(55 days)
The OSOM™ Card 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.
OSOM Card hCG-Urine Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a red test line in Result Window will appear to indicate a positive result.
Here's a breakdown of the acceptance criteria and study information for the OSOM™ Card hCG-Urine Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study Type | Comparison Device/Method |
|---|---|---|---|
| Sensitivity (Ability to correctly identify positive samples) | 100% | Comparative Study | Abbott TestPack Plus hCG Urine Test |
| Specificity (Ability to correctly identify negative samples) | 100% | Comparative Study | Abbott TestPack Plus hCG Urine Test |
| Agreement with Expected Results for negative, low positive, and moderate positive samples | 100% agreement | Evaluation at Physician Offices | Expected results (implied gold standard for panel) |
2. Sample Size Used for the Test Set and Data Provenance
- Comparative Study (Sensitivity & Specificity):
- Sample Size: 227 urine specimens
- Data Provenance: Not explicitly stated (e.g., country of origin). The study seems retrospective as it compared the OSOM Card hCG-Urine Test to the Abbott TestPack Plus hCG Urine Test using these specimens.
- Evaluation at Physician Offices:
- Sample Size: A "randomly coded panel consisting of negative, low positive and moderate positive samples." The exact number of samples in this panel is not specified, but it was tested over three days.
- Data Provenance: Not explicitly stated, but implies prospective testing in a clinical setting ("three physicians offices").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "expected results" for the physician office evaluation and the reference values for the 227 urine specimens are not attributed to specific experts or their qualifications.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was not explicitly mentioned or described. The studies focused on device performance against a predicate device and known panels, not on comparing human readers with and without AI assistance.
- Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as this was not an AI-assisted device study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, a standalone performance study was implicitly done. The OSOM Card hCG-Urine Test is a qualitative immunoassay. The reported sensitivity and specificity of 100% and the 100% agreement with expected results in physician offices represent the performance of the device itself (the "algorithm" in a broad sense, though it's a chemical reaction and visual interpretation) without explicitly factoring in trained human readers as a separate variable in these performance metrics. The device's output (presence/absence of a red line) is a direct result.
7. The Type of Ground Truth Used
- Comparative Study: The "ground truth" for the 227 urine specimens appears to be established by the Abbott TestPack Plus hCG Urine Test. The OSOM test's results were compared against this predicate device. This is a form of agreement with a recognized standard.
- Evaluation at Physician Offices: The ground truth for the "randomly coded panel" was based on "expected results." This suggests a known panel with confirmed concentrations of hCG (or absence thereof), likely derived from quantitative assays or spiking experiments, implying a form of reference standard/laboratory-confirmed truth.
8. The Sample Size for the Training Set
This information is not applicable/not provided as this device is a qualitative immunochromatographic test, not an AI/machine learning algorithm that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the reasons stated above.
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Image /page/0/Picture/2 description: The image shows the Wyntek Diagnostic logo. 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, enclosed within a circle. The text "Wyntek" is written in a bold, sans-serif font, with the word "diagnostic" appearing in smaller letters below it.
510 (k) Summarv 8.
K973819
OSOM Card hCG 510 (k)
NOV - 4 1997
619 452 3198 619.452.3258
Diagnostics Inc. દા વેદ Nancy Ridge Drive Suite 101 San Diego California 9212 ાડિત
Wyntek
| 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: | |
|---|---|
| Common Name: | |
| Classification Name: | |
| Classification Number: |
OSOM™ Card hCG-Urine Test hCG Urine Pregnancy Test Kit Human chorionic gonadotropin (hCG) test 75JHI
Intended Use: The OSOM Card 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.
Description: OSOM Card hCG-Urine Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a red test line in Result Window will appear to indicate a positive result.
- Substantial Equivalence: OSOM Card hCG-Urine Test is substantially equivalent to Quidel RapidVue hCG Test and Abbott TestPack Plus hCG Urine Test. All three 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.
- Precision: The OSOM Card hCG-Urine Test, when compared to Abbott TestPack Plus hCG Urine Test with a total of 227 urine specimens, results in a sensitivity of 100% and a specificity of 100%. Also, an evaluation of the OSOM Card 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: Shu-Ching Cheng Date: Oct 28, 1991
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 4 1997
Mr. Shu-Ching Cheng Vice President, Operations Wyntek Diagnostics, Inc. 6146 Nancy Ridge Drive, Suite 101 San Diego, California 92121
Re: K973879 OSOM™ Card hCG-Urine Test Trade Name: Regulatory Class: II Tier: II Product Code: JHI Dated: September 9, 1997 Received: September 10, 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 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 Requlation (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 requlatory 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.qov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation ' Center for Devices and Radioloqical Health
Enclosure
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OSOM Card hCG 510 {K} - ...... -
2. Device Indications For Use
510 (k) Number: K973879
Device Name: OSOM Card hCG-Urine Test
Indication For Use:
The OSOM™ Card 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) (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number _ OR Over-The-Counter Use Prescription Use (Per 21 CFR 801.109)
§ 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.