(49 days)
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 patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.
The PREMIER Platinum HpSA® PLUS test is a microwell-based enzyme immunoassay that detects H. pylori antigens present in human stool. The test utilizes a plurality (mixture) of monoclonal antibodies adsorbed to microwells. Diluted patient samples and an enzyme conjugate reagent are added to the microwells and incubated for one hour at room temperature. A wash is performed to remove unbound material. Substrate is added and incubated for 10 minutes at room temperature. Color develops in the presence of bound enzyme. Stop solution is added and the results are interpreted visually or spectrophotometrically. No calculations are required and the visual color change makes the interpretation of results objective and simple.
In addition, the HpSA test permits assessment of established or novel anti-H. pylori treatment during and posttherapy to monitor for treatment effectiveness, relapse or eradication.
PREMIER Platinum HpSA PLUS (K053335), as the predicate device for this submission, was a modification of PREMIER Platinum HpSA (K983255, K980076) that provided increased signal strengths with positive test results and better discrimination between low positive and negative tests. This submission is for modifications to the antibodies used in the microwells and conjugate reagent.
The PREMIER Platinum HpSA PLUS assay is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool, intended to aid in the diagnosis of H. pylori infection and to monitor response during and post-therapy.
Here's the breakdown of the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The modification being assessed is to the antibodies used in the microwells and conjugate reagent of the PREMIER Platinum HpSA® PLUS. The relevant performance characteristics for comparison are based on the predicate device.
| Performance Metric | Acceptance Criteria (Predicate Device) | Reported Device Performance (Modified Device) |
|---|---|---|
| Analytical Sensitivity (LoD) | ≥ 4.67 ng H. pylori protein/mL of stool | 4.66 ng H. pylori protein/mL of stool (meets) |
| Clinical Sensitivity (PPA) | 100% | 100% |
| Clinical Specificity (NPA) | 94.8% | 100% |
| Reproducibility | Not explicitly stated as a minimum, but implied to be high based on predicate acceptance | 100% (300/300) of results as expected |
| Cross-Reactivity | None of the listed organisms affected positive or negative test results | None of the listed organisms affected positive or negative test results |
| Interfering Substances | None of the listed substances interfered with positive or negative test results | None of the listed substances interfered with positive or negative test results |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Study: 159 archived, unpreserved stool samples.
- Data Provenance: The samples were from symptomatic patients but no country of origin is specified. The samples were "archived," indicating a retrospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The documentation does not provide details on the number or qualifications of experts used to establish the ground truth for this specific clinical study comparing the modified device to the predicate. The "ground truth" for this comparison was the result obtained from the predicate device itself.
4. Adjudication Method for the Test Set
Not applicable. The study involved a direct comparison of the modified device's results against the predicate device's results. There was no independent adjudication of individual cases against an external ground truth in the traditional sense, as the predicate served as the reference.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an in-vitro diagnostic (EIA) test for detecting antigens, not an imaging or diagnostic aid that involves human readers interpreting results in a variable manner. The interpretation of results is visual or spectrophotometric, implying a more objective, less reader-dependent outcome.
6. Standalone Performance Study
Yes, a standalone performance of the modified device was effectively demonstrated by comparing its results against the predicate device on the same set of samples. The performance metrics (sensitivity, specificity, reproducibility, analytical sensitivity, cross-reactivity, interfering substances) are all measures of the algorithm's (or device's) standalone performance under specified conditions.
7. Type of Ground Truth Used
For the clinical study, the ground truth was established by the predicate device (PREMIER Platinum HpSA® PLUS K053335). The study aimed to demonstrate substantial equivalence by showing agreement between the modified device and the predicate. For analytical studies, the ground truth was based on controlled experimental conditions (e.g., known concentrations of H. pylori protein for LoD, known presence/absence of microorganisms for cross-reactivity, known interfering substances).
8. Sample Size for the Training Set
The document does not specify a separate "training set" sample size. The PREMIER Platinum HpSA PLUS is an enzyme immunoassay, implying a deterministic chemical reaction, not a machine learning algorithm that requires a separate training phase. The development of the device would involve optimization and internal testing, which might be analogous to model training, but these details are not provided in terms of sample size or methodology.
9. How the Ground Truth for the Training Set Was Established
As noted above, there's no mention of a traditional "training set" in the context of an EIA device. The "ground truth" during initial development and optimization would have been established through controlled experiments using known concentrations of H. pylori antigens and various other substances (cross-reactants, interferents) to characterize the assay's performance and specificity. This would involve laboratory standards and analytical methods to confirm the composition of samples.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 4, 2018
Meridian Bioscience, Inc. Jack Rogers Director of Regulatory Affairs and Design Assurance 3471 River Hills Drive Cincinnati, Ohio 45244
Re: K182559
Trade/Device Name: PREMIER Platinum HpSA PLUS Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter fetus serological reagents Regulatory Class: Class I Product Code: LYR Dated: September 14, 2018 Received: September 17, 2018
Dear Jack Rogers:
We have reviewed vour 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/cdrh/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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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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.
Steven R. Gitterman -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
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Indications for Use
510(k) Number (if known) K182559
Device Name
PREMIER Platinum HpSA® PLUS
Indications for Use (Describe)
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 patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.
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: meridian BIOSCIENCE logo | PREMIER Platinum HpSA® PLUS | |
|---|---|---|
| Application Reference: | Section 1: Administrative Information | |
| Attachment Description: | Attachment 007: 510(k) Summary | |
| Application Date: | September 14, 2018 |
510(k) Summary
| 510(k) number: | K182559 | Date of Preparation: | October 30, 202 |
|---|---|---|---|
| Owner: | Meridian Bioscience, Inc.3471 River Hills DriveCincinnati, Ohio 45244 USAPhone: (513) 271-3700Fax: (513) 272-5213 | ||
| Contact: | Primary Contact:Jack RogersDirector, Regulatory Affairs & Design AssuranceSecondary Contact:Charles G. ThorntonVice President, Regulatory Affairs and Quality Assurance | ||
| Trade Name: | PREMIER Platinum HpSA® PLUS | ||
| Common Name: | Helicobacter Pylori | ||
| Classification Name: | Campylobacter fetus serological reagents(21 CFR 866.3110, Product Code LYR) | ||
| Predicate Device: | PREMIER Platinum HpSA® PLUSK053335 |
Device Description
The PREMIER Platinum HpSA® PLUS test is a microwell-based enzyme immunoassay that detects H. pylori antigens present in human stool. The test utilizes a plurality (mixture) of monoclonal antibodies adsorbed to microwells. Diluted patient samples and an enzyme conjugate reagent are added to the microwells and incubated for one hour at room temperature. A wash is performed to remove unbound material. Substrate is added and incubated for 10 minutes at room temperature. Color develops in the presence of bound enzyme. Stop solution is added and the results are interpreted visually or spectrophotometrically. No calculations are required and the visual color change makes the interpretation of results objective and simple.
In addition, the HpSA test permits assessment of established or novel anti-H. pylori treatment during and posttherapy to monitor for treatment effectiveness, relapse or eradication.
PREMIER Platinum HpSA PLUS (K053335), as the predicate device for this submission, was a modification of PREMIER Platinum HpSA (K983255, K980076) that provided increased signal strengths with positive test results and better discrimination between low positive and negative tests. This submission is for modifications to the antibodies used in the microwells and conjugate reagent.
8
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| Image: meridian BIOSCIENCE logo | PREMIER Platinum HpSA® PLUS | |
|---|---|---|
| Application Reference: | Section 1: Administrative Information | |
| Attachment Description: | Attachment 007: 510(k) Summary | |
| Application Date: | September 14, 2018 |
Intended Use / Indications for Use
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 patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.
Predicate Device Comparison
| Similarities Between the Modified Device and the Predicate Device | ||
|---|---|---|
| MODIFIED DEVICEPREMIER Platinum HpSA® PLUS | PREDICATE DEVICEPREMIER Platinum HpSA® PLUSK053335 | |
| Intended Use /Indications forUse | The PREMIER Platinum HpSA® PLUS in anin vitro diagnostic procedure for thedetection of Helicobacter pylori antigens inhuman stool. Test results are intended to aidin the diagnosis of H. pylori infection and tomonitor response during and post-therapy inpatients. Accepted medical practicerecommends that testing by any currentmethod, to confirm eradication, be done atleast four weeks following completion oftherapy. | The PREMIER Platinum HpSA® PLUS in anin vitro diagnostic procedure for thedetection of Helicobacter pylori antigens inhuman stool. Test results are intended to aidin the diagnosis of H. pylori infection and tomonitor response during and post-therapy inpatients. Accepted medical practicerecommends that testing by any currentmethod, to confirm eradication, be done atleast four weeks following completion oftherapy. |
| Technology | Qualitative Enzyme Immunoassay (EIA),Microwell Format | Qualitative Enzyme Immunoassay (EIA),Microwell Format |
| Interpretationof Results | Visual or Spectrophotometric | Visual or Spectrophotometric |
| Performance Characteristics | ||
| AnalyticalSensitivity(LoD) | ≥ 4.66 ng H. pylori protein/mL of stool | ≥ 4.67 ng H. pylori protein/mL of stool |
| Sensitivity | PPA: 100% | PPA: 100% |
| Specificity | NPA: 100% | NPA: 94.8% |
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| meridian BlosciENCE-) |
|---|
| --------------------------- |
PREMIER Platinum HpSA® PLUS
Application Reference: Attachment Description:
Attachment 007: 510(k) Summary
Section 1: Administrative Information
Application Date:
September 14, 2018
| Differences Between the Modified Device and the Predicate Device | ||
|---|---|---|
| MODIFIED DEVICEPREMIER Platinum HpSA® PLUS | PREDICATE DEVICEPREMIER Platinum HpSA® PLUSK053335 | |
| Crossreactivity | The specificity of the modified PREMIERPlatinum HpSA PLUS was tested by utilizing thefollowing bacterial or viral strains. Positive andnegative stools were spiked with 1.0 x 107CFU/mL (bacteria or fungi) or a finalconcentration greater than 1 x 105 TCID50/mL(viruses) and tested by the modified PREMIERPlatinum HpSA PLUS. None of the organismsaffected positive or negative test results. | The specificity of Premier Platinum HpSA PLUS wastested by utilizing the following bacterial or viralstrains. Positive and negative stools were spikedwith ≥ 1.2 X 109 bacterial or yeast organisms/mL andtested by Premier Platinum HpSA PLUS. Theconcentration of viral organisms was not calculated.None of the organisms affected positive or negativetest results. |
| Microorganism or virusAdenovirus 41, Aeromonas hydrophila, Bacillussubtilis, Borrelia burgdorferi, Campylobacter coli,Campylobacter fetus, Campylobacter jejuni,Campylobacter lari, Candida albicans,Citrobacter freundii, Clostridium difficile,Clostridium perfringens, Enterobacter cloacae,Enterococcus faecalis, Escherichia coli O157:H7,Escherichia coli, Escherichia coli 8739,Escherichia coli 9637, Escherichia fergusonii,Escherichia hermanii, Escherichia hermaniiEMDI-64 Haemophilus influenzae, Klebsiellapneumoniae, Lactococcus lactis, Listeriamonocytogenes, Peptostreptococcus anaerobius,Proteus vulgaris, Pseudomonas aeruginosa,Pseudomonas fluorescens, Rotavirus,Salmonella dublin, Salmonella hilversum,Salmonella heidelberg (Group B), Salmonellaminnesota, Salmonella typhimurium, Serratialiquefaciens, Serratia marcescens, Shigellaboydii, Shigella dysenteriae, Shigella flexneri,Shigella sonnei, Staphylococcus aureus,Staphylococcus aureus (Cowan Strain I),Staphylococcus epidermidis, Yersiniaenterocolitica | Microorganism or virusAdenovirus, Aeromonas hydrophila, Campylobacterlari, Campylobacter fetus, Campylobacter jejuni,Campylobacter jejuni 2, Campylobacter jejunisolution, Candida albicans, Citrobacter freundii,Clostridium difficile, Clostridium perfringens,Enterobacter cloacae, Enterococcus faecalis,Escherichia coli O157:H7, Escherichia coli 8739,Escherichia coli 9637, Escherichia fergusonii,Escherichia hermanii, Escherichia hermanii EMDi-64,Klebsiella pneumonia, Lactobacillus lactis, Listeriamonocytogenes, Peptostreptococcus anaerobius ,Proteus vulgaris, Pseudomonas aeruginosa,Pseudomonas fluorescens, Rotavirus, SalmonellaGroup B, Salmonella typhimurium, Serratialiquefaciens, Serratia marcescens, Shigella boydii,Shigella flexneri, Shigella dysenteriae, Shigellasonnei, Staphylococcus aureus, Staphylococcusaureus (Cowans 1), Staphylococcus epidermidis,Streptococcus faecalis, Salmonella enterica serovarHilversum, Salmonella enterica subsp. Entericaserovar Hilversum, Salmonella enterica subsp.Enterica serovar Minnesota, Yersinia enterocolitica | |
| InterferingSubstances | The following substances, that may be present inhuman stool, do not interfere with positive ornegative test results at the stated concentrationsper 500 µl human stool:• Barium sulfate - 25 mg• Mylanta – 11.5 mg• Pepto-Bismol - 0.44 mg• Prilosec OTC - 1 mg• Tagamet - 1 mg• TUMS - 10 mg• Hemoglobin - 62.5 mg• Mucin - 17 mg• NSAID Ibuprofen – 0.25 mg• Stearic acid - 5.3 mg• Palmitic acid - 2.65 mg• White blood cells - 250 uL | The following substances, that may be present inhuman stool do not interfere with positive or negativetest results at the stated concentrations, per 500 µlhuman stool:• Barium sulfate - 10mg• Mylanta - 0.84mg• Pepto-Bismol - 0.35mg• Prilosec OTC - 1mg• Tagamet - 1mg• TUMS - 10mg• Human Hemoglobin (i.e. dark stool) - 15 mg• Mucin - 6.7mg• Steric + Palmitic Acids (i.e. Fatty stool) - 7.9mg• Whole Blood - 100 µl |
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| Image: meridian BIOSCIENCE logo | PREMIER Platinum HpSA® PLUS |
|---|---|
| Application Reference: Section 1: Administrative Information | |
| Attachment Description: Attachment 007: 510(k) Summary | |
| Application Date: September 14, 2018 |
NON-CLINICAL PERFORMANCE DATA
Analytical Performance
Reproducibility
Assay precision, intra-assay variability and inter-assay variability were assessed with a reference panel prepared from moderately positive samples (n=3), low positive samples (n=3), high negative samples (n=3) and a true negative sample (n=1). In addition, the positive kit controls were run when each panel was tested. Each panel was tested once a day by two technicians, at three different laboratory sites, for 5 consecutive days. Overall. 100% (300/300. 98.7-100%, 95% Cl) of results obtained with the PREMER Platinum HpSA PLUS were as expected. There were no invalid results generated during the study (0.0%; 0/300; 0.0-1.3%, 95% C1).
Analytical Sensitivity
Analytical sensitivity studies were performed to determine the analytical limit of detection (LoD) for the modified PREMIER Platinum HpSA® PLUS. The limit of detection is defined as the first dilution containing the target organism that produces positive results approximately 95% of the time. Three lots of the modified assay were evaluated.
The limit of detection for the PREMIER Platinum HpSA PLUS assay was determined to be 4.66 ng/mL.
Analytical Specificity
Cross-Reactivity:
The specificity of PREMER Platinum HpSA PLUS was tested by utilizing the following bacterial or viral strains. Potentially cross-reactive microorganisms were added at a target concentration of 1.0 x 107 CFU/mL (bacteria or fungi), or a concentration greater than 1 x 105 TCIDs/mL (viruses), to a natural negative and a contrived positive sample. None of the organisms affected positive or negative test results.
Microorganism or virus
Adenovirus 41, Aeromonas hydrophila, Bacillus subtilis, Borrelia burgdorferi, Campylobacter fetus, Campylobacter jejuni, Campylobacter lari, Cardida albicans, Citrobacter freundii, Clostridium perfringens, Enterobacter cloacae, Enterococcus faecalis, Escherichia coli, Escherichia coli, Escherichia coli 8739, Escherichia coli 9637, Escherichia fergusonii, Escherichia hermanii EMDI-64, Haemophilus influenzae, Kebsiella pneumoniae, Lactoccus lactis, Listeria monocytogenes, Peptostreptococus anaerobius, Proteus vulgaris, Pseudomonas aeruginosa, Pseudomonas fluorescens, Rotavirus, Salmonella hilversum, Salmonella heidelberg (Group B), Salmonella minnesota, Salmonella typhimurium, Serratia marcescens, Shigella boydii, Shigella dysenteriae, Shigella flexneri, Staphylococus aureus, Staphylococus aureus (Cowan Strain 1), Staphylococcus epidermidis and Yersinia enterocolitica
Interfering Substances:
The following substances, that may be present in human stool, do not interfere with positive test results at the stated concentrations per 500 uL human stool: Barium sulfate – 25 mg, Mylanta – 11.5 mg, Pepto-Bismol – 0.44 mg, Prilosec (omeprazole) – 1 mg, Tagamet (cimetidine) – 1 mg, Hemoglobin – 62.5 mg, Mucin – 17 mg, NSAID Ibuprofen - 0.25 mg, Stearic acid - 5.3 mg, Palmitic acid - 2.65 mg, White blood cells - 250 ul, Whole blood -250 uL.
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| Image: meridian BIOSCIENCE logo | PREMIER Platinum HpSA® PLUS | |
|---|---|---|
| Application Reference: | Section 1: Administrative Information | |
| Attachment Description: | Attachment 007: 510(k) Summary | |
| Application Date: | September 14, 2018 |
CLINICAL PERFORMANCE DATA
Clinical Study
Comparison of Modified PREMIER Platinum HpSA PLUS to PREMIER Platinum HpSA PLUS (Predicate)
One hundred and fifty-nine (159) archived, unpreserved stool samples from symptomatic patients were analyzed for H. pylori antigen by the modified PREMER Platinum HpSA PLUS and PREMIER Platinum HpSA PLUS (Predicate) to demonstrate that changes to the microwell and conjugate antibodies do not affect assay performance. The performance of the modified PREMIER Platinum HoSA PLUS was substantially equivalent to the predicate device, generating 100% positive percent and 100% negative percent agreement with 95% confidence intervals of 93.7-100.0% and 96.4-100.0%, respectively.
| PP HpSA PLUS (Predicate) | |||
|---|---|---|---|
| ModifiedPP HpSA PLUS | Positive | Negative | Total |
| Positive | 57 | 0 | 57 |
| Negative | 0 | 102 | 102 |
| Total | 57 | 102 | 159 |
| 95% CI | |||
| PositiveAgreement | 57/57 | 100.0% | 93.7-100.0% |
| NegativeAgreement | 102/102 | 100.0% | 96.4-100.0% |
CONCLUSION
The modified PREMIER Platinum HpSA® PLUS assay is substantially equivalent to the predicate device.
§ 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).