CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800

K973457 · Shared Systems, Inc. · GMZ · Jan 2, 1998 · Microbiology

Device Facts

• Record ID: K973457
• Device Name: CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800
• Applicant: Shared Systems, Inc.
• Product Code: GMZ · Microbiology
• Decision Date: Jan 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3255
• Device Class: Class 1

Intended Use

The E. coli 0157 Latex Agglutination Test is a rapid test for E. coli serogroup 0157 detection in all primary cultures suspected to be E. coli spp.

Device Story

Chromalex E. coli 0157 Latex Agglutination Test System is an in vitro diagnostic device for rapid identification of E. coli serogroup 0157. Input consists of primary culture samples suspected of containing E. coli. Principle of operation involves latex agglutination; specific antibodies coated on latex particles bind to E. coli 0157 antigens in the sample, causing visible clumping (agglutination). Output is a qualitative visual result (positive or negative). Used in clinical laboratories by trained personnel. Results assist clinicians in identifying E. coli 0157 infections, facilitating timely clinical management and patient care.

Clinical Evidence

No clinical data provided; device clearance based on substantial equivalence to existing legally marketed devices.

Technological Characteristics

Latex agglutination assay; utilizes antibody-coated latex particles for antigen detection. In vitro diagnostic test system.

Indications for Use

Indicated for the detection of E. coli serogroup 0157 in primary cultures suspected to contain E. coli spp. For professional use in clinical laboratory settings.

Regulatory Classification

Identification

Escherichia coli serological reagents are devices that consist of antigens and antisera used in serological tests to identify Escherichia coli from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist of Escherichia coli antisera conjugated with a fluorescent dye used to identify Escherichia coli directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium belonging to the genus Escherichia, and provides epidemiological information on diseases caused by this microorganism. Although Escherichia coli constitutes the greater part of the microorganisms found in the intestinal tract in humans and is usually nonpathogenic, those strains which are pathogenic may cause urinary tract infections or epidemic diarrheal disease, especially in children.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN - 2 1998

Mr. Robert C. Hicks President Shared Systems P.O. Box 211587 Martinez, GA 30917

Re: K973457

Trade Name: Chromalex E. coli 0157 Latex Agglutination Test System Regulatory Class: II Product Code: GMZ Dated: December 16, 1997 Received: December 17, 1997

Dear Mr. Hicks:

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 of the Act. The general controls provisions 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 action. In addition, FDA may publish further announcements 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 Regulations.

{1}------------------------------------------------

## 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Butman

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

{2}------------------------------------------------

Page __ 1_ of __ 1_

K 973457 510(k) Number (if known):

Device Name: Chromalex E. coli 0157 Latex Agglutination Test System

Indications For Use:

"The E. coli 0157 Latex Agglutination Test is a rapid test for E. coli serogroup 0157 detection in all primary cultures suspected to be E. coli spp."

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|

*(Division Sign-Off)*

Division of Clinical Laboratory Devices

| 510(k) Number | K973457 |
|---------------|---------|
|---------------|---------|

Prescription Use (Per 21 CFR 801.109)

. .

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96) -- -