(106 days)
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No
The summary describes an in vitro diagnostic immunoassay for detecting mumps antibodies. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device is described as for manual use or with a semi-automated fluid handler, which does not imply AI/ML.
No
This device is for in vitro diagnostic use, specifically for detecting antibodies to mumps virus in human serum, which helps in determining immune status or diagnosing primary infection. It does not directly treat or alleviate a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only," indicating its function as a diagnostic device.
No
The intended use and indications for use describe an in vitro diagnostic (IVD) device that performs enzyme immunoassay on human serum. This process inherently involves physical reagents and laboratory equipment, indicating it is not a software-only device. The mention of "manual use" and a "semi-automated fluid handler" further confirms the presence of hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The first point under "Intended Use / Indications for Use" explicitly states:
- 1. For in vitro diagnostic use only.
This directly identifies the device as intended for use in diagnosing conditions outside of the living body, which is the definition of an in vitro diagnostic device. The subsequent points further elaborate on the specific diagnostic purpose (detecting mumps virus antibodies in human serum).
N/A
Intended Use / Indications for Use
-
- For in vitro diagnostic use only.
-
- For the qualitative and semi-quantitative detection of IgG antibodies to mumps virus in human serum by enzyme immunoassay.
-
- Individual specimens may be used for the determination of immune status.
-
- Paired (acute / convalescent) sera, may be used to demonstrate seroconversion or significant rises in antibody level, as an aid in the diagnosis of primary infection.
-
- For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.
Product codes
LJY
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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§ 866.3380 Mumps virus serological reagents.
(a)
Identification. Mumps virus serological reagents consist of antigens and antisera used in serological tests to identify antibodies to mumps virus in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used in serological tests to identify mumps viruses from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of mumps and provides epidemiological information on mumps. Mumps is an acute contagious disease, particularly in children, characterized by an enlargement of one or both of the parotid glands (glands situated near the ear), although other organs may also be involved.(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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 3 1998
Robert A. Cort Vice President, Quality Assurance Ouest International, Inc. 1938 N.E. 148th Terrace North Miami, FL 33181
K980059 Re: Trade Name: SeraQuest Mumps IgG Regulatory Class: I Product Code: LJY Dated: March 6, 1998 Received: March 9, 1998
Dear Mr. Cort:
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 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). 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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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Page 2
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 yours,
Steven Butman
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
2
Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No.
APPENDIX 10
Page -
K 980059 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: SeraQuest Mumps IgG
Indications For Use:
-
- For in vitro diagnostic use only.
-
- For the qualitative and semi-quantitative detection of IgG antibodies to mumps virus in human serum by enzyme immunoassay.
- റ്റ് Individual specimens may be used for the determination of immune status.
-
- Paired (acute / convalescent) sera, may be used to demonstrate seroconversion or significant rises in antibody level, as an aid in the diagnosis of primary infection.
- For manual use, or for use with the HyPrep System Plus semi-automated fluid 5. handler.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
4/21/98
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K980059
OR
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)