(92 days)
The Instant-View TM Pregnancy Combo Dip-Strip Test is designed for qualitative detection of the human chorionic gonadotropin (hCG) in human urine and serum. The test is for use as an aid in the diagnosis of early pregnancy.
The Instant-View Pregnancy Combo Test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine or serum 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
Here's an analysis of the provided text regarding the acceptance criteria and study for the Instant-View™ Pregnancy Combo Dip-Strip Test, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate device characteristics) | Reported Device Performance (Instant-View™ Test) |
|---|---|
| Qualitative detection of hCG in human urine and serum. | Yes (stated intended use). |
| Detection level close to or greater than 25 mIU/ml hCG (calibrated against WHO 3rd IS 75/537). | Yes (stated performance characteristic). |
| Accuracy (correlation with predicate device) | 100% agreement. |
| Agreement with expected results (from clinical lab and physician's offices) | 100% agreement. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify:
- The exact sample size (number of urine/serum samples) used for the test set.
- The country of origin of the data.
- Whether the study was retrospective or prospective.
It only mentions "results from clinical lab and three physician's offices," suggesting clinical testing was performed, but without quantitative details on the number of patients or samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states: "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."
This phrasing is vague. It indicates that multiple individuals (likely staff at the clinical lab and the physician's offices) interpreted the results. However, it does not specify:
- The exact number of "experts" (e.g., how many individuals in the clinical lab, how many physicians).
- Their specific qualifications (e.g., "radiologist with 10 years of experience" - this level of detail is absent).
- Who established the "results expected" (ground truth). It implies a reference method was used, but details are missing.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method (such as 2+1 or 3+1). It simply states that the "persons with diverse educational backgrounds and working experience agreed 100% with the results expected." This implies either perfect agreement or that the "ground truth" was directly compared without a separate adjudication process for reader discrepancies.
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 conducted. The study primarily focused on demonstrating substantial equivalence to a predicate device and direct agreement with expected results, not on comparing human reader performance with and without AI assistance (as this is a qualitative immunoassay, not an AI-driven image analysis tool).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The Instant-View™ Pregnancy Combo Dip-Strip Test is itself a standalone diagnostic device. Its performance is evaluated based on its ability to produce a visual result (presence or absence of a T line) when presented with a sample. The "evaluation results" refer to the interpretation of this visual result by various personnel. There's no separate "algorithm" in the modern AI sense, but the device itself is a self-contained test system. The reported accuracy of 100% against the predicate and 100% agreement with expected results can be considered its standalone performance.
7. The Type of Ground Truth Used
The ground truth was established by:
- Correlation with a legally marketed predicate device: The results were compared to the "QuikpacII-One Step HCG Combo Test made by Syntron Bioresearch, Inc." The document states a 100% correlation.
- "Results expected": The outcome of the test (positive or negative) was compared against "results expected," which would logically be derived from a reference method or established clinical pregnancy status for the samples used. The document does not explicitly state the specific "reference standard" for these "expected results" beyond the predicate device comparison.
8. The Sample Size for the Training Set
The document does not mention a "training set." This type of immunoassay device does not typically involve machine learning or AI models that require distinct training sets in the computational sense. The "training" for such devices would be the manufacturing and quality control processes to ensure consistent performance, not a data-driven model training process.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of data for an algorithm, there is no information on how its ground truth was established.
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Image /page/0/Picture/0 description: The image shows the logo for Alfa Scientific Designs, Inc. The logo includes the company name in all caps, with the word "ALFA" in a larger font size than the rest of the name. To the left of the company name is a stylized graphic. Above the company name is the date 2/16/99.
Medical Diagnostic Devices. Contract R&D. OEM 11494 Sorrento Vallev Rd. Suite F & M San Diego, CA 92121 Tel: (619) 350-9798 Fax: (619) 350-9709
Fax: (619) 350-9709
E-mail: asdi@worldnet.att.net 510(K) Summary (K984080)
Submitter
Name and address: Alfa Scientific Designs, Inc. 11494 Sorrento Vallev 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 Combo Dip-Strip 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 TM Pregnancy Combo Dip-Strip Test is substantially equivalent to other legally marketed devices for the similar intended use. The device used for comparison study is the QuikpacII-One Step HCG Combo Test made by Syntron Bioresearch, Inc. The 510(K)# is K945951.
Device description
A single step, visually read, qualitative chromatographic immunoassay, single use cassette test
Intended use
The Instant-View TM Pregnancy Combo Dip-Strip Test is designed for qualitative detection of the human chorionic gonadotropin (hCG) in human urine and serum. The test is for use as an aid in the diagnosis of early pregnancy.
Continued on next page
510(K) Summary
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The intended use and performance characteristics: . Summary of the Both devices are intended to use for an early detection of hCG similarities to the in human urine and serum at the level close to or greater than 25 predicate device mIU/ml (calibrated against the WHO 3rd IS 75/537). ● Technological characteristics: 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. Interpretation of results: . The presence of C line serves as an internal quality control, and the presence of the T line indicates a positive result. The accuracy by correlation of the results from the Instant-● Discussion and View "M Pregnancy Combo Dip-Strip Test and the legally Conclusion marketed test compared is 100%, indicating that the Instant-View "M Pregnancy Combo 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-View TM Pregnancy Combo 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 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 three overlapping faces. The figure is positioned inside a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" 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
K984080 Re:
Trade Name: Instant-View Pregnancy Combo 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 (OS) 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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| Labels | Values |
|---|---|
| 510(k) Number (if known): | K984080 |
| Device Name: | Instant-View |
| Pregnancy Combo Dip-Strip Test |
Indications For Use:
The Instant-View Pregnancy Combo Test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy.
This test is for laboratory and professional use only.
Crain Croger
(Division Sign-Off)
Division of Clinical Laboratory Devices 11 984080 510(k) Number
(PLEASE DO NOT WRITE BBLOW 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.