(29 days)
No
The device description details a lateral flow immunochromatographic assay, which is a traditional biochemical test. There is no mention of AI, ML, image processing, or any computational analysis of the results. The interpretation is based on the visual appearance of colored lines.
No
The device aids in diagnosis by detecting antibodies, it does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device aids "in the diagnosis of H. pylori infection."
No
The device description clearly outlines a physical lateral flow immunochromatographic assay with a membrane strip, plastic housing, and chemical reactions, indicating it is a hardware-based diagnostic test, not software only.
Based on the provided text, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "qualitative detection of IgG antibodies to Helicobacter pylori in whole blood, serum or plasma to aid in the diagnosis of H. pylori infection". This clearly indicates that the device is used to test samples taken from the human body (in vitro) to provide information for diagnostic purposes.
- Device Description: The description details a "rapid chromatographic immunoassay" that analyzes "whole blood, serum and plasma" samples to detect specific antibodies. This aligns with the typical characteristics of an in vitro diagnostic test.
- Performance Studies: The mention of performance studies conducted on "plasma, serum and whole blood samples" further supports its use with biological specimens outside of the body.
The definition of an IVD is a medical device that is used to perform tests on samples such as blood, urine, or tissues, to detect diseases or other conditions. The provided information perfectly fits this definition.
N/A
Intended Use / Indications for Use
The Signify® H. pylori cassette is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.
The Signify® H. pylori cassette is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.
The Clearview® H. pylori test is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.
The Clearview® H. pylori test is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.
Product codes
LYR
Device Description
The Alere H. pylori tests are lateral flow immunochromatographic assays for the qualitative detection of Immunoglobulin G (IgG) antibodies to Helicobacter pylori (H. pylori) in whole blood, serum and plasma. The test devices consist of a membrane strip coated with immobilized human IgG antibodies and H. pylori antigen encased in a plastic housing. In the test procedure, anti-human IgG is immobilized in the test line region of the cassette. The sample reacts with H. pylori antigen-coated particles that have been applied to the label pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized anti-human IgG. If the sample contains H. pylori IgG antibodies, a colored line will appear in the test line region indicating a positive result. If the sample does not contain H. pylori IgG antibodies, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of sample has been added and membrane wicking has occurred.
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
adults 18 years of age and older.
Intended User / Care Setting
Not Found
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
An interfering substance study was conducted to determine the performance of the H. pylori tests when testing samples with increased levels of triglycerides. Separate tests were conducted for plasma, serum and whole blood samples.
H. pylori standards - low positive and high positive - plus an H. pylori negative plasma sample were spiked each with two concentrations of triglyceride reference material (797 mg/dL and 3454 mg/dL) and tested in replicates of three per sample. Three unspiked replicates of each of the H. pylori standards and negative were also tested.
Summary of Performance Studies
Interfering substance study.
All negative and positive H. pylori samples tested as expected with no false results due to the presence of high levels of triglycerides in the samples.
Key Metrics
Not Found
Predicate Device(s)
Alere H. pylori Rapid Test Strip and Test Device
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, with flowing lines extending from the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ALERE SAN DIEGO, INCORPORATED JOSEPH DE LA ROSA RA SPECIALIST 9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121
August 12, 2015
Re: K151935
Trade/Device Name: Alere Signify H. pvlori Whole Blood. Serum, Plasma Alere Signify H. pvlori Whole Blood Only Alere Clearview H. pylori Whole Blood, Serum, Plasma Alere Clearview H. pylori Whole Blood Only Regulation Number: 21 CFR 866.3110
Regulation Name: Campylobacter fetus serological reagents Regulatory Class: I Product Code: LYR Dated: July 13, 2015 Received: July 14, 2015
Dear Mr. De La Rosa:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Uwe Scherf -S
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151935
Device Name
Alere Signify® H. pylori – Whole Blood, Serum, Plasma; Alere Signify® H. pylori - Whole Blood Only; Alere Clearview® H. pylori – Whole Blood, Serum, Plasma;
Indications for Use (Describe)
The Signify® H. pylori cassette is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.
The Signify® H. pylori cassette is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.
The Clearview® H. pylori test is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.
The Clearview® H. pylori test is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image features a square with rounded corners, filled with a solid magenta color. The word "Alere" is prominently displayed in white, sans-serif font within the square. In the bottom right corner, the letters "TM" are visible, indicating a trademark symbol.
510(K) SUMMARY
GENERAL INFORMATION Submitted By: Alere, Inc. 9975 Summers Ridge Road San Diego, CA 92121 Establishment # 2027969
| Company Contact: | Joseph De La Rosa |
|---|---|
| Regulatory Affairs Specialist | |
| 858-805-3181 | |
| Joseph.delarosa@alere.com | |
| Date Prepared: | August 10, 2015 |
DEVICE IDENTIFICATION
| Trade or Proprietary Names: | Alere Signify® H. pylori – Whole Blood, Serum, Plasma
Alere Signify® H. pylori – Whole Blood Only
Alere Clearview® H. pylori – Whole Blood, Serum, Plasma
Alere Clearview® H. pylori – Whole Blood Only |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Qualitative Immunoassay for H. pylori |
| Device Classification Name: | Campylobacter pylori |
| Product Code: | LYR |
| Regulatory Class: | Class I (reserved) |
| Classification Regulation: | 21 CFR 866.3110 |
| Predicate Device: | Alere H. pylori Rapid Test Strip and Test Device |
DEVICE DESCRIPTION
The Alere H. pylori tests are lateral flow immunochromatographic assays for the qualitative detection of Immunoglobulin G (IgG) antibodies to Helicobacter pylori (H. pylori) in whole blood, serum and plasma. The test devices consist of a membrane strip coated with immobilized human IgG antibodies and H. pylori antigen encased in a plastic housing. In the test procedure, anti-human IgG is immobilized in the test line region of the cassette. The sample reacts with H. pylori antigen-coated particles that have been applied to the label pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized anti-human IgG. If the sample contains H. pylori IgG antibodies, a colored line will appear in the test line region
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Image /page/4/Picture/0 description: The image shows the logo for Alere. The logo consists of a purple square with a rounded corner at the top right. The word "Alere" is written in white, sans-serif font in the bottom left corner of the square. The letters are bold and slightly spaced apart. A trademark symbol is located in the bottom right corner of the square.
indicating a positive result. If the sample does not contain H. pylori IgG antibodies, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of sample has been added and membrane wicking has occurred.
Intended Use
The Alere H. pylori Immunoassay intended use statements are as follows:
| Product Name | Intended Use |
|---|---|
| Alere Signify® H. pylori - | |
| Whole Blood, Serum, Plasma | The Signify® H. pylori cassette is a rapid chromatographic |
| immunoassay for the qualitative detection of IgG antibodies to | |
| Helicobacter pylori in whole blood, serum or plasma to aid in | |
| the diagnosis of H. pylori infection in adults 18 years of age and | |
| older. | |
| Alere Signify® H. pylori - | |
| Whole Blood Only | The Signify® H. pylori cassette (Whole Blood) is a rapid |
| chromatographic immunoassay for the qualitative detection of | |
| IgG antibodies to Helicobacter pylori in whole blood to aid in | |
| the diagnosis of H. pylori infection in adults 18 years of age and | |
| older. | |
| Alere Clearview® H. pylori - | |
| Whole Blood, Serum, Plasma | The Clearview® H. pylori test is a rapid chromatographic |
| immunoassay for the qualitative detection of IgG antibodies to | |
| Helicobacter pylori in whole blood, serum or plasma to aid in | |
| the diagnosis of H. pylori infection in adults 18 years of age and | |
| older. | |
| Alere Clearview® H. pylori - | |
| Whole Blood Only | The Clearview® H. pylori test is a rapid chromatographic |
| immunoassay for the qualitative detection of IgG antibodies to | |
| Helicobacter pylori in whole blood to aid in the diagnosis of H. | |
| pylori infection in adults 18 years of age and older. |
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Image /page/5/Picture/0 description: The image features a logo for a company or brand named "Alere." The logo consists of the word "Alere" in a bold, sans-serif font, positioned in the lower-left corner of a solid, dark pink or magenta square with a rounded upper-right corner. The letters are white, creating a strong contrast against the colored background, and there is a trademark symbol (TM) in the bottom right corner.
COMPARISON WITH PREDIC ATE
| Attribute | Alere H. pylori Immunoassays | ACON H. pylori Rapid Test
Strip and Test Device
(K024350) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | The Alere H. pylori cassette is a rapid
chromatographic immunoassay for the
qualitative detection of IgG antibodies to
Helicobacter pylori in whole blood, serum
or plasma to aid in the diagnosis of H.
pylori infection in adults 18 years of age
and older. | Same |
| Format | Qualitative lateral flow antigen/antibody
immunoassay | Same |
| Sample | Whole blood, serum, plasma | Same |
| Minimum sample
volume | Approximately 50 µL | Same |
| Analyte | IgG antibodies specific to Helicobacter
pylori in human blood, serum or plasma | Same |
| Quality control | Control region bound to test strip. Red
line in control region indicates valid
sample application. Positive and negative
control sample included in kit. | Same |
| Test Time | 10 minutes | Same |
| Endpoint | Colored lines | Same |
| Differences | | |
| Interfering
substances | No interference with the H. pylori test
results was observed in samples
containing high levels of hemoglobin (up | No interference with ACON H.
Pylori Rapid Test Device (Whole
Blood/Serum/Plasma results was observed) |
to 1,000 mg/dL), bilirubin (up to 1,000 observed in samples containing mg/dL) and human serum albumin (up high levels of hemoglobin (up to to 2,000 mg/mL) and triglycerides (up to 1000 mg/dL), bilirubin (up to 1000 mg/dL) and human serum albumin 3454 mg/dL). The test results were also unaffected when the hematocrit was (up to 2000 mg/mL). The test results were also unaffected when altered ranging from 20% to 67%. the hematocrit was altered ranging from 20% to 67%.
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Image /page/6/Picture/0 description: The image is a logo for Alere. The logo is a square with rounded corners, and the square is a dark pink color. The word "Alere" is written in white letters on the bottom left corner of the square. The font is sans-serif and the letters are bold. There is a trademark symbol on the bottom right corner of the square.
PERFORMANCE DATA
An interfering substance study was conducted to determine the performance of the H. pylori tests when testing samples with increased levels of triglycerides. Separate tests were conducted for plasma, serum and whole blood samples.
H. pylori standards - low positive and high positive - plus an H. pylori negative plasma sample were spiked each with two concentrations of triglyceride reference material (797 mg/dL and 3454 mg/dL) and tested in replicates of three per sample. Three unspiked replicates of each of the H. pylori standards and negative were also tested. All negative and positive H. pylori samples tested as expected with no false results due to the presence of high levels of triglycerides in the samples.
CONCLUSIONS
The differences indicated between the modified labeling for the device and the predicate do not constitute a new intended use. There are no changes to the safety and effectiveness of the device and the impact on clinical management and patient health. Therefore the device with modified labeling is considered substantially equivalent to the predicate.