(154 days)
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No
The 510(k) 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 an in vitro diagnostic test system "intended for the quantitative and/or quantitative detection of IgG/A/M-class antibody to Legionella pneumophila Groups 1 - 6 in human serum" and "intended to be used as an aid in the diagnosis of Legionella-related infections." It does not provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section states, "The test system is intended to be used as an aid in the diagnosis of Legionella-related infections." This clearly indicates its purpose in the diagnostic process.
No
The device is an in vitro diagnostic test system, which is a hardware-based medical device used to analyze biological samples. The summary describes a "test system" for detecting antibodies, which inherently involves physical components and reagents, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "This test is for in vitro diagnostic use." This is the primary indicator that the device is an IVD.
N/A
Intended Use / Indications for Use
The Zeus Scientific, Inc. Legionella ELISA test system is intended for the quantitative and/or quantitative detection of IgG/A/M-class antibody to Legionella pneumophila Groups 1 - 6 in human serum. The test system is intended to be used as an aid in the diagnosis of Legionella-related infections. This test is for in vitro diagnostic use.
Product codes
LHL
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
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§ 866.3300
Haemophilus spp. serological reagents.(a)
Identification. Haemophilus spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye, that are used in serological tests to identifyHaemophilus spp. directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusHaemophilus and provides epidemiological information on diseases cause by these microorganisms. Diseases most often caused byHaemophilus spp. include pneumonia, pharyngitis, sinusitis, vaginitis, chancroid venereal disease, and a contagious form of conjunctivitis (inflammation of eyelid membranes).(b)
Classification. Class II (special 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 shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 18 1997
Mark J. Kopnitsky Vice President Research & Development ... . . Zeus Scientific, Inc. P.O. Box 38 Raritan, NJ 08869
ને
Re:
K970149 Trade Name: Legionella ELISA Test System Regulatory Class: II Product Code: LHL Dated: June 4, 1997 Received: June 9, 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. Ports 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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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Page
| 510(k) Number (if known): | |
|---|---|
| Device Name: | Legionella ELISA Test System |
Indications For Use:
The Zeus Scientific, Inc. Legionella ELISA test system is intended for the quantitative and/or quantitative detection of IgG/A/M-class antibody to Legionella pneumophila Groups 1 - 6 in human serum. The test system is intended to be used as an aid in the diagnosis of Legionella-related infections. This test is for in vitro diagnostic use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Clinical Laboratory Devices
510(k) Number -----
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
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