CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST

K964155 · Genzyme Diagnostics · JHI · Nov 25, 1996 · Clinical Chemistry

Device Facts

• Record ID: K964155
• Device Name: CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST
• Applicant: Genzyme Diagnostics
• Product Code: JHI · Clinical Chemistry
• Decision Date: Nov 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

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.

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.

Indications for Use

Indicated for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early determination of pregnancy in clinical and physician office settings.

Regulatory Classification

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)

Submission Summary (Full Text)

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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: [phone]
Fax: [phone] |
| 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.

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