QUIX RAPID E. COLI O157 STRIP TEST

K972156 · Guardian Scientific, Corp. · GMZ · Oct 16, 1997 · Microbiology

Device Facts

• Record ID: K972156
• Device Name: QUIX RAPID E. COLI O157 STRIP TEST
• Applicant: Guardian Scientific, Corp.
• Product Code: GMZ · Microbiology
• Decision Date: Oct 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3255
• Device Class: Class 1

Intended Use

The Quix™ Rapid E. coli 0157 Strip Test is an immunochromatographic assay for the qualitative detection of E. coli O157 in human feces. The test is designed to be used as an aid to the diagnosis of diarrhea caused by E. coli 0157 and as an adjunct to culture methodology.

Device Story

Quix™ Rapid E. coli 0157 Strip Test is an immunochromatographic assay for qualitative detection of E. coli O157 in human feces. Device functions as an aid to diagnosis of diarrhea and adjunct to culture methodology. Intended for use in clinical laboratory settings. Healthcare providers interpret visual results on the test strip to assist in clinical decision-making regarding patient management for E. coli O157 infections.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Immunochromatographic assay; qualitative strip test format.

Indications for Use

Indicated for the qualitative detection of E. coli O157 in human fecal samples to aid in the diagnosis of diarrhea caused by E. coli O157. Used as an adjunct to culture methodology.

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)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## OCT 16 1997

Kathryn B. Powers Quality Manager Universal Health Watch, Inc. Oakland Center 8990-E Route 108 Columbia, Maryland 21045

Re: K972156

Trade Name: Ouix™ Rapid E. Coli 0157 Strip Test Regulatory Class: I Product Code: GMZ Dated: August 27, 1997 Received: August 28, 1997

Dear Ms. Powers:

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 (OS) 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.

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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 Autman

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: Quix™ Rapid E. coli 0157 Strip test

Sponsor Name: Universal HealthWatch Inc.

Indications For Use:

#### INTENDED USE

The Quix™ Rapid E. coli 0157 Strip Test is an immunochromatographic assay for the qualitative detection of E. coli O157 in human feces. The test is designed to be used as an aid to the diagnosis of diarrhea caused by E. coli 0157 and as an adjunct to culture methodology.

Sean Cooper

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_Kg2

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ਿ Over-The-Counter-Use 0

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