IMMUNOCARD STAT! EHEC, MODEL 751630
Device Facts
| Record ID | K062546 |
|---|---|
| Device Name | IMMUNOCARD STAT! EHEC, MODEL 751630 |
| Applicant | Meridian Bioscience, Inc. |
| Product Code | GMZ · Microbiology |
| Decision Date | Feb 14, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3255 |
| Device Class | Class 1 |
| Attributes | Pediatric |
Intended Use
ImmunoCard STAT! EHEC is an immunochromatographic rapid test for the qualitative detection of Shiga toxins 1 and 2 (also called Verotoxins) produced by E. coli in cultures derived from clinical stool specimens. ImmunoCard STAT! EHEC is used in conjunction with the patient’s clinical symptoms and other laboratory tests to aid in the diagnosis of diseases caused by enterohemorrhagic E. coli (EHEC) infections.
Device Story
ImmunoCard STAT! EHEC is a rapid, single-use, lateral flow immunochromatographic assay for detecting Shiga toxins 1 and 2 (ST1, ST2) in broth-enriched stool cultures. The device consists of a test strip in a plastic housing. The user applies the sample to a port; the sample migrates through a reaction zone containing gold-labeled monoclonal antibodies specific to ST1 and ST2. If toxins are present, they form complexes with the gold-labeled antibodies, which are then captured by immobilized antibodies in the test window, creating visible red lines. A control line confirms proper flow and reagent activity. The test is performed by laboratory professionals in a clinical setting. Results are interpreted visually by the technician. The output aids clinicians in diagnosing EHEC infections, which can cause life-threatening illness in children, the elderly, and immunocompromised patients. No instruments are required.
Clinical Evidence
Clinical study evaluated 469 samples from US, Canada, and Argentina. Compared ImmunoCard STAT! EHEC against Premier EHEC using GN and MacConkey broths. Mac broth: 93.8% positive agreement (60/64), 99.7% negative agreement (384/385). GN broth: 89.1% positive agreement (57/64), 99.7% negative agreement (380/381). Discrepant samples were negative by reference cytotoxin assay. Analytical sensitivity is 1.25 ng/mL for both toxins. No cross-reactivity observed with 40+ common stool pathogens/flora.
Technological Characteristics
Lateral flow immunochromatographic assay. Components: nitrocellulose test strip, gold-labeled murine monoclonal antibodies, sample diluent, positive control. No instruments required. Storage: 2-8°C. Qualitative visual readout (red-colored bands).
Indications for Use
Indicated for the qualitative detection of Shiga toxins 1 and 2 in cultures derived from clinical stool specimens of patients of all ages and genders suspected of having gastroenteritis caused by enterohemorrhagic E. coli (EHEC) infections.
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
Related Devices
- K990263 — IMMUNOCARD STAT! E. COLI O157:H7 · Meridian Diagnostics, Inc. · Aug 9, 1999
- K121364 — SHIGA TOXIN QUIK CHEK · Techlab Inc., Corporate Research Center · Oct 2, 2012
Submission Summary (Full Text)
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K062546
#### SUMMARY OF SAFETY AND EFFECTIVENESS
#### IDENTIFICATION INFORMATION
FEB 1 4 2007
# SUBMITTERS INFORMATION
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.20.
SUBMITTER'S NAME AND ADDRESS: Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati, OH 45244
PHONE NUMBER: (513) 271-3700
FAX NUMBER: (513) 272-5213
CONTACT PERSON: Susan Rolih Official correspondent
DATE SUMMARY PREPARED: August 29, 2006
TRADE NAME: ImmunoCard STAT! EHEC
COMMON NAME: E coli toxins detection test
CLASSIFICATION NAME: Escherichia coli serological reagents
REGULATION: 866.3255
INTENDED USES: ImmunoCard STAT! EHEC is an immunochromatographic rapid test for the qualitative detection of Shiga toxins 1 and 2 (also called Verotoxins) produced by E. coli in cultures derived from clinical stool specimens. ImmunoCard STAT! EHEC is used in conjunction with the patient's clinical symptoms and other laboratory tests to aid in the diagnosis of diseases caused by enterohemorrhagic E. coli (EHEC) infections.
PREDICATE DEVICE: Premier EHEC (K953362)
BACKGROUND: Among the E. coli human pathogens, Shiga toxin-producing strains of E. coli have gained in importance in recent years. The group of EHEC, with their highly pathogenic serovars 0157:H7. 026, 0103, 0111, 0145, and other strains are of particular concern. Production of Shiga toxins is the most common criteria for the detection of this group of bacteria. Shiga toxins can be classified into two main categories: Shiga toxin 1 (ST1) and Shiga toxin 2 (ST2). EHEC strains may produce ST1 or ST2 only or both ST1 and ST2 simultaneously. EHEC are capable of initiating life-threatening illnesses, particularly in young children, the elderly or patients with immune deficiency. The main sources of infection are contaminated, raw or insufficiently heated foods of animal origin, eg, meat and dairy products. The reservoir for EHEC is the feces of cattle. sheep and goats. These microorganisms can enter food during the processing of meat and dairy products if hygienic conditions are inadequate. The incidence of food infection caused by Shiga toxin-producing E. coli demands reliable and rapid methods of detection. In addition to traditional culture methods, immunological techniques are becoming more useful due to their improved specificity and sensitivity. ImmunoCard STAT! EHEC is an immunological screening test based on the lateral flow principle.
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This product was previously cleared to market as Duopath Verotoxin GLISA (K031367) to identify Shiga toxin 1 or Shiga toxin 2-producing strains of E coli isolated from colonies derived from human stools cultured on Sorbitol MacConkey agar plates. This application adds now intended use to the device (use with broth cultures inoculated with human stool) and changes the name of the product.
#### Type of test
Qualitative, rapid, single use, immunochromatographic assay
#### Specimen type
Human stool samples inoculated into enrichment media (GN or Mac broth) (This application.)
#### Conditions for use
ImmunoCard STAT! EHEC is designed for use by laboratory professionals under normal environmental conditions. The assay, which is stored at 2-8 C when not in use, is brought to room temperature (20-25 C) before use. Normal laboratory lighting, humidity and temperature do not affect the performance of the assay.
#### Contraindications
There are no contraindications associated with the use of this product.
#### Special instrument requirements
No instruments are used with this device.
# Combination with other medical devices
No other medical devices are used in combination with this device.
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able 1. Comparison of ImmunoCard STAT! EHEC to the predicate device and its prior design
: 1
:
| Characteristics | ImmunoCard STAT! EHEC | Premier EHEC (predicate) | Duopath Verotoxin GLISA (predicate) |
|----------------------------------------------|---------------------------------------------|-------------------------------------------|---------------------------------------------|
| Device Type | | | |
| Technology | Single use, rapid, lateral flow immunoassay | Microwell-based enzyme-linked immunoassay | Single use, rapid, lateral flow immunoassay |
| In vitro diagnostic device | Yes | Yes | Yes |
| Control | Includes external control reagent | Includes external control reagent | No control reagent included |
| Calibrator | No | No | No |
| Assay Features | | | |
| Human factors | No special equipment | EIA-related equipment | No special equipment |
| Sterile device | No | No | No |
| Mechanical safety | Not applicable | Not applicable | Not applicable |
| Environmental safety | Normal medical waste | Normal medical waste | Normal medical waste |
| Chemical hazards | None | None | None |
| Radiation safety | Not applicable | Not applicable | Not applicable |
| Intended Use | | | |
| Detection of Shiga toxins 1 and 2 | Yes | Yes | Yes |
| Differentiation between Shiga toxins 1 and 2 | Yes | No | Yes |
| Screening test | Yes | Yes | Yes |
| Diagnostic test | No | No | No |
| Identification test | Yes | No | Yes |
| Monitoring therapy | No | No | No |
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| ble Samples | ImmunoCard STAT! EHEC | Premier EHEC<br>(predicate) | Duopath Verotoxin GLISA |
|-------------------------|---------------------------------------|------------------------------|---------------------------------------|
| Droth culture | Yes | Yes | No |
| agar culture | Yes | No | Yes |
| stool | No | Yes | No |
| s/Components | | | |
| Medium | Test Device with nitrocellulose strip | Antibody-coated microwell | Test Device with nitrocellulose strip |
| gate Reagent | In Test Device | Stand alone reagent | In Test Device |
| Diluent/Negative | Yes | Yes | Yes |
| e | | | |
| ol (external) | No | Yes | No |
| rate Reagent | No | Yes | No |
| Solution | Yes | No | Yes |
| al positive run control | Yes | No | Yes |
| al negative run control | Yes | Yes | No |
| al positive control | Yes | Yes | No |
| of<br>/Antibodies | | | |
| re ST1 antibodies | Murine monoclonal | Murine monoclonal | Murine monoclonal |
| re ST2 antibodies | Murine monoclonal | Murine monoclonal | Murine monoclonal |
| cor ST1 Antbodies | Murine monoclonal | Rabbit polyclonal | Murine monoclonal |
| cor ST2 Antibodies | Murine monoclonal | Rabbit polyclonal | Murine monoclonal |
| e Control | Inactivated toxin | Inactivated toxin | None |
| ison of assay steps* | None | EIA-related | None |
| oment Required | Moderately complex | Moderately complex | Moderately complex |
| I of skill required | 5 | 15 | 5 |
| y steps | Pink-red band | Yellow color | Pink-red band |
| point | | OD > 0.150 (dual wavelength) | Pos = color band Neg = no color |
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# Section 5
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Table 1 continued
| Performance Characteristics | ImmunoCard STAT! EHEC | Premier EHEC (predicate) | Duopath Verotoxin GLISA |
|-----------------------------------------|-----------------------|----------------------------|-----------------------------------------------|
| Clinical Sensitivity | 90.3% | 100% | Not calculated |
| Clinical Specificity | 100% | 97.9% | Not calculated |
| Precision/Reproducibility (intra-assay) | 100% | 100% | 100% |
| Linearity/reportable range | N/A | N/A | N/A |
| Analytical limit | ST1 = 25 ug/mL | ST1 = 7 pg/well | N/A |
| Detection/sensitivity | ST2 = 25 ug/mL | ST2 = 15 pg/well | ST1 and ST2 = one colony per enrichment broth |
| Assay cutoff | N/A | OD 0.150 (dual wavelength) | N/A |
| Indeterminant range | N/A | N/A | N/A |
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# DEVICE DESCRIPTION AND TECHNOLOGICAL PRINCIPLES
#### Construct
Each ImmunoCard STAT! EHEC test kit contains three reagents/components.
- 1. Test Devices, in individual foil pouches with desiccants.
- 2. Sample Diluent (Negative Control) in a plastic dropper vial
- 3. Positive Control in a plastic dropper vial
#### Calibrators
No calibrators are needed for this device.
#### Controls
This assay includes an internal control line that is used to demonstrate that the broth samples have been applied, that it has flowed correctly, and that the conjugated detector antibodies are active at the time of use. A colorless to faint pink background around the Toxin 1 and 2 Test Lines serves as a negative control and indicates the reagents were performing correctly at the time of testing.
The Positive Control external control reagent is used with the Sample Diluent/Negative Control when external control testing is warranted. The readents also serve as indicators that the test was performed correctly, that reagents were active and specific at the time of use, and that the Test Device membrane supports proper sample flow.
Failure of the internal and external controls to produce the expected results suggests the test was not performed correctly.
#### Technological principles
- ImmunoCard STAT! EHEC is an immunochromatographic rapid test utilizing monoclonal antibodies labeled with red-colored gold particles. The test device has a circular sample port and an oval-shaped test (Toxin 1, Toxin 2) and control (Control) window.
- 1. The sample is applied to the chromatography paper via the circular sample port (Sample).
- 2. The sample is absorbed through the pad to the reaction zone containing colloidal, gold-labeled antibodies specific to Shiga toxins.
- 3.Any Shiga toxin (ST1 and ST2) antigen present complexes with the gold-labeled antibody and migrates through the pad until it encounters the binding zones in the test (Toxin 1, Toxin 2) area.
- 4.The binding zones (Toxin 1 and Toxin 2) contain another anti-ST1 or -ST2 antibody, which immobilizes any Shiga toxin-antibody comblex present. Due to the gold labeling, a distinct red line is then formed.
- 5.The remainder of the sample continues to migrate to another binding reagent zone within the control zone, and also forms a further distinct red line (positive control). Regardless of whether any Shiga toxin is present or not, a distinct red line should always be formed in the control zone and confirms that the test is working correctly.
#### CLINICAL TRIAL DATA
#### Performance evaluation
ImmunoCard STAT! EHEC is a modification of Duopath Verotoxin GLISA (K031367), cleared to market to detect EHEC in stool samples that had been cultured on Sorbitol MacConkey plates. This premarket submission describes the evaluations performed with clinical samples to validate the product's new intended use with broth cultures inoculated with human stool.
This study was conducted with samples tested fresh or following frozen storage. Samples were collected in the United States, Canada and Argentina. A total of 360 stool samples were evaluated in either GN, MacConkey (Mac) broths or both. 340 of these samples produced growth in GN broth, while 344 produced growth in Mac broth. Table 2 identifies the ages of the patients from whom samples were collected during the study. Table 3 provides the gender of each patient. Table 4 summarizes the sensitivity obtained with GN and Mac stool broth samples. Samples producing discrepant results between Premier EHEC and ImmunoCard
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| | Specimen Type | | |
|---------------------------------|---------------|--------------|-------------|
| GN Samples | Male | Female | Not defined |
| Clinical site 3 | | | |
| Total tested | 37 | 51 | 213 |
| Mean positive reaction strength | 2.0 | 3.1 | 3.5 |
| Positive reaction range | 0.5-8.0 | 0.5-6.0 | 0.5-8.0 |
| Clinical site 4 | | | |
| Total tested | 14 | 25 | 0 |
| Mean positive reaction strength | 1.0 | All Negative | N/A |
| Positive reaction range | 0.5-5.0 | All Negative | N/A |
| Clinical site Totals | | | |
| Total tested | 51 | 76 | 213 |
| Mean positive reaction strength | 1.9 | 3.1 | 3.5 |
| Positive reaction range | 0.5-5.0 | 0.5-6.0 | 0.5-8.0 |
| MAC Samples | Male | Female | Not defined |
| Clinical site 3 | | | |
| Total tested | 40 | 52 | 213 |
| Mean positive reaction strength | 2.8 | 3.3 | 3.3 |
| Positive reaction range | 0.5-7.0 | 0.5-7.0 | 0.5-6.0 |
| Clinical site 4 | | | |
| Total tested | 14 | 25 | 0 |
| Mean positive reaction strength | 3.0 | All Negative | N/A |
| Positive reaction range | 3.0 | All Negative | N/A |
| Clinical site Totals | | | |
| Total tested | 54 | 77 | 213 |
| Mean positive reaction strength | 2.9 | 3.3 | 3.3 |
| Positive reaction range | 0.5-7.0 | 0.5-7.0 | 0.5-6.0 |
Table 3 Classification of patients from whom samples were collected based on gender.
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STAT! EHEC were further analyzed using cytotoxin assay (Table 5). These samples generally produced weak reactions (less than 0.300) in Premier EHEC (Table 6). Some of the samples grew in MAC broth but not GN broth.
#### Patient exclusion criteria
There are no patient exclusion criteria associated with ImmunoCard STAT! EHEC.
# Influence of other disease states
There is no influence by other disease states on test results.
Table 2. Categories of patients by age from whom samples were collected for clinical studies
| Patient Age and Sample Storage GN Samples | birth to 1<br>month | >1 month to<br>2 years | >2 years to<br>12 years | >12 years to<br>21 years | >21 years | Not Defined |
|--------------------------------------------|---------------------|------------------------|-------------------------|--------------------------|-----------|--------------|
| Clinical site 3 | | | | | | |
| Total tested | 1 | 4 | 12 | 10 | 62 | 213 |
| Mean positive reaction strength | All Negative | All Negative | 3.6 | 2.6 | 2.4 | 3.5 |
| Positive reaction range | All Negative | All Negative | 1.0-5.0 | 0.5-6.0 | 0.5-6.0 | 0.5-8.0 |
| Clinical site 4 | | | | | | |
| Total tested | N/A | 1 | N/A | 2 | 35 | 0 |
| Mean positive reaction strength | N/A | All Negative | N/A | All Negative | 1.0 | N/A |
| Positive reaction range | N/A | All Negative | N/A | All Negative | 1.0 | N/A |
| Clinical site Totals | | | | | | |
| Total tested | 1 | 5 | 12 | 12 | 97 | 213 |
| Mean positive reaction strength | All Negative | All Negative | 3.6 | 2.6 | 2.3 | All Negative |
| Positive reaction range | All Negative | All Negative | 1.0-5.0 | 0.5-6.0 | 0.5-6.0 | All Negative |
| Patient Age and Sample Storage MAC Samples | birth to 1<br>month | >1 month to<br>2 years | >2 years to<br>12 years | >12 years to<br>21 years | >21 years | Not Defined |
| Clinical site 3 | | | | | | |
| Total tested | 1 | 5 | 13 | 10 | 63 | 213 |
| Mean positive reaction strength | All Negative | All Negative | 3.9 | 2.6 | 3.1 | 3.3 |
| Positive reaction range | All Negative | All Negative | 0.5-6.0 | 0.5-7.0 | 0.5-7.0 | 0.5-6.0 |
| Clinical site 4 | | | | | | |
| Total tested | N/A | 1 | N/A | 2 | 36 | 0 |
| Mean positive reaction strength | N/A | All Negative | N/A | All Negative | 3.0 | N/A |
| Positive reaction range | N/A | All Negative | N/A | All Negative | 3.0 | N/A |
| Clinical site Totals | | | | | | |
| Total tested | 1 | 6 | 13 | 12 | 99 | 213 |
| Mean positive reaction strength | All Negative | All Negative | 3.9 | 2.6 | 3.0 | 3.3 |
All Negative
All Negative
0.5 - 6.0
0.5 - 7.0
Positive reaction range
0.5 · 7.0
0.5 - 6.0
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# Table 6. Analysis of samples producing discrepant results
| Site | Specimen<br>Serial# | Specimen Storage | ICS EHEC<br>Result | Premier<br>Absorbance | Premier Interp | CTA Result |
|------|---------------------|--------------------|--------------------|-----------------------|----------------|--------------------|
| 3 | 2831 | Cary-Blair 2-8 C | Negative | 0.223 | Positive | Negative |
| 3 | 282 | Unpreserved --70 C | Negative | 0.289 | Positive | Cytotoxin Positive |
| 3 | 281 | Unpreserved -70 C | Negative | 0.387 | Positive | Negative |
| 3 | 280 | Unpreserved -70 C | Negative | 0.151 | Positive | Negative |
| 3 | 269 | Unpreserved -70 C | Negative | 0.535 | Positive | Cytotoxin Positive |
| 3 | 266 | Unpreserved -70 C | Negative | 0.159 | Positive | Negative |
| 3 | 289 | Unpreserved -70 C | Negative | 0.280 | Positive | Negative |
# GN broth-enriched samples
Mac broth-enriched samples
| Site | Specimen Serial # | Specimen Storage | ICS EHEC Result | Premier Absorbance | Premier Interp | CTA Result |
|------|-------------------|-------------------|-----------------|--------------------|----------------|--------------------|
| 3 | 2831 | Cary-Blair 2-8 C | Negative | 0.314 | Positive | Cytotoxin Positive |
| 3 | 282 | Unpreserved -70 C | Negative | 0.174 | Positive | Negative |
| 3 | 281 | Unpreserved -70 C | Negative | 0.239 | Positive | Cytotoxin Positive |
| 3 | 280 | Unpreserved -70 C | Negative | 0.355 | Positive | Cytotoxin Positive |
| 3 | 110 | Unpreserved -70 C | Negative | 0.157 | Positive | Negative |
Legend: CTA = cytotoxin assay
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able 4 Clinical sensitivity and specificity tabl
| GN Broth Enrichment Cultures<br>Premier EHEC | | | | MacConkey Broth Enrichment Cultures<br>Premier EHEC | | | |
|----------------------------------------------|----------|----------|-------------|-----------------------------------------------------|----------|----------|-------|
| ICS EHEC GN | Positive | Negative | Total | ICS EHEC MAC | Positive | Negative | Total |
| Positive | 54 | 0 | 54 | Positive | 58 | 0 | 58 |
| Negative | 7 | 279 | 286 | Negative | 5 | 281 | 281 |
| Total | 61 | 279 | 340 | Total | 63 | 281 | 344 |
| Sensitivity | 54/61 | 88.5% | 77.8%-95.3% | Sensitivity | 58/63 | 92.1% | 82.4% |
| Specificity | 279/279 | 100.0% | 98.7%-100% | Specificity | 281/281 | 100.0% | 98.7% |
| PPV | 54/54 | 100.0% | 93.4%-100% | PPV | 58/58 | 100.0% | 93.8% |
| NPV | 279/286 | 97.6% | 95.0%-99.0% | NPV | 281/286 | 98.3% | 96.0% |
| Correlation | 333/340 | 97.9% | 95.8%-99.2% | Correlation | 339/344 | 98.5% | 96.6% |
ombined Broth Total
Total
..............................................................................................................................................................................
| | Premier EHEC | | |
|-------------------|--------------|----------|---------------|
| ICS EHEC<br>Total | Positive | Negative | Total |
| Positive | 112 | 0 | 112 |
| Negative | 12 | 560 | 572 |
| Total | 124 | 560 | 684 |
| Sensitivity | 112/124 | 90.3% | 83.7% - 94.9% |
| Specificity | 560/560 | 100.0% | 99.3% - 100% |
| PPV | 112/112 | 100.0% | 96.8% - 100% |
| NPV | 560/572 | 97.9% | 96.4% - 98.9% |
| Correlation | 672/684 | 98.2% | 97.0% - 99.1% |
82.4% - 97.4%
286 344
58
98.7% - 100% 93.8% - 100%
96.0% - 99.4% 96.6% - 99.5%
ble 5 Test Data following resolution of discrepant samples by cytotoxin assa
| GN Broth Enrichment Cultures | | | | MacConkey Broth Enrichment | |
|------------------------------|-----------------------|----------|-------------|----------------------------|------------------|
| ICS EHEC GN | Premier EHEC Positive | Negative | Total | ICS EHEC MAC | Premier Positive |
| Positive | 54 | 0 | 54 | Positive | 58 |
| Negative | 2 | 284 | 286 | Negative | 4 |
| Total | 56 | 284 | 340 | Total | 62 |
| Sensitivity | 54/56 | 96.4% | 87.7%-99.6% | Sensitivity | 58/62 |
| Specificity | 284/284 | 100.0% | 98.7%-100% | Specificity | 282/282 |
| PPV | 54/54 | 100.0% | 93.4%-100% | PPV | 58/58 |
| NPV | 284/286 | 99.3% | 97.5%-99.9% | NPV | 282/286 |
| Correlation | 338/340 | 99.4% | 97.9%-99.9% | Correlation | 340/344 |
| An-an experience of the results |
|---------------------------------|
| |
| |
| |
Total
Negative
richment Cultures
TEHEC
| | Premier | EHEC | |
|-------------------|----------|----------|---------------|
| ICS EHEC<br>Total | Positive | Negative | Total |
| Positive | 112 | 0 | 112 |
| Negative | 6 | 566 | 572 |
| Total | 118 | 566 | 684 |
| Sensitivity | 112/118 | 94.9% | 89.3% - 98.1% |
| Specificity | 566/566 | 100.0% | 99.4% - 100% |
| PPV | 112/112 | 100.0% | 96.8% - 100% |
| NPV | 566/572 | 99.0% | 97.7% - 99.6% |
| Correlation | 678/684 | 99.1% | 98.1% - 99.7% |
84.3% - 98.2%
93.5%
286 344
282 282
58
0
98.7% - 100% 93.8% - 100%
100.0% 100.0%
:
96.5% - 99.6%
97.1% - 99.7%
98.8%
98.6%
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# EPRODUCIBILIT
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able 7 Results of reproducibility evaluatio
| Sample ID | Sample<br>Qual.<br>Result | Site 3 | | | | | | Site 4 | | | | | |
|-------------------------------------|---------------------------|----------------|----------------|----------------|----------------|----------------|----------------|----------------|----------------|----------------|----------------|----------------|----------------|
| | | Day 1<br>Run 1 | Day 1<br>Run 2 | Day 2<br>Run 1 | Day 2<br>Run 2 | Day 3<br>Run 1 | Day 3<br>Run 2 | Day 1<br>Run 1 | Day 1<br>Run 2 | Day 2<br>Run 1 | Day 2<br>Run 2 | Day 3<br>Run 1 | Day 3<br>Run 2 |
| 1 HP ST1 | 7 | 7.0 | 7.0 | 7.0 | 7.0 | 7.0 | 7.0 | 7.0 | 7.0 | 8.0 | 8.0 | 7.0 | 6.0 |
| 2 HP ST2 | 7 | 7.0 | 7.0 | 7.0 | 7.0 | 7.0 | 7.0 | 7.0 | 8.0 | 8.0 | 6.0 | 7.0 | 7.0 |
| 3 Cut off LP ST1 | 3 | 2.0 | 2.5 | 2.0 | 3.0 | 2.5 | 2.0 | 1.0 | 1.0 | 2.0 | 1.0 | 1.0 | 1.0 |
| 4 Cut off LP ST1 | 3 | 3.0 | 3.0 | 2.5 | 2.5 | 2.5 | 2.0 | 1.0 | 1.0 | 1.0 | 1.0 | 2.0 | 1.0 |
| 5 Cut off LP ST2 | 3 | 2.5 | 2.5 | 2.0 | 2.0 | 2.5 | 3.0 | 1.0 | 1.0 | 1.0 | 1.0 | 2.0 | 2.0 |
| 6 Cut off LP ST2 | 3 | 3.0 | 2.5 | 3.0 | 3.0 | 2.5 | 3.0 | 1.0 | 1.0 | 2.0 | 1.0 | 1.0 | 1.0 |
| 7 Cut off HN ST1 | 0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| 8 Cut off HN ST1 | 0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| 9 Cut off HN ST2 | 0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| 10 Cut off HN ST2 | 0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| 11 LN | 0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Average high<br>negative value | | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Average low positive<br>value | | 2.6 | 2.6 | 2.4 | 2.6 | 2.5 | 2.5 | 1.0 | 1.0 | 1.5 | 1.3 | 1.5 | 1.3 |
| Percent Correlation | | 100% | | | | | | 100% | | | | | |
| Correlation of cut off<br>Specimens | | Site 3<br>100% | | | | | | Site 4<br>100% | | | | | |
| Precision | | Site 3<br>100% | | | | | | Site 4<br>100% | | | | | |
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Meridian Bioscience, Inc. Cincinnati, OH
510(k) application ImmunoCard STAT! EHEC
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# Comparison to predicate
The following table compares the outcomes of trials using ImmunoCard STAT! EHEC to the data published for the predicate device, Premier EHEC.
Table 8 Comparison of the clinical performance of ImmunoCard STAT! to Premier EHEC
| Performance Characteristics in Direct Comparison to<br>Clinical Status or Condition<br>(Combined Samples) | ImmunoCard STAT!<br>EHEC<br>Combined broths | Premier EHEC<br>(predicate)<br>Combined broths |
|-----------------------------------------------------------------------------------------------------------|---------------------------------------------|------------------------------------------------|
| Clinical Sensitivity | 90.3% | 100% |
| Clinical Specificity | 100% | 97.9% |
| Predictive Value of a Positive Test | 100% | Not done |
| Predictive Value of a Negative Test | 97.9% | Not done |
| Correlation | 98.2% | 98.1% |
| Performance characteristics | | |
| Precision/Reproducibility | 100% | 100% |
| Linearity/reportable range | N/A | N/A |
| Limit of detection | ST1 = 1.25 ng/mL<br>ST2 = 1.25 ng/mL | ST1 = 7 pg/well<br>ST2 = 15 pg/well |
| Assay cutoff | N/A | OD 0.150 (dual<br>wavelength |
#### CONCLUSIONS
IlmmunoCard STAT! EHEC can be used to detect Shiga-toxin forming strains of E. coli in human stool samples. The performance of this device for the stool broth intended use is substantially equivalent to the predicate Premier EHEC
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/12/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's three main goals: protecting the health of all Americans, providing essential human services, and strengthening the nation's health and well-being. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Susan Rolih Official Correspondent Meridian Bioscience, Inc. 3474 River Hills Drive Cincinnati, OH 45244
FEB 1 4 2007
Re: k062546 Trade/Device Name: ImmunoCardSTAT! EHEC Regulation Number: 21 CFR 866.3255 Regulation Name: Escherichia coli serological reagents Regulatory Class: Class I Product Code: GMZ Dated: February 6, 2007 Received: February 6, 2007
Dear Ms. Rolih:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sally, artur
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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ImmunoCard STAT! EHEC
510(k) Notification Meridian Bioscience, Inc.
### INDICATIONS FOR USE STATEMENT ImmunoCard STAT! EHEC
**510(K) Number:** K062544
ImmunoCard STAT! EHEC is an immunochromatographic rapid test for the qualitative detection of Shiga toxins 1 and 2 (also called Verotoxins) produced by E. coli in cultures derived from dinical stool specimens. ImmunoCard STAT! EHEC is used in conjunction with the patient's clinical symptoms and other laboratory tests to aid in the diagnosis of diseases caused by enterchemorrhagic E. coli (EHEC) infections.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Fuddie M. Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
576/k) KO62546
