(69 days)
The MiniStick Pregnancy Test is a monoclonal antibody-based immunoassay intended for the visual qualitative detection of human Chorionic Gonadotropin (HCG) in urine as an early indicator of pregnancy. Its intended use is identical to that of several professional products currently available for use in clinical laboratories or physicians' offices.
The MiniStick Pregnancy Test is an immunodiagnostic system that detects the presence of HCG in the urine sample through the formation of a complex which is held together by the HCG molecule. The patient's urine sample enters a paper reservoir which is in contact with a pad containing a dried conjugate of colloid gold-monoclonal antibody (reddish in color). The urine sample will then reconstitute the dried conjugate. If HCG is present in the sample, it will react with the monoclonal antibody to form a complex of colloid gold-monoclonal antibody-HCG. This complex migrates up a membrane strip chromatographically and through a band of immobilized goat anti-HCG. Because the antibody of this immobilized goat anti-HCG is able to bind the HCG molecule of the migrating complex, a visible reddish band is formed along the exact location of the immobilized goat anti-HCG antibody. If there is no HCG present in the sample, the colloid gold-monoclonal antibody conjugate will pass through the immobilized goat anti-HCG band and no colored line will form -a negative test result. Further up the membrane, past the anti-HCG test region consisting of a band of immobilized goat anti-mouse IgG. This band of antibody will bind only conjugate and form a colored line, regardless of whether HCG is present in the urine or not. Appearance of the control line assures reagent integrity as well as correct testing procedure.
The provided document describes the MiniStick Pregnancy Test, a qualitative visual test system for the detection of human Chorionic Gonadotropin (HCG) in urine.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accuracy (Laboratory Testing) | "virtually 100% accurate in laboratory testing" |
| Accuracy (Clinical Trials / Clinical Performance) | "greater than 99% accurate in clinical trials" |
| Correlation with substantially equivalent predicate device | "100% correlation in test results between the MiniStick Pregnancy Test and the HOMECLINIC One-Step Pregnancy Test" |
| User Acceptance of direct urine stream application (if applicable for consumer use) | "All the women participating in the study had a favorable response to performing the test by holding the device in their urine stream to obtain a sample." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 206 clinical urine specimens (55 positive and 151 negative).
- Data Provenance: The study was conducted by "Vanguard personnel" through "laboratory testing." The origin of the urine samples (e.g., country) is not specified, but they are referred to as "clinical urine specimens," implying they were collected from human patients. The study is retrospective as it used pre-collected urine specimens.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications used to establish the ground truth for the 206 clinical urine specimens. It simply states that the specimens were "55 positive and 151 negative," implying a pre-existing classification.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. The ground truth (positive/negative status of the 206 specimens) appears to be pre-established. The study focused on comparing the MiniStick to the HOMECUNIC One-Step Pregnancy Test against this pre-established ground truth.
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 study compares two devices (MiniStick and HOMECLINIC) for their accuracy in detecting HCG, not the performance of human readers with or without an AI assistant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is a qualitative visual immunoassay pregnancy test, which fundamentally requires human interpretation of a visual line. Therefore, a purely standalone algorithm performance in the modern sense (i.e., AI interpreting the test) was not performed. The "standalone" performance here refers to the device itself providing a visual result that a human then reads. The study evaluates the accuracy of this device's visual output.
7. The Type of Ground Truth Used
The ground truth used was the known HCG status (positive or negative) of the 206 clinical urine specimens. This implies a reference method or prior clinical testing was used to determine the true HCG status of each sample.
8. The Sample Size for the Training Set
The document does not mention a separate training set. This is not an AI or machine learning device in the modern sense. It's an immunoassay. The concept of "training set" as used in AI does not apply here. The "training" in this context would be the original development and optimization of the immunoassay reagents and design.
9. How the Ground Truth for the Training Set was Established
As there's no explicit training set mentioned for an AI context, this question is not applicable. For the immunoassay development, the ground truth would have been established through known concentrations of HCG and other related hormones, and clinical samples with confirmed HCG status, to optimize the monoclonal antibody specificity andassay parameters. However, specific details of this development are not provided in the 510(k) summary.
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Image /page/0/Picture/1 description: The image shows the logo for Vanguard Biomedical Corporation. The logo consists of a triangle made up of three nested triangles on the left. To the right of the triangle is the word "VANGUARD" in a bold, sans-serif font, with a horizontal line underneath. Below the line is the text "BIOMEDICAL CORPORATION" in a smaller, sans-serif font.
10225 BARNES CANYON ROAD, SUITE A108
SAN DIEGO, CALIFORNIA 92121 USA
TEL: (619) 554-1361 FAX: (619) 554-1362
MAY - 1 1996
MiniStick Pregnancy Test for Consumer Use
510(k) Summary of Product Safety and Effectiveness
Contact: John Chiu, Ph.D. Director, Research & Development Prepared: February 23, 1996
The trade name of this device is MiniStick Pregnancy Test. It is a qualitative visual test system for the detection of human Chorionic Gonadotropin (HCG) in urine as an indicator of pregnancy and would be classified as a Human Chorionic Gonadotropin Test System.
Vanguard Biomedical Corporation considers the MiniStick to be substantially equivalent to other comparable FDA-approved products in intended use, test procedure, and test principles.
INTRODUCTION
Human Chorionic Gonadotropin (HCG) is a glycoprotein hormone produced by the placenta and found in the urine of pregnant women (1). This hormone increases rapidly during pregnancy and normally reaches levels in excess of 100,000 mIU/ml during the first trimester (2).
The molecular structure of HCG is similar to other glycoprotein hormones normally found in the urine, i.e., Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Thyroid Stimulating Hormone (TSH). However, HCG can be differentiated from the others by using a monoclonal antibody against a specific site on the HCG molecule. MiniStick Pregnancy Test is a qualitative immunoassay which uses a specific monoclonal antibody for HCG detection. This test is virtually 100% accurate in laboratory testing and is greater than 99% accurate in clinical trials.
REFERENCES
- (1) Braunstein, G.D., Rasor, J., Adler, D., Danzer, H., and Wade, M.E., Am. J. Obstet. Gynecol., 126:678 (1976).
- Lenton, E.A., Neal, L.M., and Sulaiman, R., Fertility and Sterility, 37:773 (1982). (2)
PRINCIPLES OF THE TEST SYSTEM
The MiniStick Pregnancy Test is an immunodiagnostic system that detects the presence of HCG in the urine sample through the formation of a complex which is held together by the HCG molecule.
The patient's urine sample enters a paper reservoir which is in contact with a pad containing a dried conjugate of colloid gold-monoclonal antibody (reddish in color). The urine sample will then reconstitute the dried conjugate. If HCG is present in the sample, it will react with the monoclonal antibody to form a complex of colloid gold-monoclonal antibody-HCG. This complex migrates up a membrane strip chromatographically and through a band of immobilized goat anti-HCG. Because the antibody of this immobilized goat anti-HCG is able to bind the HCG molecule of the migrating complex, a visible reddish band is formed along the exact location of the immobilized goat anti-HCG antibody. If there is no HCG present in the sample, the colloid gold-monoclonal antibody conjugate will pass through the immobilized goat anti-HCG band and no colored line will form -a negative test result.
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Further up the membrane, past the anti-HCG test region consisting of a band of immobilized goat anti-mouse IgG. This band of antibody will bind only conjugate and form a colored line, regardless of whether HCG is present in the urine or not. Appearance of the control line assures reagent integrity as well as correct testing procedure.
SUBSTANTIAL EQUIVALENCE
Vanguard Biomedical Corporation considers the MiniStick Pregnancy Test to be substantially equivalent to other comparable FDA-approved products in intended use, test principles, and test procedures.
INTENDED USE
The MiniStick Pregnancy Test is a monoclonal antibody-based immunoassay intended for the visual qualitative detection of human Chorionic Gonadotropin (HCG) in urine as an early indicator of pregnancy. Its intended use is identical to that of several professional products currently available for use in clinical laboratories or physicians' offices.
| These include: ANSWER 1-Step Pregnancy Test | Carter Products DivisionCarter-Wallace, Inc.New York, NY 10105 |
|---|---|
| 1 Step ADVANCE Pregnancy Test | Advanced Care ProductsOrtho Pharmaceutical Corp.Raritan, NJ 08869 |
| Conceive Pregnancy Test | Quidel Corp.10165 McKellar CourtSan Diego, CA 92121 |
For the reasons presented below, and by the data presented in the Clinical Performance Section, Vanguard Biomedical Corporation believes that the MiniStlick Pregnancy Test is substantially equivalent to commercially available products for the visual qualitative detection of HCG in urine specimens.
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SYSTEMS COMPARISON
The MiniStick Pregnancy Test is similar in immunological principles and procedures to ANSWER 1-Step Pregnancy Test from Carter-Wallace, Inc. A comparison of the two systems is described below.
- Both tests are visual qualitative immunoassays for the detection of HCG in urine as l an indicator of pregnancy.
- Both tests are "sandwich" type immunoassays in which HCG is captured between 2 an antibody attached to a solid phase and a colloid gold-monoclonal antibody conjugate in the liquid phase.
- Both tests use polyclonal antibodies on the solid phase . 3
- Both tests use color deposition on the solid phase through chromatographic 4 migration of the colloid gold-monoclonal antibody conjugate, as an indicator of a positive result, i.e., the presence of HCG in the sample.
- 5 Both tests use monoclonal anti-HCG Beta subunit antibodies to assure specificity for HCG.
- 6 Both tests have a control band by which the user can be assured that the assay was performed correctly and the reagents were working properly. This band shows color each time the test is run regardless of the sample being positive or negative for HCG. Should color fail to appear at the control band, the user is alerted to potential problems invalidating the test results.
- 7 Both tests collect sample by holding the sample collection region in the urine stream for direct application.
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CLINICAL PERFORMANCE
A total of 206 clinical urine specimens ( 55 positive and 151 negative) were assayed with the MiniStick Pregnancy Test and with the HOMECLINIC One-Step Pregnancy Test 1510 (k) Number K914253) following package directions. The MiniStick Pregnancy Test is chemically and structurally identical to the HOMECUNIC One-Step Pregnancy Test; however, the former has sample applied directly to a collection region by holding the tip of the Test Unit in the urine stream, whereas the latter requires a urine sample to be collected first, then a few drops of that sample are applied to a sample well in the test unit. Assay results were equivalent in all specimens tested, resulting in a 100% correlation in test results between the Mini Stick Pregnancy Test and the HOMECLINIC One-Step Pregnancy Test.
The results of the Clinical Evaluation showed substantial equivalence in accuracy of clinical performance for the MiniStick Pregnancy Test and the HOMECLINIC One-Step Pregnancy Test, as determined by laboratory testing by Vanguard personnel.
All the women participating in the study had a favorable response to performing the test by holding the device in their urine stream to obtain a sample.
§ 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.