← Product Code [LYR](/submissions/MI/subpart-d%E2%80%94serological-reagents/LYR) · K053335

# PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480 (K053335)

_Meridian Bioscience, Inc. · LYR · Mar 10, 2006 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LYR/K053335

## Device Facts

- **Applicant:** Meridian Bioscience, Inc.
- **Product Code:** [LYR](/submissions/MI/subpart-d%E2%80%94serological-reagents/LYR.md)
- **Decision Date:** Mar 10, 2006
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3110
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## 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.

## Device Story

Premier Platinum HpSA PLUS is an in vitro diagnostic, microwell-based enzyme-linked immunoassay (EIA) for detecting H. pylori antigen in human stool. The device consists of microwells coated with capture antibodies, enzyme conjugate (detector antibodies), sample diluent, wash buffer, substrate solution, stop solution, and positive control. Used in clinical laboratories by technicians; the assay requires no calibrators. The operator adds stool samples to the microwells; the presence of H. pylori antigen is detected via a colorimetric reaction measured by a dual-wavelength spectrophotometer (450/630 nm). Results are interpreted against a fixed cutoff (OD ≥ 0.100). The output aids clinicians in diagnosing H. pylori infection and monitoring patient response to eradication therapy. By providing a qualitative assessment of bacterial presence, the device assists in determining the success of treatment regimens, potentially reducing unnecessary follow-up or guiding further clinical intervention.

## Clinical Evidence

Method comparison study using 291 symptomatic patient samples. Compared subject device to predicate; 100% positive agreement (94/94) and 94.8% negative agreement (183/193). Discrepant analysis against CLO, histology, or UBT confirmed subject device results were accurate in cases where it differed from the predicate. Analytical performance included precision/reproducibility studies (100% reproducibility) and analytical specificity testing against numerous bacterial, yeast, and viral strains, showing no interference.

## Technological Characteristics

Qualitative EIA kit; microwells coated with monoclonal anti-H. pylori antibodies. Peroxidase-conjugated monoclonal antibody detection. Energy source: spectrophotometer (optional). Dimensions/form factor: standard microwell plate format. Connectivity: standalone. Sterilization: N/A. Software: None (manual/spectrophotometric interpretation).

## Regulatory Identification

Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter 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.

## Predicate Devices

- Premier Platinum HpSA ([K980076](/device/K980076.md), [K983255](/device/K983255.md))

## Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
K053335

B. Purpose for Submission:
Change from polyclonal to monoclonal antibody technology

C. Measurand:
Helicobacter pylori antigen

D. Type of Test:
Qualitative enzyme immunoassay (EIA)

E. Applicant:
Meridian Bioscience Inc.

F. Proprietary and Established Names:
Premier Platinum HpSA PLUS

G. Regulatory Information:
1. Regulation section:
21 CFR 866.3110
2. Classification:
Class I
3. Product code:
LYR – Campylobacter pylori
4. Panel:
Microbiology (83)

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H. Intended Use:

1. Intended 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.

2. Indication 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.

3. Special conditions for use statement:

For prescription use

4. Special instrument requirements:

Results may be read with a single or dual wavelength spectrophotometer

I. Device Description:

The device is a kit consisting of microwells coated with antibodies specific for H. pylori, positive and negative controls, wash buffer, enzyme conjugate, substrate and stop solution.

J. Substantial Equivalence Information:

1. Predicate device name:

Premier Platinum HpSA

2. Predicate 510(k) numbers:

K980076 & K983255

3. Comparison with predicate:

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|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Intended Use | Same | Same  |
|  Stool matrix | Same | Same  |
|  |   |   |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Limit of detection | ≥ 4.67 ng/mL stool | ≥ 184 ng/mL in stool  |
|  Assay cut off | 0.100 at OD 450/630 | 0.120 at OD450/630  |
|  |   |   |

## K. Standard/Guidance Document Referenced (if applicable):

FDA Draft Guidance: Review Criteria for Assessment of Laboratory Tests for the detection of antibodies to Helicobacter pylori. Sep. 1992

## L. Test Principle:

The Premier Platinum HpSA PLUS test utilizes a mixture of monoclonal anti- $H.$  pylori capture antibodies adsorbed to microwells. Diluted patient samples and a conjugate (peroxidase conjugated to monoclonal antibodies) 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

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

#### a. Precision/Reproducibility:

Assay precision, intra-assay variability and inter-assay variability were assessed with a reference panel prepared from high positive samples ( $n = 2$ ), low negative samples ( $n = 2$ ), and low positive and high negative specimens ( $n = 1$  each). The latter were diluted to near the assay limit of sensitivity. Nine replicates each of the low positive and high negative samples were included in the panel to bring the total cohort to 22 reference specimens. Each reference specimen was coded to prevent its identification during testing. Each was evaluated twice per day for three consecutive days by three different laboratories. High negative samples (OD value just below 0.100) produced weakly positive results (OD values just above 0.100) in 42 out of 162 tests. It is expected that high negative samples prepared at the cut-off will produce weakly positive results  $50\%$  of the time. (See EP12-A, User protocol for evaluation of qualitative performance; approved guideline;

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NCCLS/CLSI, Vol. 22, no.14, 2002.) Low positive, high positive and low negative samples produced the correct results 100% of the time. Reproducibility was 100% with no intra-assay and inter-assay variability for samples prepared above or below the limit of analytical sensitivity.

b. Linearity/assay reportable range:
N/A

c. Traceability, Stability, Expected values (controls, calibrators, or methods):
N/A

d. Detection limit:
Serial dilutions of purified H. pylori flagellar antigen and a H. pylori bacterial strain (ATCC 43504) were prepared in stool or Sample Diluent and used to determine the lowest concentration of antigen that would still yield a definitive positive result (A₄₅₀/₆₃₀ ≥ 0.100 on Premier Platinum HpSA PLUS). Final concentrations were calculated from the data points using linear regression analysis. The analytical limit for H. pylori flagellar antigen is 4.67 ng/mL in stool and 0.69 ng/mL in sample diluent. The limit for H. pylori bacterial strain is 1.0 X 10⁶ organisms/mL in stool and 4.4 X 10⁴ organisms/mL in Sample Diluent.

e. Analytical specificity:
The specificity of Premier Platinum HpSA PLUS was tested by utilizing the following bacterial, yeast or viral strains. Positive and negative stools were spiked with ≥ 1.2 X 10⁹ bacterial or yeast organisms/mL and tested by Premier Platinum HpSA PLUS. The concentration of viral organisms was not calculated. None of the organisms affected positive or negative test results.

Microorganism or virus

|  Adenovirus | Aeromonas hydrophila | Campylobacter lari | Campylobacter fetus  |
| --- | --- | --- | --- |
|  Campylobacter jejuni | Campylobacter mi 2 | Campylobacter jejuni solution | Campylobacter lari  |
|  Candida albicans | Citrobacter freundii | Clostridium difficile | Clostridium perfringens  |
|  Enterobacter cloacae | Enterococcus faecalis | Escherichia coli 0157:H7 | Escherichia coli 8739  |
|  Escherichia coli 9637 | Escherichia fergusonii | Escherichia hermannii | Escherichia hermannii EMDi-64  |
|  Helicobacter pylori | Klebsiella pneumoniae | Lactobacillus lactis | Listeria monocytogenes  |
|  Peptostreptococcus | Proteus vulgaris | Pseudomonas | Pseudomonas  |

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|  anaerobius |  | aeruginosa | fluorescens  |
| --- | --- | --- | --- |
|  Salmonella Group B | Salmonella typhimurium | Serratia liquefaciens | Serratia liquefaciens  |
|  Serratia marcescens | Shigella boydii | Shigella flexneri | Shigella dysenteriae  |
|  Shigella sonnei | Staphylococcus aureus | Staphylococcus aureus (Cowans 1) | Staphylococcus epidermidis  |
|  Streptococcus faecalis | Yersinia enterocolitica | Yersinia enterocolitica | Rotavirus  |
|  Salmonella enterica serovar | Salmonella enterica subsp. Enterica serovar | Salmonella enterica subsp. Enterica serovar Minnesota |   |

# TESTS FOR INTERFERING SUBSTANCES

The following substances, that may be present in human stool do not interfere with positive or negative test results at the stated concentrations per 500 uL human stool: TUMS - 10 mg, Mylanta - 0.84 mg, Pepto Bismol - 0.35 mg, Tagamet - 1 mg, Prilosec OTC - 1 mg, barium sulfate - 10 mg, whole blood - 100 uL, mucin - 6.7 mg, human hemoglobin (ie, dark stool) - 15 mg steric + palmitic acids (ie, fatty stool) - 7.9 mg.

## f. Assay cut-off:

The cut-off value of 0.100 was established on a lot-to-lot basis with specific procedures for optimizing solid phase and conjugate reagents. The validity of selection of this cut-off was proven in verification studies and clinical studies performed on three lots of fully manufactured product. The histogram provided below plots the values of samples tested during the clinical studies. The histogram shows that most samples consistently produce values that fall well above the cut-off, or well below that value.

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![img-0.jpeg](img-0.jpeg)

## 2. Comparison studies:

### a. Method comparison with predicate device:

Tests with 291 samples from symptomatic patients collected either prior to or following treatment were used to demonstrate that Premier Platinum HpSA PLUS performed similarly to Premier Platinum HpSA. Thirty three of these samples were originally evaluated in an earlier trial to demonstrate the effectiveness of Premier Platinum HpSA. Test performance is detailed in the following table.

|  PP HpSA PLUS | PP HpSA (Predicate)  |   |   |
| --- | --- | --- | --- |
|   |  Positive | Negative | Indeterminate  |
|  Positive | 94 | 10 | 3  |
|  Negative | 0 | 183 | 1  |
|  |   |   |   |
|  Agreement | Positive test | 94/94 = 100%  |   |
|   | Negative Test | 183/193 = 94.8%  |   |
|   | Overall | 277/287 = 96.5%  |   |

Eight of the ten samples that were positive by Premier Platinum HpSA PLUS, but negative by Premier Platinum HpSA, were positive by CLO, histology or UBT testing. The three samples that were positive by Premier Platinum HpSA PLUS but indeterminate by Premier Platinum HpSA were positive by CLO, histology or UBT testing. The one sample, that was negative by Premier Platinum HpSA PLUS but indeterminate by Premier Platinum HpSA, was negative by CLO, histology or UBT testing.

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b. Matrix comparison:
N/A

3. Clinical studies:
a. Clinical Sensitivity:
N/A
b. Clinical specificity:
N/A
c. Other clinical supportive data (when a. and b. are not applicable):
See 2 (a) Comparison Studies

4. Clinical cut-off:
Comparison to the predicate showed 100% positive agreement and 94.8% negative agreement.

5. Expected values/Reference range:
Studies on the epidemiology of H. pylori have shown that this organism is present worldwide. Gastritis caused by H. pylori has been shown to correlate with age, ethnic background, family size and socioeconomic class. The prevalence of H. pylori infection in a given population can vary from 20% to 90%. In patients diagnosed with duodenal ulcers, however, it has been shown in every age group to be approximately 80%. Currently recommended eradication treatments have an efficacy rate between 75% and 90%.

The Premier Platinum HpSA PLUS test detects the presence of H. pylori antigens in human stool. Expected values for a given population should be determined for each laboratory. The rate of positivity may vary depending on geographic location, method of specimen collection, handling and transportation, test employed and general health environment of patient population under study. As demonstrated by Premier Platinum HpSA in tests conducted in the United States, Canada and Italy, incidence of disease ranged from 34% to 53% to 69% respectively.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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O. Conclusion:

1. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LYR/K053335](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LYR/K053335)

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