PHEM-ALERT

K032161 · Femtek,Llc. · LNW · Sep 30, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032161
• Device Name: PHEM-ALERT
• Applicant: Femtek,Llc.
• Product Code: LNW · Clinical Chemistry
• Decision Date: Sep 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1550
• Device Class: Class 1

Intended Use

The pHEM-ALERT® test measures vaginal pH and is intended for use by women who have any of the following vaginal symptoms: Itching – burning – unpleasant odor – unusual discharge This test may help decide if these symptoms are caused by an infection that may require follow-up by your healthcare provider. This test is only intended for women who have normal menstrual periods (periodic vaginal bleeding) or who may currently be pregnant. If you are pregnant, always discuss your symptoms and the result of this test with your healthcare provider and NEVER treat yourself.

Device Story

pHEM-ALERT® is an OTC vaginal pH test; used by women experiencing vaginal symptoms (itching, burning, odor, discharge). Device consists of a probe with mounted pH paper; user applies vaginal secretion to the probe; color change indicates pH level. Results assist users in determining need for professional medical consultation. Device is a physical modification of the predicate (K012230), featuring a thinner, rounded probe design. Intended for both non-pregnant and pregnant symptomatic women.

Clinical Evidence

No new clinical data provided; relies on performance characteristics established in predicate K012230.

Technological Characteristics

Qualitative vaginal pH test; probe-based form factor with pH-sensitive paper. Physical design: thin, rounded probe end. OTC use; no instrumentation required.

Indications for Use

Indicated for women with vaginal symptoms (itching, burning, unpleasant odor, unusual discharge) who have normal menstrual periods or are pregnant, to assist in deciding if follow-up with a healthcare provider is required.

Regulatory Classification

Identification

A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.

Predicate Devices

• pHEM-ALERT® (K012230)

Submission Summary (Full Text)

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# KO32161

# 510(k) SUMMARY pHEM-ALERT July 11, 2003

This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in this 510(k) premarket notification was in accordance with 21 CFR 807.87.

# 1. Sponsor/Submitter

## Sponsor

FemTek, LLC 50 Bellefontaine Street Pasadena, CA 91105-3181 Attention: James C. Caillouette, M.D., President [phone] Telephone: Facsimile: [phone]

# Submitted by:

## Consultant

Joel S. Faden, Ph.D., Inc. 11605 Hitching Post Lane Rockville, MD 20852 Contact person: Joel Faden [phone] Telephone: Facsimile: [phone]

#### 2. Name of Device

Trade Name: pHEM-ALERT Common/Usual Name: pH paper Classification Name: "Obstetric pH Paper", 85LNW, unclassified

# 3. Legally Marketed Predicate Devices

#### pHEM-ALERT 510(k) K012230

#### 4. Indications for Use / Intended Use

The indications and intended uses for the pHEM-ALERT device are:

The pHEM-ALERT® test measures vaginal pH and is intended for use by women who have any of the following vaginal symptoms:

Itching - Burning - Unpleasant odor - Unusual discharge

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This test may help decide if these symptoms are caused by an infection that may require follow-up by your healthcare provider. This test is only intended for women who have normal menstrual periods (periodic vaginal bleeding) or who may currently be pregnant. If you are pregnant, always discuss your symptoms and the result of this test with your healthcare provider and NEVER treat yourself.

# 5. Device Description

The pHEM-ALERT provides a method for the lay user to measure her vaginal pH. The pHEM-ALERT test is comprised of a plastic probe with pH paper on one end, a color chart and a package insert. The plastic probe is in the shape of small flat key. pHEM-ALERT is indicated for measuring vaginal pH for the purpose of differentiating normal and abnormal conditions in symptomatic women. The device is inserted into the vagina and the measurement taken.

# 6. Substantial Equivalence

This Premarket Notification [510(k)] was submitted because FemTek wishes to make two changes to the package insert for the pHEM-ALERT Over-The-Counter (OTC) device, which was cleared on October 9, 2001 (K012230).

Specifically, the package insert has been modified in the following manner:

- Modify the warning to read: . "This is NOT a test for diseases such as HIV, chlamydia, herpes, gonorrhea or syphilis."
- Remove the exclusionary language in the current package insert pertaining to pregnant . women, and revise the labeling to allow symptomatic pregnant women to use the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract design of an eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" encircling the design. The seal is in black and white.

SEP 3 0 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEMTEK, LLC c/o Joel S. Faden, Ph.D. President/CEO Joel S. Faden, Ph.D., Inc. Regulatory Consultants 11605 Hitching Post Lane Rockville, MD 20852

k032161 Re:

> Trade/Device Name: pHEM-ALERT Regulation Number: 21 CFR 862.1550 Regulation Name: Urinary pH (nonquantitative) test system Regulatory Class: Class I Product Code: LNW Dated: July 11, 2003 Received: July 28, 2003

Dear Dr. Faden:

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).

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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). You may obtain other general information on your responsibilities under the Act 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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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pHEM-ALERT 510(k)

CONFIDENTIAL

#### INDICATIONS FOR USE

K032161

Device Name: pHEM-ALERT

#### Indications For Use:

The pHEM-ALERT® test measures vaginal pH and is intended for use by women who have any of the following vaginal symptoms:

Itching -- Burning - Unpleasant odor - Unusual discharge

This test may help decide if these symptoms are caused by an infection that may require follow-up by your healthcare provider. This test is only intended for women who have normal menstrual periods (periodic vaginal bleeding) or who may currently be pregnant. If you are pregnant, always discuss your symptoms and the result of this test with your healthcare provider and NEVER treat yourself.

Sean Cooper
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032161

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109) OR

Over-The-Counter:

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(Optional Format 1-2-96)