(106 days)
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- For in vitro diagnostic use only.
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- For the qualitative and semi-quantitative detection of IgG antibodies to mumps virus in human serum by enzyme immunoassay.
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- Individual specimens may be used for the determination of immune status.
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- 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.
Not Found
The provided text for device K980059 is a 510(k) clearance letter from the FDA for the "SeraQuest Mumps IgG" device. This document primarily focuses on regulatory approval and does not contain the detailed study information needed to answer your questions regarding acceptance criteria, performance data, sample sizes, ground truth establishment, or expert qualifications.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has been determined to be as safe and effective as a previously cleared device. However, it does not include the actual study data, acceptance criteria, or performance metrics from the studies submitted by Quest International, Inc. to demonstrate this substantial equivalence.
Therefore, I cannot provide the requested information based on the given text. To answer your questions, I would need access to the full 510(k) summary or the original study reports submitted to the FDA by the manufacturer.
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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 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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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
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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:
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- For in vitro diagnostic use only.
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- 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)
§ 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.