TREP-SURE TREPONEMAL ANTIBODY EIA

K053570 · Phoenix Biotech Corp. · LIP · Aug 7, 2006 · Microbiology

Device Facts

• Record ID: K053570
• Device Name: TREP-SURE TREPONEMAL ANTIBODY EIA
• Applicant: Phoenix Biotech Corp.
• Product Code: LIP · Microbiology
• Decision Date: Aug 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3830
• Device Class: Class 2

Intended Use

TREP-SURE™ EIA is a qualitative enzyme immunoassay for the in vitro diagnostic detection of Treponema pallidum (syphilis) antibodies in human serum or plasma.

Device Story

Trep-Sure EIA is an in vitro diagnostic enzyme immunoassay (EIA) for detecting Treponema pallidum antibodies in human serum or plasma samples. The device functions as a laboratory-based screening or confirmatory test for syphilis. It is intended for professional use in clinical laboratory settings. The assay provides qualitative results to healthcare providers to aid in the diagnosis of syphilis infection. It is not indicated for blood or plasma donor screening.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Enzyme immunoassay (EIA) for qualitative detection of antibodies. In vitro diagnostic reagent system.

Indications for Use

Indicated for use as an initial screening test or as a confirmatory diagnostic test for Treponema pallidum (syphilis) antibodies in human serum or plasma. Not intended for screening blood or plasma donors.

Regulatory Classification

Identification

Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), the Treponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies to Treponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema and provides epidemiological information on syphilis.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Phoenix Bio-Tech Corporation c/o Mr. Gary Lehnus Lehnus & Associates Consulting

AUG - 7 2006

k053570 Re:

150 Cherry Lane Road

East Stroudsburg, PA 18301

Consultant

Trade/Device Name: Trep-Sure EIA Test Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LIP Dated: July 28, 2006 Received: July 31, 2006

Dear Mr. Lehnus:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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,

Sally, atton

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

TREP-SURE EIA is a qualitative enzyme immunoassay for the in vitro diagnostic detection of Treponema pallidum (syphilis) antibodies in human serum or plasma. This product can be used as an initial screening test or as a confirmatory diagnostic test, but is not cleared (approved) by the U.S. Food and Drug Administration (FDA) for use in screening blood or plasma donors.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (OIVD)

Freddie M. Poole
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

500(k) K053570

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