(124 days)
CLOtest
Not Found
No
The device description details a standard enzyme immunoassay (EIA) procedure with visual or spectrophotometric interpretation, and there are no mentions of AI, ML, or related concepts in the provided text.
No
Explanation: This device is an in vitro diagnostic test designed to detect H. pylori antigens in stool to aid in diagnosis, not to treat or directly manage a disease.
Yes
The device is described as an "in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool" and states that "Test results are intended to aid in the diagnosis of H. pylori infection in adult symptomatic patients." This explicitly indicates its role in diagnosis.
No
The device description clearly outlines a laboratory-based enzyme immunoassay procedure involving physical reagents, microwells, and spectrophotometric interpretation, indicating it is a hardware-based diagnostic test, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Premier Platinum HpSA enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool."
The term "in vitro" is the key indicator that this device is an IVD, as it means "in glass" or "in the laboratory," referring to tests performed outside of the living organism. The device analyzes a human sample (stool) to aid in diagnosis, which is the core function of an IVD.
N/A
Intended Use / Indications for Use
The Premier Platinum HpSA enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. Test results are intended to aid in the diagnosis of H. pylori infection in adult patients.
Product codes (comma separated list FDA assigned to the subject device)
LYR
Device Description
The Premier Platinum HpSA test utilizes polyclonal anti-H. pylori capture antibody adsorbed to microwells. Diluted patient samples and a peroxidase conjugated polyclonal antibody are added to the wells and incubated for one hour at room temperature. A wash is performed to remove unbound material. Substrate is added and incubated for ten minutes at room temperature. Color develops in the presence of bound enzyme. Stop solution is added and the results are interpreted visually or spectrophotometrically.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult patients
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
The Premier Platinum HpSA test was evaluated on 200 symptomatic adults at one midwestern United States location, one site in Canada, and two sites in Italy. The patients studied had a wide cross-section of gastric pathologies noted, including: antral gastritis (n=81), antral gastropathy (n=25), antral erosions (n=24), esophagitis (n=21), duodenal ulcer (n=15), erosive duodemitis (n=10), GERD (n=10), "normal" (n=10), duodenitis (n=9), gastric ulcer (n=8), total stomach gastritis (n=6), hiatal hernia (n=6), Schatzki's ring (n=4), pyloric ulcer (n=2), and esophageal ulcer (n=1). HpSA test results were compared to diagnosis of H. pylori infection as judged by objective reference methods (culture, rapid urease, histology and UBT). Patients were considered positive if culture was positive, or if two or more of the other three tests were positive. Nine patients with negative or no culture results, and only one other test positive, were considered unevaluable.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study type: Clinical Performance Evaluation
Sample size: 200 symptomatic adults
Key results: The HpSA test was 96.1% sensitive, 95.7% specific and showed 95.9% correlation with H. pylori infection. Confidence intervals were calculated by the exact binomial method.
Trial Site #1 (Sample size: 53)
Sensitivity: 94.4% (72.7 to 99.9% 95% CI)
Specificity: 91.4% (76.9 to 98.2% 95% CI)
Positive PV: 85.0% (62.1 to 96.8% 95% CI)
Negative PV: 97.0% (84.2 to 99.9% 95% CI)
Correlation: 92.5% (81.8 to 97.9% 95% CI)
Reference Methods: Histology, Rapid Urease, Breath Test. Readings Single and Dual Wavelength.
Trial Site #2 (Sample size: 17)
Sensitivity: 100.0% (66.4 to 100.0% 95% CI)
Specificity: 100.0% (63.1 to 100.0% 95% CI)
Positive PV: 100.0% (66.4 to 100.0% 95% CI)
Negative PV: 100.0% (63.1 to 100.0% 95% CI)
Correlation: 100.0% (80.5 to 100.0% 95% CI)
Reference Methods: Histology, Rapid Urease, Culture, Breath Test. Readings Single and Dual Wavelength.
Trial Site #3 (Sample size: 70)
Sensitivity: 97.8% (88.2 to 99.9% 95% CI)
Specificity: 100.0% (85.8 to 100.0% 95% CI)
Positive PV: 100.0% (92.0 to 100.0% 95% CI)
Negative PV: 96.0% (79.6 to 99.9% 95% CI)
Correlation: 98.6% (92.2 to 100.0% 95% CI)
Reference Methods: Histology, Rapid Urease, Culture, Breath Test. Readings Single Wavelength.
Trial Site #4 (Sample size: 60)
Sensitivity: 93.5% (78.6 to 99.2% 95% CI)
Specificity: 96.3% (81.0 to 99.9% 95% CI)
Positive PV: 96.7% (82.8 to 99.9% 95% CI)
Negative PV: 92.9% (76.5 to 99.1% 95% CI)
Correlation: 94.8% (85.6 to 98.9% 95% CI)
Reference Methods: Histology, Rapid Urease. Readings Dual Wavelength.
Compiled Data From All Sites (Sample size: 200 total)
Sensitivity: 96.1% (90.4 to 98.9% 95% CI)
Specificity: 95.7% (89.5 to 98.8% 95% CI)
Positive PV: 96.1% (90.4 to 98.9% 95% CI)
Negative PV: 95.7% (89.5 to 98.8% 95% CI)
Correlation: 95.9% (92.2 to 98.2% 95% CI)
Reproducibility:
Intra-Assay Reproducibility (CV%) at 450nm and 450-630nm, Visible 100%
Negative: 4.3% - 5.1% (450nm), 8.1% - 13.5% (450-630nm)
Low Positive: 9.2% - 14.8% (450nm), 11.0% - 16.6% (450-630nm)
Medium Positive: 8.8% - 9.0% (450nm), 9.6% - 9.6% (450-630nm)
High Positive: 11.2% (450nm), 11.6% (450-630nm)
Negative Control: 6.2% (450nm), 20.2% (450-630nm)
Positive Control: 2.2% (450nm), 1.9% (450-630nm)
Inter-Assay Reproducibility (CV%) at 450nm and 450-630nm, Visible 100%
Negative: 10.6% - 13.2% (450nm), 51.0% - 57.5% (450-630nm)
Low Positive: 15.3% - 27.9% (450nm), 18.0% - 32.9% (450-630nm)
Medium Positive: 17.6% - 19.3% (450nm), 19.7% - 19.7% (450-630nm)
High Positive: 19.8% (450nm), 20.0% (450-630nm)
Negative Control: 15.3% (450nm), 60.2% (450-630nm)
Positive Control: 22.8% (450nm), 23.9% (450-630nm)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 96.1%
Specificity: 95.7%
Correlation: 95.9%
Positive Predictive Value (PPV): 96.1%
Negative Predictive Value (NPV): 95.7%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
CLOtest
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
MAY 1 2 1998
510(k) Summary
Identification Information
Submitter's Information:
Submitter's Name and Address:
Meridian Diagnostics, Inc. River Hills Drive Cincinnati, OH 45244
Phone Number: 1-800-543-1980
Contact Person: Allen D. Nickol, PhD Director of Scientific and Regulatory Affairs
Date Summary Prepared: May 5, 1998
Name of Device: Premier Platinum HpSA.
- Classification Name: Campylobacter pylori, 83LYR
Predicate Equivalent Device:
CLOtest, rapid urease test for biopsy specimens.
Description of Device:
The Premier Platinum HpSA test utilizes polyclonal anti-H. pylori capture antibody adsorbed to microwells. Diluted patient samples and a peroxidase conjugated polyclonal antibody are added to the wells and incubated for one hour at room temperature. A wash is performed to remove unbound material. Substrate is added and incubated for ten minutes at room temperature. Color develops in the presence of bound enzyme. Stop solution is added and the results are interpreted visually or spectrophotometrically.
Intended Use:
The Premier Platinum HpSA enzyme immunoassay (EIA) is an in virro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. Test results are intended to aid in the diagnosis of H. pylori infection in adult patients.
Comparison with Predicate Devices:
1
The following comparison of the use, technology, function and performance supports the Statement of Equivalence between the Premier Platinum HpSA test The differences in technology does not raise additional and the CLO test. concerns regarding safety and effectiveness. Safety and effectiveness are demonstrated to be substantially equivalent.
| Method | Premier HpSA | Rapid
Urease |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Detection of H. pylori antigens in
patient stool | Detection of H. pylori associated
urease activity in biopsy
specimens |
| Results | Qualitative | Qualitative |
| Specimen Required | Stool | Gastric or Duodenal biopsy |
| Technology | Sandwich Enzyme Immunoassay | H. pylori urease catalyzed pH
change visualize by color change
indicator |
| Level of Skill
Required | Laboratory Technician | Gastroenterologist for biopsy and
laboratory technician for reading
result and QA. |
| Function | 1. Specimen diluted 1/3 and
added to well containing
rabbit anti-H. pylori capture
Ab.
2. One drop HRP-conjugated
detection Ab added.
3. Incubation 1 hr at room
temperature.
4. Wash 5 times.
5. Add 2 drops substrate.
6. Incubate 10 minutes at room
temperature.
7. Add one drop stop solution
and read visually or
spectrophotometrically | 1. Biopsy specimen place in
device and incubated at 30-
40°C for 3 hours. The keep at
room temperature up to 24
hours.
2. Read results for visual color
change. Negatives at 24 hours
if still yellow. Positive turn
pink, orange or magenta. |
| Interpretation | Pos/Neg read visually or
spectrophotometrically. Fixed
cutoff 0.140 single wavelength
(450nm) or 0.100 dual
wavelength (450-630nm) | Pos/Neg |
| Method | Premier HpSA | Rapid
Urease |
| Sensitivity | 96.2% (90.4-98.9%) | 95.4% (89.6-98.5%) |
| Specificity | 95.7% (89.5-98.8%) | 100.0% (96.4-100.0%) |
| Correlation | 96.0% (92.2-98.2%) | 97.6% (94.5-99.2%) |
2
Response Items, Round 2: K980076 Premier Platinum HpSA
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
Performance Characteristics:
The Premier Platinum HpSA test was evaluated on 200 symptomatic adults at one midwestern United States location, one site in Canada, and two sites in Italy. The patients studied had a wide cross-section of gastric pathologies noted, including: antral gastritis (n=81), antral gastropathy (n=25), antral erosions (n=24), esophagitis (n=21), duodenal ulcer (n=15), erosive duodemitis (n=10), GERD (n=10), "normal" (n=10), duodenitis (n=9), gastric ulcer (n=8), total stomach gastritis (n=6), hiatal hernia (n=6), Schatzki's ring (n=4), pyloric ulcer (n=2), and esophageal ulcer (n=1). HpSA test results were compared to diagnosis of H. pylori infection as judged by objective reference methods (culture, rapid urease, histology and UBT). Patients were considered positive if culture was positive, or if two or more of the other three tests were positive. Nine patients with negative or no culture results, and only one other test positive, were considered unevaluable. The HpSA test was 96.1% sensitive, 95.7% specific and showed 95.9% correlation with H. pylori infection. Confidence intervals were calculated by the exact binomial method.
4
| Trial | Site | #1 |
|---|---|---|
| Test | | Diagnosis | | Sensitivity
± 95% CI | Specificity
± 95% CI | Positive PV
± 95% CI | Negative PV
± 95% CI | Correlation
± 95% CI |
|--------|--------|-----------|--------------|-------------------------|-------------------------|-------------------------|-------------------------|-------------------------|
| Method | Result | Infected | Not Infected | | | | | |
| HpSA | Pos | 17 | 3 | 94.4% | 91.4% | 85.0% | 97.0% | 92.5% |
| EIA | Neg | 1 | 32 | 72.7 to 99.9% | 76.9 to 98.2% | 62.1 to 96.8% | 84.2 to 99.9% | 81.8 to 97.9% |
Reference Methods: Histology, Rapid Urease, Breath Test. Readings Single and Dual Wavelength.
Trial Site #2
| Test | Diagnosis | | Sensitivity
± 95% CI | Specificity
± 95% CI | Positive PV
± 95% CI | Negative PV
± 95% CI | Correlation
± 95% CI | |
|--------|-----------|----------|-------------------------|-------------------------|-------------------------|-------------------------|-------------------------|----------------|
| Method | Result | Infected | Not Infected | | | | | |
| HpSA | Pos | 9 | 0 | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
| EIA | Neg | 0 | 8 | 66.4 to 100.0% | 63.1 to 100.0% | 66.4 to 100.0% | 63.1 to 100.0% | 80.5 to 100.0% |
| | Equ | 0 | 0 | | | | | |
Reference Methods: Histology, Rapid Urease, Culture, Breath Test. Readings Single and Dual Wavelength.
Trial Site #3
| Test | | Diagnosis | | Sensitivity
± 95% CI | Specificity
± 95% CI | Positive PV
± 95% CI | Negative PV
± 95% CI | Correlation
± 95% CI |
|--------|--------|-----------|--------------|-------------------------|-------------------------|-------------------------|-------------------------|-------------------------|
| Method | Result | Infected | Not Infected | | | | | |
| HpSA | Pos | 44 | 0 | 97.8% | 100.0% | 100.0% | 96.0% | 98.6% |
| EIA | Neg | 1 | 24 | 88.2 to 99.9% | 85.8 to 100.0% | 92.0 to 100.0% | 79.6 to 99.9% | 92.2 to 100.0% |
| | Equ | 1 | 0 | | | | | |
Reference Methods: Histology, Rapid Urease, Culture, Breath Test. Readings Single Wavelength.
Trial Site #4
| Test | Diagnosis | | Sensitivity
± 95% CI | Specificity
± 95% CI | Positive PV
± 95% CI | Negative PV
± 95% CI | Correlation
± 95% CI | |
|--------|-----------|----------|-------------------------|-------------------------|-------------------------|-------------------------|-------------------------|---------------|
| Method | Result | Infected | Not Infected | | | | | |
| HpSA | Pos | 29 | 1 | 93.5% | 96.3% | 96.7% | 92.9% | 94.8% |
| EIA | Neg | 2 | 26 | 78.6 to 99.2% | 81.0 to 99.9% | 82.8 to 99.9% | 76.5 to 99.1% | 85.6 to 98.9% |
| | Equ | 2 | 0 | | | | | |
Reference Methods: Histology, Rapid Urease. Readings Dual Wavelength.
Compiled Data From All Sites
| Test | | Diagnosis | | Sensitivity
± 95% CI | Specificity
± 95% CI | Positive PV
± 95% CI | Negative PV
± 95% CI | Correlation
± 95% CI |
|--------|--------|-----------|--------------|-------------------------|-------------------------|-------------------------|-------------------------|-------------------------|
| Method | Result | Infected | Not Infected | | | | | |
| HpSA | Pos | 99 | 4 | 96.1% | 95.7% | 96.1% | 95.7% | 95.9% |
| EIA | Neg | 4 | 90 | 90.4 to 98.9% | 89.5 to 98.8% | 90.4 to 98.9% | 89.5 to 98.8% | 92.2 to 98.2% |
| | Equ | 3 | 0 | | | | | |
Additional Information/Non-clinical Test Results:
Reproducibility:
Reproducibility of the Premier Platinum HpSA test was determined using negative (n=2), low positive (n=2). medium postive (n=2) and high positive (n=1) samples tested in triplicate in three separate batches / runs at each of two separate sites. Intra- and inter-assay coefficients of variation were determined and are presented below (ranges are the results from two different specimens):
| | Intra-Assay
Reproducibility: Read at | Inter-Assay
Reproducibility: Read at |
| -- | ----------------------------------------- | ----------------------------------------- |
|---|
5
Response Items, Round 2: K980076 Premier Platinum HpSA
| Specimen Type | 450nm | 450-630nm | Visible | 450nm | 450-630nm | Visible |
|---|---|---|---|---|---|---|
| Negative | 4.3% - | |||||
| 5.1% | 8.1% - | |||||
| 13.5% | 100% | 10.6% - | ||||
| 13.2% | 51.0% - | |||||
| 57.5% | 100% | |||||
| Low | ||||||
| Positive | 9.2% - | |||||
| 14.8% | 11.0% - | |||||
| 16.6% | 100% | 15.3% - | ||||
| 27.9% | 18.0% - | |||||
| 32.9% | 100% | |||||
| Medium | ||||||
| Positive | 8.8% - | |||||
| 9.0% | 9.6% - | |||||
| 9.6% | 100% | 17.6% - | ||||
| 19.3% | 19.7% - | |||||
| 19.7% | 100% | |||||
| High | ||||||
| Positive | 11.2% | 11.6% | 100% | 19.8% | 20.0% | 100% |
| Negative | ||||||
| Control | 6.2% | 20.2% | 100% | 15.3% | 60.2% | 100% |
| Positive | ||||||
| Control | 2.2% | 1.9% | 100% | 22.8% | 23.9% | 100% |
Frozen Stools:
Samples were tested on day 0, then put through four freeze / thaw cycles, being tested each time. The data supports four freeze / thaw cycles.
Cross-Reactivity:
The specificity of Premier Platinum HpSA was tested by utilizing the following bacterial or viral strains. Positive and negative stools were spiked with ≥1x10° organisms / ml and tested by Premier Platinum HpSA. H. pylori gave a positive result when tested. All organisms were found to be negative when spiked into the negative stool. In addition, they did not interfere with the positive specimen:
Microorganism or virus (# strains tested)
| Adenovirus Type II (1) | Rotavirus (1) |
|---|---|
| Campylobacter coli (1) | Mycobacterium smegmatis (1) |
| Campylobacter fetus (1) | Nocardia asteroides (1) |
| Campylobacter jejuni (1) | Proteus vulgaris (1) |
| Campylobacter lari (1) | Salmonella (Group B) (1) |
| Candida albicans (1) | Salmonella dublin (1) |
| Citrobacter freundii (1) | Salmonella hilversum (Group N) (1) |
| Clostridium difficile (2) | Salmonella minnesota (1) |
| Clostridium perfringens (2) | Salmonella typhimurium (1) |
| Enterococcus faecalis (1) | Serratia liquefaciens (1) |
| Enterobacter cloacae (1) | Shigella boydii (1) |
| Escherichia coli (2) | Shigella dysenteriae (1) |
| Escherichia fergusonii (1) | Shigella flexneri (1) |
6
- Response Items, Round 2: K980076 Premier Platinum HpSA
- Escherichia hermanii (1) Helicobacter cinaedi (1) Helicobacter mustelae (1) Klebsiella pneumoniae (1) Providencia stuartii (1) Pseudomonas aeruginosa (1) Pseudomonas fluorescens (2)
Interfering Substances: None
- Shigella sonnei (1) Staphylococcus aureus (1) Staphylococcus aureus (Cowan I) (1) Staphylococcus epidermidis (1) Streptococcus agalactiae (1) Steptococcus faecalis (1) Yersinia enterocolitica (2)
7
Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare and medicine.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 2 1998
Dr. Allen D. Nickol Meridian Diagnostics, Inc. Director, Scient. & Req. Affairs 3471 River Hills Drive Cincinnati, Ohio 45244
K980076 Re: Trade Name: Premier Platinum HpSA Requlatory Class: I Product Code: LYR Dated: April 8, 1998 Received: April 9, 1998
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 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 aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಡ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements actien. 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 requlations.
8
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 vour 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 Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
9
Response Items: K980076 Premier Platinum HpSA
Indications For Use Statement
510(k) Number (if known): K980076
Device Name: Premier HpSA
Indications For Use:
The Premier Platinum HpSA enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. Test results are intended to aid in the diagnosis of H. pylori infection in adult symptomatic patients.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubois
ision of Clinical Laboratory Devi 510(k) Number.
Prescription Jse X (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
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