(71 days)
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No
The device description and performance studies indicate a simple immunochromatographic test with visual interpretation, and there are no mentions of AI, ML, or image processing.
No.
The device is intended for the qualitative determination of human chorionic gonadotropin in urine for early detection of pregnancy, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The device is intended for the "qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy," which is a diagnostic purpose to identify a medical condition (pregnancy).
No
The device description clearly states it uses "color immunochromatographic stick technology with antibodies coated on the membrane," indicating a physical, in vitro diagnostic device, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "FOR LABORATORY AND PROFESSIONAL IN VITRO USE ONLY." and describes the qualitative determination of hCG in urine, which is a test performed outside of the body.
- Device Description: The description details a "color immunochromatographic stick technology with antibodies coated on the membrane," which is a common method for in vitro diagnostic tests.
- Intended User / Care Setting: The intended user is "LABORATORY AND PROFESSIONAL IN VITRO USE ONLY," further reinforcing its use in a laboratory or professional setting for in vitro testing.
N/A
Intended Use / Indications for Use
A qualitative determination of human chorionic gonadotropin, hCG, in urine for early detection of pregnancy. FOR LABORATORY AND PROFESSIONAL IN VITRO DIAGNOSTICS USE ONLY.
Product codes
JHI
Device Description
Wyntek's OSOM hCG- Urine Test uses color immunochromatographic stick technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line will appear to indicate a positive result.
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
FOR LABORATORY AND PROFESSIONAL IN VITRO DIAGNOSTICS USE ONLY
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
Precision: The OSOM hCG-Urine Test, when compared to Abbott TestPack Plus hCG Urine Test with a limited sample size, results in a sensitivity of 100% and a specificity of 100%. Also, an evaluation of the OSOM hCG-Urine Test was conducted at three physicians offices. Each site tested the randomly coded panel consisting of negative, low positive and moderate positive samples for three days. The results obtained had 100% agreement with the expected results
Key Metrics
sensitivity of 100% and a specificity of 100%.
Predicate Device(s)
Abbott Test Pack hCG Urine test.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.
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Image /page/0/Picture/3 description: The image shows the logo for Wyntek diagnostics. The logo consists of a circular icon to the left of the company name. The icon appears to be a stylized representation of a person. The text "diagnostics" is written in a smaller font size below the word "Wyntek".
DEC 2 4 1997
510 (k) Summary - OSOM hCG-Urine Test (K974159)
619.452.3258
Submitter : Wyntek Diagnostics, Inc. 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: | OSOM ® hCG- Urine Test |
---|---|
Common Name: | hCG-Urine Pregnancy Test Kit |
Classification Name: | Human chorionic gonadotropin (hCG) test system |
Intended Use: A qualitative determination of human chorionic gonadotropin, hCG, in urine for early detection of pregnancy. FOR LABORATORY AND PROFESSIONAL IN VITRO DIAGNOSTICS USE ONLY
Description: Wyntek's OSOM hCG- Urine Test uses color immunochromatographic stick technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line will appear to indicate a positive result.
Substantial Equivalence:
Wyntek™ OSOM® hCG- Urine Test is substantially equivalent to Abbott Test Pack hCG Urine test. Both tests utilize membrane, monoclonal and polyclonal antibodies to identify hCG in urine. Both tests also interpret the results through the development of the color lines.
Precision: The OSOM hCG-Urine Test, when compared to Abbott TestPack Plus hCG Urine Test with a limited sample size, results in a sensitivity of 100% and a specificity of 100%. Also, an evaluation of the OSOM hCG-Urine Test was conducted at three physicians offices. Each site tested the randomly coded panel consisting of negative, low positive and moderate positive samples for three days. The results obtained had 100% agreement with the expected results
Applicant Signed: St - car Un Date: " Dec 17, 1997 Shu-Ching Cheng
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 4 1997
Shu-Ching Cheng · VP Operations Wyntek Diagnostics 6146 Nancy Ridge Drive, Suite 101 San Diego, California 92121
Re : K974159 OSOM™ hCG-Urine Test Regulatory Class: II Product Code: JHI Dated: November 11, 1997 Received: November 14, 1997
Dear Mr. Cheng:
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 Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 Reqister. 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
sincerely yours,
Steven Litman
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
3
Device Indications For Use
974159 510 (k) Number: 1959
Device Name: OSOM™ hCG-Urine Test
Indication For Use:
The OSOM™ hCG-Urine Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy. FOR LABORATORY AND PROFESSIONAL IN VITRO USE ONLY.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A.H. m Al Muth
L
Division Sign-Off Division of Clinical Laboratory De 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR Over-The-Counter Use