CAPTIAM SYPHILIS-G ASSAY

K014233 · Trinity Biotech, Plc · LIP · Jan 24, 2002 · Microbiology

Device Facts

• Record ID: K014233
• Device Name: CAPTIAM SYPHILIS-G ASSAY
• Applicant: Trinity Biotech, Plc
• Product Code: LIP · Microbiology
• Decision Date: Jan 24, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3830
• Device Class: Class 2

Intended Use

CAPTIA™ Syphilis (T. pallidum )-G is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis) CAPTIA™ Syphilis (T. pallidum )-G is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis.

Device Story

CAPTIA™ Syphilis-G is an enzyme immunoassay (EIA) for qualitative detection of IgG antibodies to Treponema pallidum. Device processes serum or plasma specimens in a clinical laboratory setting. Principle of operation involves immunological binding of IgG antibodies to T. pallidum antigens. Output is qualitative result indicating presence or absence of IgG antibodies. Used by laboratory technicians to provide serological evidence of syphilis infection or to screen blood/plasma donors. Results assist clinicians in diagnosing syphilis when used with non-treponemal tests; however, positive results may indicate prior treated infection and negative results do not exclude incubating or early primary disease.

Technological Characteristics

Enzyme immunoassay (EIA) for qualitative detection of IgG antibodies. Utilizes T. pallidum antigens for antibody binding. In vitro diagnostic test format.

Indications for Use

Indicated for qualitative detection of IgG antibodies to T. pallidum in serum specimens to provide serological evidence of syphilis infection, and for screening serum or plasma specimens from blood/plasma donors to exclude history of syphilis.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 4 2002

Ms. Fiona Campbell Regulatory Affairs Manager Trinity Biotech, plc IDA Business Park Bray, Co. Wicklow Ireland

k014233 Re:

Trade/Device Name: CAPTIA™ Syphilis-G Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema Pallidum Treponemal Test Reagents Regulatory Class: Class II. Product Code: LIP Dated: December 20, 2001 Received: December 26, 2001

Dear Ms. Campbell:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the enactment date of 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 I ou may, are er exercy in the Act include requirements for annual registration, listing of general conable profice wing 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 or any 1 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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This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will anow you to begin marketing your device of your device to a legally marketed
notification. The FDA finding of substantial equivalence of your device to notification. The FDA iniding of substantal equivalities of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (2) CFR Part 801 and If you desire specific advice for your do real please contact the Office of Compliance at additionally 809.10 for the viro diagnostions on the promotion and advertising of your device, [phone]. Additionally, for questions on are processes on the regulation presse contact the Office of Compilation at (2017 on the art (21CFR 807.97). Other general entitled, "INISTIanding by releveles to premailer included from the Division of Small
information on your responsibilities under the Act may be obtained to comber (800) 632, information on your responsibilities and consumer Assistance at its toll-free number [phone] or
Manufacturers International and Consumer Assistance at its (dama/demam Manufacturers International and Collibanter Fissterials and Collection of the Marian html".
[phone] or at its internet address "http://www.fda.gov/odrh/dsma/dsmamain.h

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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510(k) Number (if known): Holy233

CAPTIA™ Syphilis-G Device Name:

Indications for Use:

CAPTIA™ Syphilis (T. pallidum )-G is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis)

CAPTIA™ Syphilis (T. pallidum )-G is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis.

(Note the following boxed warning appears directly below Intended Use in Package Insert.)

Warning: A positive result is not useful for establishing a diagnosis of syphilis. In most situations, such a result may reflect a prior treated infection; a negative result can exclude a diagnosis of syphilis except for incubating or early primary disease.

Luddi lu. Poole

ion Sinnivision of Clinical Laboratory Dev

510(k) Number K014233

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use

Or

Over the counter Use

(per 21 CFR 801.109)

(Optional Format 3-10-98)