(127 days)
Not Found
No
The description focuses on a chemical reaction and analysis using a Gas Isotope Ratio Mass Spectrometer (GIRMS), with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is described as a diagnostic tool for detecting Helicobacter pylori and monitoring treatment, not for providing therapy or treatment itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients." This directly indicates its role in diagnosing a medical condition.
No
The device description explicitly states it is a "combination kit diagnostic drug/device composed of the following principle components: Test Meal, Pranactin Diagnostic Drug Dosage, Sterile Water, Breath Bag, Evacuated Breath Specimen Collection Tubes." It also relies on a Gas Isotope Ratio Mass Spectrometer (GIRMS) for analysis, which is a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients." This describes a test performed on a sample (breath) taken from the human body to provide information about a disease state.
- Device Description: The description details a "combination kit diagnostic drug/device" that collects breath samples for analysis. The analysis is performed using a Gas Isotope Ratio Mass Spectrometer ("GIRMS") to measure the ratio of 13CO2 to 12CO2 in the breath samples. This is a laboratory-based analysis of a biological sample.
- Sample Type: The device collects breath samples, which are biological specimens.
- Analysis Method: The analysis is performed using a Gas Isotope Ratio Mass Spectrometer, a laboratory instrument used for diagnostic testing.
- Performance Studies: The document includes details about clinical field trials and performance metrics like sensitivity, specificity, and NPV, which are standard for evaluating the performance of diagnostic tests.
All of these characteristics align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality.
N/A
Intended Use / Indications for Use
The MERETEK UBT® Breath Test Collection Kit is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. The test may be used for monitoring treatment if used at least four weeks following completion of therapy. For these purposes, the system utilizes a Gas Isotope Ratio Mass Spectrometer ("GIRMS") for the measurement of the ratio of 13CO2 to 12CO2 in breath samples.
For administration by health care professionals. To be administered under a physician's supervision.
Product codes (comma separated list FDA assigned to the subject device)
MSQ
Device Description
The device is a combination kit diagnostic drug/device composed of the following principle components: Test Meal (of approximately 220 calories) Pranactin Diagnostic Drug Dosage Sterile Water Breath Bag Evacuated Breath Specimen Collection Tubes
Principle of the Test: In the MERETEK UBT® Breath Test for H. pylori, 125 mg of reconstituted 13C-urea is ingested by the patient. In the presence of urease associated with gastric H. pylori, 13C-urea is decomposed to 13CO2 and NH4+ according to the following equation: (NH2)213CO + H2O + 2H+ - Urease > 13CO2 + 2NH4+. The 13CO2 is absorbed in the blood, then exhaled in the breath. This results in an increase in the ratio of 13CO2 to 12CO2 in a TEST breath sample compared to a BASELINE sample taken before the Pranactin® solution was consumed. Analysis of the breath samples is performed by Gas Isotope Ratio Mass Spectrometry ("GIRMS") at Meretek's clinical laboratories or at other qualified laboratories licensed by MERETEKdiagnostics, inc.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human stomach
Indicated Patient Age Range
adult patients
Intended User / Care Setting
health care professionals, administered under a physician's supervision
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 method comparison data presented here were collected from two (2) independent double blind clinical field trials which involved treatment of H.pylori infection. The studies included 499 adult patients with duodenal ulcer disease at 75 clinical sites in the United States. Patients were tested for H.pylori infection initially (using histopathology, microbiological culture, CLOtest®, and the MERETEK UBT®), and at various posttreatment intervals throughout the study (using histopathology, microbiological culture, and the MERETEK UBT®). In these clinical trials patients were treated with various combinations of clarithromycin, omeprazole and placebo.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing:
Experimental Design: The method comparison data were collected from two (2) independent double blind clinical field trials which involved treatment of H.pylori infection. The studies included 499 adult patients with duodenal ulcer disease at 75 clinical sites in the United States. Patients were tested for H.pylori infection initially (using histopathology, microbiological culture, CLOtest®, and the MERETEK UBT®), and at various post-treatment intervals throughout the study (using histopathology, microbiological culture, and the MERETEK UBT®). Patients were treated with various combinations of clarithromycin, omeprazole and placebo.
Results: Method comparison results are presented in two-way contingency tables.
Performance Characteristics for Initial Diagnosis:
- Comparison with CLOtest® (Table 1):
- Sample Size: 445 patients
- Relative sensitivity: 92.8 % [95% CI: (89.9,95.0)]
- Relative specificity: 94.1 % [95% CI: (71.3,99.9)]
- Comparison with histology (Table 2):
- Sample Size: 444 patients
- Relative sensitivity: 95.2 % [95% CI: (92.6,97.0)]
- Relative specificity: 90.0 % [95% CI: (73.5,97.9)]
- Comparison with combined endoscopic methods (CLOtest®, histology and culture) for Initial Visit (Table 3):
- Sample Size: 444 patients
- Sensitivity: 95.2 % [95% CI: (92.6,97.0)]
- Specificity: 89.7 % [95% CI: (72.6,97.8)]
Performance Characteristics for Post-Treatment Monitoring (Table 4 - Comparison with combined endoscopic methods: histology and culture, four weeks or more after End of Treatment (EOT)):
- 1 Month EOT:
- Sensitivity: 96.9 % [95% CI: (93.4,98.8)]
- Specificity: 95.1 % [95% CI: (88.9,98.4)]
- 3 Months EOT:
- Sensitivity: 93.9 % [95% CI: (88.3,97.3)]
- Specificity: 95.6 % [95% CI: (89.1,98.8)]
- 6 Months EOT:
- Sensitivity: 94.8 % [95% CI: (88.3,98.3)]
- Specificity: 97.6 % [95% CI: (91.5,99.7)]
- 1-6 Months Combined:
- Sensitivity: 95.5 % [95% CI: (93.0,97.2)]
- Specificity: 96.0 % [95% CI: (93.0,98.0)]
Negative Predictive Value (NPV) for Post-Treatment Monitoring: Given the post-treatment sensitivity (95.5%) and specificity (96.0%) observed in these studies, and assuming a treatment efficacy of 90% (10% prevalence of residual H.pylori infection), the NPV of the MERETEK UBT® is greater than 99%. When efficacy of treatment drops to 50%, the NPV is still greater than 95%.
Adverse Events: There were no adverse events related to the use of the MERETEK UBT® reported during the clinical trials.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Initial Diagnosis:
- Relative sensitivity (compared to CLOtest®): 92.8 % [95% CI: (89.9,95.0)]
- Relative specificity (compared to CLOtest®): 94.1 % [95% CI: (71.3,99.9)]
- Relative sensitivity (compared to histology): 95.2 % [95% CI: (92.6,97.0)]
- Relative specificity (compared to histology): 90.0 % [95% CI: (73.5,97.9)]
- Sensitivity (compared to combined endoscopic methods): 95.2 % [95% CI: (92.6,97.0)]
- Specificity (compared to combined endoscopic methods): 89.7 % [95% CI: (72.6,97.8)]
Post-Treatment Monitoring (1-6 Months Combined):
- Sensitivity: 95.5 % [95% CI: (93.0,97.2)]
- Specificity: 96.0 % [95% CI: (93.0,98.0)]
- Negative Predictive Value (NPV): >99% (assuming 90% treatment efficacy), >95% (assuming 50% treatment efficacy).
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.
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
Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, seemingly handwritten. The sequence reads 'K9723552'. The characters are rendered in a bold, somewhat irregular style, giving them a distinct, hand-drawn appearance. The contrast between the characters and the background is high, making them easily readable.
510(k) SUMMARY
The MERETEK UBT® Breath Test for Detection of H.pylori
Applicant's Name, Address, Contact Person, and Date of Preparation A.
MERETEKdiagnostics, inc. 618 Grassmere Park Drive Suite 20 Nashville, Tennessee 37211
Please direct any requests for information to:
Mr. Kerry C. Bush Vice President and Chief Operating Officer MERETEKdiagnostics, inc. 618 Grassmere Park Drive Suite 20 Nashville, Tennessee 37211
(615) 333-6336 Phone: (615) 333-6202 Fax:
This 510(k) summary was prepared October, 1997.
Device Name and Classification B.
Trade Name of the Device: The MERETEK UBT® Breath Test for H.pylori
Common Name of the Device:
Breath Test for Helicobacter pylori; UBT
Classification:
Campylobacter pylori (presence) Name: Campylobacter pylori was officially renamed Helicobacter pylori in 1989. Note: Class: I
C. The Predicate Device
Since this Premarket Notification is for labeling modification to a cleared device (K952220), the predicate device is the device itself: The MERETEK UBT® Breath Test for Detection of H. pylori.
Description of the Device D.
The device is a combination kit diagnostic drug/device composed of the following principle components:
1
Test Meal (of approximately 220 calories) Pranactin Diagnostic Drug Dosage Sterile Water Breath Bag Evacuated Breath Specimen Collection Tubes
Principle of the Test
In the MERETEK UBT® Breath Test for H. pylori, 125 mg of reconstituted 13C-urea is ingested by the patient. In the presence of urease associated with gastric H. pylori, 13Curea is decomposed to 13CO2 and NH4+ according to the following equation:
(NH2)213CO + H2O + 2H+ - 40Urease > 13CO2 + 2NH4+ 13C-urea
The 13CO2 is absorbed in the blood, then exhaled in the breath. This results in an increase in the ratio of 13CO2 to 12CO2 in a TEST breath sample compared to a BASELINE sample taken before the Pranactin® solution was consumed. Analysis of the breath samples is performed by Gas Isotope Ratio Mass Spectrometry ("GIRMS") at Meretek's clinical laboratories or at other qualified laboratories licensed by MERETEKdiagnostics, inc.
E. Intended Use
The MERETEK UBT® Breath Test Collection Kit is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. The test may be used for monitoring treatment if used at least four weeks following completion of therapy. For these purposes, the system utilizes a Gas Isotope Ratio Mass Spectrometer ("GIRMS") for the measurement of the ratio of 13CO2 to 12CO2 in breath samples.
For administration by health care professionals. To be administered under a physician's supervision.
Technological Characteristics of the Device and the Predicate Device F.
The technological characteristics of the subject device are the same as the predicate device.
G. Clinical Testing
Experimental Design
The method comparison data presented here were collected from two (2) independent double blind clinical field trials which involved treatment of H.pylori infection. The studies included 499 adult patients with duodenal ulcer disease at 75 clinical sites in the United States. Patients were tested for H.pylori infection initially (using histopathology, microbiological culture, CLOtest®, and the MERETEK UBT®), and at various posttreatment intervals throughout the study (using histopathology, microbiological culture, and the MERETEK UBT®). In these clinical trials patients were treated with various
2
combinations of clarithromycin, omeprazole and placebo. Note, however, that there is no evidence that differing treatment regimens affect the performance of the MERETEK UBT®.
Results
Method comparison results are presented in two-way contingency tables. In tables 1, 2 and 3, the MERETEK UBT® Breath Test results are compared with the CLOtest®, histology and with the combined endoscopic method results for the initial patient visit. In table 4, the MERETEK UBT® Breath Test results are compared with the combined endoscopic method results (histology and culture) for the post-treatment visits which occurred four weeks or more after end of treatment. The exact binomial distribution was used to calculate the lower and upper limits of the 95% confidence intervals of the performance statistics. The confidence intervals are entered in parentheses following the point estimate of the statistic.
Performance Characteristics for Initial Diagnosis
Table 1. Comparison with CLOtest® for Initial Visit
| Meretek UBT® Breath Test results | |||
|---|---|---|---|
| CLOtest® | positive | negative | Total |
| positive | 397 | 31 | 428 |
| negative | 1 | 16 | 17 |
| Total | 398 | 47 | 445 |
Relative sensitivity: 92.8 % [95% CI: (89.9,95.0)] Relative specificity: 94.1 % [95% CI: (71.3,99.9)]
| Table 2. Comparison with histology for Initial Visit | |||||
|---|---|---|---|---|---|
| ------------------------------------------------------ | -- | -- | -- | -- | -- |
| Meretek UBT® Breath Test results | |||
|---|---|---|---|
| Histology | positive | negative | Total |
| positive | 394 | 20 | 414 |
| negative | 3 | 27 | 30 |
| Total | 397 | 47 | 444 |
Relative sensitivity: 95.2 % [95% CI: (92.6,97.0)] Relative specificity: 90.0 % [95% CI: (73.5,97.9)]
- Table 3. Comparison with combined endoscopic methods for Initial Visit (Combined endoscopic methods used were CLOtest®, histology and culture per DAIDP guidelines for pre-treatment diagnosis.)
| Meretek UBT® Breath Test results | |||
|---|---|---|---|
| Endoscopy | positive | negative | Total |
| positive | 395 | 20 | 415 |
| negative | 3 | 26 | 29 |
| Total | 398 | 46 | 444 |
Sensitivity: 95.2 % [95% CI: (92.6,97.0)] Specificity: 89.7 % [95% CI: (72.6,97.8)}
3
Performance Characteristics for Post-Treatment Monitoring
| | 1 Month
EOT | | 3 Months
EOT | | 6 Months
EOT | | 1-6 Months
Combined | |
|-------------|----------------|-----|-----------------|-----|-----------------|-----|------------------------|-----|
| Endoscopy | pos | neg | pos | neg | pos | neg | pos | neg |
| positive | 187 | 6 | 123 | 8 | 91 | 5 | 401 | 19 |
| negative | 5 | 97 | 4 | 87 | 2 | 80 | 11 | 264 |
| Sensitivity | 96.9 | | 93.9 | | 94.8 | | 95.5 | |
| (95% CI) | (93.4,98.8) | | (88.3,97.3) | | (88.3,98.3) | | (93.0,97.2) | |
| Specificity | 95.1 | | 95.6 | | 97.6 | | 96.0 | |
| (95% CI) | (88.9,98.4) | | (89.1,98.8) | | (91.5,99.7) | | (93.0,98.0) | |
Table 4. Comparison with combined endoscopic methods * for Post-Treatment Visits (four weeks or more after End of Treatment (EOT))
* Combined endoscopic methods used were histology and culture per DAIDP guidelines for post-treatment monitoring)
Please note that the post-treatment performance characteristics at 1, 3 and 6 months after therapy are not statistically different. Therefore, the single best estimates of sensitivity and specificity are presented in the 1-6 Months Combined column.
Negative Predictive Value (NPV) for Post-Treatment Monitoring
Given the post-treatment sensitivity (95.5%) and specificity (96.0%) observed in these studies, and assuming a treatment efficacy of 90% (10% prevalence of residual H.pylori infection), the NPV of the MERETEK UBT® is greater than 99%. When efficacy of treatment drops to 50%, the NPV is still greater than 95%.
H. Adverse Events
There were no adverse events related to the use of the MERETEK UBT® reported during the clinical trials.
I. Conclusion
The MERETEK UBT® is safe and effective for its intended use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, with three overlapping profiles suggesting a sense of community or interconnectedness. The figure is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 2 9 1997
Claudia T. Hitchcock President & Chief Executive Officer Meretek Diagnostics, Inc. 618 Grassmere Park Drive Suite 20 Nashville, TN 37211
Re: K972352
Trade Name: The Meretek UBT™ Breath Test for Helicobacter pylori Regulatory Class: II Product Code: MSQ Dated: September 2, 1997 Received: September 3, 1997
Dear Mr. Bush:
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 against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
5
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. -Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely vours.
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
X. STATEMENT OF INDICATIONS FOR USE
Device Name:
MERETEK UBT™ Breath Test For H.pylori
Indications for Use:
The MERETEK UBT™ Breath Test Collection Kit is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. For this purpose, the system utilizes a Gas Isotope Ratio Mass Spectrometer ("GIRMS") for the measurement of the ratio of 13CO, to 12CO2 in breath samples. ----------------------------------------
For administration by health care professionals. To be administered under a physician's supervision.
Prescription Use: Yes
Alan Cooper
on Sign-Off Division of Clinical Laboratory Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)