MODIFICATION TO: PREMIER PLATINUM HPSA

K983255 · Meridian Diagnostics, Inc. · LYR · Dec 17, 1998 · Microbiology

Device Facts

• Record ID: K983255
• Device Name: MODIFICATION TO: PREMIER PLATINUM HPSA
• Applicant: Meridian Diagnostics, Inc.
• Product Code: LYR · Microbiology
• Decision Date: Dec 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Intended Use

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, and to monitor response during and post-therapy in adult 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 is an in vitro diagnostic enzyme immunoassay (EIA) for detecting Helicobacter pylori antigens in human stool samples. The device uses microwells coated with polyclonal anti-H. pylori capture antibodies. Patient stool samples and peroxidase-conjugated polyclonal antibodies are added to the wells; after incubation and washing, a substrate is added. Color development indicates the presence of bound enzyme, which is interpreted visually or spectrophotometrically by a laboratory technician. The test aids clinicians in diagnosing H. pylori infection and monitoring treatment efficacy in adult patients. By providing a non-invasive stool-based alternative to breath testing, it facilitates clinical decision-making regarding eradication therapy, with testing recommended at least four weeks post-therapy.

Clinical Evidence

Clinical performance evaluated against reference methods. Sensitivity reported at 94.7% (95% CI: 74.0-99.0%) and specificity at 96.1% (95% CI: 88.9-99.2%). Correlation with reference methods was 95.8% (95% CI: 89.6-98.8%).

Technological Characteristics

Sandwich enzyme immunoassay (EIA) utilizing polyclonal anti-H. pylori capture antibodies adsorbed to microwells. Peroxidase-conjugated detection antibody. Visual or spectrophotometric readout (fixed cut-off 0.140 at 450nm or 0.100 at 450-630nm).

Indications for Use

Indicated for adult patients to aid in the diagnosis of Helicobacter pylori infection and to monitor response during and post-therapy via detection of H. pylori antigens in human stool.

Regulatory Classification

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

• Meretek UBT

Submission Summary (Full Text)

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Meridian Diagnostics, Inc. Cincinnati, OH 45244

## 510(k) Notification Premier Platinum HpSA

K98325J

#### 510(k) Summary A.

## Identification Information

Submitter's Information:

## Submitter's Name and Address:

Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati, OH 45244

Phone Number: 1-800-543-1980

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

Date Summary Prepared: September 14, 1998

Name of Device: Premier Platinum HpSA

## Classification Name: Campylobacter pylori, 83LYR

Predicate Equivalent Device: Meretek UBT

### Description of Device:

The Premier Platinum HpSA test utilizes polyclonal anti-H. pvlori 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.

#### Intended Use:

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, and to monitor response during and post-therapy in adult patients. Accepted medical practice recommends that testing by any current method, to confirm eradication. be done at least four weeks following completion of therapy.

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# Comparison with Predicate Device:

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

| Intended Use | Detection of <i>H. pylori</i> antigens in patient<br>stool | Detection of <i>H. pylori</i> associated urease<br>activity in breath specimens |
|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Results | Qualitative | Qualitative |
| Specimen Required | Stool | Before and after breath specimens |
| Technology | Sandwich Enzyme Immunoassay | <i>H. pylori</i> urease catalyzed conversion of<br>$^{13}C-urea$ to $^{13}CO_2$ and ammonia. $^{13}CO_2$ is<br>detected by GC-mass spectroscopy |
| Level of Skill Required | Laboratory Technician | Nurse or physician to administer test and<br>collect specimens. G/C Mass Spec and<br>certified lab / technician to perform<br>analysis. |
| Function | 1. Specimen diluted 1/3 and added to<br>well containing rabbit anti- <i>H. pylori</i><br>capture Ab.<br>2. One drop HRP-conjugated detection<br>Ab added.<br>3. Incubation 1 hr at room<br>temperature.<br>4. Wash 5 times.<br>5. Add 2 drops substrate.<br>6. Incubate 10 minutes at room<br>temperature.<br>7. Add one drop stop solution and read<br>visually or spectrophotometrically | 1. Baseline breath specimens are taken<br>in duplicate.<br>2. Pudding and urea solution are<br>ingested. 30 minute metabolism.<br>3. Test breath specimens are taken in<br>duplicate.<br>4. Samples are mailed in for analysis<br>by licensed laboratory.<br>5. Results reported as ratio of Delta<br>over Baseline (DOB) |
| Interpretation | Pos/Neg read visually or<br>spectrophotometrically. Fixed cut-off<br>0.140 single wavelength (450nm) or<br>0.100 dual wavelength (450-630nm) | DOB ≥ 2.4: Positive<br>DOB < 2.4: Negative |
| Performance vs.<br>Reference Methods<br>Sensitivity<br>Specificity<br>Correlation | 94.7% (74.0-99.0%)<br>96.1% (88.9-99.2%)<br>95.8% (89.6-98.8%) | 85.0% (62.1-96.8%)<br>96.1% (88.9-99.2%)<br>93.8% (86.9-97.7%) |

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DEC 1 7 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Allen D. Nickol. Ph.D. Director of Clinical and Regulatory Affairs Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati, OH 45244

Re: K983255 Trade Name: Premier Platinum HPSA Regulatory Class: I Product Code: LYR Dated: December 1, 1998 Received: December 2, 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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections. the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 regulations.

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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 [phone].

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 your 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

Steven Sutman

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

Enclosure

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#### E. Indications for Use Statement

983255 510(k) Number (if known):

Device Name: Premier Platinum HpSA

Indications For Use:

్లో స్టే

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, and to monitor response during and post-therapy in adult patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woodley Dubois

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983255

Prescription Use (Per 21 CFR 801.109)

OR

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