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 Description

Stool or culture material are prepared / diluted and added to the sample port of the device. The sample mobilizes gold particles, coated with monoclonal 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.

AI/ML Overview

This document describes the ImmunoCard STAT! STEC O157 device, a rapid test for detecting E. coli O157 antigens.

Here's an analysis of its acceptance criteria and the study performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for the ImmunoCard STAT! STEC O157. However, it presents the performance of the device in comparison to a predicate device (E. coli O157 Elisa Stool Assay), which implies these performance metrics are considered acceptable for market clearance. The key performance metrics are Sensitivity and Specificity for stool samples.

Metric	Acceptance Criteria (Implied)	Reported Device Performance (ImmunoCard STAT! STEC O157)
Sensitivity	Not explicitly stated but expected to be comparable to predicate or acceptable for diagnostic aid	82% (for Stool specimens)
Specificity	Not explicitly stated but expected to be comparable to predicate or acceptable for diagnostic aid	99% (for Stool specimens)

Note: The document also lists performance for the predicate device across various sample types including formalinized stool, MacConkey broth, and SMAC plates (100% Sensitivity, 99-100% Specificity), but these are for the predicate and not the ImmunoCard explicitly across all those sample types in the summary table.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not explicitly state the sample size used for the clinical test set evaluating the ImmunoCard STAT! STEC O157.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions "patient stool" in the intended use and comparison tables.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not provide information on the number of experts used or their qualifications for establishing the ground truth of the test set.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a manual, visually read lateral flow immunoassay. Its interpretation is straightforward (presence or absence of a line). Therefore, a study focusing on inter-reader variability or the improvement of human readers with AI assistance would not be applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, the study primarily describes the standalone performance of the device. The ImmunoCard STAT! STEC O157 is a rapid test that provides a visual reading (red/purple line) after ten minutes, interpreted by a laboratory technician without any algorithmic or AI involvement. The reported sensitivity and specificity are for this standalone operation.

7. Type of Ground Truth Used:

The document doesn't explicitly state the exact "ground truth" method used for the clinical study. However, given that it's a diagnostic test for E. coli O157 and the comparison to "culture" is mentioned (in the statement "The safety and effectiveness of both assays are both substantially equivalent when compared to culture"), it is highly probable that bacteriological culture was used as the gold standard for confirming the presence or absence of E. coli O157 in patient stool samples.

8. Sample Size for the Training Set:

The document does not provide information on a "training set" sample size. This type of device (lateral flow immunoassay) typically does not involve machine learning algorithms that require a distinct training set. Its development involves optimizing chemical and biological components, not training a model on data in the conventional sense.

9. How the Ground Truth for the Training Set Was Established:

As there is no mention of a training set for a machine learning model, there is no information on how its ground truth was established. The development of such a diagnostic test relies on fundamental microbiology, immunology, and chemistry principles, not data-driven model training.

Summary

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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: anickol@meridiandiagnostics.com

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. Stool2. Stool in modified Cary-Blair Transport3. MacConkey Broth4. Non-Sorbitol fermenting colonies from a SMAC Plate	1. Stool2. 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.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.2. Incubate 20 minutes at room temperature.3. Wash wells 3 times.4. Add 2 drops of Enzyme Conjugate to each well.5. Incubate 10 minutes at room temperature.6. Wash wells 3 times.7. Add one drop each Substrates A and B. Mix and incubate 5 minutes at room temperature.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 withSensitivitySpecificity	Stool82%99%	FormalinizedMac.Broth SMACPlate Stool Stool 100% 100% 93% 100% 100% 100% 99% 99%

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

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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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 (770)488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubois

Kyy 510(k) Number.

Prescription Use
(Per 21 CFR 801.109)

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

Regulation Number and Section

§ 866.3255

Escherichia coli serological reagents.(a)
Identification. Escherichia coli serological reagents are devices that consist of antigens and antisera used in serological tests to identifyEscherichia coli from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist ofEscherichia coli antisera conjugated with a fluorescent dye used to identifyEscherichia 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 genusEscherichia, and provides epidemiological information on diseases caused by this microorganism. AlthoughEscherichia 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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.