(198 days)
The CLOtest®
Not Found
No
The device description outlines a system that measures the ratio of isotopes using a laser and applies a fixed cutoff value to determine the result. There is no mention of adaptive algorithms, learning from data, or any other characteristics typically associated with AI/ML.
No
The device is intended for the qualitative detection of urease associated with Helicobacter pylori infection and as an aid in diagnosis, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Pylori-Chek Test System is "for the qualitative detection of urease associated with Helicobacter pylori infection in the human stomach and as an aid in the diagnosis of H. pylori infection in symptomatic adult patients." This directly indicates its role in diagnosing a medical condition.
No
The device description explicitly states that the system is comprised of two components: a breath test kit (hardware for sample collection) and a Laser Assisted Ratio Analyzer (hardware for measurement). This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the qualitative detection of urease associated with Helicobacter pylori infection in the human stomach and as an aid in the diagnosis of H. pylori infection in symptomatic adult patients." This describes a test performed on a sample taken from the human body to provide information for diagnosis.
- Device Description: The description details a system that analyzes breath samples ("in vitro") to detect a biological marker (the ratio of 13CO2 to 12CO2) that indicates the presence of H. pylori. This analysis is performed outside of the body.
- Sample Type: The device uses breath samples, which are biological specimens taken from the human body.
- Purpose: The purpose is to aid in the diagnosis of a medical condition (H. pylori infection).
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Pylori-Chek Test System is intended for use with the LARA Laser Assisted Ratio Analyzer for the qualitative detection of urease associated with Helicobacter pylori infection in the human stomach and as an aid in the diagnosis of H. pylori infection in symptomatic adult patients. The Pylori-Chek Test system consists of a Pylori-Chek test kit for the collection of breath samples and a LARA Laser Assisted Ratio Analyzer for the measurement of the ratio of 13CO2 to 12CO2 in the breath sample.
Product codes (comma separated list FDA assigned to the subject device)
MSO (LYR)
Device Description
The Alimenterics LARA Breath Test System is based on the ability of the H.pylori organism to produce large amounts of the enzyme urease, which hydrolyses urea to NHl and CO3, the latter being exhaled. Using 30-labeled urea, an increase in the ratio of 130, to "CO, over time is an indication for the presence of H. pylori. This change can be detected by the LARA System based on a comparison of pre- and post-ingestion measurements of the patient's breath.
The Alimenterics breath test procedure involves a pre-ingestion analysis of a sample of the patient's breath to determine the baseline ratios of '30, to '200, Following ingestion of a test meal and 100 mg 13C-labeled urea, breath samples are collected at thirty and sixty minutes thereafter. The samples are then introduced into the LARA analyzer which, based on the laser optogalvanic effect, measures the ratio of 13CO2 to 12CO2 The results of the three readings, with respect to a calibration standard, are determined concurrently by the analyzer. A specified change in the ratio of 13CO2 to 12CO2 in the 30 or 60 minute samples as compared to the baseline sample constitutes a positive test. Test values are generated and a report is printed for each patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human stomach, gastrointestinal system
Indicated Patient Age Range
symptomatic adult patients
Intended User / Care Setting
healthcare professionals. To be 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
Pivotal Study:
Sample Size: One thousand forty eight subjects were enrolled at 10 clinical sites. Of the 1048 subjects, 875 were included in the analysis.
Reference Methods: the IDE protocol standard, the CDER standard, the CDRH standard, the CLOtest, and central histopathology.
Supplemental ("Cold Trap") Study:
Sample Size: Four hundred thirty-two patients were enrolled in this study. Four hundred thirty-one patients attempted to take the Pylori-Chek Breath Test and, of those, 397 were included in the analyses.
Reference Standards: same five reference standards that were used in the Pivotal Study.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Tests:
Pivotal Study:
Study type: Clinical study
Sample Size: 1048 subjects enrolled, 875 included in analysis.
Key Results: Overall study sensitivity ranged between 91.29% and 94.15%, specificity ranged from 90.38% to 91.21%, PPV ranged from 90.50% to 91.51%, and NPV ranged from 90.93% to 94.12%. PPVs above 91% and NPVs above 94% were obtained for the breath test using all five reference standards. A diagnostic cutoff of 7.88 was calculated with an indeterminate zone between 7.018 and 8.600 (which excluded 4.1% of the patients).
Supplemental ("Cold Trap") Study:
Study type: Clinical study
Sample Size: 432 patients enrolled, 397 included in analyses.
Key Results: Using the diagnostic cutoff of 7.80 with an indeterminate zone of 7.01 to 8.600 (which excluded 3.2% of the patients), sensitivity ranged from 90.09% to 93.21% and specificity ranged from 98.04% to 98.11%, PPV ranged from 98.54% - 98.58%, and NPV ranged from 86.71% to 91.23%. These results were comparable to those obtained in the Pivotal Study, with specificity increasing by more than 7%.
An ROC analysis yielded a cutoff of 6.18 with an indeterminate zone between 5.510 and 6.700 (which excluded 3% of the patients). Using the 6.18 cutoff, sensitivity ranged from 92.92% to 96.05%, specificity ranged from 95.97% to 96.71%, PPV ranged from 97.29% to 97.84%, and NPV ranged from 89.24% to 93.59%.
Nonclinical Tests:
Storage of Breath Specimens: Demonstrated 30-day shelf life for breath collectors.
Transport Study: Demonstrated retention of sufficient CO2 after extreme transport conditions.
Control Stability: Second study being conducted to demonstrate 60-day stability of control samples in sealed pouches.
Carryover Study: Batch carryover effect ranged from 0.67% to 2.13% (average 1.67%, SD 0.51%). High 13C content samples do not affect baseline results of next patient specimen.
Verification of Calibration (Control Frequency) Study: LARA System can maintain calibration for an 8-hour period using one control sample.
Intersytem Comparison: Analysis of control gas was reproducible using three different LARA Systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Pivotal Study:
Sensitivity: 91.29% to 94.15%
Specificity: 90.38% to 91.21%
PPV: 90.50% to 91.51%
NPV: 90.93% to 94.12%
Supplemental ("Cold Trap") Study (using 7.80 cutoff):
Sensitivity: 90.09% to 93.21%
Specificity: 98.04% to 98.11%
PPV: 98.54% - 98.58%
NPV: 86.71% to 91.23%
Supplemental ("Cold Trap") Study (using 6.18 cutoff):
Sensitivity: 92.92% to 96.05%
Specificity: 95.97% to 96.71%
PPV: 97.29% to 97.84%
NPV: 89.24% to 93.59%
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.
The 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
FEB 2 8 1998
K973000 510(k) SUMMARY FOR THE ALIMENTERICS LARA BREATH TEST SYSTEM
I. SYSTEM SPONSOR
A. Sponsor Name and Address
Alimenterics, Inc. 301 American Road Morris Plains, NJ 07950 (973) 285-3100
B. Official Correspondent and Address
Janet George Murnick, Ph.D. President and CEO Alimenterics, Inc. 301 American Road Morris Plains, NJ 07950 (973) 285-3100
SYSTEM IDENTIFICATION II.
A. Trade/Proprietary Name of the System
The Alimenterics LARA Breath Test System is comprised of two components:
- (1) the Pylori-Chek Breath Test Kit; and
- (2) the LARATM (Laser Assisted Ratio Analyzer) System
Common Name of the System B.
13C-Urea breath test for the presence of Helicobacter pylori
PREDICATE DEVICE III.
The CLOtest® is a slide with a dispersed gel, which contains urea and a pH indicator. A biopsy acquired during endoscopy is immersed in the CLOtest® gel. If urease activity (associated with H.pylori) is present in the specimen, ammonia is generated, causing a pH change. This pH change is detected by the change in color of the pH indicator within 24 hours.
1
IV. BACKGROUND
Peptic ulcer disease is a chronic inflammatory condition of the stomach and duodenum. Despite the fact that the disease has relatively low mortality, it results in substantial suffering of those affected.
A strong association between H. pylori, chronic superficial gastrointestinal disease has been well established. H.pylori is associated with type B gastritis, 12 duodenal ulcer, 34 gastric ulcer, 56 gastric cancer", and non-Hodgkins lymphoma.7
H. pylori was first cultured successfully from human gastric mucosa in 1982. The organisms, spiral gram negative bacteria, are found in the human stomach between the gastric epithelium and the mucosa. Isolates implicated in the above mentioned diseased states are distinguished by the production of copious amounts of endogenous urea amidohydrolase (urease).200 The enzyme catalyzes the breakdown of urea to carbon dioxide and ammonia, which are absorbed into the bloodstream.
Several methods are employed to determine the presence of H. pylori in the gastointestinal tract. Histologic staining of biopsy tissue using various stains has been shown to give adequate results with a specificity of over 90%.11 Mucosal biopsy samples can be cultured using selective and non-selective enriched media. However, due to the exacting needs of the organism, culture is the least sensitive (70-80%)" of all available techniques. Direct detection of urease activity of biopsy specimens is achieved by placing tissue in Christensen's urea agar and observing a color change. Biopsy and its associated analytic techniques are invasive and not particularly helpful in screening. Non-invasive tests consist of serum assays for IgG and IgA antibodies against H. pylori. However, these are not indicative of current infection. Urea breath tests using the radioactive isotope "4C or the stable isotope 13C can detect current infection with H. pylori, and have been shown to be highly sensitive methods. 12.13
V. DEVICE DESCRIPTION
The Alimenterics LARA Breath Test System is based on the ability of the H.pylori organism to produce large amounts of the enzyme urease, which hydrolyses urea to NHL and CO3, the latter being exhaled. Using 30-labeled urea, an increase in the ratio of 130, to "CO, over time is an indication for the presence of H. pylori. This change can be detected by the LARA System based on a comparison of pre- and post-ingestion measurements of the patient's breath.
The Alimenterics breath test procedure involves a pre-ingestion analysis of a sample of the patient's breath to determine the baseline ratios of '30, to '200, Following ingestion of a test meal and 100 mg 13C-labeled urea, breath samples are collected at thirty and sixty minutes thereafter. The samples are then introduced into the LARA analyzer which, based on the laser
2
2
optogalvanic effect, measures the ratio of 13CO2 to 12CO2 The results of the three readings, with respect to a calibration standard, are determined concurrently by the analyzer. A specified change in the ratio of 13CO2 to 12CO2 in the 30 or 60 minute samples as compared to the baseline sample constitutes a positive test. Test values are generated and a report is printed for each patient.
INTENDED USE VI.
The Alimenterics Pylori-Chek Breath Test kit is intended for use with the LARA Breath Test System for the qualitative detection of urease associated with Helicobacter pylori as an aid in the diagnosis of H.pylori infection.
SUBSTANTIAL EQUIVALENCE COMPARISON VII.
The Alimenterics LARA Breath Test System and the CLOtest® have the same basic intended use: to detect the presence of H.pylori in human gastric mucosa.
The same chemical reaction (hydrolysis of urea catalyzed by H. pylori urease) forms the basis of both tests. When H. pylori is present, urea introduced either by ingestion in the case of the LARA Breath Test System or by contact in the case of the CLOtest, hydrolyses the urease produced by the H. pylori, which in turn produces both CO2 and NH. As explained above, with the CLOtest®, this chemical reaction takes place in vitro using an endoscopic biopsy, if H. pylori is present, the generation of NH, causes a pH change, which is reflected by a change in the color of the pH indicator. With the Alimenterics LARA Breath Test System, the chemical reaction takes place in vivo, and results in an increase in 13002 in the patient's excreted breath which is detected with the LARA instrument.
A table comparing the technological characteristics of both systems follows:
| | Organism | Reagent | Detection of
Urea
Degradation | Physical
Safety | Time | Temp. |
|-----------------------------|-----------------|----------|----------------------------------------------------------------------|-------------------------------------------------------------------------------|--------------|---------------------------------------------|
| CLOtest® | H.pylori | Urea | Visual detection of
urea degradation:
Urea→NH₄→Color
Change | Requires
invasive tissue
sampling | 3-24
hrs. | Requires
incubation
at 35 or
37° C |
| Alimenterics
Breath Test | H.pylori | ¹³C-Urea | LARA detection of
excess ¹³CO₂:
¹³C-Urea→¹³CO₂ | No tissue
sampling; no
adverse effects
from ingestion
of ¹³C-Urea | 1 hr. | LARA
operates at
ambient
temps. |
3
PERFORMANCE DATA VIII.
Clinical Tests A.
Clinical studies were conducted using the LARA Breath Test System. The objectives and results of the Pivotal and Supplemental studies are summarized below:
Pivotal Study ﺎ .
The objectives of the study were to evaluate the ability of the LARA Breath Test System to detect the presence of H. pylori infections in the gastrointestinal system and to evaluate the sensitivity and specificity of the System as compared to reference methods. One thousand forty eight subjects were enrolled at 10 clinical sites. Of the 1048 subjects, 875 were included in the analysis. All patients who ingested the 3C-urea solution were included in the safety analysis. Only four patients reported adverse events. None of the adverse events was considered to be device related. Based on the results in this study, a diagnostic cutoff of 7.88 was calculated with an indeterminate zone between 7.018 and 8.600 (which excluded 4.1% of the patients).
Data were analyzed using five different reference standards: the IDE protocol standard, the CDER standard, the CDRH standard, the CLOtest, and central histopathology. Overall study sensitivity ranged between 91.29% and 94.15%, specificity ranged from 90.38% to 91.21%, PPV ranged from 90.50% to 91.51%, and NPV ranged from 90.93% to 94.12%. PPVs above 91% and NPVs above 94% were obtained for the breath test using all five reference standards.
During this study, some breath samples did not contain enough CO, to permit LARA System analysis. The Pylori-Chek breath collector used a desiccant to remove water vapor from the breath samples. The dessicant was found to absorb both water vapor and CO2, The device was modified to improve water vapor removal without affecting CO, content. A supplemental study, the "cold trap" study was conducted to evaluate the modified device.
2. Supplemental ("Cold Trap") Study
The objectives of the study were to verify that the modified breath test system performed comparably to the device used in the Pivotal Study and to provide an independent test (challenge) of the sensitivity and specificity calculated using the diagnostic cutoff and indeterminate zone determined in the Pivotal Study. Four hundred thirty-two patients were enrolled in this study. Four hundred thirty-one patients attempted to take the Pylori-Chek Breath Test and, of those, 397 were included in the analyses.
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Of the 431 patients, six patients reported adverse events. The adverse events were considered to be related to either the endoscopy procedure or to ingestion of the test meal which in some instances followed the procedure by as little as one hour.
Results using the modified device were compared to results obtained in the Pivotal Study using the previous device. In the Pivotal Study, 120 (3.9%) of the breath samples had low CO2 content, while in this study only 32 (2.5%) of the samples had low CO2. The device modification reduced the number of UAP samples due to low CO, content.
Using the diagnostic cutoff of 7.80 with an indeterminate zone of 7.01 to 8.600 (which excluded 3.2% of the patients), sensitivity ranged from 90.09% to 93.21% and specificity ranged from 98.04% to 98.11%, PPV ranged from 98.54% - 98.58%, and NPV ranged from 86.71% to 91.23% using the same five reference standards that were used in the Pivotal Study. These results were comparable to those obtained in the Pivotal Study where sensitivity ranged from 91.29% -94.15% and sensitivity ranged from 90.38% to 91.21%. The specificity increased by more than 7%. These results of an independent data set using any of the five reference standards show that the high sensitivity and specificity observed in the Pivotal Study could be replicated and even improved.
Based on the results in this study, an ROC analysis was performed to yield a cutoff to maximize total predictive value. Using these results, a cutoff of 6.18 was calculated with an indeterminate zone between 5.510 and 6.700 (which excluded 3% of the patients). Using the 6.18 cutoff, sensitivity ranged from 92.92% to 96.05%, specificity ranged from 95.97% to 96.71%, PPV ranged from 97.29% to 97.84%, and NPV ranged from 89.24% to 93.59%. The modified device will be used in the clinical product. Thus, results for the diagnostic cutoff, and indeterminate zone determination, obtained with this device should be used for clinical decisions.
Nonclinical Tests B.
In addition to clinical tests. Alimenterics conducted several nonclinical tests that demonstrated the performance of the Alimenterics LARA Breath Test System. These tests included the following:
Storage of Breath Specimens. This study demonstrated that the breath collectors could retain a sufficient amount of CO2 from a breath sample for 30 days under typical storage conditions. The study established a 30 day shelf life.
Transport Study. This study demonstrated that the breath collectors could retain a sufficient amount of CO, from a gas sample after experiencing the extreme transport condition.
Control Stability. The first control stability study did not demonstrate that the breath collectors could retain a sufficient amount of CO, from a control sample for 60 days under
5
5
varied storage conditions. Because a control failure occurred during the first study, a second study is being conducted to demonstrate that breath collectors packaged in sealed pouches currently used in the final product could retain a sufficient amount of CO2 from a control sample for 60 days under varied storage conditions including hot, humid conditions and cold, low pressure conditions.
Carryover Study. The data showed that the batch carryover effect ranged from 0.67% to 2.13%, with an average of 1.67% and a standard deviation of .51%. This study demonstrated that samples with high 13C content do not affect the baseline result of the next patient specimen.
Verification of Calibration (Control Frequency) Study The study demonstrated that the LARA System can maintain calibration for an 8 hour period using one control sample.
Intersvstem Comparison. The study demonstrated that analysis of a control gas was reproducible using three different LARA Systems.
C. Conclusions
The clinical studies demonstrate that the Alimenterics LARA Breath Test System performs comparably to other diagnostic methods for the presence of H.pylori in the human gastrointestinal tract, including the CLOtest® In the clinical studies of the Alimenterics LARA Breath Test System, there were no adverse events directly associated with the system. The breath test system is, thus, safer than those test methods, like the CLOtest®, that require a biopsy for evaluation. The nonclinical studies demonstrate that the Alimenterics LARA Breath Test System performs reliably under the anticipated conditions of usage.
IX. BIBLIOGRAPHY
- Andersen LP, Holck S, Poulsen CO, Elsborg L, Justesen T. Campylobacter pyloridis in 1. peptic ulcer disease. Scand. J. Gastoenterol. 22: 219-224, 1987.
- Blaser MJ. Gastric Campylobacter-like organisms, gastritis and peptic ulcer disease. 2. Gastroenterol. 93: 971-83, 1987.
- Langenberg ML, Tytgat GNJ, Schipper MEI, Rietra PJGM, Zanen HC. Campylobacter-3. like organisms in the stomach of patients and healthy individuals. Lancet i: 1348, 1984.
- Marshall, B.J., Guerrant, R.L., Plankey, M.W., et al. Comparison of "C-urea breath test, 4. microbiology and histology for the diagnosis of Campylobacter pylori (Abstract). Gastroenterol. 94:A284, 1988.
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- Graham DY, Klein PD, Opekun AR, Boutton TW. Effect of age on the frequency of ર્ડ . active Campylobacter pylori infection diagnosed by the [13C]urea breath test in normal subjects and patients with peptic ulcer disease. J. Infect. Dis. 157: 777-780, 1988.
- Marshall BJ, Warren JR. Unidentified curved bacilli in the stomach of patients with ર . gastritis and peptic ulceration. Lancet 1: 1311-15, 1984.
- Parsonnet J, Hansen S, Rodriguez L, Gelb AB, Warnke RA, Jellum E, Orentreich N, 7. Vogelman JH, Friedman GD. Helicobacter pylori infection and gastric lymphoma. The New England Journal of Medicine 330: 1267-1271, May 1994.
- Marshall BJ. Royce H. Annear D1. Goodwin CS, Pearman JW, Armstrong JA. Original 8. isolation of Campylobacter pyloridis from human gastric mucosa. Microbios. Lett. 25: 83-88, 1983.
- Hazell SL, Borody TJ, Gal A, Lee A. Campylobacter pyloridis gastritis I: detection of ರು. urease as a marker of bacterial colonization. Am. J. Gastroenterol. 82: 292-296, 1987.
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- Marshall BJ, Warren JR, Francis GJ, et al. Rapid urease test in the management of Campylobacter pyloridis-associated gastritis. Am. J. Gastroenterol. 82: 200-10, 1987.
- 1 1 . Helicobacter pylori in peptic ulcer disease. Consensus Development Conference Statement, National Institutes of Health: Feb. 7-9, 1994.
-
- Rauws EAJ, Royen EAV, Langenberg W, Woensel JV, Vrij AA, Tytgat GNJ. "C-urea breath test in C. pylori gastritis. Gut 30: 798-803, 1989.
-
- Eggers RH, Kulp A, Ludtke FE, Bauer FE. Characterization of the [13]urea breath test for the diagnosis of Campylobacter pylori infections. Stable Isotopes in Paedetriac Nutritional and Metabolic Research: 295-301, 1990.
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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 26 1998
Janet G. Murnick, Ph.D. Alimenterics Inc. 301 American Road Morris Plains, NJ, 07950
Re: K973000 Device: Alimenterics LARATM Breath Test System Regulatory Class: I Product Code: MSO (LYR) Dated: August 6, 1997 Received: August 12, 1997
Dear Dr. Murnick:
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. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
In addition, we have determined that your product contains the following component subject to regulation as drugs: 13C-Urea (powder-100 mg).
Our substantially equivalent determination does not apply to the drug component (NDA 20-900) of your product. For-information-on applicable-Agency requirements regarding the " drug component, we suggest you contact:
Mark Goldberger, M.D., M.P.H. Division Director Division of Special Pathogens and Immunologic Drug Products (HFD-590) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 827-2335
8
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 requirements, as set forth in the Quality Systems Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification only after the Center for Drug Evaluation and Research has approved the drug component of your product. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), promotion, or advertising, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Butman
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
9
510(k) Number (if known): K973000
Device Name: Alimenterics LARA™ Breath Test System
Indications For Use:
The Pylori-Chek Test System is intended for use with the LARA Laser Assisted Ratio Analyzer for the qualitative detection of urease associated with Helicobacter pylori infection in the human stomach and as an aid in the diagnosis of H. pylori infection in symptomatic adult patients. The Pylori-Chek Test system consists of a Pylori-Chek test kit for the collection of breath samples and a LARA Laser Assisted Ratio Analyzer for the measurement of the ratio of 13CO2 to 12CO2 in the breath sample.
For use by healthcare professionals. To be administered under a physician's supervision.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jtton
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K973000
Prescription Use
(Per 21 CFR 801.109)
Or
Over-The-Counter Use
(Optional Format 1-2-96)