GENZYME CONTRAST II HCG URINE/SERUM TEST

K023544 · Genzyme Corp. · JHI · Jan 16, 2003 · Clinical Chemistry

Device Facts

• Record ID: K023544
• Device Name: GENZYME CONTRAST II HCG URINE/SERUM TEST
• Applicant: Genzyme Corp.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Jan 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

The Genzyme Diagnostics Contrast® II hCG Urine/Serum test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy. This test is for use in physicians' offices and clinical laboratories.

Device Story

Contrast® II hCG Urine/Serum Test is a lateral flow, solid-phase, sandwich-format immunochromatographic assay. Device uses fixed-volume AccuPipette® to apply urine or serum sample to reaction pad. hCG in sample binds to monoclonal anti-hCG dye conjugate; complex migrates across membrane to test line containing immobilized monoclonal anti-α hCG. Control line captures excess conjugate to verify test validity. Results appear as gray or black bands in window. Used in physicians' offices and clinical laboratories by healthcare professionals. Provides qualitative pregnancy status; aids clinical decision-making regarding pregnancy confirmation.

Clinical Evidence

Clinical evaluation compared Contrast® II hCG Urine/Serum Test against a currently marketed qualitative hCG assay using 201 urine and 319 serum samples. Results showed high agreement. Two discrepant samples (one urine, one serum) were further tested with a quantitative assay (Coat-A-Count® hCG IRMA); results confirmed the subject device's negative findings were accurate (2.6 mIU/mL and 0 mIU/mL respectively).

Technological Characteristics

Lateral flow immunoassay; solid-phase sandwich format. Uses mouse monoclonal and goat polyclonal antibodies. Manual operation via fixed-volume AccuPipette®. Qualitative visual readout (gray/black bands). No electronic components or software.

Indications for Use

Indicated for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy. Intended for use by healthcare professionals in clinical 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

• Quidel QuickVue® One-Step hCG Combo Test (K020801)

Reference Devices

• Diagnostics Products Coat-A-Count® hCG IRMA

Submission Summary (Full Text)

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**510(k) SUMMARY**

JAN 1 6 2003

Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Genzyme Corporation is providing a summary of the safety and effectiveness information available for the Contrast® II hCG Urine/Serum test.

- 1. Sponsor/Applicant Name and Address:
Genzyme Corporation One Kendall Square Cambridge, MA 02139

- 2. Sponsor Contact Information:
E.V. Goorchenko Associate Director, Regulatory Affairs Phone: [phone] FAX: [phone] Email: [e-mail]

- 3. Date of Preparation of 510(k) Summary: October 21, 2002
- 4. Device Trade or Proprietary Name:

Contrast® II hCG Urine/Serum Test

- 5. Device Common/Usual or Classification Name:
hCG Test System

- 6. Legally Marketed Devices to which Equivalence is Being Claimed:
Quidel QuickVue® One-Step hCG Combo Test (K 020801)

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#### 7. Device Description

## Intended Use

The Genzyme Diagnostics Contrast® II hCG Urine/Serum test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy. This test is for use in physicians' offices and clinical laboratories.

# Principle of the Device

The Contrast® II Urine/Serum device is a solid phase, sandwich-format immunochromatographic assay for the qualitative detection of hCG. Urine or serum is added to the sample well of the test device using the fixed volume AccuPipette® provided. The sample migrates through reaction pads where hCG. if present in the sample, binds to a monoclonal anti-hCG dye conjugate. The sample then migrates across a membrane towards the results window, where the labeled monoclonal antibody-hCG complex is captured at a test line region containing immobilized monoclonal anti-α hCG. Excess conjugate will flow past the test line region and be captured at a control line region containing an immobilized antibody directed against the anti-hCG dye conjugate (with or without hCG complexed to it).

The appearance of two gray or black bands in the results window indicates the presence of hCG in the sample. If a detectable level of the hCG is not present, only the control band will appear in the results window.

### 8. Comparison of Technological Characteristics of Genzyme Contrast® II hCG Urine/Serum Test with Legally Marketed Device:

The similarities with, and differences between, the Contrast® II hCG Urine/Serum test and the Quidel One-Step device are described in Table 1.

#### Agreement with Predicate Device: 9.

A total of 201 urine samples and 319 serum samples were tested and compared to the results obtained with a currently marketed qualitative hCG assay. When tested according to the instructions and limits in the package inserts, the results obtained with the different assays were in agreement with the exception of two discrepant samples. One urine sample and one serum sample produced positive responses with the QuickVue® One-Step Combo hCG test while the Contrast® II Urine/Serum test produced negative results for those samples. The discrepant samples were tested

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with a quantitative assay (Diagnostics Products Coat-A-Count® hCG IRMA) and found to contain 2.6 mIU hCG/mL in the urine sample and 0 mIU hCG/mL in the serum sample.

| | Genzyme Contrast® II hCG<br>Urine/Serum Test | Quidel<br>QuickVue® hCG-Combo Test |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Assay Format | Lateral flow immunoassay | Lateral flow immunoassay |
| Result Format | Visible lines:<br>Negative=one gray or black<br>Control Line<br>Positive=one gray or black<br>Control Line and one gray or<br>black Test Line | Visible lines:<br>Negative =blue procedural<br>Control Line<br>Positive = one pink-to-purple<br>Test Line and one blue Control<br>Line |
| Specimen | Urine or Serum | Urine or Serum |
| Antibodies | Mouse monoclonal and<br>goat polyclonal | Mouse monoclonal and<br>goat polyclonal |
| Internal Control | Yes | Yes |
| Time<br>To<br>Result | Urine: Read result at 3<br>minutes<br>Serum: Read result at 5 or 7<br>minutes | Urine: Read result at 3 minutes<br>Serum: Read result at 5<br>minutes |
| Analytical Sensitivity | Urine: 20 mIU/mL<br>Serum: 10 mIU/mL | Urine: 20 mIU/mL<br>Serum: 10 mIU/mL |

# Table 1. Summary of Device Similarities and Differences

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# JAN 1 6 2003

Mr. E. V. Goorchenko Associate Director, Regulatory Affairs Genzyme Corporation One Kendall Square Cambridge, MA 02139

Re: k023544

> Trade/Device Name: Contrast ® II hCG Urine/Serum Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: October 21, 2002 Received: October 22, 2002

Dear Mr. Goorchenko:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act: The general controls provisions of the Act include requirements for annual registration. Iisting of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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# Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# 510(k) Number: New Application Ko23544

### Device Name :

Contrast® II hCG Urine/Serum Test

# Indications for Use:

The Contrast® II hCG Urine/Serum Test system is intended for the qualitative detection of human chorionic gonadotropin (hCG), a placental hormone, in urine or serum for the early detection of pregnancy. The test is intended for use by health care professionals.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices

k) Number K023544

✓

Prescription Use (Per 21 CRF 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)