(202 days)
There are no Predicate Device(s) K/DEN numbers in the provided text. The section "Predicate Device(s)" states "Not Found".
Not Found
No
The summary describes a biochemical assay and does not mention any AI or ML components.
No.
The device is a screening test for diagnosing vaginitis or urethritis, not a treatment for these conditions.
Yes
Explanation: The intended use states that the device is "indicated for use as an aid in the presumptive diagnosis of vaginitis or urethritis".
No
The device is a biochemical assay kit, which inherently involves physical components for sample collection and analysis, not solely software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that FemLab is a "biochemical assay intended for use as a screening test for nitrites, blood, protein, and proline-iminopeptidase in vaginal fluid samples, and also to measure vaginal fluid pH." This involves testing samples taken from the human body in vitro (outside the body) to provide information about a person's health.
- Diagnosis Aid: It is indicated for use as an "aid in the presumptive diagnosis of vaginitis or urethritis." This further confirms its role in providing diagnostic information.
- Sample Type: It uses "vaginal fluid samples," which are biological specimens.
- Professional and Laboratory Use: The indication for "professional and laboratory use only" aligns with the typical use setting for many IVD devices.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. FemLab fits this description by analyzing biological samples to aid in the diagnosis of vaginitis or urethritis.
N/A
Intended Use / 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.
Product codes
D, LNW, JMT, JIR, LJX, JTO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional and laboratory use only
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.2660 Microorganism differentiation and identification device.
(a)
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.(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 § 866.9.
0
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).
1
Page 2 -
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 (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 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
2
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)