(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 strip test
The provide text describes the 510(k) summary for the Alfa Scientific Designs' Instant-View™ Pregnancy Urine Dip-Strip Test (K984079). It details the device, its intended use, and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The submission claims 100% agreement when compared to the predicate device and expected results. The acceptance criteria appear to be based on this 100% concordance.
| Acceptance Criterion | Reported Device Performance (Instant-View™ Pregnancy Urine Dip-Strip Test) |
|---|---|
| Accuracy by correlation with legally marketed test | 100% agreement for all results compared |
| Agreement with expected results in clinical lab and physician's offices | 100% agreement with expected results |
2. Sample Size Used for the Test Set and Data Provenance
- The document implies a comparison study ("correlation of the results") with a legally marketed device (OSOM Pregnancy Urine Test). The exact sample size for this comparison is not explicitly stated.
- It also mentions "evaluation results from clinical lab and three physician's offices." The sample size for these evaluations is not explicitly stated.
- The data provenance (e.g., country of origin, retrospective or prospective) is not explicitly stated. However, given it's an FDA submission, the clinical lab and physician's offices are likely in the USA. The studies appear to be prospective for the purpose of this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The ground truth for the comparison study involved a legally marketed device (OSOM Pregnancy Urine Test). The "expected results" were also used as a ground truth.
- The evaluation in clinical labs and physician's offices involved "persons with diverse educational backgrounds and working experience." The number of experts/readers is not explicitly stated, nor are their specific qualifications (e.g., "radiologist with 10 years of experience" is not applicable here as it's a diagnostic test interpreted by general healthcare professionals).
4. Adjudication Method for the Test Set
- The document states that the results "agreed 100% with the results expected" and showed "100% accuracy by correlation." This suggests that a formal adjudication method like "2+1" or "3+1" was not necessary or not explicitly detailed because there was perfect agreement. If discrepancies existed, an adjudication method would typically be described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- A formal MRMC study as commonly understood in medical imaging (comparing reader performance with and without AI assistance) was not performed or described. The study instead focused on the device's accuracy compared to a predicate and expected results. The "persons with diverse educational backgrounds and working experience" performing the evaluations in clinical labs and physician's offices suggest multiple readers, but it's not structured as a comparative effectiveness study with vs. without AI assistance as this device is a standalone diagnostic test, not an AI assisting human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- The Instant-View™ Pregnancy Urine Dip-Strip Test is a qualitative immunoassay designed for visual interpretation. The tests described are effectively standalone performance evaluations of the device, as the human component is simply reading the presence or absence of lines, rather than an "algorithm only" in the AI sense. The entire system (strip + human reading) is the "standalone" device performance being assessed.
7. The Type of Ground Truth Used
- The ground truth relied on two main sources:
- Predicate device results: Comparison to the OSOM Pregnancy Urine Test (K953383).
- Expected results/Clinical laboratory standards: The evaluations from clinical labs and physician's offices were compared to "results expected," implying a reference standard or pre-determined truth, likely based on established laboratory methods for hCG detection.
8. The Sample Size for the Training Set
- This information is not provided. As this is a 510(k) submission for a lateral flow immunoassay, the "training set" concept (as it pertains to machine learning algorithms) isn't directly applicable in the same way. The device's design and manufacturing are based on established biochemical principles, not on training data.
9. How the Ground Truth for the Training Set was Established
- Again, this concept is not applicable in the context of this type of device. The "ground truth" for developing such a device would be the accuracy of the chemical reagents and the immunoassay design in detecting hCG at specific concentrations, which is inherent to its scientific development rather than established through training data in the ML sense.
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Image /page/0/Picture/0 description: The image shows the logo for Alfa Scientific Designs, Inc. The logo consists of the company's name in all caps, with a stylized graphic to the left. Above the logo is the date 2/16/99 written in cursive.
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 (K984079)
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
Common Name: Human Chorionic Gonadotropin (hCG) Test
Trade Name: Instant-View™ Pregnancy Urine Dip-Strip Test
Classification name: 21CFR section 862.1155, Class II. A Qualitative Human Chorionic Gonadotropin (hCG) test system.
Predicate device
The Instant-View™ Pregnancy Urine Dip-Strip 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.
A single step, visually read, qualitative chromatographic
Device description
Intended use
The Instant-View The Pregnancy Urine Dip-Strip 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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immunoassay, single use strip test
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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 Dip-Strip Test and the legally marketed test compared is 100%, indicating that the Instant-ViewTM Pregnancy Urine Dip-Strip Test is substantially equivalent to this existing legally marketed product. |
| The evaluation results from clinical lab and three physician's offices conducted by the persons with diverse educational backgrounds and working experience agreed 100% with the results expected. | |
| Based on the results of the correlation and POL studies, we may conclude that the Instant-ViewTM Pregnancy Urine Dip-Strip Test is as safe, as effective, and performs as well as the legally marketed device. Therefore, this test is suitable for use by health care professionals with diverse educational backgrounds and work experience. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three overlapping human profiles facing to the right, with flowing lines representing hair or movement.
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
K984079 Re:
Trade Name: Instant-View Pregnancy Urine Dip-Strip 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 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 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 Sutman
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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510(k) Number (if known): K984079
Device Name: Instant-View
Pregnancy Urine Dip-Strip 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.
Lain Corzin
Division Sign-Off
(Division Sign-Off) (Status Lagi. On)
Division of Clinical Laboratory Devices 510(k) Number___ K 984079
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V
(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.