(14 days)
Not Found
OSOM® Classic hCG Urine Test
No
The description focuses on immunochromatographic technology and antibody reactions, with no mention of AI, ML, or image processing.
No
This device is a diagnostic tool used to detect the presence of hCG, indicating pregnancy. It does not provide any treatment or therapy.
Yes
The device detects human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. This qualitative determination of a biomarker (hCG) to identify a physiological state (pregnancy) falls under the definition of a diagnostic device.
No
The device description clearly indicates it is a physical test kit using immunochromatographic technology with antibodies coated on a membrane, which is a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative determination of human chorionic gonadotropin, hCG, in urine for early detection of pregnancy". This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
- Device Description: The description details the technology used (color immunochromatographic technology with antibodies) to detect a specific analyte (hCG) in the urine sample. This is characteristic of an in vitro diagnostic device.
- Performance Studies: The document includes performance data (sensitivity and specificity) based on testing urine specimens, which is standard for evaluating the accuracy of an IVD.
- Predicate Devices: The mention of predicate devices (other pregnancy tests) further confirms its classification as an IVD, as regulatory submissions for IVDs often require comparison to existing devices.
The fact that it's intended for "home use" doesn't change its classification as an IVD; it simply indicates the intended user and care setting.
N/A
Intended Use / Indications for Use
OSOM® Card Pregnancy Test is a pregnancy test intended for home use. The OSOM® Card Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin, hCG, in urine for early detection of pregnancy for home use.
Product codes
LCX
Device Description
OSOM® Card Pregnancy Test uses color immunochromatographic 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
OSOM® Card Pregnancy Test, when compared to a professional hCG test. OSOM® Classic hCG Urine Test, with a total of 217 urine specimens, results in a sensitivity of 99.1% and a specificity of 100%. Also, a consumer testing was conducted. Of the 74 participants' results evaluated against their clinical status. OSOM® Card Pregnancy Test gave an overall agreement of 100%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
sensitivity of 99.1% and a specificity of 100%. overall agreement of 100%.
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows a combination of handwritten and printed text along with a logo. The printed text at the top reads "MAR-04-1999 09:52". Below this, there is a handwritten date "3/9/99". To the right, there is a logo with the word "Wyntek" in bold, followed by the word "diagnostics" in a smaller font.
510k OSOM Card Pregnancy Test
619.452.3198 3 619.452.3258
510 (k) Summary 8.
1509001 EN46001 Certified
Diagnostics inc.
Wyntek
રો વેદ Nancy Ridge Drive San Diego California 92121
WWW. diagnostics
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:
OSOM® Card Pregnancy Test Proprietary Name: OTC Pregnancy Test Kit Common Name: Classification Name: Kit, Test, Pregnancy, HCG, OTC Classification Number: 75LCX
Intended Use: OSOM® Card Pregnancy Test is a pregnancy test intended for home use.
Description: OSOM® Card Pregnancy Test uses color immunochromatographic 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: OSOM® Card Pregnancy Test is substantially equivalent to Wamer-Lambert e.p.t Pregnancy Test and Carter Wallace FIRST RESPONSE Pregnancy Test. All these tests utilize immunochromatographic technology and anti-hCG antibodies to detect hCG in urine. All three tests interpret the results through the development of the color lines.
OSOM® Card Pregnancy Test, when compared to a Precision: professional hCG test. OSOM® Classic hCG Urine Test, with a total of 217 urine specimens, results in a sensitivity of 99.1% and a specificity of 100%. Also, a consumer testing was conducted. Of the 74 participants' results evaluated against their clinical status. OSOM® Card Pregnancy Test gave an overall agreement of 100%.
Applicant Signed: SL. Date: March 3, 1999
Shu-Ching Cheng
1
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that converge at the bottom.
MAR - 9 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Shu-Ching Cheng Vice President of Operations Wyntek Diagnostics, Inc. 6146 Nancy Ridge Drive, Suite 101 San Diego, California 92121
K990576 Re: Trade Name: OSOM® Card Pregnancy Test Regulatory Class: II Product Code: LCX Dated: February 22, 1999 Received: February 23, 1999
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 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 vour 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/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
3
2. Device Indications For Use
K990576 510 (k) Number: TBD
Device Name: OSOM® Card Pregnancy Test
Indication For Use:
The OSOM® Card Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin, hCG, in urine for early detection of pregnancy for home use.
| (Division Sign-Off) | Sean Cooper |
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Division of Clinical Laboratory Services
| 510(k) Number | K990576 |
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| --------------- | --------- |
| Division of Clinical Laboratory Devices | |
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| (Division Sign-Off) | |
| 510(k) Number |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
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