(71 days)
The OSOM™ Mono Test is intended for the qualitative determination of infectious mononucleosis heterophile antibodies in serum, plasma or whole blood as an aids in the diagnosis of infectious mononucleosis .
OSOM Mono Test uses color immunochromatographic technology with bovine erythrocyte extract coated on the membrane. If the specific IM heterophile antibody is present in the sample, a visible blue test line will appear to indicate a positive result.
The provided text is a 510(k) summary for the OSOM™ Mono Test, an in vitro diagnostic device. It does not contain the detailed study information or acceptance criteria requested in the prompt.
Specifically, the document focuses on:
- Device Identification: Proprietary name, common name, classification.
- Intended Use: Qualitative determination of infectious mononucleosis heterophile antibodies.
- Description: Color immunochromatographic technology.
- Substantial Equivalence Claim: Comparing it to two predicate devices (Meridian's MonoSpot Latex Test and Pacific Biotech's CARDS OS Mono Test) based on similar intended use and technology.
- Regulatory Communication: An FDA letter granting substantial equivalence.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, ground truth information, or details about MRMC or standalone studies because this information is not present in the provided text.
The document implies that the device meets criteria for substantial equivalence to predicates, but it does not specify what those criteria are or present the data from a study to demonstrate performance against such criteria. The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices, which means its performance is considered comparable enough, but the specific data supporting that comparison is not in this extract.
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Image /page/0/Picture/0 description: The image shows the logo for Wyntek diagnostics. The logo consists of a circular icon on the left and the company name on the right. The icon features a stylized figure with a heart shape in the center. The text "Wyntek" is in bold, and the word "diagnostics" is in a smaller font below it.
KA72231
Mono 510 (k)
619 452 3198 619.452.3258
510 (k) Summary 8.
000000 Children Certified
6146 Nancy Ridge Drive Suite 101 San Diego California 97171 USA
Wyntek Diagnostics, Inc. Submitter : 6146 Nancy Ridge Dr. Ste. 101 San Diego, CA 92121 Tel: 619-452-3198 Fax: 619-452-3258
Contact Person: Shu-Ching Cheng
Product Name:
Proprietary Name: Common Name: Classification Name: Classification Number:
OSOM™ Mono Test Mono Test System, Test, Infectious mononucleosis 82KTN
AUG 26 -----
Intended Use: OSOM™ Mono Test is intended for the qualitative determination of infectious mononucleosis heterophile antibodies in serum, plasma or whole blood as an aids in the diagnosis of infectious mononucleosis .
Description: OSOM Mono Test uses color immunochromatographic technology with bovine erythrocyte extract coated on the membrane. If the specific IM heterophile antibody is present in the sample, a visible blue test line will appear to indicate a positive result.
Substantial Equivalence:
OSOM Mono Test is substantially equivalent to Meridian's MonoSpot Latex Test and Pacific Biotech's CARDS OS Mono Test. All three tests are rapid tests for the qualitative determination of infectious mononucleosis heterophile antibodies in serum, plasma or whole blood except that MonoSpot Test can not be used for whole blood. All three tests aid in the diagnostics of infectious mononucleosis.
Applicant Signed: $\qquad\qquad\qquad$Date: $\qquad\qquad\qquad\qquad$6/13/97
Shu-Ching Cheng
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Appendix I -Directional Inserts Used for Assay Comparisons:
- MonoSpot Latex Meridian Diagnostics, Inc. .
- CARDS OS Mono Test Pacific Biotech, Inc., a subsidiary of Quidel . Corp.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands representing the department's mission. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The overall design is simple and monochromatic, emphasizing the official nature of the seal.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Shu-Ching Cheng Vice President, Operations Wyntek Diaqnostics, Inc. 6146 Nancy Ridge Drive, Suite 101 San Diego, California 92121 -- -----
AUG 26 1997
K972231 Re : OSOM™ Mono Test Trade Name: Regulatory Class: II Product Code: KTN Dated: June 13, 1997 Received: June 16, 1997
Dear Mr. Chenq:
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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 Putman
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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2. Device Indications For Use
510 (k) Number: To-Be-Assigned
Device Name: OSOM™ Mono Test
Indication For Use:
The OSOM™ Mono Test is intended for the qualitative detection of infectious mononucleosis heterophile antibodies in serum, plasma or whole blood as an aid in the diagnosis of infectious mononucleosis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Maksimi
(Division Sign-Off)
Division of Citincal Laboratory : evil 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use
(Per 21 CFR 801.109)
OR Over-The-Counter Use
§ 866.5640 Infectious mononucleosis immunological test system.
(a)
Identification. An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.(b)
Classification. Class II (performance standards).