ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025

K981512 · Skd, Inc. A Beckman Coulter Co. · JHI · May 28, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981512
• Device Name: ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025
• Applicant: Skd, Inc. A Beckman Coulter Co.
• Product Code: JHI · Clinical Chemistry
• Decision Date: May 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

A rapid qualitative test designed to detect human chorionic gonadotropin (hCG) in urine or serum, as an aid in the early detection of pregnancy. The ICON® Fx hCG test is for professional use.

Device Story

ICON® Fx hCG is a rapid, qualitative immunochromatographic assay for detecting human chorionic gonadotropin (hCG) in urine or serum samples. It utilizes two specific mouse monoclonal antibodies targeting alpha and beta subunits of the hCG molecule. The device is a single-step test card; the user applies the sample to a sample pad and closes the card to initiate the reaction. Results are determined via visual detection of color changes in the test window; no instrumentation is required. Internal controls include a procedural control, a negative control (to detect human anti-mouse antibodies), and a flow indicator. The device is intended for use by health professionals in clinical settings. It provides a qualitative result to aid in early pregnancy detection, offering a simplified, one-step procedure compared to multi-step predicate assays.

Clinical Evidence

Multi-center clinical trial testing compared the ICON® Fx hCG to the predicate device. Results showed an overall level of agreement greater than 99.5% for both urine and serum samples.

Technological Characteristics

Immunochromatographic assay; utilizes two specific mouse monoclonal antibodies for alpha and beta hCG subunits. Visual detection; no instrumentation. Internal controls: procedural control, negative control for human anti-mouse antibodies, and flow indicator. Limit of detection: 20 mIU/mL (urine), 10 mIU/mL (serum).

Indications for Use

Indicated for professional use to detect hCG in urine or serum as an aid in early pregnancy detection.

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

• ICON® II HCG ImmunoConcentration™ Assay

Submission Summary (Full Text)

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SKD, Inc. A Beckman Coulter Company
ICON® Fx hCG Immunochemical Test for hCG
510(k) Premarket Notification

KG81512

MAY 2 8 1998

### 510(k) SUMMARY ICON® Fx hCG Immunochemical Test for hCG

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _

| Developed by: | SKD, Inc. A Beckman Coulter Company<br>1050 Page Mill Road, Bldg. 2B<br>Palo Alto, CA USA 94303-0105<br>Attention: Karen L. Richards, Manager, Clinical<br>and Regulatory Affairs<br>Phone: [phone], Fax [phone] |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufactured by: | Beckman Coulter San Diego<br>8958 Terman Court<br>San Diego, CA USA 92196-9006 |
| Proprietary name: | ICON® Fx hCG |
| Classification name: | Human Chorionic Gonadotropin Test System |
| Predicate Device: | ICON® II HCG ImmunoConcentrationTM<br>Assay |

Karen L. Bishop

April 27, 1998
**Date**

Karen L. Richards Manager, Clinical and Regulatory Affairs

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| Device Description: | The ICON® Fx hCG test uses two distinct<br>monoclonal antibodies specific to the alpha and<br>beta subunits of hCG to provide a test capable of<br>detecting hCG concentrations as low as 20<br>mIU/mL urine and 10 mIU/mL serum<br>(IU=International Units). |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | A rapid qualitative test designed to detect<br>human chorionic gonadotropin (hCG) in urine or<br>serum, as an aid in the early detection of<br>pregnancy. |
| Labeling: | Labeling is provided in this 510(k) for multiple<br>configurations of the ICON® Fₓ hCG test. The<br>urine-serum test differs from the urine test only by<br>labeling; all materials in the Test Card remain the |

same across the multiple configurations.

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# Comparison of ICON® II HCG and ICON® Fx hCG Test Systems

| | ICON® II HCG<br>(Predicate Device) | ICON® Fx hCG |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | An ImmunoConcentration™<br>Assay for the Determination<br>of human chorionic<br>gonadotropin (hCG) in urine<br>or serum. (Summary and<br>Explanation section of the<br>product instructions discusses<br>hCG as a marker for the early<br>detection of pregnancy.) | A rapid, qualitative test<br>designed to detect human<br>chorionic gonadotropin<br>(hCG) in urine or serum, as<br>an aid in the early detection<br>of pregnancy. |
| Used by | Health professionals | Health professionals |
| Principles<br>of the Test | ImmunoConcentration™<br>Assay utilizing two specific<br>mouse monoclonal antibodies<br>to the alpha and beta subunits<br>of the hCG molecule for the<br>detection of intact hCG. | Immunochromatographic<br>Assay utilizing the same two<br>specific mouse monoclonal<br>antibodies to the alpha and<br>beta subunits of the hCG<br>molecule as the ICON® II<br>HCG test, for the detection of<br>intact hCG. |
| Test<br>Procedure | Multi-step, multiple reagent<br>addition test. | One-step, no reagents<br>required. |
| Method of<br>Detection | Visual detection; no<br>instrumentation required. | Visual detection; no<br>instrumentation required. |
| | ICON® II HCG<br>(Predicate Device) | ICON® Fx hCG |
| Chemical/<br>Biological<br>Safety | Universal biological safety<br>precautions for sample<br>handling should be observed.<br>Some reagents contain 0.1%<br>sodium azide, and must be<br>disposed of using universal<br>precautions. | Universal biological safety<br>precautions for sample<br>handling should be observed. |
| Internal<br>Controls | 1) Positive Control/Reference<br>Zone: With serum, the<br>amount of color reaction<br>present on the Test spot may<br>be compared to the color<br>reaction present on the<br>Control/Reference spot, for a<br>semi-quantitative<br>interpretation at 25 mIU<br>hCG/mL. For urine and<br>serum, a positive<br>Control/Reference zone<br>demonstrates that the reagents<br>were working properly.<br>2) Negative Control Zone:<br>Identifies nonspecific<br>immunological binding or<br>insufficient washing. If color<br>develops in the negative<br>control zone, the test is<br>invalid. | 1) Positive Procedural<br>Control: Demonstrates that<br>sample was added correctly<br>and the detection reagents<br>were working properly.<br>2) Negative Control: A<br>second line appearing in the<br>Test Window, indicating the<br>presence of human anti-<br>mouse antibodies in the test<br>sample. Appearance of this<br>second line indicates an<br>invalid test result.<br>3) Flow Indicator: Blue<br>color developing in the Flow<br>Indicator window indicates<br>that sample was added<br>properly and flowed down<br>the test strip. |
| | ICON® II HCG<br>(Predicate Device) | ICON® Fx hCG |
| Limit of<br>Detection | Urine: 20 mIU hCG/mL<br>Serum: 10 mIU hCG/mL | Urine: 20 mIU hCG/mL<br>Serum: 10 mIU hCG/mL |
| Specificity | No reaction with homologous<br>hormones hLH, hFSH, hTSH<br>— urine and serum | No reaction with homologous<br>hormones hLH, hFSH, hTSH<br>— urine; hLH, hFSH, hTSH,<br>hPL and hGH - serum |
| Complexity | Sample is added to the test<br>cylinder, enzyme-linked<br>antibody is added to the<br>cylinder and allowed to react.<br>Unbound antibody is washed<br>away, substrate solution is<br>added to the cylinder and<br>allowed to react. Adding wash<br>solution stops the reaction. | Sample is added to the<br>Sample Pad. The test card is<br>closed, and reactions take<br>place. |

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## Comparison of ICON® II HCG and ICON® Fx hCG Test Systems (continued)

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### Comparison of ICON® II HCG and ICON® Fx hCG Test Systems (continued)

Additionally, the high level of agreement in the multi-center clinical trial testing supports the substantial equivalence of these two test kits. For both urine and serum samples, the overall level of agreement was greater than 99.5% (See Tab 8).

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle's head and neck are formed by the silhouettes of the human profiles, creating a sense of unity and collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, emphasizing the organization's name and national affiliation.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 8 1998

Karen L. Richards · Manager, Clinical and Regulatory Affairs SKD, Inc. 1050 Page Mill Road, Bldg. 2B Palo Alto, California 94303-0105

Re : K981512 ICON® Fx hCG Immunochemical Test for hCG Regulatory Class: II Product Code: JHI Dated: April 27, 1998 Received: April 28, 1998

Dear Ms. Richards:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set™ forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement

510(k) Number (if known):

Device Name: ICON® Fy hCG Immunochemical Test for hCG

Indications for Use: The ICON® Fx hCG test is a rapid qualitative test designed to detect human chorionic gonadotropin (hCG) in urine or serum, as an aid in the early detection of pregnancy. The ICON® Fx hCG test is for professional use.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 12981512

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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Prescription Use

(Per 21 CFR 801.109)

OR

Over-The-Counter Use

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