PROSPECT CAMPYLOBACTER MICROPLATE ASSAY

K982315 · Alexon - Trend, Inc. · LQP · Nov 18, 1998 · Microbiology

Device Facts

• Record ID: K982315
• Device Name: PROSPECT CAMPYLOBACTER MICROPLATE ASSAY
• Applicant: Alexon - Trend, Inc.
• Product Code: LQP · Microbiology
• Decision Date: Nov 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Indications for Use

The ProSpecT® Campylobacter Microplate Assay is an in vitro microplate EIA for the qualitative detection of Campylobacter Specific Antigen in fecal specimens and broth enriched fecal cultures. ProSpecT Campylobacter Microplate Assay is intended for use as an aid in the diagnosis of Campylobacter infections.

Device Story

ProSpecT Campylobacter Microplate Assay is an in vitro microplate enzyme immunoassay (EIA) for qualitative detection of Campylobacter-specific antigen. Input: fecal specimens or broth-enriched fecal cultures. Operation: manual microplate-based EIA procedure. Output: qualitative result indicating presence or absence of Campylobacter antigen. Used in clinical laboratory settings by trained laboratory personnel. Results assist clinicians in diagnosing Campylobacter infections, facilitating appropriate patient management.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Microplate-based enzyme immunoassay (EIA) for qualitative antigen detection. In vitro diagnostic device. Manual procedure.

Indications for Use

Indicated for the qualitative detection of Campylobacter Specific Antigen in fecal specimens and broth enriched fecal cultures to aid in the diagnosis of Campylobacter infections in patients suspected of having such infections.

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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Public Health Service

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Ken Hood Director of Regulatory Affairs Alexon-Trend, Inc. 14000 Unity Street NW Ramsey, Minnesota 55303-9115

Re: K982315/S2

> ProSpecT® Campylobacter Microplate Assay Trade Name: Requlatory Class: I Product Code: LQP Dated: November 2, 1998 Received: November 3, 1998

Dear Mr. Hood:

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 Requlations, 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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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 [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Gutman

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 K982315

Device Name: ProSpecT® Campylobacter Microplate Assay

## INDICATIONS FOR USE:

The ProSpecT® Campylobacter Microplate Assay is an in vitro microplate EIA for the qualitative detection of Campylobacter Specific Antigen in fecal specimens and broth enriched fecal cultures. ProSpecT Campylobacter Microplate Assay is intended for use as an aid in the diagnosis of Campylobacter infections.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Woody Defors |
|-----------------------------------------|--------------|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K98 2315 |

Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter Use __

( Optional Format 1-2-96)