(118 days)
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No
The summary describes an ELISA test system for detecting antibodies, which is a standard laboratory technique and does not mention any AI or ML components.
No.
The device is for in vitro diagnostic use, aiding in the diagnosis of disease by detecting antibodies, rather than providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "this test system may aid in the diagnosis of disease associated with M. pneumoniae" and that it is "for in vitro diagnostic use."
No
The device description explicitly states "Zeus Scientific Mycoplasma IgM ELISA Test System," which is an in vitro diagnostic test system. ELISA tests are laboratory-based assays that involve physical reagents and equipment, indicating it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "The test system is for in vitro diagnostic use." It also describes its use in aiding the diagnosis of disease associated with M. pneumoniae by detecting antibodies in human serum, which is a classic IVD function.
- Device Description: The name "Zeus Scientific Mycoplasma IgM ELISA Test System" suggests a laboratory-based test, typical of IVDs.
- Intended User/Care Setting: "in vitro diagnostic use" reinforces its classification as an IVD.
The information provided clearly indicates that this device is intended to be used outside of the body to examine specimens (serum) for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For patients presenting such clinical symptoms, this test system may aid in the r or pationto provent's serological status, and therefore, may aid in the diagnosis of disease associated with M. pneumoniae. The test system provides a means for the qualitative detection of IgM-class antibody to M. pneumoniae in adult human serum. The test system is for in vitro diagnostic use.
Product codes
LJZ
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
adult human serum
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.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3375
Mycoplasma spp. serological reagents.(a)
Identification. Mycoplasma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toMycoplasma spp. in serum. Additionally, some of these reagents consist ofMycoplasma spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyMycoplasma spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusMycoplasma and provides epidemiological information on diseases caused by these microorganisms.Mycoplasma spp. are associated with inflammatory conditions of the urinary and respiratory tracts, the genitals, and the mouth. The effects in humans of infection withMycoplasma pneumoniae range from inapparent infection to mild or severe upper respiratory disease, ear infection, and bronchial pneumonia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
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Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized eagle symbol. The eagle is depicted with three lines forming its body and wings, giving it a modern and abstract appearance. The text is arranged around the top and sides of the circle, with the eagle symbol positioned in the center.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mark J. Kopnitsky Research and Development Zeus Scientific, Inc. P.O. Box 38 . . . . . . . Raritan, New Jersey 08869
AUG 20 1997
Re: K971503 Trade Name: Mycoplasma IgM ELISA Test System Regulatory Class: I Product Code: LJZ Dated: July 8, 1997 Received: July 10, 1997
Dear Mr. Kopnitsky:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely vours.
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
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| 510(k) Number (if known): | K971503 |
|---|---|
| Device Name: | Zeus Scientific Mycoplasma IgM ELISA Test System. |
Indications For UseMycoplasma IgM ELISA test system; K971503
M. pneumoniae is the simplest self-replicating microorganism known. It is primarily a w. proumoman and is one of the most common causes of pneumonia and respiratory tract purrogen, and . Clinical signs of the onset of illness are gradual and uppor roophatory tract international malaise, and fever, cough is prominent, and sore throat is frequent.
For patients presenting such clinical symptoms, this test system may aid in the r or pationto provent's serological status, and therefore, may aid in the diagnosis of disease associated with M. pneumoniae. The test system provides a means for the qualitative detection of IgM-class antibody to M. pneumoniae in adult human serum. The test system is for in vitro diagnostic use.
Rev: 8/6/97
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Wm. Poole for Arleen F. Runkos
Division Sign-Off) Division of Clinical Laboratory Devices 1503 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use