The Premier Platinum HpSA 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 in adult symptomatic patients.

Device Description

The Premier Platinum HpSA test utilizes polyclonal anti-H. pylori capture antibody adsorbed to microwells. Diluted patient samples and a peroxidase conjugated polyclonal antibody are added to the wells and incubated for one hour at room temperature. A wash is performed to remove unbound material. Substrate is added and incubated for ten 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 details for the Premier Platinum HpSA device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the overall performance evaluation. They aim to demonstrate that the Premier Platinum HpSA test is "substantially equivalent" to existing methods for detecting H. pylori.

Performance Metric	Acceptance Criteria (Implied/Predicate)	Reported Premier Platinum HpSA Performance (Compiled Data)
Sensitivity	~95.4% (89.6-98.5%) (from predicate CLOtest) or demonstrating high clinical agreement	96.1% (90.4-98.9%)
Specificity	~100.0% (96.4-100.0%) (from predicate CLOtest) or demonstrating high clinical agreement	95.7% (89.5-98.8%)
Correlation	~97.6% (94.5-99.2%) (from predicate CLOtest) or demonstrating high clinical agreement (95.9% desired)	95.9% (92.2-98.2%)

Note: The document explicitly states, "The differences in technology does not raise additional concerns regarding safety and effectiveness. Safety and effectiveness are demonstrated to be substantially equivalent." This indicates that the reported performance metrics for the Premier Platinum HpSA were considered sufficient to meet the acceptance criteria by demonstrating equivalence.

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

Sample Size: 200 symptomatic adults were evaluated in the clinical study. Nine patients were considered unevaluable, meaning the effective sample size for performance calculations was 191 (99 infected, 90 not infected, plus 2 'Equ' and 1 'Equ' at site 3, 2 'Equ' at site 4, which were excluded from the main table's infected/not infected counts but are implicitly part of the overall 200 evaluated).
Data Provenance: The data was collected prospectively from four sites:
- One midwestern United States location
- One site in Canada
- Two sites in Italy

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

The document does not specify the number of experts or their qualifications directly. However, it states that the diagnosis of H. pylori infection (ground truth) was "judged by objective reference methods." These reference methods are:

Culture
Rapid Urease Test (RUT)
Histology
Urea Breath Test (UBT)

It's implied that these objective reference methods were interpreted by qualified personnel (e.g., microbiologists for culture, pathologists for histology, and trained technicians for RUT and UBT), but no specific number or detailed qualifications are provided.

4. Adjudication Method for the Test Set

Patients were considered H. pylori positive if:

Culture was positive, OR
Two or more of the other three tests (Rapid Urease, Histology, UBT) were positive.

Patients were considered unevaluable if:

They had negative or no culture results, AND
Only one other test (RUT, Histology, UBT) was positive.

This acts as a consensus-based adjudication method for establishing the ground truth.

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

No, an MRMC comparative effectiveness study was not done. The study compares the Premier Platinum HpSA test (an in vitro diagnostic device) against established diagnostic reference methods for H. pylori infection (the ground truth), not against human readers with and without AI assistance. The device in question is a laboratory assay, not an AI-powered image analysis tool for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The Premier Platinum HpSA test is a standalone in vitro diagnostic device. Its performance metrics (Sensitivity, Specificity, Correlation) are reported for the device itself, functioning independently, with results interpreted visually or spectrophotometrically. There is no "human-in-the-loop" component in the direct processing of the sample by the device; rather, it's a lab test where technicians perform the procedure and interpret the final result based on established cutoffs.

7. The Type of Ground Truth Used

The ground truth used was a composite reference standard based on objective laboratory and pathological evidence. Specifically, it relied on a combination of:

Culture
Rapid Urease Test (RUT)
Histology
Urea Breath Test (UBT)

A patient was considered positive if culture was positive, or if two or more of the other three tests were positive. This is referred to as expert consensus (albeit on objective data) or composite clinical diagnosis.

8. The Sample Size for the Training Set

The document does not specify a separate training set or its sample size. This device is an immunoassay, not a machine learning model that typically requires a distinct training phase. Therefore, the concept of a "training set" in the context of AI models does not apply here. The performance evaluation is based on a clinical test set.

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

As noted in point 8, there is no mention of a "training set" for this immunoassay device. The ground truth for the test set was established using a composite reference standard (Culture, Rapid Urease, Histology, UBT) as detailed in point 7.

Summary

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MAY 1 2 1998

510(k) Summary

K980076

Identification Information

Submitter's Information:

Submitter's Name and Address:

Meridian Diagnostics, Inc. River Hills Drive Cincinnati, OH 45244

Phone Number: 1-800-543-1980

Contact Person: Allen D. Nickol, PhD Director of Scientific and Regulatory Affairs

Date Summary Prepared: May 5, 1998

Name of Device: Premier Platinum HpSA.

Classification Name: Campylobacter pylori, 83LYR

Predicate Equivalent Device:

CLOtest, rapid urease test for biopsy specimens.

Description of Device:

Intended Use:

The Premier Platinum HpSA enzyme immunoassay (EIA) is an in virro 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 in adult patients.

Comparison with Predicate Devices:

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The following comparison of the use, technology, function and performance supports the Statement of Equivalence between the Premier Platinum HpSA test The differences in technology does not raise additional and the CLO test. concerns regarding safety and effectiveness. Safety and effectiveness are demonstrated to be substantially equivalent.

Method	Premier HpSA	RapidUrease
Intended Use	Detection of H. pylori antigens inpatient stool	Detection of H. pylori associatedurease activity in biopsyspecimens
Results	Qualitative	Qualitative
Specimen Required	Stool	Gastric or Duodenal biopsy
Technology	Sandwich Enzyme Immunoassay	H. pylori urease catalyzed pHchange visualize by color changeindicator
Level of SkillRequired	Laboratory Technician	Gastroenterologist for biopsy andlaboratory technician for readingresult and QA.
Function	1. Specimen diluted 1/3 andadded to well containingrabbit anti-H. pylori captureAb.2. One drop HRP-conjugateddetection Ab added.3. Incubation 1 hr at roomtemperature.4. Wash 5 times.5. Add 2 drops substrate.6. Incubate 10 minutes at roomtemperature.7. Add one drop stop solutionand read visually orspectrophotometrically	1. Biopsy specimen place indevice and incubated at 30-40°C for 3 hours. The keep atroom temperature up to 24hours.2. Read results for visual colorchange. Negatives at 24 hoursif still yellow. Positive turnpink, orange or magenta.
Interpretation	Pos/Neg read visually orspectrophotometrically. Fixedcutoff 0.140 single wavelength(450nm) or 0.100 dualwavelength (450-630nm)	Pos/Neg
Method	Premier HpSA	RapidUrease
Sensitivity	96.2% (90.4-98.9%)	95.4% (89.6-98.5%)
Specificity	95.7% (89.5-98.8%)	100.0% (96.4-100.0%)
Correlation	96.0% (92.2-98.2%)	97.6% (94.5-99.2%)

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Response Items, Round 2: K980076 Premier Platinum HpSA

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Performance Characteristics:

The Premier Platinum HpSA test was evaluated on 200 symptomatic adults at one midwestern United States location, one site in Canada, and two sites in Italy. The patients studied had a wide cross-section of gastric pathologies noted, including: antral gastritis (n=81), antral gastropathy (n=25), antral erosions (n=24), esophagitis (n=21), duodenal ulcer (n=15), erosive duodemitis (n=10), GERD (n=10), "normal" (n=10), duodenitis (n=9), gastric ulcer (n=8), total stomach gastritis (n=6), hiatal hernia (n=6), Schatzki's ring (n=4), pyloric ulcer (n=2), and esophageal ulcer (n=1). HpSA test results were compared to diagnosis of H. pylori infection as judged by objective reference methods (culture, rapid urease, histology and UBT). Patients were considered positive if culture was positive, or if two or more of the other three tests were positive. Nine patients with negative or no culture results, and only one other test positive, were considered unevaluable. The HpSA test was 96.1% sensitive, 95.7% specific and showed 95.9% correlation with H. pylori infection. Confidence intervals were calculated by the exact binomial method.

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Trial	Site	#1

Test		Diagnosis		Sensitivity± 95% CI	Specificity± 95% CI	Positive PV± 95% CI	Negative PV± 95% CI	Correlation± 95% CI
Method	Result	Infected	Not Infected
HpSA	Pos	17	3	94.4%	91.4%	85.0%	97.0%	92.5%
EIA	Neg	1	32	72.7 to 99.9%	76.9 to 98.2%	62.1 to 96.8%	84.2 to 99.9%	81.8 to 97.9%

Reference Methods: Histology, Rapid Urease, Breath Test. Readings Single and Dual Wavelength.

Trial Site #2

Test	Diagnosis		Sensitivity± 95% CI	Specificity± 95% CI	Positive PV± 95% CI	Negative PV± 95% CI	Correlation± 95% CI
Method	Result	Infected	Not Infected
HpSA	Pos	9	0	100.0%	100.0%	100.0%	100.0%	100.0%
EIA	Neg	0	8	66.4 to 100.0%	63.1 to 100.0%	66.4 to 100.0%	63.1 to 100.0%	80.5 to 100.0%
	Equ	0	0

Reference Methods: Histology, Rapid Urease, Culture, Breath Test. Readings Single and Dual Wavelength.

Trial Site #3

Test		Diagnosis		Sensitivity± 95% CI	Specificity± 95% CI	Positive PV± 95% CI	Negative PV± 95% CI	Correlation± 95% CI
Method	Result	Infected	Not Infected
HpSA	Pos	44	0	97.8%	100.0%	100.0%	96.0%	98.6%
EIA	Neg	1	24	88.2 to 99.9%	85.8 to 100.0%	92.0 to 100.0%	79.6 to 99.9%	92.2 to 100.0%
	Equ	1	0

Reference Methods: Histology, Rapid Urease, Culture, Breath Test. Readings Single Wavelength.

Trial Site #4

Test	Diagnosis		Sensitivity± 95% CI	Specificity± 95% CI	Positive PV± 95% CI	Negative PV± 95% CI	Correlation± 95% CI
Method	Result	Infected	Not Infected
HpSA	Pos	29	1	93.5%	96.3%	96.7%	92.9%	94.8%
EIA	Neg	2	26	78.6 to 99.2%	81.0 to 99.9%	82.8 to 99.9%	76.5 to 99.1%	85.6 to 98.9%
	Equ	2	0

Reference Methods: Histology, Rapid Urease. Readings Dual Wavelength.

Compiled Data From All Sites

Test		Diagnosis		Sensitivity± 95% CI	Specificity± 95% CI	Positive PV± 95% CI	Negative PV± 95% CI	Correlation± 95% CI
Method	Result	Infected	Not Infected
HpSA	Pos	99	4	96.1%	95.7%	96.1%	95.7%	95.9%
EIA	Neg	4	90	90.4 to 98.9%	89.5 to 98.8%	90.4 to 98.9%	89.5 to 98.8%	92.2 to 98.2%
	Equ	3	0

Additional Information/Non-clinical Test Results:

Reproducibility:

Reproducibility of the Premier Platinum HpSA test was determined using negative (n=2), low positive (n=2). medium postive (n=2) and high positive (n=1) samples tested in triplicate in three separate batches / runs at each of two separate sites. Intra- and inter-assay coefficients of variation were determined and are presented below (ranges are the results from two different specimens):

	Intra-AssayReproducibility: Read at	Inter-AssayReproducibility: Read at
--	-----------------------------------------	-----------------------------------------

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Response Items, Round 2: K980076 Premier Platinum HpSA

Specimen Type	450nm	450-630nm	Visible	450nm	450-630nm	Visible
Negative	4.3% -5.1%	8.1% -13.5%	100%	10.6% -13.2%	51.0% -57.5%	100%
LowPositive	9.2% -14.8%	11.0% -16.6%	100%	15.3% -27.9%	18.0% -32.9%	100%
MediumPositive	8.8% -9.0%	9.6% -9.6%	100%	17.6% -19.3%	19.7% -19.7%	100%
HighPositive	11.2%	11.6%	100%	19.8%	20.0%	100%
NegativeControl	6.2%	20.2%	100%	15.3%	60.2%	100%
PositiveControl	2.2%	1.9%	100%	22.8%	23.9%	100%

Frozen Stools:

Samples were tested on day 0, then put through four freeze / thaw cycles, being tested each time. The data supports four freeze / thaw cycles.

Cross-Reactivity:

The specificity of Premier Platinum HpSA was tested by utilizing the following bacterial or viral strains. Positive and negative stools were spiked with ≥1x10° organisms / ml and tested by Premier Platinum HpSA. H. pylori gave a positive result when tested. All organisms were found to be negative when spiked into the negative stool. In addition, they did not interfere with the positive specimen:

Microorganism or virus (# strains tested)

Adenovirus Type II (1)	Rotavirus (1)
Campylobacter coli (1)	Mycobacterium smegmatis (1)
Campylobacter fetus (1)	Nocardia asteroides (1)
Campylobacter jejuni (1)	Proteus vulgaris (1)
Campylobacter lari (1)	Salmonella (Group B) (1)
Candida albicans (1)	Salmonella dublin (1)
Citrobacter freundii (1)	Salmonella hilversum (Group N) (1)
Clostridium difficile (2)	Salmonella minnesota (1)
Clostridium perfringens (2)	Salmonella typhimurium (1)
Enterococcus faecalis (1)	Serratia liquefaciens (1)
Enterobacter cloacae (1)	Shigella boydii (1)
Escherichia coli (2)	Shigella dysenteriae (1)
Escherichia fergusonii (1)	Shigella flexneri (1)

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Response Items, Round 2: K980076 Premier Platinum HpSA
Escherichia hermanii (1) Helicobacter cinaedi (1) Helicobacter mustelae (1) Klebsiella pneumoniae (1) Providencia stuartii (1) Pseudomonas aeruginosa (1) Pseudomonas fluorescens (2)

Interfering Substances: None

Shigella sonnei (1) Staphylococcus aureus (1) Staphylococcus aureus (Cowan I) (1) Staphylococcus epidermidis (1) Streptococcus agalactiae (1) Steptococcus faecalis (1) Yersinia enterocolitica (2)

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Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare and medicine.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 2 1998

Dr. Allen D. Nickol Meridian Diagnostics, Inc. Director, Scient. & Req. Affairs 3471 River Hills Drive Cincinnati, Ohio 45244

K980076 Re: Trade Name: Premier Platinum HpSA Requlatory Class: I Product Code: LYR Dated: April 8, 1998 Received: April 9, 1998

Dear Dr. Nickol:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಡ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements actien. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Steven Gutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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Response Items: K980076 Premier Platinum HpSA

Indications For Use Statement

510(k) Number (if known): K980076

Device Name: Premier HpSA

Indications For Use:

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubois

ision of Clinical Laboratory Devi 510(k) Number.

Prescription Jse X (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

للزاري سندر به

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).