(69 days)
No
The device description details a standard immunoassay based on chemical reactions and visual interpretation, with no mention of AI or ML components.
No
This device is an in vitro diagnostic device used to detect a condition (pregnancy), not a device used for treating a condition.
Yes
The "Intended Use" clearly states it's for "visual qualitative detection of human Chorionic Gonadotropin (HCG) in urine as an early indicator of pregnancy," which is a diagnostic purpose. The "Device Description" also labels it as an "immunodiagnostic system."
No
The device description clearly outlines a physical immunodiagnostic system involving a paper reservoir, pads, a membrane strip, and chemical reactions to detect HCG. This is a hardware-based test, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "visual qualitative detection of human Chorionic Gonadotropin (HCG) in urine as an early indicator of pregnancy." This involves testing a biological sample (urine) outside of the body to gain information about a physiological state (pregnancy).
- Device Description: The description details an "immunodiagnostic system" that detects a substance (HCG) in a urine sample using antibodies and a chromatographic process. This is a classic description of an in vitro diagnostic test.
- Clinical Performance Study: The document describes a clinical performance study where clinical urine specimens were assayed with the device. This type of study is conducted to evaluate the performance of an IVD.
The definition of an IVD generally includes devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease or for the determination of the state of health. The MiniStick Pregnancy Test fits this definition by analyzing a urine sample to determine the state of pregnancy.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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, is 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
206 clinical urine specimens (55 positive and 151 negative) were assayed with the MiniStick Pregnancy Test and with the HOMECLINIC One-Step Pregnancy Test. The MiniStick Pregnancy Test is chemically and structurally identical to the HOMECUNIC One-Step Pregnancy Test. Assay results were equivalent in all specimens tested.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
100% correlation in test results between the Mini Stick Pregnancy Test and the HOMECLINIC One-Step Pregnancy Test.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
1
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 Division
Carter-Wallace, Inc.
New York, NY 10105 |
|---------------------------------------------|---------------------------------------------------------------------------|
| 1 Step ADVANCE Pregnancy Test | Advanced Care Products
Ortho Pharmaceutical Corp.
Raritan, NJ 08869 |
| Conceive Pregnancy Test | Quidel Corp.
10165 McKellar Court
San 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.
2
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.
3
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.