(77 days)
Not Found
No
The device description and intended use clearly describe a simple pH test using a plastic probe and color chart, with no mention of AI or ML.
No.
The device measures vaginal pH to help determine if symptoms are caused by an infection, which may require follow-up by a healthcare provider. It does not provide treatment or actively alleviate symptoms.
Yes
Explanation: The device measures vaginal pH to help determine if symptoms are caused by an infection, which aids in diagnosing the cause of the symptoms.
No
The device description explicitly states it is comprised of a plastic probe with pH paper, a color chart, and a package insert, indicating it is a physical device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to measure vaginal pH to help women with specific vaginal symptoms decide if those symptoms are caused by an infection. This is a diagnostic purpose, providing information about a potential medical condition.
- Device Description: The device is a test that measures a biological parameter (vaginal pH) using a sample (vaginal fluid) obtained from the body. This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Anatomical Site: The test is performed on a sample from the vagina, which is a part of the human body.
- Intended User: While the intended user is a lay user, the purpose of the test is still diagnostic in nature, providing information that may lead to follow-up with a healthcare provider.
The fact that it measures a biological parameter (pH) from a human sample (vaginal fluid) to provide information about a potential medical condition (infection) firmly places it in the category of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
LNW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
lay user
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1550 Urinary pH (nonquantitative) test system.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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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 (626) 796-3200 Telephone: Facsimile: (626) 793-1651
Submitted by:
Consultant
Joel S. Faden, Ph.D., Inc. 11605 Hitching Post Lane Rockville, MD 20852 Contact person: Joel Faden (301) 881-9139 Telephone: Facsimile: (301) 881-9249
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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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
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:
(Optional Format 1-2-96)