(413 days)
No
The device description details a standard immunochromatographic assay based on chemical reactions and visual interpretation of lines. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI/ML. The performance studies focus on agreement with predicate devices, not on the performance of an AI/ML model.
No
This device is a diagnostic tool used to detect antibodies, aiding in the diagnosis of an H. pylori infection. It does not provide treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "to aid in the diagnosis of H. pylori infection."
No
The device is a rapid immunochromatographic assay kit that utilizes physical components like a nitrocellulose membrane, sample window, and evaluation window to perform the test. It is a hardware-based diagnostic test.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of antibodies against Helicobacter pylori (H. pylori) in urine to aid in the diagnosis of H. pylori infection." This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information for diagnosis.
- Device Description: The description details an "immunochromatographic assay" that uses a urine specimen and reagents to detect specific antibodies. This is a typical method used in IVD devices.
- Performance Studies: The document describes clinical studies comparing the device's performance to other established diagnostic tests (HM-CAP™ EIA Test and UBiT-IR300 Infrared Spectrophotometer method), which is a requirement for demonstrating the clinical utility of an IVD.
- Predicate Devices: The mention of predicate devices (other IVDs) further confirms its classification as an IVD.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RAPIRUN H. pylori Antibody Detection Kit is a rapid immunochromatographic assay intended for the qualitative detection of antibodies against Helicobacter pylori (H. pylori) in urine to aid in the diagnosis of H. pylori infection. The RAPIRUN Kit is suitable for use in both point-of-care and clinical laboratory settings.
Product codes
LYR
Device Description
The RAPIRUN H. pylori Antibody Detection Kit is an immunochromatographic method for the qualitative detection of anti-H. pylori antibodies in urine using a nitrocellulose membrane immobilized with proteins extracted from H. pylori as an antigen. The test device includes a sample window in which the test specimen is placed in a dropwise manner and an evaluation window in which a test line and a control line are visible. Colloidal gold-conjugated anti-human IgG (Fc) polyclonal antibody (goat) is present between the sample window and the evaluation window. The test line and the control line in the evaluation window are immobilized with H. pylori-extracted protein and with anti-human IgG polyclonal antibodies (goat), respectively.
When a urine specimen diluted with the sample diluent is added dropwise to the sample window, the IgG in the diluted sample reacts with the conjugated antibodies. Immunocomplexes are formed and flow into the nitrocellulose membrane. If anti-H. pylori IgG antibody complexes are present in these immunocomplexes, they react with the H. pylori antigen immobilizing on the test line and are captured producing a red band. On the other hand, immunocomplexes without anti-H. pylori IgG antibodies pass the test line and are captured by the anti-human IgG polyclonal antibodies (goat) immobilizing on the control line producing a red band. A test specimen is judged to be positive for anti-H. pylori antibodies if red colored bands appear in both the test zone and the control zone, or is judged to be negative for anti-H. pylori antibodies if a red colored band only appears in the control zone.
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
Not Found
Intended User / Care Setting
point-of-care and clinical laboratory settings.
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
A clinical study was conducted to evaluate the performance of the RAPIRUN H. pylori Antibody Detection Kit for the qualitative detection of antibodies to H. pylori in urine. The multi-center, prospective study was designed to compare the RAPIRUN H. pylori Antibody Detection Kit for the qualitative detection of antibodies to H. pylori in urine to the HM-CAP™ H. pylori Enzyme Immunoassay Test for the detection of antibodies to H. pylori in serum and to the UBiT-IR300 Infrared Spectrophotometer method for measuring 13CO2 enrichment in breath. Subjects were recruited at four Physician Office Laboratory (POL)/Point-of-Care (POC) settings. The total number of evaluable subjects was 188 across all participating sites.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing
A series of nonclinical studies was conducted to assess the performance of the RAPIRUN H. pylori Antibody Detection Kit. These studies evaluated reproducibility, interfering substances, cross-reactivity, high-dose hook effect, sample treatment and handling, and kit stability. The results of all studies demonstrated that the RAPIRUN Kit performed according to its specifications.
Clinical Testing
A clinical study was conducted to evaluate the performance of the RAPIRUN H. pylori Antibody Detection Kit for the qualitative detection of antibodies to H. pylori in urine. The multi-center, prospective study was designed to compare the RAPIRUN H. pylori Antibody Detection Kit for the qualitative detection of antibodies to H. pylori in urine to the HM-CAP™ H. pylori Enzyme Immunoassay Test for the detection of antibodies to H. pylori in serum and to the UBiT-IR300 Infrared Spectrophotometer method for measuring 13CO2 enrichment in breath. Subjects were recruited at four Physician Office Laboratory (POL)/Point-of-Care (POC) settings. The total number of evaluable subjects was 188 across all participating sites.
The primary endpoint was the percent agreement of the RAPIRUN Kit results as compared to the HM-CAP™ EIA Test results. Both of these methods are tests for the qualitative detection of antibodies to H. pylori. The percent agreement for all subjects is as follows:
% Overall Agreement: 87.23% [95% CI: (81.97, 91.39)]
% Positive Agreement: 84.71% [95% CI: (75.82, 91.30)]
% Negative Agreement: 89.32% [95% CI:(81.96, 94.31)]
A secondary endpoint was the percent agreement of the RAPIRUN H. pylori Antibody Detection Kit as compared to the UBiT-IR300 Infrared Spectrophotometer method for measurement of 13CO2 enrichment in breath. The percent agreement for all subjects is as follows:
% Overall Agreement: 93.09% [95% CI: (88.51, 96.27)]
% Positive Agreement: 86.46% [95% CI: (78.53, 92.40)]
% Negative Agreement: 100.00% [95% CI:(96.17, 100.00)]
For reference purposes, the results from the HM-CAP™ EIA Test also were compared to the results from the UBiT-IR300 Breath Test. The percent agreement for all subjects is as follows:
% Overall Agreement: 88.83% [95% CI: (83.69, 92.65)]
% Positive Agreement: 83.33% [95% CI: (75.02, 90.16)]
% Negative Agreement: 94.57% [95% CI:(87.97, 97.83)]
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
NOV 16 2006
510(k) Summary for RAPIRUN H. pylori Antibody Detection Kit
1. SPONSOR
Otsuka Pharmaceutical Co., Ltd. 2-9 Kanda Tsukasa-cho, Chiyoda-ku Tokyo 101-8535 Japan
Contact Person:
| Japan: | Kuniaki Natsume |
|---|---|
| Telephone: | 81-3-3257-0539 |
U.S.: Kyoko Tsuchiya Telephone: 720-479-6449
Date Prepared: September 28, 2005
2. DEVICE NAME
| Proprietary Name: | RAPIRUN H. pylori Antibody Detection Kit |
|---|---|
| Common/Usual Name: | Qualitative Immunoassay for H. pylori |
| Classification Name: | Campylobacter pylori |
3. PREDICATE DEVICES
- HM-CAP™ H. pylori Enzyme Immunoassay Test . Enteric Products, Inc. K984544, K955085, K944159
- . UBiT-IR300 Infrared Spectrophotometer Otsuka Pharmaceutical Co., Ltd. K013371
- . Instant-View H. pylori Rapid Test Alfa Scientific Designs, Inc. K024360
1
DEVICE DESCRIPTION 4.
The RAPIRUN H. pylori Antibody Detection Kit is an immunochromatographic method for the qualitative detection of anti-H. pylori antibodies in urine using a nitrocellulose membrane immobilized with proteins extracted from H. pylori as an antigen. The test device includes a sample window in which the test specimen is placed in a dropwise manner and an evaluation window in which a test line and a control line are visible. Colloidal gold-conjugated anti-human IgG (Fc) polyclonal antibody (goat) is present between the sample window and the evaluation window. The test line and the control line in the evaluation window are immobilized with H. pylori-extracted protein and with anti-human IgG polyclonal antibodies (goat), respectively.
When a urine specimen diluted with the sample diluent is added dropwise to the sample window, the IgG in the diluted sample reacts with the conjugated antibodies. Immunocomplexes are formed and flow into the nitrocellulose membrane. If anti-H. pylori IgG antibody complexes are present in these immunocomplexes, they react with the H. pylori antigen immobilizing on the test line and are captured producing a red band. On the other hand, immunocomplexes without anti-H. pylori IgG antibodies pass the test line and are captured by the anti-human IgG polyclonal antibodies (goat) immobilizing on the control line producing a red band. A test specimen is judged to be positive for anti-H. pylori antibodies if red colored bands appear in both the test zone and the control zone, or is judged to be negative for anti-H. pylori antibodies if a red colored band only appears in the control zone.
5. INTENDED USE
The RAPIRUN H. pylori Antibody Detection Kit is a rapid immunochromatographic assay intended for the qualitative detection of antibodies against Helicobacter pylori (H. pylori) in urine to aid in the diagnosis of H. pylori infection. The RAPIRUN Kit is suitable for use in both point-of-care and clinical laboratory settings.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The RAPIRUN Kit and the predicate devices cited above are all qualitative tests intended for use in the diagnosis of H. pylori infection. Like the RAPIRUN Kit, both the HM-CAP™ Test and the Instant-View Test detect IgG antibodies to H. pylori in the test sample. The UBiT-IR300 method measures changes in 1302 content in breath CO2 gas. The test samples vary among the devices. The RAPIRUN Kit is
2
used with urine samples, while the HM-CAP™ Test is used with serum or plasma, the UBiT-IR300 with breath, and the Instant-View Test with whole blood or serum.
Both the RAPIRUN Kit and the Instant-View Test are laminar flow chromatographic immunoassays with detection by visual inspection. The HM-CAP™ Test is an enzyme immunoassay with absorbance measured at 450 nm and the UBiT-IR300 is an infrared spectrophotometric method with detection by infrared absorption. The RAPIRUN Kit, UBiT-IR300, and Instant-View Test are primarily intended for use in point-of-care settings while the HM-CAPTM Test is for use in clinical laboratory settings.
The differences between the RAPIRUN Kit and the predicate devices do not impact the safety or effectiveness of the proposed RAPIRUN Kit for its intended use.
7. PERFORMANCE TESTING
7.1 Nonclinical Testing
A series of nonclinical studies was conducted to assess the performance of the RAPIRUN H. pylori Antibody Detection Kit. These studies evaluated reproducibility, interfering substances, cross-reactivity, high-dose hook effect, sample treatment and handling, and kit stability. The results of all studies demonstrated that the RAPIRUN Kit performed according to its specifications.
7.2 Clinical Testing
A clinical study was conducted to evaluate the performance of the RAPIRUN H. pylori Antibody Detection Kit for the qualitative detection of antibodies to H. pylori in urine. The multi-center, prospective study was designed to compare the RAPIRUN H. pylori Antibody Detection Kit for the qualitative detection of antibodies to H. pylori in urine to the HM-CAP™ H. pylori Enzyme Immunoassay Test for the detection of antibodies to H. pylori in serum and to the UBiT-IR300 Infrared Spectrophotometer method for measuring 13CO2 enrichment in breath. Subjects were recruited at four Physician Office Laboratory (POL)/Point-of-Care (POC) settings. The total number of evaluable subjects was 188 across all participating sites.
3
The primary endpoint was the percent agreement of the RAPIRUN Kit results as compared to the HM-CAP™ EIA Test results. Both of these methods are tests for the qualitative detection of antibodies to H. pylori. The percent agreement for all subjects is as follows:
| % Overall Agreement: | 87.23% | [95% CI: (81.97, 91.39)] |
|---|---|---|
| % Positive Agreement: | 84.71% | [95% CI: (75.82, 91.30)] |
| % Negative Agreement: | 89.32% | [95% CI:(81.96, 94.31)] |
A secondary endpoint was the percent agrecment of the RAPIRUN H. pylori Antibody Detection Kit as compared to the UBiT-IR300 Infrared Spectrophotometer method for measurement of '300_enrichment in breath. The percent agreement for all subjects is as follows:
| % Overall Agreement: | 93.09% [95% CI: (88.51, 96.27)] |
|---|---|
| % Positive Agreement: | 86.46% [95% CI: (78.53, 92.40)] |
| % Negative Agreement: | 100.00% [95% CI:(96.17, 100.00)] |
For reference purposes, the results from the HM-CAP™ EIA Test also were compared to the results from the UBiT-IR300 Breath Test. The percent agreement for all subjects is as follows:
| % Overall Agreement: | 88.83% [95% CI: (83.69, 92.65)] |
|---|---|
| % Positive Agreement: | 83.33% [95% CI: (75.02, 90.16)] |
| % Negative Agreement: | 94.57% [95% CI:(87.97, 97.83)] |
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Otsuka Pharmaceutical Co., Ltd. Cynthia A. Sinclair, RAC Principal Consultant, Regulatory Services Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
NOV 16 2006
K052716 Re:
Trade/Device Name: RAPIRUN H. pylori Antibody Detection Kit Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter Fetus Serological Reagents Regulatory Class: Class I Product Code: LYR Dated: October 3, 2006 Received: October 5, 2006
Dear Ms. Sinclair:
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).
5
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 (240)276-0450. 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,
Sally antrom
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name: __ RAPIRUN H. pylori Antibody Detection Kit
Indications for Use:
The RAPIRUN H. pylori Antibody Detection Kit is a rapid immunochromatographic assay. intended for the qualitative detection of antibodies against Helicobacter pylori (H. pylori) in urine to aid in the diagnosis of H. pylori infection. The RAPIRUN Kit is suitable for use in both point-of-care and clinical laboratory settings.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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 Device Evaluation and Safety (OIVD)
Rucell. Park.
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K052716
Otsuka Pharmaceutical Co., Ltd. 510(k) RAPIRUN H. pylori Antibody Detection Kit
September 28, 2005
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