IMMUNOCARDSTAT HPSA

K032222 · Meridian Bioscience, Inc. · LYR · Dec 5, 2003 · Microbiology

Device Facts

• Record ID: K032222
• Device Name: IMMUNOCARDSTAT HPSA
• Applicant: Meridian Bioscience, Inc.
• Product Code: LYR · Microbiology
• Decision Date: Dec 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Intended Use

ImmunoCard STAT! HpSA is a rapid in vitro qualitative assay for the detection of Helicobacter pylori antigen (HpSA) in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment. Conventional medical practice recommends that testing by any method to confirm the loss of antigen be done at least four weeks following completion of therapy.

Device Story

ImmunoCard STAT! HpSA is a rapid lateral flow immunoassay for qualitative detection of H. pylori antigen in human stool. Device consists of chromatography strips in a plastic frame; strips are impregnated with monoclonal anti-H. pylori capture antibodies, red latex-conjugated detector antibodies, and blue latex-conjugated anti-protein control antibodies. User adds stool sample to diluent, then dispenses into device window. If antigen is present, it binds to detector antibody-latex conjugate; complex is captured by membrane-bound monoclonal antibody, forming a visible pink-red line. Control line (blue) confirms adequate flow. Used in clinical settings to aid diagnosis and confirm eradication post-treatment. Results are interpreted visually by healthcare providers. Benefits include rapid, point-of-care assessment of H. pylori status without requiring spectrophotometric equipment.

Clinical Evidence

Clinical study of 227 dyspeptic patients compared ImmunoCard STAT! HpSA to gold standard (histology, rapid urease, culture). Sensitivity 90.6% (95% CI: 84.9-97.1%), specificity 91.5% (95% CI: 87.5-96.5%). Post-treatment eradication study (n=85) showed sensitivity 95.4% (95% CI: 86.0-100%) and specificity 100%. Analytical studies confirmed 100% intra/inter-assay reproducibility and no interference from common antacids, fecal fats, or blood.

Technological Characteristics

Lateral flow immunoassay; utilizes monoclonal anti-H. pylori capture antibody and red latex-conjugated detector antibody on a membrane strip. Enclosed in a plastic cassette. Qualitative visual readout. No instrumentation required. Preservatives include <0.1% sodium azide. Operates at room temperature (20-26°C).

Indications for Use

Indicated for the qualitative detection of H. pylori antigen in human stool to aid in the diagnosis of H. pylori infection and to monitor the loss of antigen following treatment in patients. No specific age or gender restrictions noted. No known contraindications.

Regulatory Classification

Identification

Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases. Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.

Predicate Devices

• Premier Platinum HpSA (K983255)

Submission Summary (Full Text)

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# DEC - 5 2003

Image /page/0/Picture/2 description: The image contains the text "K032222", "510(k) Notification", and "ImmunoCard STAT! HpSA". The text appears to be part of a document or label. The text "K032222" is at the top, followed by "510(k) Notification", and then "ImmunoCard STAT! HpSA".

### AMENDED 510(k) SUMMARY OF SAFETY & EFFECTIVENESS (Amended 11/25/03)

#### IDENTIFICATION INFORMATION

#### SUBMITTER'S INFORMATION

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K032222

SUBMITTER'S NAME AND ADDRESS: Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati, OH 45244

PHONE NUMBER: [phone]

FAX NUMBER: [phone]

CONTACT PERSON: Susan Rolih Vice President, Regulatory Affairs and Quality Assurance Official Correspondent

DATE SUMMARY PREPARED: July 18, 2003

NAME OF DEVICE: ImmunoCard STAT!® HpSA® (ImmunoCard STAT! and HpSA are registered trademarks of Meridian Bioscience, Inc.)

COMMON NAME: Lateral flow immunoassay for H. pvlori stool antigen

CLASSIFICATION NAME: Campylobacter pvlori [83LYR]

REGULATION: 866,3110

PREDICATE EQUIVALENT DEVICES: Premier Platinum HpSA® (K983255)

#### INTENDED USE:

ImmunoCard STAT! HpSA is a rapid in vitro qualitative assay for the detection of Helicobacter pylori antigen (HpSA) in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment. Conventional medical practice recommends that testing by any method to confirm the loss of antigen be done at least four weeks following completion of therapy. (1)

### BACKGROUND:

pylori is a spiral gram-negative bacterium that invades the mucosal membrane of the H. gastrointestinal tract. It causes chronic gastritis, predisposes some infected patients to gastric and peptic duodenal ulcers. (1-3) Noninvasive in vitro diagnostic assays, such as ImmunoCard STAT! HpSA, have been shown to be effective in differentiating infected patients. Such noninvasive assays are also recommended to

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monitor the success and failure of treatment regimens to eradicate the organism. (3)

H. pylor is found in the stomachs of humans. Infections with the organism are distributed world -wide, however the preponderance appears in developing countries, where the incidence of infection is 70-80%. In developed or more industrialized countries, the incidence of infection is only 25-50%. The incidence continues to decrease in persons in higher socioeconomic levels. Infections in all groups appear to occur in childhood and many before the age of 10 years. Males and females appear to be infected at the same rates. (4) Transmission of the organism between humans is not well understood. particularly since the harbor for the infection is the human stomach. It is most likely that all infections have occurred through ingestion of fecally contaminated materials.

All infected patients develop chronic gastric inflammation but the condition is usually asymptomatic. H. pylor is the direct cause of most gastric and duodenal ulcers. Eradication of the orqanism leads to oure of the ulcers. Infection due to H. pylor is strongly associated with atrophic gastritis (which is a precursor to gastric cancer) and with adenocarcinoma of the distal stomach.

A variety invasive and noninvasive tests are used to detect and isolate H pylori. Invasive testing includes histological biopsy for hematoxylin and eosin (H and E) staining, bacterial culture, urease testing and PCR analysis. Invasive tests present some slight degree of risk for the patient due to complications. Noninvasive tests include those to monitor breath, serum, gastric juice and urine for the direct or indirect presence of organisms.

#### DEVICE DESCRIPTION:

ImmunoCard STAT! HpSA is a qualitative horizontal flow in vitro diagnostic device used to detect the presence of H. pylori antigen in human stool specimens. The intended use of the device is identical to that of Premier Platinum HpSA (Meridian Bioscience, Inc., Cincinnati, OH) an enzyme-linked immunoassay previously cleared to market under 510(k) K983255. While assay methods differ, both are designed to detect Helicobacter pylori antigen in the stools of patients. The results of both tests are intended to aid in the diagnosis of H. pylori infection and to monitor bacterial reduction in response to anti-bacterial therapy.

#### A. Technological characteristics compared to predicate device:

| Characteristics | IC STAT! HpSA | Premier Platinum HpSA |
|------------------------------------------------|---------------|-----------------------|
| <b>Device Type</b> | | |
| In vitro diagnostic device | Yes | Yes |
| Control | No | No |
| Calibrator | No | No |
| <b>Intended Use</b> | | |
| Detection of H. pylori antigens in human stool | Yes | Yes |
| <b>Acceptable Sample</b> | | |
| Formed stool | Yes | Yes |
| Semi-solid stool | Yes | Yes |
| Liquid stool | Yes | Yes |
| Watery stool samples | No | No |
| Stool collected in transport media | No | No |

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## Comparison of Assay Methods

| Characteristic | IC STAT! HpSA | Premier Platinum HpSA |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Detection of <i>H. pylori</i> antigen in stool | Detection of <i>H. pylori</i> antigen in stool |
| Results | Qualitative | Qualitative |
| Specimen Required | 1. Stool | 1. Stool |
| Technology | Lateral flow chromatography | Enzyme-linked immunoassay |
| Level of skill required | Laboratory Technician | Laboratory Technician |
| Assay steps | 1. Dilute specimen in Sample Diluent<br>2. Add diluted specimen to test port<br>3. Incubate at 20-26 C for 5 minutes<br>4. Read results visually | 1. Dilute specimen in Sample Diluent<br>2. Add diluted specimen to test well<br>3. Incubate at 22-27 C for 60 minutes<br>4. Wash test well<br>5. Add Conjugate Reagent<br>6. Add Substrate Reagent<br>7. Incubate at 22-27 C for 10 minutes<br>8. Add Stop Solution<br>9. Read results using spectrophotometer |
| End point | Visual color line | Color change, change in optical density of solution |
| Interpretation of test<br>result | Positive = pink-red line<br>Negative = no line | Positive = OD ≥ 0.120 at A450/630 nm or<br>> 0.160 at A450 nm<br>Negative = OD ≤ 0.100 at A450/630 nm or<br>< 0.140 at A450 nm |

#### B. Device Components:

- Test Devices: lateral flow membrane strips impregnated with monoclonal anti-H. 1. pylori as the capture antibody, red latex-conjugated detector antibody. The strips are enclosed in a plastic case with a window.
- Positive Control: a dilute suspension of inactivated H. pylori in a buffered solution 2. containing <0.1% sodium azide as a preservative.
- Specimen Diluent: a buffered salt solution containing <0.1% sodium azide as a റ്റ് preservative.

### C. Principle of the Test:

ImmunoCard STAT! HpSA uses capture solid phase technology to detect the presence of antigen in test specimens.

To perform the test, patient stool is added to the Sample Diluent using the applicator stick that is ro perform the Sample Diluent Vial. The diluted stool sample (approximately a 1 in 10 dilution) is dispensed through the tip of the Sample Diluent Vial into the round sample window of the device. H. pylori antigen, if present in the diluted sample, binds to the detector antibody-latex conjugate as the sample moves through the device. The capture monoclonal antibody, which is bound to as the sample throught through, binds the antigen-antibody-latex complex and yields a visible pink-red line. When no antigen is present, no complex is formed and no pink-red line will appear at the test position of the central window.

A control line, appearing at the control position in the test window, shows whether adequate flow has occurred through the device during a test run. The control line is a protein of nonmammalian origin.

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Blue latex particles conjugated with a monoclonal antibody to this protein co-migrate with the latex Blue latex particles conjugated with a monocolar antibody only be control on the device in the device bound detector antibody during the incubation step. "A black our of the some of the test is considered invalid.

# D. Contraindications, precautions, Warnings:

There are no known contraindications for ImmunoCard STAT! HpSA. See product labeling for There are no Khowr Contraindications for immans sala in vitro diagnostic device.

## MARKETING HISTORY:

ImmunoCard STAT! HpSA has been marketed since 2002 outside the United States. It is currently ImmunoCard STAT! HDSA has been marketed shiec 2002 outcle with and and studies conducted outside of the United States. (5-9)

# ADVERSE EFFECTS OF THE DEVICE ON HEALTH:

There are no potential adverse effects of health associated with the use of this in with and There are no potential adverse ellects of health associated withings symptoms of the patient and device. The diagnosis of H. pylon mieculor is news of the or stool speciments. Conventional in vitro diagnostic methods for confirming H pylori infection include:

- iagnostic methods for confilming in pylor mecaon molder.
13c or 4C-labeled urea breath test to detect 33c or 14C-labeled CO2 expired in air as a result of 1) H. pylori urease activity
- H. pylon drease activity
Serology to detect circulating H. pylori IgG antibody in serum or whole blood
- 2) Stool assay for the detection of bacterial antigen 3)

## SUBSTANTIAL EQUIVALENCE:

Four independent laboraories tested specimens in parallel with Comparative studies: Comparative Studies: Four intepence ELSA in in ImmunoCard STAT! HpSA and a leleleine Lawner Samples giving discordant results of the HpSA (Meridian Broscience, The, Ciffelinan) Only between the two assays were sent to and evaluated by a rolerone and more investigation of discordant samples by the referee laboratory.

| | Initial Trial Results | Corrected Results |
|---------------------------------|-----------------------|-------------------|
| Total samples tested | 457 | 457* |
| Concordant test results | 433 | 436 |
| Positive samples | 102 | 105 |
| Negative samples | 331 | 331 |
| Discordant test results | 21 | 20 |
| Premier +, ImmunoCard - | 6 | 6 |
| Premier -, ImmunoCard + | 15 | 14 |
| Indeterminant | 3 | 1 |
| Premier Equivocal, ImmunoCard + | 2 | 1 |
| Premier Equivocal, ImmunoCard - | 1 | 0 |
| % correlation | 95% | N/A |

* Two discordant samples were QNS for follow up analysis.

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The lower limit of detection of this assay is 64 ng/mL in tests with sonicaled antigen prepared The lower limit of delection of this assay is 64 igine in took and to semi-solid stool.
from H. pylori strain TV1970. This limit does not vary from formed (solid) to semi-so

Clinical studies: Stool samples from 227 consecutive dyspeptic patients, who were not usings Clinical studies: Stool Samples from 227 Golloodi.ro oferred for endoscopy were tested with acid suppressant therapy of antibiolos, and who were taken for histology, rapid urease test and ImmunoCard STAT! HpSA. Diopsy Specifiched with H. pylor if histology and urease tests were culture. Patlents were denned as linected with 1. pyron in keeregy of
positive, or if culture was positive. Eighty five of the 227 patients were found H. pylori positive. The results are summarized in the following table.

Diagnostic accuracy of ImmunoCard STAT! HpSA before and after H. pylori eradication treatment.

| | <i>H. pylori</i> status by<br>endoscopy/biopsy/gold standard | True Positive | True Negative | Total |
|------------------------------------------|--------------------------------------------------------------|-----------------------|---------------|-------|
| IC STAT! HpSA + | | 77 | 12 | 89 |
| IC STAT! HpSA - | | 8 | 130 | 138 |
| Total | | 85 | 142 | 227 |
| Estimated clinical sensitivity (95% CI) | | 90.6% (84.9 to 97.1%) | | |
| Estimated clinical specificity (95% CI) | | 91.5% (87.5 to 96.5%) | | |
| Predictive value, positive test (95% CI) | | 86.5% (79.9 to 94.1%) | | |
| Predictive value, negative test (95% CI) | | 94.2% (90.1 to 97.9%) | | |
| Correlation (CI 95%) | | 91.2% (87.3 to 94.7%) | | |

Correlation of ImmunoCard STAT! HpSA test results with eradication treatment

| | H. pylori status by<br>endoscopy/biopsy/gold standard | | |
|------------------------------------------|-------------------------------------------------------|----------------------|-------|
| | True Positive | True Negative | Total |
| IC STAT! HpSA + | 21 | 0 | 21 |
| IC STAT! HpSA - | 1 | 63 | 64 |
| Total | 22 | 63 | 85 |
| Estimated clinical sensitivity (95% CI) | | 95.4% (86.0 to 100%) | |
| Estimated clinical specificity (95% CI) | | 100% | |
| Predictive value, positive test (95% CI) | | 100% | |
| Predictive value, negative test (95% CI) | | 98.4% (94.5 to 100%) | |
| Correlation (CI 95%) | | 98.8% (96.8 to 100%) | |

### REPRODUCIBILITY

The reproducibility of ImmunoCard STAT! HpSA was determined with known negative (n = 5) and The reproduciblity of Inn fullocald OTAT: riper wo works sorted to prevent their identities. Two of positive (n = 5) samples), that were couce and randemly on the assay The reproducibility
the five positive samples were near the limit of detection Intro-ass the five positive samples were near the links of assession of thee independent test sites. Intra-assay and interassay reproducibility was 100%.

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| Sample Status | Premier OD reading | IC STAT! graded reading * | Referee (MBI) Day 1 | Referee (MBI) Day 2 | Referee (MBI) Day 3 | Clinical Site # 1 Day 1 | Clinical Site # 1 Day 2 | Clinical Site # 1 Day 3 | Clinical Site # 2 Day 1 | Clinical Site # 2 Day 2 | Clinical Site # 2 Day 3 | Clinical Site # 3 Day 1 | Clinical Site # 3 Day 2 | Clinical Site # 3 Day 3 |
|---------------|--------------------|---------------------------|---------------------|---------------------|---------------------|-------------------------|-------------------------|-------------------------|-------------------------|-------------------------|-------------------------|-------------------------|-------------------------|-------------------------|
| Neg | 0.017 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pos | 0.737 | 4/5 | + | + | + | + | + | + | + | + | + | + | + | + |
| Neg | 0.016 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pos | 1.140 | 7 | + | + | + | + | + | + | + | + | + | + | + | + |
| Neg | 0.028 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Low Pos | 1.442 | 1 | + | + | + | w | w | w | + | w | + | + | + | + |
| Neg | 0.042 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Low Pos | 1.041 | 2 | + | + | + | + | w | + | + | + | + | + | + | + |
| Pos | 1.493 | 5 | + | + | + | + | + | + | + | + | + | + | + | + |
| Neg | 0.058 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pos Cont | 2.309 | N/A | + | + | + | + | + | + | + | + | + | + | + | + |
| Neg Cont | 0.034 | N/A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |

* The signal intensity (strength) of a positive reaction in ImmunoCard STAT! will not necessarily correlate with the OD value obtained in Premier Platinum HpSA EIA.

Legend: 0 = negative, 1-10 = semiquanitiative scoring scale used in the interpretation of ImmunoCard STAT! positive test results. (A value was assigned to the intensity of color in the Test Line, where 1 is the weakest visible positive reaction and 10 is the strongest. A 4/5 means the reaction fell between a grade of 4 and a gradicor (s) sub = weak (correlates with a semiquantitative reaction grade of +/-, 1 or 2)

## ASSAY SPECIFICITY

The specificity of ImmunoCard STAT! HpSA was tested utilizing the following bacterial, viral and yeast strains. Positive and negative stools were spiked with ≥ 1 X 10° bacteria or yeast. None of the microorganisms tested yielded a positive result in the negative stool or interfered with detection of the positive stool. Both the negative and positive stool was positive when spiked with Helicobacter pylori strain 43504.

Adenovirus Type 2 Adenovirus Type 40 Coxsackie Type B1 Coxsackie Type B6 Echovirus Type 22 Feline calicivirus Rotavirus

Aeromonas hydrophila Campylobacter coli

રન્ડ

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Meridian Bioscience, Inc. Cincinnati, OH

Campylobacter jejuni Candida albicans Citrobacter freundii Clostridium perfringens Clostridium difficile (2) Enterobacter cloacae Enterococcus faecalis (2) E. coli (2) E. coli 0157:H7 (2) E. ferqusonii Helicobacter felis Klebsiella pneumoniae Proteus vulgaris Pseudomonas aeruginosa Salmonella dublin Salmonella (Group B) Salmonella hilversum Salmonella minnesota Salmonella typhimurium Staphylococcus aureus Staphylococcus aureus (Cowan I) Staphylococcus epidermidis Serratia liquifaciens Shigella boydii Shigella dysenteriae Shigella flexneri Shigella sonnei Yersinia enterocolitica

Borrelia burgdorferi (Stool inoculated with antigen protein to a final conc. of 32 ug/mL)

#### TESTS FOR INTERFERING SUBSTANCES

The following substances were found to have no effect on results when present in stool at the concentrations indicated. Tums® Antiacid (5 mg/mL) Tagamet® (5 mq/mL) Prilosec® (5 mg/mL) Mylanta® Antacid (1:20) Pepto-Bismol® (1:20) Barium sulfate (5%) Whole Blood (50%) Leukocytes (50%) Mucin (3.4%) Stearic acid/palmitic acid (fecal fat) (4%) Hemoglobin (tarry stool) (12.5%)

BIBLIOGRAPHY:

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- Marshall BJ, Warren JR. Unidentified curved bacilli in the stomach of patients with gastritis (1) and peptic ulceration Lancet 1984:1:1311-14.
- Dunn BE, Cohen H, Blaser MJ. Helicobacter pylori. Clin Miocobiol Reviews, 1997;10:720-41. (2)
- Vaira D, Malferthainer P, Megraaud F, et al. Diagnosis of Helicobacter pylori infection with a (4) valla D, Mallerthallier F , Mogralassay. Lancet 1999:345:30-3.
- Graham D. Helicobacter pylori: Its epidemiology and its role in duodenal disease. J (5) Gastroenterol, 1991:4:105-13.
- Calvet K, Quesada M, Rosello M, et al. Stool antigen for the ddiagnosis of Helicobacter pylori (6) Calver K, Quesada M, Rosello M, Erai. Ottor anigen for and the one of the macol Ther 2003:12:727-31.
- 2003;12:727-31.
Calvet X, Salceda F, Sanfeliu I, et al. Testing a new in-office test for determination of faecal
Calvet X, Salceda F, Sanfeliu I, et al. Testing a new in-of (6) Calvel A, Salecual P, Samillan, Med Clin (Barc) 202; 118:126-9.
- Antos D, Konstantopoulos N, Crone J, Koletzko S. Evaluation of a novel rapid one-step (7) Antos D, Konstantopoulos N, Cruite J, Koletion of H. pylori antigen in stool in children.
monoclonal enzyme immunoassay for detection of H. pylori antigen in the Podiatic monocional enzyme immanodosay for desiring European Society for Pediatric Abstract presented at the 20 "Annual Mocally Laropour Co., Progue, Czech Republic, June 2003.
- Perna F, Tampieri A, Rici C et al. Evaluation of a new rapid one step stool antigen test for (8) Perna F, Tamplen A, Rici C et al. Evandalion of d'hother eneshalt the XV International Helicobacter pylori (HP) intection ulagnosis. Abstracted prosunted and Creece, September 11-14, 2002.
- Lebdolter A, Wolle K, Wex T et al. Evaluation of a novel rapid H. pylori stool antigen test: Is a
rease (છ) Lebdolter A, VVolle K, VVEX T et al. Evaluation of a novel rapia villa in pyromation
reliable now possible in the doctor's office? Abstract presented at the Digestive Dise Week, Orlando Florida, May 2003.

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Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Public Health Service

DEC - 5 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Susan Rolih Vice President, Regulatory Affairs and Quality Assurance Official Correspondent Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati, OH 45244

k032222 Re:

> Trade/Device Name: ImmunoCard STAT! HpSA Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter Fetus Serological Reagents Regulatory Class: Class I Product Code: LYR Dated: October 24, 2003 Received: October 27, 2003

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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### Page 2 -

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K032222

Device Name: ImmunoCard STAT! HpSA

Indications For Use: ImmunoCard STAT! HpSA is a rapid in vitro qualitative assay for the detection of Helicobacter pylori antigen (HpSA) in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment. Conventional medical practice recommends that testing by any method to confirm the loss of antigen be done at least four weeks following completion of therapy.

Prescription Use V No (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use No (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Fidelity Poolo

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

1/ 1/32222