PYLORITEK VP TEST KIT 5140VP

K014038 · Serim Research Corp. · LYR · Feb 8, 2002 · Microbiology

Device Facts

• Record ID: K014038
• Device Name: PYLORITEK VP TEST KIT 5140VP
• Applicant: Serim Research Corp.
• Product Code: LYR · Microbiology
• Decision Date: Feb 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Intended Use

The PyloriTek VP Test Kit includes materials for detection of urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori. The test is for use on symptomatic patients by healthcare professionals.

Device Story

The PyloriTek VP Test Kit is a rapid urease test used by healthcare professionals in clinical settings to detect Helicobacter pylori in gastric biopsy specimens. The device consists of a reaction chamber, a hydration reagent, and test strips containing a substrate pad (urea) and a reaction pad (pH indicator). During operation, a biopsy specimen is placed in the reaction chamber with the test strip; the hydration reagent is applied to the substrate pad. If H. pylori is present, the urease enzyme hydrolyzes urea into ammonia and carbon dioxide. The ammonia gas passes through a semi-permeable membrane to the reaction pad, causing a pH-dependent color change (yellow to blue) in the bromophenol blue indicator. The healthcare provider visually inspects the strip for color development within one hour to determine the presence of H. pylori. A separate positive control paper is used to verify test functionality. The test aids in the presumptive diagnosis of H. pylori infection, supporting clinical decision-making regarding patient treatment.

Clinical Evidence

Clinical performance was evaluated by testing replicate gastric biopsy specimens from 84 patients using both the PyloriTek VP and the predicate PyloriTek Test Kit. The study reported 100% sensitivity and 98.5% specificity for the PyloriTek VP Test Kit compared to the predicate device.

Technological Characteristics

The device is a manual, non-electronic, in vitro diagnostic test. It utilizes a chemical reaction principle: urease-mediated hydrolysis of urea to ammonia, detected by a bromophenol blue pH indicator. Components include a plastic reaction chamber, paper-based test strips with a semi-permeable membrane, and a liquid hydration reagent. The device is standalone and does not require power or software.

Indications for Use

Indicated for the presumptive identification of Helicobacter pylori in symptomatic patients via detection of urease activity in gastric biopsy specimens collected during endoscopy.

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

• Serim PyloriTek Test Kit (K953632)

Submission Summary (Full Text)

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Serim Research Corporation 510(k) Summary- PyloriTek VP Test Kit FEB 0 82002

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Image /page/0/Picture/3 description: The image shows the logo for Serim Research Corp. The logo features the word "Serim" in a bold, stylized font, with a small graphic above the "i" that resembles a drop. Below "Serim" is the text "RESEARCH CORP" in a smaller, sans-serif font. The image also includes the company's address, phone number, and fax number: P.O. Box 4002, Elkhart, IN 46514-0002, [phone], and FAX [phone].

# 510(k) SUMMARY

Serim™ PyloriTek® VP Test Kit

### Submitted by:

Robert J. Carrico Serim Research Corporation P.O. Box 4002 Elkhart, IN 46514

Phone: [phone] Fax: [phone]

Contact person: Robert J. Carrico

December 5, 2001 Date prepared:

#### Device Name:

| Trade name: | SERIM™ PyloriTek VP Test Kit |
|----------------------|------------------------------|
| Common name: | Rapid urease test |
| Classification name: | HELICOBACTER PYLORI |

#### Device Class

Class I

#### Legally Marketed Equivalent Device:

This product is very similar in design, composition and function to the Serim PyloriTek Test Kit manufactured by Serim Research Corporation which was the subject of Premarket Notification K953632.

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# Description of the Serim PyloriTek VP Test Kit and PyloriTek VP Positive Control Papers

Helicobacter pylori grows on the gastric mucosa and colonies can be collected with biopsies taken during gastrointestinal endoscopy. H. pylori produces urease which is a useful marker for gastric infections. Pyloritek VP Test Kit detects urease activity in gastric biopsy specimens.

Serim PyloriTek VP Test Kit has the following components:

Reagent strips which contain, in separate dry reagent matrices, the substrate urea (Substrate Pad) and a pH indicator (Reaction Pad). The Reaction Pad containing the pH indicator is covered by a semi-permeable membrane which allows passage of gaseous ammonia but prevents passage of gastric tissue fluid or Hydration Reagent from the Substrate Pad.

Hydration Reagent which contains a buffer that is dispensed on the Substrate Pad prior to performing the test.

Reaction Chamber which is a plastic device that holds developing strips and provides solid contact between the gastric biopsy, the Substrate Pad and the Indicator Pad. This arrangement ensures that ammonia gas generated is directed through the semi-permeable membrane to the pH indicator.

PyloriTek VP Positive Control Paper is provided separately to be used as a quality control material with the PyloriTek VP Test Kit. This control is a 0.2 x 3.25 inch strip of paper containing dry urease, buffer and stabilizer. PyloriTek VP Positive Control is run on PyloriTek VP Test Strips separate from biopsy specimens.

#### Intended Use:

The PyloriTek VP Test Kit includes materials for detection of urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori. The test is for use on symptomatic patients by healthcare professionals.

# Technological Comparison to Predicate Device:

The basic principles of PyloriTek VP and PyloriTek Test Kits are identical. H. pylori produces urease which is not present in mammalian tissues. The tests detect urease activity in gastric biopsy specimens according to the following reaction:

$$\begin{array}{ccccc} \text{Urea} & + & \text{H}_2\text{O} & & \xrightarrow{\text{Urea}} & & \text{2 NH}_3 & + & \text{CO}_2 \\ \end{array}$$

The ammonia is detected with a pH indicator (bromophenol blue) which turns from yellow to blue at the elevated pH produced by ammonia.

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### Serim Research Corporation 510(k) Summary- PyloriTek VP Test Kit

Differences between the two kits are:

| | Feature | PyloriTek VP Test Kit | PyloriTek Test Kit |
|----|------------------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Test strip width | 0.75 inch | 1.0 inch |
| 2. | Positive control | Urease dried in a separate<br>Positive Control Paper. | Built-in urease control<br>dried on test strip. |
| 3. | Procedure | Apply 3 drops of Hydration<br>Reagent to Substrate pad.<br><br>Positive control is run<br>separate from specimens. | Apply 4 drops of<br>Hydration Reagent to<br>Substrate pad.<br><br>Positive control<br>develops simultaneously<br>while specimens are tested. |

PyloriTek VP Test Strips are 0.75 inch wide compared to 1.0 inch for PyloriTek strips. This change was made for economic reasons. The narrower strips require 3 drops of Hydration Reagent instead of 4 drops.

The built-in positive control on PyloriTek strips is replaced by a separate positive control for PyloriTek VP strips. In practice a PyloriTek VP Positive Control Paper is placed on the Reaction Pad of a PyloriTek VP strip. Hydration Reagent is applied to the Substrate Pad, the PyloriTek VP Test Strip is folded and placed in the reaction chamber. Development of dark blue color on the yellow indicator membrane within 15 minutes indicates that the PyloriTek VP Test Strip is functioning properly.

PyloriTek VP Positive Control Paper can also be used to verify the functionality of PyloriTek VP Test Strips after biopsy specimens are tested. At the end of the one hour period required for reading a PyloriTek VP Test Strip with a negative specimen the test strip is removed from the Reaction Chamber, unfolded and the positive control paper is placed on the Reaction Pad. Then the assembly is reinserted in the reaction chamber and development of dark blue color on the yellow indicator membrane within 15 minutes indicates that the PyloriTek VP test is functioning properly.

#### Statement of Substantial Equivalence

Replicate biopsy specimens from 84 patients were tested for H. pyloriTek VP and PyloriTek Test Kits. In this comparison the PyloriTek VP Test Kit had 100% sensitivity and 98.5% specificity.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Patricia Rupchock Manager Regulatory Affairs Serim Research Corporation 2356 Reedy Drive Elkhart, IN 46514

FEB 0 8 2002

Re: k014038 Trade/Device Name: Serim™ PyloriTek® VP Test Kit Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter Fetus Serological Reagents Regulatory Class: Class I Product Code: LYR Dated: December 6, 2001 Received: December 7, 2001

Dear Ms. Rupchock:

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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/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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Page __of_

510(k) Number (if known): _ h 014038

Device Name: PyloriTek VP Test Kit

# Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Fildelito-Palo

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number _KO/ -1037

Prescription Use i (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)