← Product Code [LCX](/productcode/LCX) · K960733 # MINISTICK PREGNANCY TEST (K960733) _Vanguard Biomedical Corp. · LCX · May 1, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K960733 ## Device Facts - **Applicant:** Vanguard Biomedical Corp. - **Product Code:** [LCX](/productcode/LCX.md) - **Decision Date:** May 1, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1155 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## 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. Its intended use is identical to that of several professional products currently available for use in clinical laboratories or physicians' offices. ## Device Story MiniStick Pregnancy Test is a lateral flow, qualitative immunoassay for HCG detection in urine. Device consists of a paper reservoir and membrane strip containing dried colloid gold-monoclonal antibody conjugate. Operation: user holds device tip in urine stream; urine reconstitutes conjugate; HCG (if present) binds conjugate and migrates to immobilized goat anti-HCG band, forming a visible reddish line. Control band (immobilized goat anti-mouse IgG) confirms reagent integrity. Used by consumers for home pregnancy testing. Output is visual color change; positive result indicates pregnancy. Simplifies testing by allowing direct stream application rather than separate sample collection. ## Clinical Evidence Clinical study compared MiniStick against HOMECLINIC One-Step Pregnancy Test (K914253) using 206 urine specimens (55 positive, 151 negative). Results showed 100% correlation between the two devices. Study confirmed accuracy and user preference for the direct-stream application method. ## Technological Characteristics Lateral flow immunochromatographic assay. Components: paper reservoir, membrane strip, colloid gold-monoclonal antibody conjugate, immobilized goat anti-HCG (test line), immobilized goat anti-mouse IgG (control line). Qualitative visual readout. No external energy source. Standalone device. ## Regulatory 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. 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. ## Predicate Devices - HOMECLINIC One-Step Pregnancy Test ([K914253](/device/K914253.md)) ## Reference Devices - ANSWER 1-Step Pregnancy Test - 1 Step ADVANCE Pregnancy Test - Conceive Pregnancy Test ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K960733 VANGUARD BIOMEDICAL CORPORATION 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). (2) Lenton, E.A., Neal, L.M., and Sulaiman, R., *Fertility and Sterility*, 37:773 (1982). ## 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, is a control 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 **MiniStick** 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. 1. Both tests are visual qualitative immunoassays for the detection of HCG in urine as an indicator of pregnancy. 2. Both tests are "sandwich" type immunoassays in which HCG is captured between an antibody attached to a solid phase and a colloid gold-monoclonal antibody conjugate in the liquid phase. 3. Both tests use polyclonal antibodies on the solid phase. 4. Both tests use color deposition on the solid phase through chromatographic 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 [510 (k) Number K914253] following package directions. The MiniStick Pregnancy Test is chemically and structurally identical to the HOMECLINIC 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 MiniStick 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. --- **Source:** [https://fda-staging.innolitics.com/device/K960733](https://fda-staging.innolitics.com/device/K960733) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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