PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480

• K Number: K053335
• Device Name: PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
• Manufacturer: MERIDIAN BIOSCIENCE, INC.
• Date Cleared: 2006-03-10 ( 99 days)
• Product Code: LYR
• Regulation Number: 866.3110

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.

Device Description

Premier Platinum HpSA PLUS is an in vitro diagnostic, microwell-based, enzymelinked immunoassay for the detection of Helicobacter pylori antigen in human stool. The assay is intended for use in clinical laboratories to test for bacterial colonization to aid diagnosis, or monitor a patient's response during therapy to eradicate infection. The assay consists of Microwells coated with specific antibodies (solid phase/capture antibodies), Enzyme Conjugate (detector antibodies), Sample Diluent, Premier 20X Wash Buffer I, Premier Substrate Solution I, Premier Stop Solution I and Positive Control. Sample Diluent also functions as the Negative Control reagent. No calibrators are needed to use this device.

Predicate Devices

K980076, K983255

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies detail a standard enzyme immunoassay (EIA) procedure. There is no mention of AI, ML, image processing, or any computational analysis beyond basic optical density measurements and comparisons to a fixed cutoff value.

Therapeutic

No
The device aids in the diagnosis and monitoring of H. pylori infection, but it is an in vitro diagnostic test for detecting antigens and does not directly provide therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section states that the test results "are intended to aid in the diagnosis of H. pylori infection."

SaMD (Software as a Medical Device)

No

The device is described as an in vitro diagnostic, microwell-based, enzyme-linked immunoassay, which involves physical components and chemical reactions, not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use/Indications for Use: The document explicitly states "The Premier Platinum HpSA PLUS enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool." It also mentions the test results are intended to "aid in the diagnosis of H. pylori infection and to monitor response during and post-therapy in patients." This clearly indicates the device is used outside of the body to analyze a human sample for diagnostic purposes.
• Device Description: The description further reinforces this by stating "Premier Platinum HpSA PLUS is an in vitro diagnostic, microwell-based, enzyme-linked immunoassay for the detection of Helicobacter pylori antigen in human stool."
• Anatomical Site: The sample analyzed is "human stool," which is a biological specimen taken from the human body.
• Intended User/Care Setting: The device is intended for use in "clinical laboratories," which are settings where in vitro diagnostic tests are performed.

All of these points align with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Premier Platinum HpSA PLUS enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. Test results are intended to aid in the diagnosis of H. pylori infection and to monitor response during and post-therapy in patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.

Product codes (comma separated list FDA assigned to the subject device)

LYR

Device Description

Premier Platinum HpSA PLUS is an in vitro diagnostic, microwell-based, enzymelinked immunoassay for the detection of Helicobacter pylori antigen in human stool. The assay is intended for use in clinical laboratories to test for bacterial colonization to aid diagnosis, or monitor a patient's response during therapy to eradicate infection. The assay consists of Microwells coated with specific antibodies (solid phase/capture antibodies), Enzyme Conjugate (detector antibodies), Sample Diluent, Premier 20X Wash Buffer I, Premier Substrate Solution I, Premier Stop Solution I and Positive Control. Sample Diluent also functions as the Negative Control reagent.

No calibrators are needed to use this device.

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

clinical laboratories

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

Comparison of Premier Platinum HpSA PLUS to Premier Platinum HpSA: 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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance Evaluation Data Summarized
Comparison of Premier Platinum HpSA PLUS to Premier Platinum HpSA: 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 including 95% confidence intervals is detailed in the following table.

• Correlation: 277/287 (96.5%), 95% CI: 93.7% - 98.3%
• Agreement, positive tests: 94/94 = 100%
• Agreement, negative tests: 183/193 = 94.8%

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.

Analysis of samples producing discordant results
Samples producing discordant results between Premier Platinum HpSA PLUS and the predicate were evaluated against test data from other conventional tests such as CLO, Histology, or UBT to determine the trueness of the results.

Therapeutic Monitoring
Study design: A panel of frozen, archival specimens from four patients who were monitored during eradication therapy and tested using the predicate Premier Platinum HpSA (K980076 and K983255) were assessed using the Premier Platinum HpSA PLUS assay. One of the panels represented a low positive state with the predicate at the beginning of eradication therapy (See Figure 1.) The remaining three panels represented strongly positive states. (See Figures 2-4.) That data obtained with Premier Platinum HpSA PLUS was compared to that originally obtained with the predicate. In the case of strongly positive samples, the eradication curves for the two tests are substantively the same. The eradication curve for Premier Platinum HpSA PLUS differs from that of the predicate with low positive samples at the beginning of therapy since it produces stronger test results. However, by week four following treatment, the curves are identical. Conclusions to the study: Premier Platinum HpSA performs similarly to the predicate when used to monitor the effectiveness of eradication therapy.

Reproducibility
Assay precision, intra-assay variability and inter-assay variability were assessed with a reference panel prepared from high positive samples (n = 2), low low negative samples (n = 2), and low positive and high neqative 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. In accordance with the IFU, values of

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).

Summary

0

510(k) SUMMARY

510(k) number: K053335

Submitters name and address: Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati. OH 45244 513-271-3700 Contact: Susan Rolih

Date summary prepared: January 30, 2006

Name of the device: Premier Platinum HpSA PLUS Enzyme Immunoassay for the detection of H. pylori antigen in human stool specimens

Classification: LYR, CFR section 866.3110

Predicate device to which this device is being compared: Premier Platinum HpSA (Meridian Bioscience, Inc., Cincinnati, OH) (K980076, K983255)

Device description: Premier Platinum HpSA PLUS is an in vitro diagnostic, microwell-based, enzymelinked immunoassay for the detection of Helicobacter pylori antigen in human stool. The assay is intended for use in clinical laboratories to test for bacterial colonization to aid diagnosis, or monitor a patient's response during therapy to eradicate infection. The assay consists of Microwells coated with specific antibodies (solid phase/capture antibodies), Enzyme Conjugate (detector antibodies), Sample Diluent, Premier 20X Wash Buffer I, Premier Substrate Solution I, Premier Stop Solution I and Positive Control. Sample Diluent also functions as the Negative Control reagent.

No calibrators are needed to use this device.

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.

There is no change to the intended use of this device from its predicate.

Comparison charts (Premier Platinum HpSA PLUS vs Predicate Device):

| Characteristics | Premier Platinum HpSA
PLUS | Premier Platinum HSA
(predicate) |
|--------------------------------|--------------------------------------|--------------------------------------|
| Device Type | | |
| In vitro diagnostic device | Yes | Yes |
| Control | Includes external control
reagent | Includes external control
reagent |
| Calibrator | No | No |
| Intended Use | | |
| Detection of H. pylori antigen | Yes | Yes |
| Screening test | Yes | Yes |
| Diagnostic test | No | No |
| Monitoring therapy | Yes | Yes |
| Acceptable Sample | | |
| Stool | Yes | Yes |

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| Laboratory Equivalence with (Predicate Device) | Premier Platinum HpSA
PLUS | Predicate |
|------------------------------------------------|-------------------------------|-------------------------------|
| Combined Totals | | |
| Agreement, positive tests | 100% | N/A |
| Agreeement, negative tests | 94.8% | N/A |
| Agreement, overall | 96.5% | N/A |
| Performance characteristics | | |
| Precision/Reproducibility (intra-assay) | 97% | 100% |
| Linearity/reportable range | N/A | N/A |
| Analytical limit of detection/sensitivity | ≥ 4.67 ng in stool | ≥ 184 ng in stool |
| Assay cutoff | 0.100 at OD450/630 | 0.120 at OD450/630 |
| Indeterminant range | None | 0.100 - 0.120 at
OD450/630 |

Interpretation of test results

The results of bench tests were read using a standard laboratory dual wave length spectrophotometer. Results were interpreted according to the following scale:

Spectrophotometric dual wavelength (450/630 nm) Negative 3.000" signifies the signal exceeded the high limit of the plate reader used in the study was Auses 2.999.

Sample	2-128
	Run 1	Run 2	Run 3	Avg
Unspiked Sample	0.386	0.382	0.323	0.364
Campylobacter lari	0.399	0.398	0.390	0.396
Campylobacter jejuni	0.468	0.442	0.456	0.455
Campylobacter jejuni solution	0.432	0.427	0.409	0.423
Campylobacter jejuni 2	0.414	0.410	0.393	0.406
Campylobacter fetus	0.398	0.427	0.383	0.403

4

Sample	2-42
	Run 1	Run 2	Run 3	Avg
No Spike	0.011	0.009	0.014	0.011
No Spike	0.006	0.005	0.008	0.006
No Spike	0.006	0.007	0.014	0.009
No Spike	0.005	0.007	0.007	0.006
No Spike	0.006	0.008	0.006	0.007

	2-42
Sample	Run 1	Run 2	Run 3	Avg
Adenovirus	0.007	0.007	0.006	0.007
Aeromonas hydrophila	0.004	0.006	0.006	0.005
Borrelia bergdorferi	0.012	0.006	0.007	0.008
Campylobacter lari	0.008	0.007	0.004	0.006
Campylobacter fetus	0.007	0.008	0.004	0.006
Campylobacter jejuni	0.016	0.006	0.008	0.010
Campylobacter jejuni 2	0.000	0.006	0.007	0.004
Campylobacter jejuni solution	0.004	0.009	0.007	0.007
Campylobacter lari	0.005	0.007	0.006	0.006
Candida albicans	0.006	0.008	0.008	0.007
Citrobacter freundii	0.005	0.016	0.006	0.009
Clostridium difficile	0.010	0.011	0.009	0.010
Clostridium perfringens	0.010	0.008	0.008	0.009
Enterobacter cloacae	0.003	0.003	0.004	0.003
Enterococcus faecalis	0.002	0.002	0.007	0.004
Escherichia coli 0157:H7	0.005	0.034	0.064	0.034
Escherichia coli 8739	0.005	0.005	0.007	0.006
Escherichia coli 9637	0.003	0.007	0.006	0.005
Escherichia fergusonii	0.004	0.002	0.007	0.004
Escherichia hermannii	0.008	0.007	0.008	0.008
Escherichia hermannii EMDI-64	0.006	0.008	0.007	0.007
Helicobacter pylori	> 3.000	> 3.000	> 3.000	> 3.000
Klebsiella pneumoniae	0.004	0.004	0.007	0.005
Lactobacillus lactis	0.007	0.007	0.017	0.010
Listeria monocytogenes	0.008	0.005	0.009	0.007
Peptostreptococcus anaerobius	0.008	0.008	0.009	0.008
Proteus vulgaris	0.004	0.000	0.007	0.004
Pseudomonas aeruginosa	0.011	0.026	0.021	0.019
Pseudomonas fluorescens	0.006	0.007	0.007	0.007
Rotavirus	0.006	0.005	0.005	0.005
Salmonella enterica serovar Hilversum	0.008	0.007	0.009	0.008
Salmonella enterica subsp. Enterica serovar Hilversum	0.002	0.010	0.045	0.019
Salmonella enterica subsp. Enterica serovar Minnesota	0.005	0.008	0.005	0.006
Salmonella Group B	0.007	0.006	0.007	0.007

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Sample	Run 1	Run 2	Run 3	Avg
Salmonella typhimurium	0.003	0.007	0.005	0.005
Serratia liquefaciens	0.007	0.007	0.007	0.007
Serratia liquefaciens	0.000	0.003	0.004	0.002
Serratia marcescens	0.007	0.008	0.008	0.008
Shigella boydii	0.006	0.000	0.003	0.003
Shigella flexneri	0.004	0.027	0.004	0.012
Shigella dysenteriae	0.006	0.005	0.050	0.020
Shigella sonnei	0.007	0.002	0.009	0.006
Staphylococcus aureus	0.008	0.004	0.008	0.007
Staphylococcus aureus (Cowans 1)	0.007	0.009	0.007	0.008
Staphylococcus epidermidis	0.008	0.003	0.007	0.006
Streptococcus faecalis	0.006	0.005	0.007	0.006
Yersinia enterocolitica	0.005	0.004	0.008	0.006
Yersinia enterocolitica	0.004	0.003	0.006	0.004

Performance Evaluation Data Summarized

Comparison of Premier Platinum HpSA PLUS to Premier Platinum HpSA: 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 including 95% confidence intervals is detailed in the following table.

		PP HpSA
PP HpSA PLUS	Positive	Negative	Indeterminate
Positive	94	10	3
Negative	0	183	1
Correlation	277/287 (96.5%)	93.7% - 98.3%
	95% CI
Agreement	Positive test	94/94 = 100%
	Negative test	183/193 = 94.8%

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.

Analysis of samples producing discordant results

Samples producing discordant results between Premier Platinum HpSA PLUS and the predicate were evaluated against test data from other conventional tests such as CLO, Histology, or UBT to determine the trueness of the results. The results of that evaluation are provided shown in the Table below.

6

| Sample
Number | PP HpSA PLUS Results | CLO/Histology/UBT
Results | PP HpSA Results
(Predicate) | Interpretation using
CLO/Hist/UBT |
|------------------|----------------------|------------------------------|--------------------------------|--------------------------------------|
| UC82 | Positive | Negative | Negative | FP--PPHpSAPLUS |
| 2 | Positive | Positive | Indeterminate | TP--PPHpSAPLUS |
| 3-44 | Negative | Negative | Indeterminate | TN--PPHpSAPLUS |
| U082 | Positive | Positive | Negative | TP--PPHpSAPLUS |
| U004 | Positive | Positive | Negative | TP--PPHpSAPLUS |
| U120 | Positive | Positive | Negative | TP--PPHpSAPLUS |
| U159 | Positive | Positive | Negative | TP--PPHpSAPLUS |
| U056 | Positive | Positive | Negative | TP--PPHpSAPLUS |
| U137 | Positive | Positive | Indeterminate | TP--PPHpSAPLUS |
| U161 | Positive | Positive | Negative | TP--PPHpSAPLUS |
| P026 | Positive | Positive | Negative | TP--PPHpSAPLUS |
| P040 | Positive | Negative | Negative | FP--PPHpSAPLUS |
| P172 | Positive | Positive | Indeterminate | TP--PPHpSAPLUS |
| P173 | Positive | Positive | Negative | TP--PPHpSAPLUS |

Legend: FP = false positive, TP = true positive, TN = true negative

Performance Comparison Table

Performance Characteristics (rounded) in Direct Comparison to	Premier Platinum HpSA	Premier Platinum HpSA
Clinical Status or Condition	PLUS	(Predicate)
Estimated Clinical Sensitivity	N/A	96.1%
Estimated Clinical Specificity	N/A	95.7%
Predictive Value of a Positive Test	N/A	96.1%
Predictive Value of a Negative Test	N/A	95.7%
Laboratory Equivalence with (Predicate Device) Combined Totals
Agreement, positive tests	100%	N/A
Agreement, negative tests	94.8%	N/A
Correlation	96.5%	95.9%
Performance characteristics
Precision/Reproducibility	100%	100%
Linearity/reportable range	N/A	N/A
Limit of detection	≥ 4.67 ng in stool	≥ 184 ng in stool
Assay cutoff	0.100 at OD450/630	0.120 at OD450/630

Therapeutic Monitoring

Study design: A panel of frozen, archival specimens from four patients who were monitored during eradication therapy and tested using the predicate Premier Platinum HpSA (K980076 and K983255) were assessed using the Premier Platinum HpSA PLUS assay. One of the panels represented a low positive state with the predicate at the beginning of eradication therapy (See Figure 1.) The remaining three panels represented strongly positive states. (See Figures 2-4.) That data obtained with Premier Platinum HpSA PLUS was compared to that originally obtained with the predicate. In the case of strongly positive samples, the eradication curves for the two tests are substantively the same. The eradication curve for Premier Platinum HpSA PLUS differs from that of the predicate with low positive samples at the beginning of therapy since it produces stronger test results. However, by week four following treatment, the curves are identical. Conclusions to the study: Premier Platinum HpSA performs similarly to the predicate when used to monitor the effectiveness of eradication therapy.

7

Image /page/7/Figure/2 description: Figure 1 shows a graph of the absorbance of two different substances, Predicate 450/630 and PLUS 450/630, for Patient 41. The x-axis represents the specimen number, ranging from 1 to 7, while the y-axis represents the absorbance. The absorbance of Predicate 450/630 is relatively low, ranging from 0.02 to 0.27, while the absorbance of PLUS 450/630 is higher, ranging from 0.00 to 3.00.

Image /page/7/Figure/3 description: The image contains the text "Figure 2.". The text is in a simple sans-serif font. The figure number is likely a reference to a larger document or publication.

Image /page/7/Figure/4 description: This image shows a graph titled "Patient 51" with "Absorbance" on the y-axis and "Specimen" on the x-axis. There are two lines on the graph, one labeled "Predicate 450/630" and the other labeled "PLUS 450/630". The graph shows the absorbance values for each specimen, with the values for "Predicate 450/630" being 3.000, 1.945, 0.034, 0.026, and 0.025, and the values for "PLUS 450/630" being 3.000, 2.868, 0.041, 0.007, and 0.006.

Figure 3.

Image /page/7/Figure/6 description: This image is a graph for patient 71 showing absorbance versus specimen number. There are two lines on the graph, one for predicate 450/630 and one for PLUS 450/630. Both lines start at 3.000 for specimens 1 and 2, but then drop to around 0.030 for specimens 3-9.

8

Image /page/8/Figure/2 description: The image shows a graph and table for Patient 87. The graph plots absorbance on the y-axis versus specimen number on the x-axis for two different predicates, 450/630 and PLUS 450/630. Both predicates start with an absorbance of 3.000 for specimens 1 and 2, but then drop to 0.030 and 0.009 respectively for specimen 3. The absorbance values for specimens 4 through 7 are all below 0.033.

Figure 4.

Reproducibility

Assay precision, intra-assay variability and inter-assay variability were assessed with a reference panel prepared from high positive samples (n = 2), low low negative samples (n = 2), and low positive and high neqative 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. In accordance with the IFU, values of Trade/Device Name: Premier Platinum HpSA PLUS Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter Fetus Serological Reagents Regulatory Class: Class I Product Code: LYR Dated: January 31, 2006 Received: February 1, 2006

Dear Ms. Rolih:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

12

Page 2 --

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotel will and my your he FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sales, a Hogg

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

13

Premier Platinum HpSA PLUS

510(k) Notification Meridian Bioscience, Inc.

INDICATIONS FOR USE STATEMENT Premier Platinum HpSA PLUS

510(K) Number: K053335

The Premier Platinum HpSA PLUS enzyme immunoassay (EIA) is an in vitro qualitative procedure for The Trention of Helicobacter pylor antigens in human stool. Test results are intended to aid in the the decodion of H. pylor infection and to monitor response during and post-therapy in patients. Accepted ulaginosis or i. pyron invocion that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

freddie lu. loob

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

C1934) K05 3335

Section 4, Page 1 of 1