(94 days)
No
The device description details a standard enzyme immunoassay (EIA) procedure. There is no mention of AI, ML, or any computational analysis beyond visual or spectrophotometric interpretation of color development, which is typical for this type of assay. The performance studies focus on analytical sensitivity and method comparison, not on training or testing AI/ML models.
No
This device is an in vitro diagnostic test designed to detect H. pylori antigens in stool samples, aiding in diagnosis and monitoring, and does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test results "are intended to aid in the diagnosis of H. pylori infection." Additionally, the "Device Description" mentions it as a "qualitative, in vitro diagnostic test." The performance studies also refer to a "diagnostic H. pylori antigen test."
No
The device is described as a microwell-based enzyme immunoassay that involves physical steps like adding reagents, incubation, washing, and visual or spectrophotometric interpretation, indicating it is a hardware-based in vitro diagnostic test, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is an "in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool." The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of the living body.
- Device Description: The description details a "microwell-based enzyme immunoassay" that detects antigens in human stool specimens. This is a laboratory-based test performed on a biological sample.
- Purpose: The test is intended to "aid in the diagnosis of H. pylori infection and to monitor response during and post- therapy in patients." This clearly indicates a diagnostic purpose performed on a sample taken from a patient.
- Regulatory Context: The document mentions FDA clearance (K182559) and a modification to an FDA-cleared device. IVDs are regulated by the FDA.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Premier HpSA Flex enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. The test is intended for use with unpreserved stool specimens or preserved stool specimens in transport media. 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.
Product codes
LYR
Device Description
Meridian Bioscience has modified its FDA-cleared PREMIER Platinum HpSA® PLUS assay (K182559), a qualitative, in vitro diagnostic test for the detection of Helicobacter pylori antigens present in unpreserved human stool specimens. This modification, to be marketed under new device trade name Premier HpSA® Flex upon FDA clearance, is the addition of a new specimen type claim to the intended use of the previously cleared device (K182559) whereby specimens may be preserved in Cary-Blair or Culture and Sensitivity (C&S) transport media.
PREMIER Platinum HpSA PLUS (K182559), as the predicate device for this submission, was a modification of the PREMIER Platinum HpSA PLUS device cleared under K053335 that included changes to the antibodies used in the microwells and conjugate reagent. Additional clearances of this device can be found under K983255 and K980076.
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
Not Found
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
Method Comparison with a Comparator Device:
There were 200 archived stool specimens enrolled in the study from patients with signs and symptoms of gastroenteritis for whom a diagnostic H. pylori antigen test had been ordered by a practicing physician. Of those 200, viable Standard of Care (SoC) data was available for 182, all of which were evaluable specimens. Specimens were preserved in Cary-Blair or C&S transport media prior to testing with the Premier HpSA Flex assay and the comparator device in a central laboratory.
Summary of Performance Studies
Study Type: Analytical Performance
Analytical Sensitivity (LoD): The LoD for the modified Premier HpSA Flex assay in stool specimens preserved in Cary-Blair or C&S transport media was 12 ng/ml. The previously established LoD using unpreserved (raw) stool was 4.66 ng/mL.
The equivalence between Cary Blair and C&S transport media was assessed at LoD and below LoD antigen concentrations, and both transport media were determined to be equivalent.
Precision/Reproducibility:
Sample Size: 360 samples (10 panels of 12 blinded samples provided to each of three laboratories).
Key Results: For preserved stool samples, the overall agreement between the Premier HpSA Flex assay result and the expected assay result was 100.0% (95% Cl: 98.9-100.0%). Reproducibility studies with unpreserved stool samples were previously evaluated under K182559.
Specimen Storage Stability:
Up to 120 hours at 2–8 C or 19–27 C.
Up to 14 days frozen (–20 C and/or -80 C).
Freeze/Thaw:
Up to two (2) freeze/thaw cycles for specimens stored frozen (≤ -20 C).
Analytical Specificity/Interference:
Interference testing performed with 13 chemical and biological substances (TUMS, Mylanta, Pepto-Bismol, Tagamet, Prilosec OTC, Barium Sulfate, Whole Blood, Leukocytes, Mucin, Hemoglobin, Stearic Acid, Palmitic Acid, NSAID, Ibuprofen) in contrived H. pylori low positive and negative preserved human stool samples. No interference was observed.
Analytical Specificity/Cross-reactivity:
Cross-reactivity and microbial interference study performed with various bacteria, fungi, and viral strains (listed in the document). Each organism was tested with a true negative sample and a contrived low positive sample (approximately 2X LoD). No cross-reactivity or microbial interference was observed.
Method Comparison with a Comparator Device:
Sample Size: 182 evaluable archived stool specimens.
Key Results:
Positive Agreement: 49/49 (100.0%) [95% Cl: 92.7% - 100.0%]
Negative Agreement: 131/133 (98.5%) [94.7% - 99.6%]
*1/2 Premier HpSA Flex false positive specimens produced a positive result by the Standard of Care (SoC) testing using an FDA-cleared commercial assay.
No observable differences in performance with respect to preserved media type (Cary-Blair and C&S), kit lot, or patient characteristics (age, sex, and race).
Key Metrics
Positive Agreement: 100.0% [92.7% - 100.0%]
Negative Agreement: 98.5% [94.7% - 99.6%]
Predicate Device(s)
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).
0
Image /page/0/Picture/0 description: The image shows 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 3, 2023
Meridian Bioscience, Inc. Heather Planck Senior Regulatory Affairs Specialist 3471 River Hills Drive Cincinnati, Ohio 45244
Re: K230901
Trade/Device Name: Premier HpSA Flex (619096) Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter Fetus Serological Reagents Regulatory Class: Class I, reserved Product Code: LYR Dated: March 31, 2023 Received: March 31, 2023
Dear Heather Planck:
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/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
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/5 description: The image shows the name "Ribhi Shawar -S" in a large, clear font. The text is horizontally aligned and appears to be the primary focus of the image. The background is plain, which makes the text stand out prominently.
Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230901
Device Name
Premier® HpSA® Flex
Indications for Use (Describe)
The Premier HpSA Flex enzyme immunoasay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. The test is intended for use with unpreserved stool specimens or preserved stool specimens in transport media. 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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3
| Premier® HpSA® Flex | |
|---|---|
| eSTAR Section Reference: | Administrative Documentation |
| Attachment Description: | 025_510(k) Summary |
| Application Date: | March 31, 2023 |
510(k) Summary
510(k) number: K230901
Date of Preparation: June 30, 2023
A. Submitter details
| Name: | Meridian Bioscience Inc. |
|---|---|
| Address: | 3471 River Hills Drive |
| Cincinnati, OH 45244 | |
| USA | |
| Telephone: | (513) 991-5946 |
| Contact Person: | Heather Planck, Senior Regulatory Affairs |
| Specialist | |
| Heather.Planck@meridianbioscience.com |
B. Device Details
Proprietary and Established Names: Premier® HpSA® Flex
Requlatory Information:
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| LYR | I | 21 CFR 866.3110 – | |
| Campylobacter fetus serological | |||
| reagents | MI – Microbiology (83) |
Predicate:
Premier® Platinum HpSA® PLUS
C. Device Description
Meridian Bioscience has modified its FDA-cleared PREMIER Platinum HpSA® PLUS assay (K182559), a qualitative, in vitro diagnostic test for the detection of Helicobacter pylori antigens present in unpreserved human stool specimens. This modification, to be marketed under new device trade name Premier HpSA® Flex upon FDA clearance, is the addition of a new specimen type claim to the intended use of the previously cleared device (K182559) whereby specimens may be preserved in Cary-Blair or Culture and Sensitivity (C&S) transport media.
PREMIER Platinum HpSA PLUS (K182559), as the predicate device for this submission, was a modification of the PREMIER Platinum HpSA PLUS device cleared under K053335 that included changes to the antibodies used in the microwells and conjugate reagent. Additional clearances of this device can be found under K983255 and K980076.
4
| Image: meridian BIOSCIENCE logo | Premier® HpSA® Flex | |
|---|---|---|
| eSTAR Section Reference: | Administrative Documentation | |
| Attachment Description: | 025_510(k) Summary | |
| Application Date: | March 31, 2023 |
Reagents and Test Components:
The Premier HpSA Flex assav kit includes:
- Premier HpSA Flex Antibody Coated Microwells: Breakaway plastic wells coated with a plurality ● of murine monoclonal antibodies specific for H. pylori.
- . Premier HpSA Flex Positive Control: pH 7.2, Inactivated H. pylori in 10 mM phosphatebuffered solution with 0.02% Thimerosal.
- . Premier HpSA Flex Sample Diluent/Negative Control: pH 7.2, 10 mM phosphate-buffered solution with 0.02% Thimerosal.
- PREMIER 20X Wash Buffer I: pH 6.8, 180 mM phosphate-buffered solution with 0.2% . Thimerosal. Diluted to 1X prior to use.
- Premier HpSA Flex Enzyme Coniugate: A plurality of murine monoclonal antibodies specific . for H. pylori, conjugated to horseradish peroxidase in a pH 7.8, 50 mM Tris-buffered solution containing 0.02% Thimerosal.
- . PREMIER Substrate I: a-buffered solution containing urea peroxide and tetramethylbenzidine. (pH 5.0)
- . PREMIER Stop Solution I: 1M phosphoric acid.
- Transfer Pipettes ●
- Plate Sealers
- Wooden Applicator Sticks ●
D. Principle of Operation
The Premier HpSA Flex test is a microwell-based enzyme immunoassay that detects H. pylori antigens present in human stool specimens, either unpreserved in transport media. The test uilizes a plurality (mixture) of monoclonal anti-H. pylori capture 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 post-therapy to monitor for treatment effectiveness, relapse, or eradication,
E. Measurand
Helicobacter pylori antigens
F. Intended Use / Indications for Use
The Premier HpSA Flex enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. The test is intended for use with unpreserved stool specimens or preserved stool specimens in transport media. 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.
Special Conditions for use Statement(s): For prescription use only.
G. Technological characteristics of Device vs. Predicate
The technological characteristics of Premier® HpSA® Flex are identical to those of the predicate, Premier Platinum HpSA® PLUS (K182559) in respect of material, chemical composition, and energy
5
| Image: meridian BIOSCIENCE logo | Premier ® HpSA® Flex | |
|---|---|---|
| eSTAR Section Reference: | Administrative Documentation | |
| Attachment Description: | 025_510(k) Summary | |
| Application Date: | March 31, 2023 |
source, because the Premier HpSA Flex modification did not introduce any technology, engineering, or material changes to the FDA-cleared device K182559. The physical properties of the device were unchanged, including the labeled kit box, mode of packaging and labeling of components contained within the assembled kit, and the kit components (e.g., reagents, microwells, disposables). The device, upon FDA clearance of the modifications, receives new Premier HpSA Flex labeling.
H. Comparison of device with the predicate
| | Modified Device: Premier HpSA
Flex | Predicate device: PREMIER
Platinum HpSA PLUS |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for Use | The Premier HpSA Flex enzyme
immunoassay (EIA) is an in vitro
qualitative procedure for the detection
of Helicobacter pylori antigens in
human stool.
The test is intended for use with
unpreserved stool specimens or
preserved stool specimens in
transport media.
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
is an in vitro diagnostic 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. |
| General Device Characteristic Similarities | | |
| Measured analyte | Helicobacter pylori antigens | Same |
| Antibody / Technology
/ Assay format | Monoclonal / Enzyme immunoassay
(EIA) / Microwell-based | Same |
| Type of Test | Qualitative | Same |
| Controls | Positive and negative controls
included in the kit | Same |
| Reagent storage | Refrigerated (2-8°C) | Same |
| Reagent and
components | Antibody Coated Microwells; Positive
Control; Sample Diluent / Negative
Control; Premier 20X Buffer I;
Enzyme Conjugate; Premier
Substrate I; Premier Stop Solution 1;
Transfer pipettes; Microwell strip
sealer; Wooden stick applicators | Same |
| Result interpretation | Visual or spectrophotometric | Same |
| General Device Characteristic Differences | | |
| Device & Predicate
Device(s): | Device: K230901 | Predicate: K182559 |
| Addition of specimen
type | Unpreserved stool specimens and
stool specimens preserved in Cary- | Unpreserved (raw) stool specimens |
6
| Image: meridian BIOSCIENCE logo | Premier® HpSA® Flex | |
|---|---|---|
| eSTAR Section Reference: | Administrative Documentation | |
| Attachment Description: | 025_510(k) Summary | |
| Application Date: | March 31, 2023 |
Performance Characteristics 1.
1. Analytical Performance
- a. Limit of Detection (LoD) / Analytical Sensitivity:
Analytical sensitivity studies were performed to determine the analytical limit of detection (LoD) of quantified H. pylori antigen diluted in human stool matrix that has been preserved in Cary-Blair and C&S transport media for the modified Premier HpSA Flex assay. Three lots of the Premier HpSA Flex assay were evaluated. For each kit lot, an LoD was established and confirmed in separate studies for each transport media (Cary-Blair and C&S). The LoD was defined as the lowest concentration of the target analyte that produced positive results ≥ 95% of the time.
The LoD value determined for the modified Premier HpSA Flex assay detected in stool specimens preserved in Cary-Blair or C&S transport media was determined to be 12 ng/ml.. The previously established LoD using unpreserved (raw) stool was 4.66 ng/mL.
Further, the equivalence between Cary Blair and C&S transport media was assessed at LoD and below LoD antigen concentrations, and both transport media were determined to be equivalent for the preservation of specimens intended to be used with the Premier HpSA Flex assay.
b. Precision/Reproducibility:
The reproducibility of the Premier HpSA Flex assay was determined by testing preserved contrived stool samples across three independent laboratories. Samples were created with H. pylori antigen spiked into pooled negative stool matrix at high negative, low positive, and moderate positive concentrations, along with a true negative sample. Ten panels consisting of 12 blinded samples were provided to each of the three laboratories for a total of 360 samples. Testing was conducted at each laboratory over 5 different days. Each day two separate operators each tested a separate panel while alternating between kit lots. Testing included three different kit lots (2 lots per site). In addition, positive and negative controls were run when each panel was tested.
For preserved stool samples, the overall agreement between the Premier HpSA Flex assay result and the expected assay result was 100.0% (95% Cl: 98.9-100.0%). Reproducibility studies with unpreserved stool samples were previously evaluated under K182559.
-
c. Linearity/Reportable range:
Not applicable -
d. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Preserved specimen storage stability:
The specimen stability claims include storage of up to 120 hours at either refrigerated temperature (2–8 C) or room temperature (19–27 C), or for up to 14 days frozen (–20 C and/or -80 C) for clinical stool specimens preserved in Cary-Blair or C&S transport media prior to testing with the Premier HpSA Flex assay.
Freeze/Thaw:
The specimen freeze/thaw stability claims for clinical stool specimens preserved in Cary-Blair or C&S transport media include freezing and thawing specimens for up to two (2) freeze/thaw
7
| Image: meridian BIOSCIENCE logo | Premier® HpSA® Flex |
|---|---|
| eSTAR Section Reference: Administrative Documentation | |
| Attachment Description: 025_510(k) Summary | |
| Application Date: March 31, 2023 |
cycles when specimens are stored frozen (≤ -20 C) prior to testing with the Premier HpSA Flex assay.
- Analytical Specificity/Interference: e.
Interference testing was performed in the presence of chemical and biological substances introduced directly into contrived H. pv/ori low positive and negative preserved human stool samples. Substances and their respective test concentrations evaluated are listed below. Interference was not observed with the Premier HpSA Flex assay for any of the substances evaluated at their respective test concentrations. The same chemical or biological substances were previously evaluated for interference with the predicate assay (K182559).
| Substance (Active Ingredient(s)) | Target Concentration (per
500 µL of Patient Stool) |
|--------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| TUMS | 10 mg/500 µL |
| Mylanta (per 10 mL: Aluminum hydroxide 800 mg, Magnesium
hydroxide 800 mg, Simethicone 80 mg) | 11.5 mg/500 µL |
| Pepto-Bismol (Bismuth subsalicylate 525 mg/30 mL) | 0.44 mg/500 µL |
| Tagamet (Cimetidine 200 mg/tablet) | 1 mg/500 µL |
| Prilosec OTC (Omeprazole 20 mg/tablet) | 1 mg/500 µL |
| Barium Sulfate | 25 mg/500 µL |
| Whole Blood | 250 µL/500 µL |
| Leukocytes (White Blood Cells) | 250 µL/500 µL |
| Mucin | 17 mg/500 µL |
| Hemoglobin | 62.5 mg/500 µL |
| Stearic Acid (fecal fat) | 5.3 mg/500 µL |
| Palmitic Acid (fecal fat) | 2.65 mg/500 µL |
| NSAID, Ibuprofen | 0.25mg/500 µL |
- f. Analytical Specificity/Cross-reactivity:
A cross-reactivity and microbial interference study was performed to determine if potential cocontaminants of preserved human stool specimens would non-specifically react with the Premier HpSA Flex assay or interfere with detection of H. pylori antigen when present at high concentrations. The specificity of Premier HpSA Flex was evaluated by testing bacteria, fungi, and viral strains. Each organism was tested with a true negative sample and a contrived low positive sample (approximately 2X LoD) at a minimum concentration of 1.0x107 CFU/mL (for bacteria/fungi) or 1.0x105 TCID50/mL (for viruses).
No cross-reactivity or microbial interference with the Premier HpSA Flex assay was observed. The organisms evaluated for cross-reactivity are listed below. The same microbial organisms were previously evaluated for cross-reactivity and microbial interference with the predicate assay (K182559).
| Microorganism Tested | (Strain ID) | Microorganism Tested | (Strain ID) |
|---|---|---|---|
| Aeromonas hydrophila | ATCC 35654 | Listeria monocytogenes | ATCC 19115 |
| Bacillus subtilis | ATCC 6051 | Peptostreptococcus anaerobius | ATCC 27337 |
| Borrelia burgdorferi | N/A | Proteus vulgaris | ATCC 6380 |
| Campylobacter coli | ATCC 43478 | Pseudomonas aeruginosa | ATCC 10145 |
| Campylobacter fetus | ATCC 25936 | Pseudomonas fluorescens | ATCC 13525 |
| Campylobacter jejuni | ATCC 33292 | Salmonella enterica subsp. enterica | |
| serovar Dublin | ATCC 15480 | ||
| Campylobacter lari | ATCC BAA-1060 | Salmonella enterica subsp. enterica | |
| serovar Hilversum | ATCC 15784 | ||
| Candida albicans | ATCC 18804 | Salmonella enterica subsp. enterica | |
| serovar Typhimurium | ATCC 13311 |
8
| Image: meridian BIOSCIENCE logo | Premier® HpSA® Flex | ||
|---|---|---|---|
| eSTAR Section Reference: | Administrative Documentation | ||
| Attachment Description: | 025_510(k) Summary | ||
| Application Date: | March 31, 2023 | ||
| Microorganism Tested | (Strain ID) | Microorganism Tested | (Strain ID) |
| Citrobacter freundii | ATCC 43864 | Salmonella heidelberg (Group B) | ATCC 8326 |
| Clostridium difficile | ATCC 43255 | Salmonella minnesota | ATCC 9700 |
| Clostridium perfringens | ATCC 12915 | Serratia liquefaciens | ATCC 27952 |
| Enterobacter cloacae | ATCC 15337 | Serratia marcescens | ATCC 43862 |
| Enterococcus faecalis | ATCC 49532 | Shigella boydii | ATCC 9207 |
| Escherichia coli | ATCC 8739 | Shigella dysenteriae | ATCC 9361 |
| Escherichia coli | ATCC 9637 | Shigella flexneri | ATCC 12022 |
| Escherichia coli | ATCC BAA-2196 | Shigella sonnei | ATCC 25931 |
| Escherichia coli O157:H7 | |||
| (toxigenic) | ATCC 43895 | Staphylococcus aureus | ATCC 51153 |
| Escherichia fergusonii | ATCC 35469 | Staphylococcus aureus (Cowan's) | ATCC 12598 |
| Escherichia hermanii | ATCC 33650 | Staphylococcus epidermidis | ATCC 49134 |
| Escherichia hermanii | EMDI-64 | Yersinia enterocolitica | ATCC 23715 |
| Haemophilus influenzae | ATCC 9006 | Adenovirus 41 | Tak |
| Klebsiella pneumoniae | ATCC BAA-1900 | Rotavirus RV4 | |
| Lactococcus lactis | ATCC 49032 |
g. Assay Cut-Off:
Not Applicable
2. Comparison Studies
a. Method Comparison with a Comparator Device:
Method comparison testing was done to compare the performance of the Premier HpSA Flex modification to that of an FDA-cleared comparator device. There were 200 archived stool specimens enrolled in the study from patients with signs and symptoms of gastroenteritis for whom a diagnostic H. pylori antigen test had been ordered by a practicing physician. Of those 200, viable Standard of Care (SoC) data was available for 182, all of which were evaluable specimens. Specimens were preserved in Cary-Blair or C&S transport media prior to testing with the Premier HpSA Flex assay and the comparator device in a central laboratory. Clinical performance (positive and negative percent agreement) for archived specimens against the FDA-cleared comparator device is presented in the following table. There were no observable differences in performance of the Premier HpSA Flex assay with respect to preserved media type (i.e., Cary-Blair and C&S), kit lot, or patient characteristics (i.e., age, sex, and race). Clinical performance with unpreserved stool specimens was previously evaluated under K182559.
| Comparator Device | |||
|---|---|---|---|
| Premier HpSA Flex | Positive | Negative | Total |
| Positive | 49 | 2* | 51 |
| Negative | 0 | 131 | 131 |
| Total | 49 | 133 | 182 |
| 95% Cl | |||
| Positive Agreement | 49/49 | 100.0% | [92.7% - 100.0%] |
| Negative Agreement | 131/133 | 98.5% | [94.7% - 99.6%] |
- 1/2 Premier HpSA Flex false positive specimens produced a positive result by the Standard of Care (SoC) testing using an FDA-cleared commercial assay.
9
| eSTAR Section Reference: | Administrative Documentation |
|---|---|
| Attachment Description: | 025_510(k) Summary |
| Application Date: | March 31, 2023 |
- Matrix Comparison: b. Not applicable
3. Clinical Performance
- Clinical Sensitivity: a. Not applicable
- b. Clinical Specificity: Not applicable
- Other clinical supportive data (when a. and b. are not applicable): C. Not applicable
4. Clinical Cut-off:
Not applicable
5. Expected values/Reference Range:
Not applicable
J. Proposed Labeling
The labeling is sufficient, and it satisfies the requirements of 21 CFR Part 809.10.
K. Conclusion
The Premier® HpSA® Flex assay, as supported by the information submitted in this premarket submission, is substantially equivalent to the predicate device (PREMIER Platinum HpSA® PLUS; K182559).