BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST

K980798 · Princeton BioMeditech Corp. · LYR · Sep 22, 1998 · Microbiology

Device Facts

• Record ID: K980798
• Device Name: BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST
• Applicant: Princeton BioMeditech Corp.
• Product Code: LYR · Microbiology
• Decision Date: Sep 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Intended Use

BioSign™ H. pylori WB qualitatively detects anti-H. pylori antibody in human whole blood, serum or plasma specimens. The test is intended for use in the diagnosis of Helicobacter pylori infection in patients with symptoms of gastrointestinal disorders.

Device Story

BioSign™ H. pylori WB is an in vitro diagnostic test for the qualitative detection of anti-H. pylori antibodies. The device utilizes human whole blood, serum, or plasma as input samples. It operates via an immunochromatographic assay principle to detect the presence of antibodies. The test is intended for professional use in a clinical setting to assist healthcare providers in diagnosing H. pylori infection in symptomatic patients. Results are interpreted visually by the clinician to inform clinical decision-making regarding gastrointestinal disorder management.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Immunochromatographic assay for qualitative antibody detection. Form factor is a test device for whole blood, serum, or plasma specimens. Professional use only.

Indications for Use

Indicated for the qualitative detection of anti-H. pylori antibodies in human whole blood, serum, or plasma specimens to aid in the diagnosis of Helicobacter pylori infection in patients presenting with symptoms of gastrointestinal disorders.

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.

Submission Summary (Full Text)

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SEP 2 2 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Jemo Kang, Ph.D. Director Princeton BioMeditech Corp. 4242 U.S. Route 1 Monmouth Junction, NJ 08852-1905

> K980798 Trade Name: BioSign™ H. pylori WB New One Step anti-H. pylori antibody test Regulatory Class: I Product Code: LYR Dated: July 21, 1998 Received: August 4, 1998

Dear Dr. Kang:

Re:

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 QS 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 Autman

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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K980798 5 ! 0(k) Number (if known):

BioSign™ H. gylori NB Device Name:

Indications For Use:

BioSign" H. pylori WB qualitatively detects anti-H. pylori antibody in human whole blood, serum or plassua specimens. The test is intended for use in the diagnosis of Helicobacter pylori infection in parients with symptoms of gastrointestinal disorders.

. . . . . . . . ...... . ... . . . .

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--|
|--------------------------------------------------------|--|

| Woody Debars | (Division Sign-Off) |
|-----------------------------------------|---------------------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K980798 |

| Professional Use | X |
|------------------|---|
|------------------|---|

| Prescription Use | X |
|----------------------|---|
| (Per 21 CFR 801.109) | |

OR

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