(71 days)
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.
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.
Here's an analysis of the OSOM hCG-Urine Test's acceptance criteria and the study that proves its performance, based on the provided documents:
Acceptance Criteria and Device Performance for OSOM™ hCG-Urine Test
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Device must be substantially equivalent to a predicate device (Abbott Test Pack hCG Urine test) in technology and intended use. | The Wyntek™ OSOM® hCG-Urine Test is considered substantially equivalent to the Abbott Test Pack hCG Urine test. Both utilize membrane, monoclonal and polyclonal antibodies to identify hCG in urine and interpret results through color lines. |
| Analytical Sensitivity | Device should accurately detect hCG at clinically relevant levels for early pregnancy detection. (Though not explicitly stated as a numerical target, high sensitivity is implied for "early detection of pregnancy".) | In a limited sample size comparison with the Abbott TestPack Plus hCG Urine Test, the OSOM hCG-Urine Test demonstrated 100% sensitivity. In the multi-site physician office evaluation, the device showed 100% agreement with expected results for negative, low positive, and moderate positive samples, indicating high sensitivity at different hCG concentrations. |
| Analytical Specificity | Device should accurately identify the absence of hCG and avoid false positives. | In a limited sample size comparison with the Abbott TestPack Plus hCG Urine Test, the OSOM hCG-Urine Test demonstrated 100% specificity. In the multi-site physician office evaluation, the device showed 100% agreement with expected results for negative, low positive, and moderate positive samples, indicating high specificity. |
| Precision | Consistent and reproducible results. | An evaluation conducted at three physician offices, where a randomly coded panel of negative, low positive, and moderate positive samples were tested for three days, resulted in 100% agreement with the expected results. This suggests excellent precision and reproducibility across different users and days. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Comparison Study: "limited sample size" - The exact number of samples is not specified.
- Physician Office Evaluation: A "randomly coded panel consisting of negative, low positive and moderate positive samples" was used. The total number of samples in this panel is not specified, nor is how many times they were tested over the three days.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the context of a 510(k) submission for a diagnostic device prior to marketing, it is highly likely that these were prospective studies conducted specifically for regulatory submission, probably in the United States (where the company is based and the FDA operates).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The document does not specify the number of experts used to establish the ground truth.
- The qualifications of those experts are also not mentioned. The physician office evaluation implies healthcare professionals (physicians or their staff) were involved in generating the results, but their role in establishing the "expected results" (ground truth) for the coded panel is unclear.
4. Adjudication Method for the Test Set
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1).
- For the physician office evaluation, it states "The results obtained had 100% agreement with the expected results," implying a direct comparison against a pre-established ground truth without a complex adjudication process between multiple readers of the new device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This device is a rapid diagnostic test, not an imaging or complex interpretation system where MRMC studies are typically employed to assess human reader performance with and without AI assistance. The precision study involved multiple sites (physician offices) but not multiple readers for comparative effectiveness.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, the studies described primarily assess the standalone performance of the device itself (the OSOM hCG-Urine Test). Although human interpretation of the color lines is inherent to the use of such a test, the "100% agreement with expected results" suggests the test's intrinsic ability to correctly indicate positive or negative. The "algorithm" here is the immunochromatographic stick technology, and its performance is reported. There isn't an "AI" component mentioned that would typically distinguish between an algorithm-only and human-in-the-loop performance in the modern sense.
7. The Type of Ground Truth Used
- For the comparison study with the Abbott TestPack Plus hCG Urine Test, the predicate device's results likely served as a form of ground truth or reference standard.
- For the physician office evaluation, the ground truth was established as "expected results" for the randomly coded panel of negative, low positive, and moderate positive samples. This implies that the hCG concentration in these samples was independently confirmed (likely through a highly accurate laboratory method, though not specified) to determine their true positive/negative/concentration status. This would typically be a form of analytical reference standard based on known sample characteristics.
8. The Sample Size for the Training Set
- The document does not mention a "training set" in the context of machine learning or AI. This device is a chemical immunoassay, not an AI or algorithm that requires a separate training phase with labeled data. All mentioned samples are for performance evaluation (test/validation).
9. How the Ground Truth for the Training Set Was Established
- As there is no "training set" in the AI/machine learning sense for this device, this question is not applicable. The device's underlying chemistry and design are based on established biological principles, not trained on data.
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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
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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
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Division Sign-Off Division of Clinical Laboratory De 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR Over-The-Counter Use
§ 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.