BREATHTEK - UBIT UBT FOR H. PYLORI

K014225 · Meretek Diagnostics, Inc. · MSQ · Jan 17, 2002 · Microbiology

Device Facts

• Record ID: K014225
• Device Name: BREATHTEK - UBIT UBT FOR H. PYLORI
• Applicant: Meretek Diagnostics, Inc.
• Product Code: MSQ · Microbiology
• Decision Date: Jan 17, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Intended Use

The BreathTek™ - UBT for H. pylori collection kit is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. The test may be used for monitoring treatment if used at least four weeks following completion of therapy. For these purposes, the test utilizes the UBiT IR spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2content in breath gas. For administration by health care professionals. To be administered under a physician's supervision.

Device Story

BreathTek™ - UBiT® UBT kit collects human breath samples for H. pylori detection. Patient consumes Pranactin-Citric solution; 15 minutes later, patient exhales into 300cc breath bags equipped with check-valve mouthpieces. Healthcare practitioner collects samples; bags are analyzed using UBiT IR spectrophotometer to measure 13CO2/12CO2 ratio. Output assists physicians in diagnosing or monitoring H. pylori infection. Device replaces glass tube collection method with breath bags to simplify handling and eliminate sealing concerns. Stability of breath samples in bags confirmed for 3 days at room temperature.

Clinical Evidence

Bench testing only. Stability of human and simulated breath samples in 300cc breath bags was evaluated at controlled room temperature. Samples were proven stable for three days (human) and seven days (simulated).

Technological Characteristics

Kit includes Pranactin-Citric drug product, reconstitution cup, 300cc breath bags with check-valve mouthpieces, and barcode labels. Operates via infrared spectrophotometry (UBiT IR 300 System) to measure 13CO2/12CO2 ratios. Non-electronic collection components; utilizes external IR spectrophotometer for analysis.

Indications for Use

Indicated for adult patients for qualitative detection of urease associated with Helicobacter pylori in the stomach; aid in initial diagnosis and post-treatment monitoring of H. pylori infection (at least 4 weeks post-therapy). Administered by healthcare professionals under physician supervision.

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

• BreathTek™ UBT for H. pylori (NDA # 20-586/S-004)

Reference Devices

• UBiT IR 300 System (K013371)
• ABCA-NT Gas Isotope Ratio Mass Spectrometer System
• ABCA Gas Isotope Ratio Mass Spectrometer System

Submission Summary (Full Text)

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JAN 1 7 2002

Image /page/0/Picture/1 description: The image shows the logo for MERETEK, The Breath Test Company. The logo features a stylized wave design in a black square on the left, followed by the word "MERETEK" in large, bold, black letters. Below "MERETEK" is the tagline "The Breath Test Company" in a smaller font. Above the logo, the text "K014225" is written in a handwritten style.

# 510(k) Summary

### COMPANY NAME AND ADDRESS 1.

- 1.1 Sponsor
Meretek Diagnostics, Inc. 618 Grassmere Park Rd., Suite 20 Nashville, TN 37211

- Submission Contact 1.2
Denise E. Spellman Director of Quality Systems & Regulatory Affairs

| Telephone: | 1-800-945-8252 ext. 208 |
|------------|-------------------------|
| Facsimile: | 1-615-333-6202 |
| Email: | [e-mail] |

#### DEVICE NAME 2.

- Proprietary Name 2.1
- BreathTek™ UBiT® UBT for H. pylori
- 2.2 Common Name

Breath Test for Helicobacter pylori; UBT

#### CLASSIFICATION 3.

- Product Code: MSQ 3.1
- Regulatory Class: Class I 3.2

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## SUBSTANTIAL EQUIVALENCE COMPARISON 4.

| BreathTek™ UBT for H. pylori | BreathTek™ - UBiT® UBT for H. pylori |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summarized Specimen Collection<br>Method: | Summarized Specimen Collection<br>Method: |
| ♦ Patient inserts new straw within 0.5 inch of the bottom of first tube. Patient<br>takes deep breath, pauses momentarily then blows gently through the straw<br>into the bottom of the vertically positioned tube for about 3 to 5<br>seconds. Tube is slowly withdrawn off straw by health care practitioner as<br>patient continues to blow. Practitioner caps tube quickly. A backup tube is<br>prepared.<br>♦ Health care practitioner prepares<br>Pranactin-Citric by dissolving it in<br>Reconstitution Cup with 4 oz. of<br>potable water.<br>♦ Patient drinks dissolved Pranactin-<br>Citric with new straw and health care<br>practitioner starts timer previously set<br>to 15 minutes.<br>♦ After 15 minutes wait, patient inserts<br>new straw within 0.5 inch of the bottom<br>of second tube. Patient takes deep<br>breath, pauses momentarily then blows<br>gently through the straw into the<br>bottom of the vertically positioned tube<br>for about 3 to 5 seconds. Tube is<br>slowly withdrawn off straw by health<br>care practitioner as patient continues to<br>blow. Practitioner caps tube quickly.<br>A backup tube is prepared. | ♦ Patient blows into 300 cc breath bag<br>until full (evident when fully<br>expanded).<br>♦ Health care practitioner prepares<br>Pranactin-Citric by dissolving it in<br>Reconstitution Cup with 4 oz. of<br>potable water.<br>♦ Patient drinks dissolved Pranactin-<br>Citric with straw and health care<br>practitioner starts timer previously set<br>to 15 minutes.<br>♦ After 15-minute wait, patient blows<br>into 300 cc breath bag until full<br>(evident when fully expanded). |
| BreathTek™ UBT for H. pylori | BreathTek™ - UBiT® UBT for H. pylori |
| Specimen Collection Time (post-dose): | Specimen Collection Time (post-dose): |
| 15 minutes | 15 minutes |
| Non-Drug Component Summary: | Non-Drug Component Summary: |
| Reconstitution Cup Barcode Labels three (3) straws four (4) glass specimen tubes (similar to blood collection tubes) with screw-on caps Package Insert approved in NDA # 20-586/S-004. | Reconstitution Cup Barcode Labels one (1) straw two (2) 300 cc breath bags each fitted with a mouthpiece that contains a check valve. See section III for bag description. Package Insert approved in NDA # 20-586/S-004 with added information regarding use of the modified BreathTek-UBIT UBT kit. |

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#### Discussion of Similarities and Differences 5.

The scientific basis underlying the BreathTek™ UBT and the BreathTek™ -UBiT® UBT kit is identical. Both kits contain a pouch of Pranactin-Citric drug product, a reconstitution cup, sample collection containers, sample identification labels and a package insert. The parts lists of the two kits differ for types of sample collection containers, the configuration of the barcode labels and the quantity of straws provided. The UBiT version of the kit directly collects breath samples into two 300cc breath bags each fitted with a mouthpiece containing a check valve and the original kit collects breath samples via a straw into glass test tubes. The glass test tubes must be quickly sealed with screw-on caps to contain the breath; the check valve incorporated in the breath bags eliminates this concern. The original kit contains a back-up set of sample collection tubes to compensate for the fragility of the tubes' glass structure. Use of barcode labels will be mandatory for the original kit and optional for the UBiT version.

The two kits will coexist on the market and share the same package insert. The package insert will be modified to include the UBiT version's component list and step-by-step procedure for collecting samples. The package insert will instruct

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the health care provider to analyze the tube samples using a GIRMS spectrometer and the bag samples using an UBiT IR spectrophotometer. The BreathTek™ -UBiT® UBT kit will be advertised for use with the UBiT IR 300 System (510(k) # K013371). The BreathTek™ kit will be advertised for use with the ABCA-NT Gas Isotope Ratio Mass Spectrometer System and the ABCA Gas Isotope Ratio Mass Spectrometer System.

Equivalency of the breath bag and glass sample collection tube was proven in non-clinical testing. Human breath samples and simulated breath samples were placed on stability at controlled room temperature. Breath samples were proven stable for three (3) days and simulated breath samples were proven stable for seven (7) days.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is simple and recognizable, representing the department's role in public health and human services.

JAN 1 7 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Denise E. Spellman Director of Quality Systems and Regulatory Affairs Meretek Diagnostics, Inc. 618 Grassmere Park Drive, Suite 20 Nashville, TN 37211

k014225 Trade/Device Name: BreathTek™ - UBiT® UBT for H. pylori Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter fetus serological reagents Regulatory Class: Class I Product Code: MSQ Dated: December 20, 2001 Received: December 26, 2001

Dear Ms. Spellman:

Re:

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 ' 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

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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510(k) Number (if known): KO14225

BreathTek™ - UBiT® UBT for H. pylori Device Name:

# Indications For Use:

The BreathTek™ - UBT for H. pylori collection kit is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. The test may be used for monitoring treatment if used at least four weeks following completion of therapy.

For these purposes, the test utilizes the UBiT IR spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2content in breath gas.

For administration by health care professionals. To be administered under a physician's supervision.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)

Freddie Poole

Latoratory Devices

510(k) Number K014225

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)