(85 days)
Not Found
No
The device description and performance studies focus on a simple pH paper test and user readability, with no mention of AI or ML technologies.
No
Explanation: The device is described as a test that measures vaginal pH to help identify symptoms that may indicate an infection requiring follow-up by a healthcare provider. It does not treat or cure any condition; it only provides information.
Yes
The "Intended Use / Indications for Use" states that the device "may help decide if these symptoms are caused by an infection that may require follow-up by your healthcare provider," indicating its role in providing information for diagnosis. The "Device Description" also mentions its use "for differentiating normal and abnormal conditions."
No
The device description explicitly states that the device is comprised of a plastic probe with pH paper, a color chart, and a package insert, indicating it is a physical device with hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device "measures vaginal pH (acidity)" and is used to "help decide if these symptoms are caused by an infection that may require follow-up by your healthcare provider." This indicates that the test is performed on a sample (vaginal fluid) taken from the body to provide information about a health condition.
- Device Description: The description mentions that the device uses "pH paper" and a "color chart" to measure vaginal pH. This is a classic method for in vitro diagnostic tests that analyze a sample outside the body.
- Anatomical Site: While the sample is collected from the vagina, the measurement and analysis are performed on the pH paper after it has been in contact with the vaginal fluid. This is an in vitro process.
The definition of an IVD generally involves tests performed on samples taken from the human body to provide information about a physiological state, disease, or condition. The pHEM-ALERT fits this definition by measuring a chemical property (pH) of a bodily fluid (vaginal fluid) to help assess potential health issues.
N/A
Intended Use / Indications for Use
"The pHEM-ALERT® test measures vaginal pH (acidity) 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). This device is not validated for use in pregnant women."
Product codes (comma separated list FDA assigned to the subject device)
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 inscrt. The plastic probe is in the shape of small flat key. pHEM-ALERT is indicated package miser. "The present of differentiating normal and abnormal conditions in for modeling vagina price 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)
Two clinical studies were designed and carried in support of the Substantial Equivalency. The studies were designed to address the requirements, of appropriate guidelines. In particular, the clinical studies were performed to demonstrate that the lay user could read and understand the labeling and record accurate results The pHEM-ALERT and its labeling were found to be well designed, readable and understandable. The pHEM-ALERT was not affected by anticipated wariation in user technique. The pHEM-ALERT demonstrated reasonable test performance.
In conclusion, these data demonstrated that the test performance characteristics of this version of the pHEMALERT are reasonable and acceptable and that this version of the pHEM-ALERT is substantially equivalent to the original version.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
OCT - 92001
510(k) SUMMARY pHEM-ALERT September 30, 2001
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 Telephone: 626-796-7148 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: 301-881-9249 Facsimile:
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) K960648
4. Indications for Use / Intended Use
The indications and intended uses for the pHEM-ALERT device are:
"The pHEM-ALERT® test mcasures vaginal pH (acidity) and is intended for use by women who have any of the following vaginal symptoms:
- Itching ●
- Burning ●
- Unpleasant odor .
1
- 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 follow-up by your neartheate provider. This device is not validated for use in pregnant women."
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 inscrt. The plastic probe is in the shape of small flat key. pHEM-ALERT is indicated package miser. "The present of differentiating normal and abnormal conditions in for modeling vagina price is inserted into the vagina and the measurement taken.
6. Substantial Equivalence
This version of the pHEM-ALERT is identical to the currently available version, except for the package insert, which has been modified to specifically address the needs of the lay user.
Two clinical studies were designed and carried in support of the Substantial Equivalency. The studies were designed to address the requirements, of appropriate guidelines. In particular, the clinical studies were performed to demonstrate that the lay user could read and understand the labeling and record accurate results The pHEM-ALERT and its labeling were found to be well designed, readable and understandable. The pHEM-ALERT was not affected by anticipated wariation in user technique. The pHEM-ALERT demonstrated reasonable test performance.
In conclusion, these data demonstrated that the test performance characteristics of this version of the pHEMALERT are reasonable and acceptable and that this version of the pHEM-ALERT is substantially equivalent to the original version.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT - 92001
FemTek, LLC c/o Joel S. Faden, Ph.D. President/CEO 11605 Hitching Post Lane Rockville, MD 20852
K012230 Re:
Trade/Device Name: pHEM-ALERT Regulation Number: 21 CFR 862.1550 Regulation Name: Urinary pH (nonquantitative) test system Regulatory Class: Class I, reserved Product Code: LNW Dated: July 15, 2001 Received: July 16, 2001
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 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 comply 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.
3
Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
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
4
pHEM-ALERT 510(k)
CONFIDENTIAL
INDICATIONS FOR USE
Device Name: pHEM-ALERT
Indications For Use:
The indications and intended uses for the OTC version of the pHEM-ALERT device are:
"The pHEM-ALERT® test measures vaginal pH (acidity) and is intended for use by women who have any of the following vaginal symptoms:
- Itching .
- Burning .
- 속 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). This device is not validated for use in pregnant women."
Coper
(Division Sigiff)
Division of Conical Laboratory Devices
510(k) Numb
012230
(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: V
(Optional Format 1-2-96)