecting your device in claim ca it may be subject to such additional controllar - Mating - CFFA), Parts 800 to 895. In addition, FDA call be found in Thic 21, Code of I concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA s issualled of a business with other requirements of the Act
that FDA has made a determination that your device complies with other requirements of that FDA has inade a decemination that your asseed by other Federal agencies. You must or any Pederal Statures and regulations annunities. but not limited to: registration and listing (21 comply with an the Are Frequire.netts 801 and 809); and good manufacturing practice CFR Part 807), labeling (21 OF RT List 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 5 10(k) I his letter will anow you to ocgin maneeting your and equivalence of your device to a legally premarked notification: "The PDF intention for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements o your device, of for If you desire spectife information acour tising of your device, please contact the Office of In of questions on the promotion and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may of all 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/industry/support/index.html
Sincerely yours,
Sales a Tory
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): __K042118
Device Name:___AtheNA Multi-Lyte® EBV IgG Test System
Indications For Use:
The Zeus Scientific, Inc. AtheNA Multi-Lyte EBV IgG Test System is intended for the The Zeus Scientific, Inc. Athera Nitibedy to three separate EBV Antigens (EBV-VCA
qualitative detection of IgG class antibody to three separate EBV Antigens (EBV-VCA qualifative detection of IGG class antibody to through the AtheNA gg-1123, EBV-EA total and Coombinant LDN F be used with these EBV (gC markers)
Multi-Lyte System. The test system is intended to be used with these eigted Multi-Lyte System. The lest System is internation diagnosis of EBV-associated along with anti-EBV VOA igni to ald in the laberatory and caused by EBV virus.
Prescription Use _ X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)________________________________________________________________________________________________________________________________________________________________________
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