← Product Code [JHI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI) · K964155 # CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST (K964155) _Genzyme Diagnostics · JHI · Nov 25, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI/K964155 ## Device Facts - **Applicant:** Genzyme Diagnostics - **Product Code:** [JHI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI.md) - **Decision Date:** Nov 25, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1155 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use The qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early determination of pregnancy for use in the physician’s office and clinical laboratories. ## Device Story Rapid membrane-based immunoassay; qualitative detection of hCG in urine or serum; utilizes mouse monoclonal anti-hCG and sheep anti-alpha hCG polyclonal antibodies; performed in physician offices and clinical laboratories; provides visual results for pregnancy determination; aids clinical decision-making regarding pregnancy status. ## Clinical Evidence Multicenter sensitivity and reproducibility study conducted at three physician office laboratories (POL). Testing performed on coded serum specimens spiked with hCG at varying levels, in triplicate over three days. Results demonstrated detection of 10 mIU/mL hCG in serum within 7 minutes. ## Technological Characteristics Rapid membrane-based immunoassay; utilizes mouse monoclonal anti-hCG and sheep anti-alpha hCG polyclonal antibodies; qualitative detection method. ## 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 - Rapid hCG™ Urine/Serum Test ([K952319](/device/K952319.md)) ## 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} K964155 NOV 25 1996 510(k) Notification Genzyme Diagnostics Contrastᵃ /Rapid™ hCG October 15, 1996 ## 510(k) Summary of Safety and Effectiveness ## Information Upon Which An Equivalence Determination Could Be Made | Trade or Proprietary Name: | Contrastᵃ hCG Urine/Serum Test Rapid hCG™ hCG Urine/Serum Test | | --- | --- | | Common or Usual Name: | Human Chorionic Gonadotropin Test System | | Product Classification Number: | 21 CFR § 862.1155, Class II | | Manufacturer: | Genzyme Diagnostics 1531 Industrial Road San Carlos, CA 94070 | | Contact Person: | Delia R. Bethell, Ph.D. Director of Research and Development Phone: (415) 594-0513 Fax: (415) 594-0571 | | Equivalence Device: | Rapid hCG™ Urine/Serum Test 510(k) Number: K952319 Cleared June 20, 1995 | | Device Description: | Rapid membrane based immunoassay for the qualitative detection of hCG using mouse monoclonal anti-hCG and sheep anti-alpha hCG polyclonal antibodies. | | Intended Use: | The qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early determination of pregnancy for use in the physician’s office and clinical laboratories. | A multicenter sensitivity and reproducibility study was performed in three physician's offices/clinics (POL). The legally marketed Genzyme Diagnostics Rapid hCG™ Urine/Serum Test was provided to the sites. Coded serum specimens, spiked with hCG at different levels, were provided to all sites. Tests were performed in triplicate on each of three different days. Results indicated the Genzyme Diagnostics Rapid hCG™ Urine/Serum Test can detect 10 mIU/mL hCG in serum at 7 minutes. Page 8 of 31 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI/K964155](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI/K964155) **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