(92 days)
The Instant-View Pregnancy Urine Test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. This test is for laboratory and professional use only.
A single step, visually read, qualitative chromatographic immunoassay, single use cassette test. The Instant-View TM Pregnancy Urine Test is designed for qualitative detection of the human chorionic gonadotropin (hCG) in urine. The test is for use as an aid in the diagnosis of early pregnancy. Both devices are one step, qualitative, visual lateral flow immuno-Chromatographic test in a sandwich complex format of anti-hCG antibody /hCG/ anti-hCG antibody.
Here's a breakdown of the acceptance criteria and the study details for the Instant-View™ Pregnancy Urine Test, based on the provided document:
1. Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a separate section with numerical thresholds for performance metrics. However, it implies acceptance through the comparison with a predicate device and the reported accuracy. The key implied acceptance criterion is 100% agreement/accuracy when compared to a legally marketed predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to a legally marketed device (OSOM Pregnancy Urine Test) | The accuracy by correlation of the results ... and the legally marketed test is 100%. |
| Agreement with expected results in clinical settings | The evaluation results from a clinical lab and three physician's offices ... agreed 100% with the results expected. |
| Sensitivity to hCG | Close to 25 mIU/ml or greater (calibrated against WHO 3rd IS 75/537). (Predicate claims 30 mIU/ml) |
2. Sample Size for the Test Set and Data Provenance:
The document does not explicitly state the total sample size used for the correlation study or the clinical evaluation.
- Test Set Sample Size: Not explicitly stated.
- Data Provenance: The study was conducted at "a clinical lab and three physician's offices", suggesting results from real-world clinical settings, likely prospective as part of a testing and evaluation process. The country of origin is not specified, but given the submission to the FDA, it is implied to be within the United States.
3. Number of Experts and Qualifications for Ground Truth:
The document does not specify the number of individual experts or their detailed qualifications (e.g., "radiologist with 10 years of experience").
- Number of Experts: Not specified as individual numbers.
- Qualifications of Experts: Describes "persons with diverse educational backgrounds and working experience" from a clinical lab and physician's offices. This implies a range of healthcare professionals (e.g., lab technicians, nurses, physicians) who would routinely interpret such tests.
4. Adjudication Method for the Test Set:
The document does not describe a formal adjudication method (like 2+1 or 3+1). It states that the "evaluation results...agreed 100% with the results expected," which suggests a direct comparison against a known or expected outcome, rather than a reconciliation of differing interpretations among multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a MRMC comparative effectiveness study was not explicitly done or reported in this summary. The study focuses on the device's performance against a predicate and agreement with expected results, not on how human readers' performance improves with or without the device.
6. Standalone (Algorithm Only) Performance:
Yes, the primary performance evaluation seems to be of the device in a standalone manner, as a "single step, visually read, qualitative chromatographic immunoassay." The results are based on the device's ability to correlate directly with the predicate device and expected outcomes, implying performance of the device itself rather than human-in-the-loop assistance.
7. Type of Ground Truth Used:
The ground truth was established through a combination of:
- Comparison to a legally marketed predicate device: The OSOM Pregnancy Urine Test. This implies the predicate device's results were considered the "truth" for the correlation study.
- Expected results in clinical settings: For the evaluation in the clinical lab and physician's offices, this likely refers to results confirmed by other methods or clinical consensus if there were any discrepancies with the predicate.
8. Sample Size for the Training Set:
The document does not mention a separate "training set" or its sample size. As this is a chromatographic immunoassay, not an AI/machine learning device, the concept of a training set in that context is not applicable. The development of such devices typically involves R&D and optimization, not a distinct "training set" as understood in machine learning.
9. How Ground Truth for the Training Set Was Established:
This question is not applicable to this type of device, as it's not an AI/ML algorithm that requires a "training set" with established ground truth for learning. The device's underlying chemical and biological principles are established through scientific research and development, not data-driven training in the modern AI sense.
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Image /page/0/Picture/0 description: The image shows the logo for Alfa Scientific Designs, Inc. The logo is a stylized "AA" symbol. Above the logo is the date 2/16/99.
Medical Diagnostic Devices. Contract R&D. OEM 11494 Sorrento Valley Rd, Suite F & M San Diego, CA 92121 Tel: (619) 350-9798 Fax: (619) 350-9709
E-mail: asdi@worldnet.att.net 510(K) Summary (K984076)
Submitter
Name and address: Alfa Scientific Designs, Inc. 11494 Sorrento Valley Rd, Suite M San Diego, CA 92121 619-350-9798 (Tel) 619-350-9709 (Fax)
Contact Person: Naishu Wang, MD, Ph.D.
Date Prepared: 12/30/98
Device Name
Trade Name: Instant-View™ Pregnancy Urine Test
Common Name: Human Chorionic Gonadotropin (hCG) Test
Classification name: 21CFR section 862.1155, Class II. A Qualitative Human Chorionic Gonadotropin (hCG) test system.
Predicate device
The Instant-View Pregnancy Urine Test is substantially equivalent to other legally marketed devices for the similar intended use. The device used for comparison study is OSOM Pregnancy Urine Test made by Wyntek Diagnostic, Inc., 510K#: K953383.
Device description
Intended use
A single step, visually read, qualitative chromatographic immunoassay, single use cassette test
The Instant-View TM Pregnancy Urine Test is designed for qualitative detection of the human chorionic gonadotropin (hCG) in urine. The test is for use as an aid in the diagnosis of early pregnancy.
510(K) Summary
Continued on next page
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:
| Summary of thesimilarities to thepredicate device | ● | The intended use and performance characteristics:Both devices are intended to use for an early detection of hCGin human urine at the level close to 25 mIU/ml (OSOM claimeda sensitivity to hCG as low as 30 mIU/ml) or greater (calibratedagainst the WHO 3rd IS 75/537). |
|---|---|---|
| ● | Technological characteristics:Both devices are one step, qualitative, visual lateral flowimmuno-Chromatographic test in a sandwich complex format ofanti-hCG antibody /hCG/ anti-hCG antibody. | |
| ● | Interpretation of results:The presence of C line serves as an internal quality control, andthe presence of the T line indicates a positive result. | |
| Discussion andConclusion | ● | The accuracy by correlation of the results from the Instant-ViewTM Pregnancy Urine Test and the legally marketed test is100%, indicating that the Instant-ViewTM Pregnancy UrineTest is substantially equivalent to this existing legally marketedproduct. |
| ● | The evaluation results from a clinical lab and three physician'soffices conducted by the persons with diverse educationalbackgrounds and working experience agreed 100% with theresults expected. | |
| ● | Based on the results of the correlation and POL studies, we mayconclude that the Instant-ViewTM Pregnancy Urine Test is assafe, as effective, and performs as well as the legally marketeddevice. Therefore, this test is suitable for use by health careprofessionals with diverse educational backgrounds and workexperience. |
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure in profile, with the head, shoulders, and upper torso represented by a series of curved lines. The figure is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 6 1999
Naishu Wang, M.D., Ph.D. President Alfa Scientific Designs, Inc. 11494 Sorrento Valley Road, Suite F&M San Diego, CA 92121
Re: K984076
Trade Name: Instant-View Pregnancy Urine Test Regulatory Class: II Product Code: 75 JHI Dated: January 6, 1999 Received: January 11, 1999
Dear Dr. Wang:
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 Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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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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 Autman
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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| Labels | Values |
|---|---|
| 510(k) Number (if known) | K984076 |
| Device Name | Instant-View pregnancy Urine Test |
Indications For Use:
The Instant-View Pregnancy Urine Test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.
This test is for laboratory and professional use only.
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Division of Clinical Labora 510(k) Number_ 关
(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__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.