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.

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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study that proves the device meets them, based on the provided text.

Acceptance Criteria and Device Performance

The core of this submission is about adding a new specimen type claim (preserved stool in Cary-Blair or C&S transport media) to an already FDA-cleared device. Therefore, the "acceptance criteria" revolve around demonstrating that the device performs equivalently with these new specimen types as it did with the original unpreserved stool and that the performance remains robust.

Here's a summary of the performance characteristics presented as implicit acceptance criteria and the reported device performance:

Acceptance Criteria (Implicit by Study Design)	Reported Device Performance (Premier HpSA Flex with Preserved Stool)
Analytical Sensitivity (Limit of Detection - LoD): Demonstrate a specific LoD for H. pylori antigen in preserved stool.	LoD = 12 ng/ml in Cary-Blair or C&S transport media. (Previously established LoD for unpreserved stool was 4.66 ng/mL). Equivalence between Cary-Blair and C&S media at LoD and below LoD antigen concentrations was determined.
Precision/Reproducibility: Demonstrate consistent results across different laboratories, operators, and kit lots with preserved stool samples.	Overall agreement between assay result and expected result was 100.0% (95% CI: 98.9-100.0%). (Reproducibility with unpreserved stool was previously evaluated under K182559).
Specimen Storage Stability: Demonstrate stability of preserved stool specimens under various temperature and duration conditions.	Specimens stable up to 120 hours at 2-8°C or 19-27°C, or up to 14 days frozen (-20°C and/or -80°C).
Freeze/Thaw Stability: Demonstrate robustness of preserved stool specimens to multiple freeze/thaw cycles.	Stable for up to two (2) freeze/thaw cycles when stored frozen (≤ -20°C).
Analytical Specificity/Interference: Show no interference from common chemical and biological substances found in stool.	No interference observed for any of the evaluated substances (TUMS, Mylanta, Pepto-Bismol, Tagamet, Prilosec OTC, Barium Sulfate, Whole Blood, Leukocytes, Mucin, Hemoglobin, Stearic Acid, Palmitic Acid, NSAID, Ibuprofen) at their respective test concentrations. (Same substances previously evaluated for predicate).
Analytical Specificity/Cross-Reactivity: Show no cross-reactivity with common microorganisms or interference with H. pylori detection.	No cross-reactivity or microbial interference observed with any of the tested bacteria, fungi, and viral strains. (Same organisms previously evaluated for predicate).
Method Comparison (Clinical Performance with a Comparator Device): Achieve acceptable positive and negative percent agreement with an FDA-cleared comparator device using preserved stool.	Positive Agreement: 100.0% (49/49) [95% CI: 92.7% - 100.0%] Negative Agreement: 98.5% (131/133) [95% CI: 94.7% - 99.6%]

Study Details

Sample sizes used for the test set and the data provenance:
- Analytical Sensitivity (LoD): Not explicitly stated how many samples per lot were used in the LoD study, but it mentions "Three lots" and "positive results >= 95% of the time."
- Precision/Reproducibility: 360 samples (10 panels x 12 blinded samples x 3 laboratories). The samples were "contrived stool samples" with H. pylori antigen spiked in. Data provenance is implied to be domestic (USA) due to the submission context, and it's a prospective study looking at controlled, contrived samples.
- Preserved Specimen Storage Stability: Not explicitly stated how many samples were used, but the study was designed to validate stability claims.
- Freeze/Thaw Stability: Not explicitly stated how many samples were used.
- Analytical Specificity/Interference: Not explicitly stated how many samples were used, but testing was performed in the presence of various substances.
- Analytical Specificity/Cross-reactivity: Not explicitly stated how many samples were used, but each organism was tested with a true negative and a contrived low positive sample at specified concentrations.
- Method Comparison (Clinical Performance): 200 archived stool specimens were enrolled, of which 182 were evaluable and used for the comparison. Data provenance is of archived specimens from patients, suggesting retrospective data. The specific country of origin is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is an in-vitro diagnostic (IVD) for detecting antigens, not an imaging device requiring expert interpretation for ground truth.
- For the Precision/Reproducibility study, "expected assay result" was used as ground truth for contrived samples. This implies the ground truth was based on the known concentration of spiked antigen.
- For the Method Comparison study, the comparison was against an "FDA-cleared comparator device" and "Standard of Care (SoC) testing using an FDA-cleared commercial assay." The "ground truth" for clinical performance appears to be established by the results of these existing FDA-cleared methods. No human expert consensus was used to define the ground truth for individual samples.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No human adjudication method was mentioned or implied, as the device is an IVD detecting antigens, and ground truth was established either by known concentrations in contrived samples or by results from existing FDA-cleared assays.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was conducted. This type of study is typically performed for AI-assisted diagnostic imaging devices where human interpretation directly impacts results. This device is an immunoassay (IVD).
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance data provided (LoD, Reproducibility, Interference, Cross-reactivity, Method Comparison) represent the standalone performance of the Premier HpSA Flex assay. It's an automated or semi-automated EIA, not an algorithm requiring human interaction for its direct output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For analytical performance studies (LoD, Precision, Interference, Cross-Reactivity), the ground truth was known concentrations of H. pylori antigen in contrived samples or known presence/absence of interfering/cross-reacting substances/organisms.
- For the method comparison (clinical performance), the ground truth was established by results from an FDA-cleared comparator device and Standard of Care (SoC) testing using an FDA-cleared commercial assay.
The sample size for the training set:
- This is a traditional in-vitro diagnostic device (immunoassay), not a machine learning/AI algorithm that requires a "training set" in the conventional sense. The device's components and parameters are developed through standard chemistry and assay development processes, not through iterative training on a dataset.
How the ground truth for the training set was established:
- As stated above, there is no "training set" for an immunoassay in the context of AI/ML. The "ground truth" for the development of the assay itself would align with standard analytical validation methods, ensuring the assay accurately detects the target analyte (H. pylori antigens) at various concentrations and in the presence of relevant interferents, against known standards.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K230901

Device Name

Premier® HpSA® Flex

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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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 DriveCincinnati, OH 45244USA
Telephone:	(513) 991-5946
Contact Person:	Heather Planck, Senior Regulatory AffairsSpecialistHeather.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 serologicalreagents	MI – Microbiology (83)

Predicate:

Premier® Platinum HpSA® PLUS

C. Device Description

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.

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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

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

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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 HpSAFlex	Predicate device: PREMIERPlatinum HpSA PLUS
Intended Use /Indications for Use	The Premier HpSA Flex enzymeimmunoassay (EIA) is an in vitroqualitative procedure for the detectionof Helicobacter pylori antigens inhuman stool.The test is intended for use withunpreserved stool specimens orpreserved stool specimens intransport media.Test results are intended to aid in thediagnosis of H. pylori infection and tomonitor response during and post-therapy in patients. Accepted medicalpractice recommends that testing byany current method, to confirmeradication, be done at least fourweeks following completion oftherapy	The PREMIER Platinum HpSA PLUSis an in vitro diagnostic procedure forthe detection of Helicobacter pyloriantigens in human stool.Test results are intended to aid in thediagnosis of H. pylori infection and tomonitor response during and post-therapy in patients. Accepted medicalpractice recommends that testing byany current method, to confirmeradication, be done at least fourweeks 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 controlsincluded in the kit	Same
Reagent storage	Refrigerated (2-8°C)	Same
Reagent andcomponents	Antibody Coated Microwells; PositiveControl; Sample Diluent / NegativeControl; Premier 20X Buffer I;Enzyme Conjugate; PremierSubstrate I; Premier Stop Solution 1;Transfer pipettes; Microwell stripsealer; Wooden stick applicators	Same
Result interpretation	Visual or spectrophotometric	Same
General Device Characteristic Differences
Device & PredicateDevice(s):	Device: K230901	Predicate: K182559
Addition of specimentype	Unpreserved stool specimens andstool specimens preserved in Cary-	Unpreserved (raw) stool specimens

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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

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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 (per500 µL of Patient Stool)
TUMS	10 mg/500 µL
Mylanta (per 10 mL: Aluminum hydroxide 800 mg, Magnesiumhydroxide 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. entericaserovar Dublin	ATCC 15480
Campylobacter lari	ATCC BAA-1060	Salmonella enterica subsp. entericaserovar Hilversum	ATCC 15784
Candida albicans	ATCC 18804	Salmonella enterica subsp. entericaserovar Typhimurium	ATCC 13311

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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.

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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).

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).