← Product Code [JHI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI) · K970424 # EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST (K970424) _Excel Scientific, Inc. · JHI · Mar 6, 1997 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI/K970424 ## Device Facts - **Applicant:** Excel Scientific, Inc. - **Product Code:** [JHI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI.md) - **Decision Date:** Mar 6, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1155 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use Excel OneStep Urine hCG Pregnancy DipStick Test is Excel Scientific, Inc.'s name for professional use of solid phase migratory chromatography immunoassay in vitro diagnostic test kit for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine. ## Device Story Device is a solid-phase migratory chromatography immunoassay dipstick for qualitative hCG detection in urine. Operated by healthcare professionals in clinical settings. Input is urine specimen; capillary action draws sample through gold sol-antibody conjugate pad. hCG binds to conjugate, forming complex that migrates to immobilized anti-hCG antibody zone, producing rose-pink band if hCG concentration ≥ 25 mIU/mL. Control zone confirms reagent/device function. Output is visual color band indicating presence or absence of hCG. Results assist clinicians in pregnancy diagnosis. ## Clinical Evidence No clinical data provided. Substantial equivalence is supported by comparative bench testing against the predicate device, demonstrating identical sensitivity (25 mIU/mL) and functional performance. ## Technological Characteristics Solid-phase migratory chromatography immunoassay. Employs gold sol-antibody conjugate and immobilized anti-hCG antibodies on a membrane. Form factor is a dipstick. No external energy source or software required. ## 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 - Syntron Quikpac EIA ## Reference Devices - QuikStrip (or E.Z. Strip) Pregnancy Home 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} EXCEL "Commitment to Excellence" Attachment #4 K970424 MAR - 6 1997 # Summary of Safety and Effectiveness Excel OneStep Urine hCG Pregnancy DipStick Test Excel OneStep Urine hCG Pregnancy DipStick Test is Excel Scientific, Inc.'s name for professional use of solid phase migratory chromatography immunoassay in vitro diagnostic test kit for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine. Excel OneStep Urine hCG Pregnancy DipStick Test is based on comparative data with Syntron Quikpac EIA, an assay for human Chorionic Gonadotropin currently being marketed. The Principle of Excel OneStep Urine hCG Pregnancy DipStick Test is as follows: 1. Both the Excel OneStep Urine hCG Pregnancy DipStick and the QuikStrip (or E.Z. Strip) Pregnancy Home tests are a sandwich solid phase dye-conjugated non-enzyme immunoassay. When the Excel OneStep Urine hCG Pregnancy DipStick is placed in a urine test cup containing the urine specimen, the urine will migrate by capillary action. The gold sol-antibody conjugate in the gold sol pad of the Excel OneStep Urine hCG Pregnancy DipStick binds to the hCG molecules in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody immobilized in the positive reaction zone in the white membrane area and produces a rose-pink color band when the hCG concentration is at or greater than 25 mIU/mL. In the absence of detectable levels of hCG, there is no rose-pink band in the positive reaction zone. The reaction mixture continues to flow through the absorbent device, pass the positive reaction zone, producing a rose-pink color band in the control zone of the white membrane area, demonstrating that the reagents and the device are functioning correctly. 2. There is no difference in the testing procedure between the Excel OneStep Urine hCG Pregnancy DipStick Test and the Syntron's QuikStrip (or E.Z. Strip) Pregnancy Home test as shown below: | | QuikStrip (or E.Z. Strip) Pregnancy Home test | Excel OneStep Urine hCG Pregnancy DipStick Test | | --- | --- | --- | | Specimen Volume | 6 drops | 6 drops of urine | | Incubation | 5 minutes | 5 minutes | | Reagent | No | No | | Step | one step | one step | | Cutoff | 25 mIU/mL | 25 mIU/mL | | Urine Cup | Yes | Yes | 3. The differences between the Excel OneStep Urine hCG Pregnancy DipStick Test and the Syntron Quikpac EIA Pregnancy Test are as follows: | | Syntron Quikpac EIA Pregnancy Test | Excel OneStep Urine hCG Pregnancy DipStick Test | | --- | --- | --- | | Specimen Volume | 3 drops of urine | 6 drops of urine | | Incubation | 3 minutes with antibody and 3 minutes with substrate | 5 minutes | | Reagent | 2 bottles | No | | Step | 3 steps | one step | | Cutoff | 25 mIU/mL | 25 mIU/mL | Rev. C1, 9-96 23071 E. La Palma Ave., Yorba Linda, CA 92887, U.S.A. Tel: (714) 692-7151 Fax: (714) 692-7153 {1} EXCEL "Commitment to Excellence" 4. For questions concerning the safety and effectiveness of the Excel OneStep Urine hCG Pregnancy DipStick, please contact: Min-Lee Cheng, Ph.D. 23071 E. La Palma Avenue Yorba Linda, CA 92887 Tel: (714) 692-7151 Rev. C1, 9-06 23071 E. La Palma Ave., Yorba Linda, CA 92887, U.S.A. Tel: (714) 692-7151 Fax: (714) 692-7153 13 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI/K970424](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI/K970424) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com