(137 days)
Not Found
No
The device description and performance studies indicate a qualitative immunoassay, not a system utilizing AI/ML for analysis. There is no mention of AI, ML, or image processing.
No
This device is an in vitro diagnostic device used to detect H. pylori antigen in stool, aiding in diagnosis and monitoring treatment effectiveness. It does not provide any therapy or treatment itself.
Yes
The device's intended use is "to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment," which directly points to its role in diagnosis.
No
The device is described as a "qualitative horizontal flow in vitro diagnostic device," which is a physical test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "ImmunoCard STAT! HpSA is a rapid in vitro qualitative assay for the detection of Helicobacter pylori antigen (HpSA) in human stool."
The "Device Description" also confirms this: "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."
These statements clearly indicate that the device is intended for use outside of the body to examine specimens (human stool) for diagnostic purposes.
N/A
Intended Use / 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.
Product codes
LYR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Stool (human)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Laboratory Technician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Comparative studies: Four independent laboratories tested specimens in parallel with ImmunoCard STAT! HpSA and a referee Premier Platinum HpSA (Meridian Bioscience, Inc., Cincinnati, OH) ELISA. Total samples tested: 457. Concordant test results: Initial Trial Results 433, Corrected Results 436. Discordant test results: Initial Trial Results 21, Corrected Results 20. % correlation: 95%.
Clinical studies: Stool samples from 227 consecutive dyspeptic patients were tested with histology, rapid urease test, and ImmunoCard STAT! HpSA. Patients were defined as infected with H. pylori if histology and urease tests were positive, or if culture was positive. 85 of the 227 patients were found H. pylori positive.
Diagnostic accuracy before H. pylori eradication treatment:
True Positive: 77, True Negative: 130
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 (sample size 85):
True Positive: 21, True Negative: 63
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: Known negative (n=5) and positive (n=5) samples were tested. Two of the five positive samples were near the limit of detection. Intra-assay and inter-assay reproducibility was determined at three independent test sites. Intra-assay and interassay reproducibility was 100%.
Assay Specificity: Tested with bacterial, viral, and yeast strains (≥ 1 X 10^8 bacteria or yeast). None yielded positive result in negative stool or interfered with positive stool detection. Both negative and positive stool showed positivity when spiked with Helicobacter pylori strain 43504.
Tests for Interfering Substances: Tums Antiacid (5 mg/mL), Tagamet (5 mg/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%). No effect on results at indicated concentrations.
Key Metrics
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%)
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%)
Predicate Device(s)
Premier Platinum HpSA® (K983255)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter 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.(b)
Classification. Class I (general controls).
0
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: (513) 271-3700
FAX NUMBER: (513) 272-5213
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
1
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 |
|---|---|---|
| Device Type | ||
| In vitro diagnostic device | Yes | Yes |
| Control | No | No |
| Calibrator | No | No |
| Intended Use | ||
| Detection of H. pylori antigens in human stool | Yes | Yes |
| Acceptable Sample | ||
| 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 H. pylori antigen in stool | Detection of H. pylori 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 |
- Add diluted specimen to test port
- Incubate at 20-26 C for 5 minutes
- Read results visually | 1. Dilute specimen in Sample Diluent
- Add diluted specimen to test well
- Incubate at 22-27 C for 60 minutes
- Wash test well
- Add Conjugate Reagent
- Add Substrate Reagent
- Incubate at 22-27 C for 10 minutes
- Add Stop Solution
- Read results using spectrophotometer |
| End point | Visual color line | Color change, change in optical density of solution |
| Interpretation of test
result | Positive = pink-red line
Negative = no line | Positive = OD ≥ 0.120 at A450/630 nm or
0.160 at A450 nm
Negative = OD ≤ 0.100 at A450/630 nm or
H. pylori status by
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
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
6
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).
9
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 (301) 594-3084. 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,
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
10
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