IMMUNOCARD STAT! E. COLI O157:H7

K990263 · Meridian Diagnostics, Inc. · GMZ · Aug 9, 1999 · Microbiology

Device Facts

• Record ID: K990263
• Device Name: IMMUNOCARD STAT! E. COLI O157:H7
• Applicant: Meridian Diagnostics, Inc.
• Product Code: GMZ · Microbiology
• Decision Date: Aug 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3255
• Device Class: Class 1

Intended Use

The Immunocard STAT! STEC O157 is a rapid test for the detection of antigens from shiga toxin producing E. coli O157 as an aid in the diagnosis of E. coli O157:H7 infection. The test can be used to directly test stool specimens, or confirmatory stool cultures grown in MacConkey broth or sorbitol MacConkey (SMAC) plates.

Device Story

ImmunoCard STAT! STEC O157 is a rapid, lateral-flow, sandwich colloidal gold immunoassay for detecting shiga toxin-producing E. coli O157 antigens. Input: stool specimens or culture material (MacConkey broth/SMAC plates). Operation: sample diluted and applied to device port; sample mobilizes gold particles coated with monoclonal antibodies specific for O157 lipopolysaccharide; analytes migrate along a membrane to test/control zones. If target antigen is present, a complex forms with capture antibodies, creating a visible red/purple line in the test zone. Control line confirms proper migration. Used in clinical laboratories by technicians. Results are read visually after 10 minutes. Provides qualitative detection to aid clinical diagnosis of E. coli O157:H7 infection.

Clinical Evidence

Clinical performance evaluated by comparing the ImmunoCard STAT! STEC O157 against culture methods. Reported sensitivity for stool specimens is 82% and specificity is 99%. No further clinical study details provided.

Technological Characteristics

Lateral-flow sandwich colloidal gold immunoassay. Components include monoclonal antibody-gold conjugate and immobilized monoclonal capture antibodies on a membrane. Qualitative visual readout. Standalone device; no external energy source required. Manual procedure.

Indications for Use

Indicated for the detection of shiga toxin-producing E. coli O157 antigens in human stool specimens or stool cultures to aid in the diagnosis of E. coli O157:H7 infection.

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.

Predicate Devices

• E. coli 0157 Elisa Stool Assay

Submission Summary (Full Text)

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AUG - 9 1999

Meridian Diagnostics, Inc. Cincinnati, OH 45244

## 510(k) Summary Identification Information

#### Submitter's Information:

### Submitter's Name and Address:

Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati, OH 45244

## Phone Number: 1-800-696-0739 FAX Number: 1-513-272-5432

Contact Person: Allen D. Nickol, PhD Director of Clinical and Regulatory Affairs E-mail: [e-mail]

Date Summary Prepared: July 21, 1999

## Name of Device: ImmunoCard STAT! STEC O157

#### Classification Name:

Antigens, All types, Escherichia coli [866.3255]; 83GMZ

### Predicate Equivalent Device:

E. coli 0157 Elisa Stool Assay

#### Description of Device:

Stool or culture material are prepared / diluted and added to the sample port of The sample mobilizes gold particles, coated with monoclonal the device. antibody specific for the O157 lipopolysacchride, and migrates along the membrane through the Test and Control zones. The test zone contains immobilized monoclodal antibody specific for an epitope common to shiga toxin producing E. coli. After ten minutes the Test and Control zones are observed for the presence of red/purple lines across the membrane surface. If a shiga toxin producing E. coli O157 is present in the sample, a complex is formed between the capture antibody, the shiga toxin producing E. coli O157, and the monoclonal antibody-gold conjugate which can be seen visually as a red/purple line in the Test zone. No red/purple line in the Test zone indicates a negative result. The Control line serves as a procedural control, to assure that the sample has migrated the appropriate distance along the membrane.

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## Intended Use:

- The Immunocard STAT! STEC O157 is a rapid test for the detection of antigens . from shiga toxin producing E. coli O157 as an aid in the diagnosis of E. coli O157:H7 infection. The test can be used to directly test stool specimens, or confirmatory stool cultures grown in MacConkey broth or sorbitol MacConkey (SMAC) plates.

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# Comparison with Predicate Device:

The following comparison of the use, technology, function and performance supports the Statement of Equivalence between the ImmunoCard STAT! STEC O157 test and the E. coli ELISA Stool Assay. The differences in technology, specimens or assay procedure do not raise additional concerns regarding safety The safety and effectiveness of both assays are both and effectiveness. substantially equivalent when compared to culture.

| Method | ImmunoCard STAT!STEC O157 | E. coli O157 Elisa Stool Assay | | | | | | | | | | | | |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|
| Intended Use | Detection of E. coli O157 in patient stool | Detection of E. coli O157:H7 in patient stool | | | | | | | | | | | | |
| Results | Qualitative | Qualitative | | | | | | | | | | | | |
| Specimen Required | 1. Stool<br>2. Stool in modified Cary-Blair Transport<br>3. MacConkey Broth<br>4. Non-Sorbitol fermenting colonies from a SMAC Plate | 1. Stool<br>2. Preserved Stools (10% formalin) | | | | | | | | | | | | |
| Technology | Sandwich Colloidal Gold Immunoassay | Sandwich Enzyme Immunoassay | | | | | | | | | | | | |
| Level of Skill Required | Laboratory Technician | Laboratory Technician | | | | | | | | | | | | |
| Function | 1. Specimen is diluted and added to the sample application port.<br>2. After 10 minutes, results are read visually. | 1. Specimen is diluted (1/3 for stool; none for formalin preserved) and 100µl are added to microwells.<br>2. Incubate 20 minutes at room temperature.<br>3. Wash wells 3 times.<br>4. Add 2 drops of Enzyme Conjugate to each well.<br>5. Incubate 10 minutes at room temperature.<br>6. Wash wells 3 times.<br>7. Add one drop each Substrates A and B. Mix and incubate 5 minutes at room temperature.<br>8. Add 2 drops Stop Solution, mix and read either visually or with a plate reader. | | | | | | | | | | | | |
| Interpretation | Pos/Neg read visually | Pos/Neg read visually or spectrophotometrically | | | | | | | | | | | | |
| Performance with<br>Sensitivity<br>Specificity | Stool<br>82%<br>99% | Formalinized<br>Mac.<br>Broth SMAC<br>Plate Stool Stool 100% 100% 93% 100% 100% 100% 99% 99% | | | | | | | | | | | | |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 9 1999

Allen D. Nickol, Ph.D. Director of Clinical and Regulatory Affairs Meridian Diagnostics. Inc. 3471 River Hills Drive Cincinnati, Ohio 45244

Re: K990263 Trade Name: ImmunoCard STAT! STEC 0157 E. coli Regulatory Class: I Product Code: GMZ Dated: July 21, 1999 Received: July 22, 1999

Dear Dr. Nickol:

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 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). 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 requirements, 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.

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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 Sutman

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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Meridian Diagnostics, Inc. Cincinnati, OH 45244

Indications for Use Statement

510(k) Number (if known): K990263

Device Name: ImmunoCard STAT! STEC O157

Indications For Use:

The Immunocard STAT! STEC O157 is a rapid test for the detection of antigens from shiga toxin producing E. coli O157 as an aid in the diagnosis of E. coli O157:H7 infection. The test can be used to directly test stool specimens, or confirmatory stool cultures grown in MacConkey broth or sorbitol MacConkey (SMAC) plates.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubois

Kyy 510(k) Number.

Prescription Use
(Per 21 CFR 801.109)

OR

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