(88 days)
LIAISON® H. pylori IgG Control Set (K161139)
No
The description details a standard chemiluminescent immunoassay and analyzer, with no mention of AI or ML in the assay process, data analysis, or device operation.
No
The device is an in vitro diagnostic (IVD) assay designed to detect H. pylori antigen in stool samples for diagnostic purposes and to measure post-therapy response. It does not directly treat or alleviate a disease, but rather provides information to assist clinicians in diagnosis and management decisions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "is an aid in the diagnosis of patients suspected of H. pylori infection and to measure post therapy response".
No
The device is a chemiluminescent immunoassay (CLIA) that involves physical reagents, sample processing, and analysis on a dedicated hardware analyzer (LIAISON® XL Analyzer). It is not solely software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative determination of Helicobacter pylori (H. pylori) antigen in human stool." This is a test performed on a sample taken from the human body (stool) to provide information about a medical condition (H. pylori infection).
- Device Description: The description details a "chemiluminescent immunoassay (CLIA)" that detects H. pylori antigen in extracted stool samples. This is a laboratory-based test method.
- Performance Studies: The document describes clinical studies comparing the device's performance to established diagnostic methods (Histological Evaluation, Culture, Urease Detection Test) for diagnosing H. pylori infection.
- Predicate Device: The mention of predicate devices (K053335 and K161139) which are also IVDs further supports its classification as an IVD.
The core function of the device is to analyze a biological sample (stool) in vitro (outside the body) to aid in the diagnosis of a disease. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LIAISON® Helicobacter Antigen assay is a chemiluminescent immunoassay (CLIA) intended for the qualitative determination of Helicobacter pylori (H. pylori) antigen in human stool. The test is an aid in the diagnosis of patients suspected of H. pylori infection and to measure post therapy response from patients who have discontinued therapy for at least 4 weeks. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions.
The test must be performed on the LIAISON® XL Analyzer.
The LIAISON® Helicobacter Antigen Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Helicobacter Antigen assay.
The performance characteristics of the LIAISON® Helicobacter Antigen Control Set have not been established for any other assay or instrument platforms different from the LIAISON® XL.
Product codes
LYR, JJX, JJF
Device Description
The LIAISON® Helicobacter Antigen assay is a delayed one-step sandwich assay for detection of H. pylori stool antigen. H. pylori antigen is first extracted from human stool samples with sample diluent using the LIAISON® Stool Extraction Device.
The assay uses a monoclonal antibody for detection of H. pylori stool antigen. The assay uses 200 µL of sample consisting of a mixture of extraction buffer and stool extracted H. pylori stool antigen which is incubated with paramagnetic particles coated with a capture antibody for H. pylori stool antigen. Following incubation, an isoluminol conjugated antibody for H. pylori stool antigen is added to the reaction and incubated. After the second incubation, the unbound material is removed with a wash cycle. The starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of H. pylori stool antigen present in the calibrators, controls or samples.
All assay steps and incubations are performed by the LIAISON® XL Analyzer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human stool
Indicated Patient Age Range
The pre-therapy study population consisted of 277 male or female adult subjects (>= 22 years),
The post-therapy study population consisted of 8 male or female adult subjects (>= 22 years)
Known ages ranged from 22 to 87 years old.
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
The prospective study consisted of 285 specimens collected from subjects undergoing evaluation for H. pylori infection to determine infection status both pre and post therapy. Prospective samples were collected at multiple sites, and regions, within the US and outside the US (OUS).
The pre-therapy study population consisted of 277 male or female adult subjects (>= 22 years), undergoing evaluation to determine H. pylori infection status prior to any therapeutic intervention.
The post-therapy study population consisted of 8 male or female adult subjects (>= 22 years), undergoing evaluation to measure post therapy response for H. Pylori.
The observed prevalence of the LIAISON® Helicobacter Antigen assay was calculated from the 277 specimens obtained from eligible subjects of the pre-therapy population who underwent EGD with signs and symptoms of a Helicobacter pylori infection. The specimens were from 86 males (31%) and 191 females (69%), collected from multiple U.S. and OUS geographical locations.
Annotation Protocol: Compared the performance of the LIAISON® Helicobacter Antigen assay to at least two of the three methods which comprise the Composite Reference Method (CRM): Histological Evaluation, Culture of the Organism, and Urease Detection Test.
Summary of Performance Studies
Study type: Comparative Clinical Study, Precision/Reproducibility Study.
Sample size:
Clinical Study: 285 specimens (277 for pre-therapy, 8 for post-therapy)
Precision/Reproducibility: 6 contrived antigen samples and kit controls tested in duplicate (12 day study, 48 samples per run) and in triplicates (5 day study) at multiple sites.
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key results:
Clinical Performance (Pre-Therapy Population, N=277):
Clinical Specificity: 207/210 = 98.6% (95% CI: 95.9 – 99.7%)
Clinical Sensitivity: 64/67 = 95.5% (95% CI: 87.5 – 99.1%)
Clinical Performance (Post-Therapy Population, N=8):
Clinical Sensitivity: 8/8 = 100% (95% CI: 63.1 - 100%)
Precision/Reproducibility (12 Day Study, N=48 per sample mean):
Within-Laboratory Precision:
Neg Ctrl: Total SD 0.00, %CV 7.8% (first entry) and 8.8% (second entry)
Pos Ctrl: Total SD 0.07, %CV 2.6% (first entry) and 2.7% (second entry)
Sample #1: Total SD 0.04, %CV 4.7%
Sample #2: Total SD 0.04, %CV 4.9%
Sample #3: Total SD 0.08, %CV 4.1%
Sample #4: Total SD 0.08, %CV 4.2%
Sample #5: Total SD 0.10, %CV 3.3%
Sample #6: Total SD 0.12, %CV 3.9%
Precision/Reproducibility (5 Day Study):
Reproducibility (Total %CV):
Neg Ctrl: 13.9% (first entry) and 11.5% (second entry)
Pos Ctrl: 3.1% (first entry) and 3.3% (second entry)
Sample #1: 8.0%
Sample #2: 11.9%
Sample #3: 11.8%
Sample #4: 11.0%
Sample #5: 9.0%
Sample #6: 11.5%
Key Metrics
Clinical Specificity (Pre-Therapy): 98.6% (207/210)
Clinical Sensitivity (Pre-Therapy): 95.5% (64/67)
Clinical Sensitivity (Post-Therapy): 100% (8/8)
Predicate Device(s)
Meridian Platinum Premier HpSA PLUS Reference_K053335 assay
Reference Device(s)
LIAISON® H. pylori IgG Control Set (K161139)
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol of the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it, also in blue.
August 31, 2018
DiaSorin Inc. Sandra Zimniewicz Regulatory Affairs Specialist 1951 Northwestern Ave. Stillwater. Minnesota 55082-0285
Re: K181464
Trade/Device Name: LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter fetus serological reagents Regulatory Class: Class I Product Code: LYR, JJX, JJF Dated: June 5, 2018 Received: June 6, 2018
Dear Sandra Zimniewicz:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ribhi Shawar -S
For
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) K181464
Device Name
LIAISON® Helicobacter Antigen LIAISON® Helicobacter Antigen Control Set
Indications for Use (Describe)
The LIAISON® Helicobacter Antigen assay is a chemiluminescent immunoassay (CLIA) intended for the qualitative determination of Helicobacter pylori (H. pylori) antigen in human stool. The test is an aid in the diagnosis of patients suspected of H. pylori infection and to measure post therapy response from patients who have discontinued therapy for at least 4 weeks. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions.
The test must be performed on the LIAISON® XL Analyzer.
The LIAISON® Helicobacter Antigen Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Helicobacter Antigen assay.
The performance characteristics of the LIAISON® Helicobacter Antigen Control Set have not been established for any other assay or instrument platforms different from the LIAISON® XL.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
| SUBMITTED BY: | Sandra Zimniewicz
Regulatory Affairs Specialist
DiaSorin Inc.
1951 Northwestern Avenue
P.O. Box 285
Stillwater, MN 55082-0285
Phone (651) 351-5711
Fax (651) 351-5711
Email: sandra.zimniewicz@diasorin.com |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | August 31, 2018 |
| NAME OF DEVICE: | |
| Trade Name: | LIAISON® Helicobacter Antigen
LIAISON® Helicobacter Antigen Control Set |
| Common Names/Descriptions: | Helicobacter pylori Antigen assay and
Helicobacter pylori Antigen controls |
| Classification Names: | Campylobacter fetus serological reagents:
Class I, 21 CFR: 866.3110; Microbiology (83) |
| | Single (Specified) analyte controls (assayed
and unassayed): Class I,
21 CFR 862.1660; Clinical Chemistry (75) |
| Product Code: | LYR - Campylobacter fetus serological reagents
JJX - Single (Specified) analyte controls
(assayed and unassayed)
JJF – Analyzer, Chemistry, Micro,
For Clinical Use |
| PREDICATE DEVICES : | Meridian Platinum Premier HpSA PLUS
Reference_K053335 assay
LIAISON® H. pylori IgG Control Set (K161139) |
DEVICE DESCRIPTION:
INTENDED USE:
The LIAISON® Helicobacter Antigen assay is a chemiluminescent immunoassay (CLIA) intended for the qualitative determination of Helicobacter pylori (H. pylori) antigen in human stool. The test is an aid in the diagnosis of patients suspected of H. pylori infection and to measure post therapy response from patients who have discontinued therapy for at least 4 weeks. Assay results should be used in conjunction with other
4
clinical and laboratory data to assist the clinician in making individual patient management decisions.
The test must be performed on the LIAISON® XL Analyzer.
The LIAISON® Helicobacter Antigen Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Helicobacter Antigen assay. The performance characteristics of the LIAISON® Helicobacter Antigen Control Set have not been established for any other assay or instrument platforms different from the LIAISON® XL.
KIT DESCRIPTION:
controls or samples.
The LIAISON® Helicobacter Antigen assay is a delayed one-step sandwich assay for detection of H. pylori stool antigen. H. pylori antigen is first extracted from human stool samples with sample diluent using the LIAISON® Stool Extraction Device.
The assay uses a monoclonal antibody for detection of H. pylori stool antigen. The assay uses 200 µL of sample consisting of a mixture of extraction buffer and stool extracted H. pylori stool antigen which is incubated with paramagnetic particles coated with a capture antibody for H. pylori stool antigen. Following incubation, an isoluminol conjugated antibody for H. pylori stool antigen is added to the reaction and incubated. After the second incubation, the unbound material is removed with a wash cycle. The starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of H. pylori stool antigen present in the calibrators,
All assay steps and incubations are performed by the LIAISON® XL Analyzer.
| Similarities | ||
|---|---|---|
| Item | Device: LIAISON® Helicobacter | |
| Antigen (K181464) | Predicate: Premier | |
| Platinum HpSA PLUS | ||
| (K053335) | ||
| Product Code | LYR | Same |
| Intended Use | The LIAISON® Helicobacter Antigen | |
| assay is a chemiluminescent | ||
| immunoassay (CLIA) intended for the | ||
| qualitative determination of | ||
| Helicobacter pylori (H. pylori) antigen | ||
| in human stool. The test is an aid in | ||
| the diagnosis of patients suspected of | ||
| H. pylori infection and to measure post | ||
| therapy response from patients who | ||
| have discontinued therapy for at least | ||
| 4 weeks. Assay results should be used | ||
| in conjunction with other clinical and | The Premier Platinum | |
| HpSA PLUS enzyme | ||
| immunoassay (EIA) is an in | ||
| vitro qualitative procedure | ||
| for the detection of | ||
| Helicobacter pylori | ||
| antigens in human stool. | ||
| Test results are intended to | ||
| aid in the diagnosis of H. | ||
| pylori infection and to | ||
| monitor response during | ||
| and post-therapy in |
COMPARISON TO FDA CLEARED METHOD
5
| Similarities | ||
|---|---|---|
| Item | Device: LIAISON® Helicobacter | |
| Antigen (K181464) | Predicate: Premier | |
| Platinum HpSA PLUS | ||
| (K053335) | ||
| laboratory data to assist the clinician in | ||
| making individual patient management | ||
| decisions. | ||
| The test must be performed on the | ||
| LIAISON® XL Analyzer. | ||
| The LIAISON® Helicobacter Antigen | ||
| Control Set is intended for use as | ||
| assayed quality control samples to | ||
| monitor the performance of the | ||
| LIAISON® Helicobacter Antigen assay. | ||
| The performance characteristics of the | ||
| LIAISON® Helicobacter Antigen | ||
| Control Set have not been established | ||
| for any other assay or instrument | ||
| platforms different from the LIAISON® | ||
| XL. | patients. Accepted medical | |
| practice recommends that | ||
| testing by any current | ||
| method, to confirm | ||
| eradication, be done at | ||
| least four weeks following | ||
| completion of therapy. | ||
| Results | Qualitative | Same |
| Measurand | H. pylori antigen | Same |
| Specimen | ||
| Required | Stool | Same |
| Differences | ||
|---|---|---|
| Item | Device: LIAISON Helicobacter Antigen | |
| (K181464) | Predicate: Premier | |
| Platinum HpSA PLUS | ||
| (K053335) | ||
| Limit of | ||
| Detection | 4 ng/mL | $\ge$ 4.67 ng/mL in stool |
| Technology | Automated Chemiluminescent | |
| Immunoassay (CLIA) | Manual/Semiautomated | |
| Enzyme Immunoassay | ||
| (EIA) | ||
| Cutoff | 1.1 Index (for positive) | 0.100 at OD450/630 |
| Interpretation | Negative |