← Product Code [JHI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI) · K964156 # CONTRAST STRIP HCG (K964156) _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/K964156 ## 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 in physician’s office and clinical laboratories. ## Device Story Rapid membrane-based immunoassay for qualitative hCG detection; utilizes mouse monoclonal anti-hCG and sheep anti-alpha hCG polyclonal antibodies. Used in physician offices and clinical laboratories by professional staff. Input: human urine or serum samples. Principle: lateral flow immunoassay; hCG in sample binds to labeled antibodies, creating visible test line. Output: qualitative visual result (positive/negative). Assists clinicians in pregnancy confirmation or determining pregnancy status prior to other medical procedures (e.g., X-ray). ## Clinical Evidence Multicenter clinical study at four physician offices/clinics. Compared subject device to predicate using 209 urine and 177 serum samples. Results showed 100% agreement. Reproducibility and sensitivity panel tested by eight individuals with varying training levels; confirmed detection limits of 20 mIU/mL (urine) and 10 mIU/mL (serum) across range up to 1,000,000 mIU/mL. ## Technological Characteristics Rapid membrane-based immunoassay; utilizes mouse monoclonal anti-hCG and sheep anti-alpha hCG polyclonal antibodies. Qualitative visual readout. Sensitivity: 20 mIU/mL (urine), 10 mIU/mL (serum). ## 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} K964156 NOV 25 1996 510(k) Notification Genzyme Diagnostics Contrast® Strip hCG October 15, 1996 # 510(k) Summary of Safety and Effectiveness # Information Upon Which An Equivalence Determination Could Be Made Trade or Proprietary Name: Contrast® Strip hCG 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 in physician’s office and clinical laboratories. A multicenter clinical study was performed in four physician's offices/clinics (POL). The Genzyme Diagnostics Contrast® Strip hCG was provided to the sites. Each site also used the legally marketed Rapid hCG™ Urine/Serum Test. The Rapid hCG™ Urine/Serum Test is marketed for laboratory and professional use. Page 9 of 57 {1} 510(k) Notification Genzyme Diagnostics Contrast® Strip hCG October 15, 1996 Urine specimens were tested in four physician's offices using both Genzyme tests. Clinical subjects included female patients seeking confirmation of pregnancy, those who were confirmed pregnant, post-menopausal women and assumed negatives. Three physician's offices performed both Genzyme tests on serum specimens from female patients for either confirmation of pregnancy or non-pregnancy status prior to treatment (e.g. X-ray) for other disease states and post-menopausal women. The results with both urine (209) and serum (177) samples demonstrate that the Genzyme Diagnostics Contrast® Strip hCG has 100% agreement with the Rapid hCG™ Urine/Serum Test. | | Urine | | Serum | | | --- | --- | --- | --- | --- | | | Strip hCG | Rapid hCG™ | Strip hCG | Rapid hCG™ | | Positive | 75 | 75 | Positive | 72 | | Negative | 134 | 134 | Negative | 105 | At three POLs, eight individuals with various levels of training tested a blind reproducibility and sensitivity panel using the Genzyme Diagnostics Contrast® Strip hCG. The Genzyme Diagnostics Contrast® Strip hCG reproducibly detected hCG in urine at levels as low as 20 mIU/mL and as high as 1,000,000 mIU/mL and serum hCG at levels as low as 10 mIU/mL and as high as 1,000,000 mIU/mL. These results establish that the Genzyme Diagnostics Contrast® Strip hCG is substantially equivalent to the Rapid hCG™ Urine/Serum Test. The Genzyme Diagnostics Contrast® Strip hCG Test can detect hCG concentrations of 20 mIU/mL in urine and 10 mIU/mL in serum. The intended use of the Genzyme Diagnostics Contrast® Strip hCG is the early determination of pregnancy by the qualitative detection of human chorionic gonadotropin (hCG) in human serum or urine. Our intent is to market this product for laboratory and professional use. Page 10 of 57 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI/K964156](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI/K964156) **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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