IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT

K050352 · Ameritek Research, LLC · JTO · Sep 1, 2005 · Microbiology

Device Facts

• Record ID: K050352
• Device Name: IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT
• Applicant: Ameritek Research, LLC
• Product Code: JTO · Microbiology
• Decision Date: Sep 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2660
• Device Class: Class 1

Intended Use

FemLab is a biochemical assay intended for use as a screening test for nitrites, blood, protein, leukocytes and proline-iminopeptidase in vaginal fluid samples. It is indicated for use as an aid in the presumptive diagnosis of vaginitis or urethritis and should be used in conjunction with laboratory tests such as Gram stain, microscopic examination, culture and KOH test. The FemLab Vaginitis Test Kit is for professional and laboratory use only.

Device Story

FemLab Vaginitis Test Kit is a hand-held, professional-use diagnostic cassette; features seven sample application zones on a plastic platform. Input: vaginal fluid collected via three-step swab procedure; two samples applied directly to test zones; third sample diluted in buffer. Principle: chemical/biological indicators undergo color change upon contact with specific analytes (pH, proline-iminopeptidase, nitrite, blood, protein, leukocyte). Output: visual color change on test zones indicating positive/negative results. Used in laboratory/clinical settings by professionals to aid in presumptive diagnosis of vaginitis or urethritis; results used alongside Gram stain, culture, and microscopic examination to inform clinical decision-making.

Clinical Evidence

Multi-center study of 300 post-pubertal women. Comparison against traditional laboratory methods (pH, proline-iminopeptidase, wet mount, culture). Results: 18 true positives, 266 true negatives, 9 false positives, 7 false negatives. Overall agreement: 94.6%.

Technological Characteristics

Hand-held plastic cassette with seven test zones. Employs chemical/biological colorimetric indicators. Qualitative detection of vaginal pH (≥4.7), proline-iminopeptidase (≥20 pm/m), nitrite (≥0.06 mg/dL), blood (≥0.015 mg/dL), protein (≥1.5 mg/dL), and leukocyte (≥5 cells/h). Uses filter membrane technology. Manual operation; no electronic components or software.

Indications for Use

Indicated for use as an aid in the presumptive diagnosis of vaginitis or urethritis in patients requiring clinical evaluation of vaginal fluid. For professional and laboratory use only.

Regulatory Classification

Identification

A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of an eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ameritek Research LLC c/o Bradford Webb consultant 15205 3rd Dr. SE Mill Creek, WA 98012 ATTN: Kud Chaiang Yee

SEP 0 1 2005

k050352 Re:

K050552
Trade/Device Name: FemLab® Vaginitis Test Kit Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Regulatory Class: D, LNW, JMT, JIR, LJX, JTO Dated: June 16 2005 Received: June 16 2005

Dear Dr Yee:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premaince is substantially equivalent (for the indications
referenced above and have determined the devices devices devices were make referenced above and nave determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed in added Device Amendments. for use stated in the enclosure) to tegally manced teches dedical Device Americal Device America, or to
commerce prior to May 28, 1976, the enactment with the provision of th commerce prior to May 28, 1976, the ellacinent and of the Federal Food, Drug, devices that have been reclassified in accordance while become approval application (PMA).
and Cosmetic Act (Act) that do not require approval on assessions of the Act. The and Cosmetic Act (Act) that do not require approvate of the general controls of the Act. The Act. The Act. The Act. The You may, therefore, market the device, subject of the general or annual registration, listing of
general controls provisions of the Act include requirements for anainst misbr general controls provisions of the Act mende requirements to the many of the many of the adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), a If your device is classified (see and controls. Existing major regulations affecting your device
it may be subject to such additional controls. Existing major regulations a it may be subject to such additional comicis. Existing inghts 800 to 895. In addition, FDA
can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. I can be found in Title 21, Code of Federal Regulations (11) 77 )
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 Please be advised that FDA's issuance of a substanted other requirements of the Act
that FDA has made a determination that your device Edges of the Act that FDA has made a delermilation inalyou divines and other Federal agencies. You must
or any Federal statutes and regulations administered by other not listing or any Federal statutes and regulations and linited to: registration and listing (21
comply with all the Act's requirements, including, but not mont sevention practice comply with all the Act s requirements, increating, and good manufacturing practice
CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice CFR Part 807); labeling (21 CFR Parts 801 and 807); and good.
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manketing your article equivalence of your device to a legally premarket notification. The I DA Intuing of Justication 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, of Ir II you desire specific information acour the app of your device, please contact the Office of In
or questions on the promotion and advertising of your and advertising of In of questions on the promotion and Safety at [phone]. Also, please note the v tto Diagnostic Device Devaluation and career in (a) == (a) == (art 807.97). regulation entities, "Misolanding of Teicent on your responsibilities under the Act from the You may outling 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/industry/support/index.html.

Sincerely yours,

Carol C. Benam

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology 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 k050352

Device Name: FemLab® Vaginitis Test Kit

Indications For Use:

FemLab is a biochemical assay intended for use as a screening test for nitrites, blood, protein, r childo is a broline-iminopepidase in vaginal fluid samples, and also to measure vaginal fluid pH. It is indicated for use as an aid in the presumptive diagnosis of vaginitis or urethritis thing pri. "It is medicalled for about with other laboratory tests such as Gram stain, microscopic alla should be used in conjanetion Trail TemLab Vaginitis Test Kit is for professional and laboratory use only.

Alberto Santos

**Division Sign-Off**

Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) KO 50352

Prescription Use XX (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)