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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Alere Signify® H. pylori and Alere Clearview® H. pylori tests, which are rapid chromatographic immunoassays for the qualitative detection of IgG antibodies to Helicobacter pylori.

Here's an analysis of the acceptance criteria and study information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a table format with specific thresholds (e.g., Sensitivity > X%, Specificity > Y%). Instead, it describes a performance study related to interfering substances and concludes substantial equivalence based on the device's expected performance and lack of interference.

Implied Acceptance Criterion: The tests should produce expected (correct) positive or negative results in the presence of various interfering substances.
Reported Device Performance: All negative and positive H. pylori samples tested as expected, with no false results, even in the presence of high levels of triglycerides.

Acceptance Criteria (Implied)	Reported Device Performance
Absence of interference from high levels of hemoglobin	No interference with the H. pylori test results was observed in samples containing high levels of hemoglobin (up to 1,000 mg/dL).
Absence of interference from high levels of bilirubin	No interference with the H. pylori test results was observed in samples containing high levels of bilirubin (up to 1,000 mg/dL).
Absence of interference from high levels of human serum albumin	No interference with the H. pylori test results was observed in samples containing high levels of human serum albumin (up to 2,000 mg/mL).
Absence of interference from high levels of triglycerides	No interference was observed. H. pylori standards (low positive and high positive) and a negative plasma sample, spiked with two concentrations of triglyceride (797 mg/dL and 3454 mg/dL), all tested as expected with no false results due to the presence of high levels of triglycerides. (This was a specific study to address a difference with the predicate, which also reported no interference with triglycerides up to 1000 mg/dL).
Stable performance with varying hematocrit levels	The test results were unaffected when the hematocrit was altered, ranging from 20% to 67%.
Consistent expected results for positive and negative H. pylori samples	All negative and positive H. pylori samples tested as expected in the interfering substance study.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size:
- For the interfering substance study related to triglycerides:
  - H. pylori standards: low positive (presumably 1 sample) and high positive (presumably 1 sample).
  - H. pylori negative plasma sample: 1 sample.
  - Each of these 3 samples was spiked with two concentrations of triglyceride reference material.
  - Each spiked sample was tested in replicates of three.
  - Three unspiked replicates of each H. pylori standard and negative sample were also tested.
  - Calculation: (2 positive standards + 1 negative sample) * (2 triglyceride concentrations * 3 replicates + 3 unspiked replicates) = 3 * (6 + 3) = 3 * 9 = 27 tests in total for the triglyceride study. This is a very small sample size focused specifically on interference, not diagnostic accuracy.
- For other interfering substances (hemoglobin, bilirubin, human serum albumin, hematocrit), the document mentions "samples containing high levels" but does not specify the exact number of distinct samples or replicates tested.
Data Provenance: Not explicitly stated (e.g., country of origin). However, given the context of a medical device submission to the FDA, it is typically expected to be from a controlled laboratory setting. It is a retrospective analysis of prepared samples designed to evaluate interference.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document describes an interfering substance study, not a clinical study requiring expert diagnosis of H. pylori. The "ground truth" for the test set in this context refers to whether the samples were genuinely positive or negative for H. pylori, as well as the known concentration of the interfering substances.
The ground truth (e.g., low positive, high positive, negative H. pylori samples, and known concentrations of spiked triglycerides) would have been established by laboratory methods or reference materials.
No human experts (like radiologists) were involved in establishing the ground truth for this specific type of performance study presented.

4. Adjudication Method for the Test Set

None directly applicable as this was not an expert review or clinical trial for diagnostic accuracy. The results were assessed against expected outcomes (positive should remain positive, negative should remain negative).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes a laboratory-based interfering substance study, not a clinical study comparing human reader performance with and without AI assistance. The device itself is a rapid immunoassay, not an AI-powered diagnostic system requiring human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device itself is a standalone diagnostic (a rapid immunoassay, not an algorithm in the traditional AI sense), the performance data presented is for the device's reaction to spiked samples under controlled lab conditions, not its standalone diagnostic accuracy in a clinical population. The device provides a visual result (colored lines) that is interpreted.

7. The Type of Ground Truth Used

The ground truth used for the interfering substance study was based on known H. pylori positive/negative status of the samples (presumably established by reference methods or manufacturing standards for the "standards" used) and known spiked concentrations of interfering substances. This is a form of laboratory-controlled ground truth.

8. The Sample Size for the Training Set

The document does not mention a training set in the context of machine learning or AI. This device is a lateral flow immunoassay, which does not typically involve "training data" in the AI sense for its core function. Its design and performance are based on biochemical interactions.

9. How the Ground Truth for the Training Set Was Established

Not applicable as there is no mention of a training set for an algorithm.

Summary

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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

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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

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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)

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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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 Specialist858-805-3181Joseph.delarosa@alere.com
Date Prepared:	August 10, 2015

DEVICE IDENTIFICATION

Trade or Proprietary Names:	Alere Signify® H. pylori – Whole Blood, Serum, PlasmaAlere Signify® H. pylori – Whole Blood OnlyAlere Clearview® H. pylori – Whole Blood, Serum, PlasmaAlere 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

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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 chromatographicimmunoassay for the qualitative detection of IgG antibodies toHelicobacter pylori in whole blood, serum or plasma to aid inthe diagnosis of H. pylori infection in adults 18 years of age andolder.
Alere Signify® H. pylori -Whole Blood Only	The Signify® H. pylori cassette (Whole Blood) is a rapidchromatographic immunoassay for the qualitative detection ofIgG antibodies to Helicobacter pylori in whole blood to aid inthe diagnosis of H. pylori infection in adults 18 years of age andolder.
Alere Clearview® H. pylori -Whole Blood, Serum, Plasma	The Clearview® H. pylori test is a rapid chromatographicimmunoassay for the qualitative detection of IgG antibodies toHelicobacter pylori in whole blood, serum or plasma to aid inthe diagnosis of H. pylori infection in adults 18 years of age andolder.
Alere Clearview® H. pylori -Whole Blood Only	The Clearview® H. pylori test is a rapid chromatographicimmunoassay for the qualitative detection of IgG antibodies toHelicobacter 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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COMPARISON WITH PREDIC ATE

Attribute	Alere H. pylori Immunoassays	ACON H. pylori Rapid TestStrip and Test Device(K024350)
Similarities
Intended Use	The Alere H. pylori cassette is a rapidchromatographic immunoassay for thequalitative detection of IgG antibodies toHelicobacter pylori in whole blood, serumor plasma to aid in the diagnosis of H.pylori infection in adults 18 years of ageand older.	Same
Format	Qualitative lateral flow antigen/antibodyimmunoassay	Same
Sample	Whole blood, serum, plasma	Same
Minimum samplevolume	Approximately 50 µL	Same
Analyte	IgG antibodies specific to Helicobacterpylori in human blood, serum or plasma	Same
Quality control	Control region bound to test strip. Redline in control region indicates validsample application. Positive and negativecontrol sample included in kit.	Same
Test Time	10 minutes	Same
Endpoint	Colored lines	Same
Differences
Interferingsubstances	No interference with the H. pylori testresults was observed in samplescontaining high levels of hemoglobin (up	No interference with ACON H.Pylori Rapid Test Device (WholeBlood/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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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.

Regulation Number and Section

§ 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).