(56 days)
Not Found
No Reference Device(s) K/DEN number is found in the text.
No
The summary does not mention any AI or ML terms, image processing, or data sets typically associated with AI/ML development. The device is described as a simple over-the-counter urine test.
No
The device is a diagnostic test for pregnancy, not a device used for therapy or treatment.
Yes
The device is described as a "Pregnancy Test" intended for "detection of pregnancy," which falls under the definition of a diagnostic device as it detects a condition or state (pregnancy).
No
The description clearly states the device is an "over-the-counter urine hCG test," which is a physical test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "urine hCG test which is intended for the detection of pregnancy." This involves testing a biological sample (urine) outside of the body to gain information about a physiological state (pregnancy).
- Over-the-counter: While it's an over-the-counter device, this doesn't preclude it from being an IVD. Many IVDs are designed for home use.
- Detection of pregnancy: This is a diagnostic purpose.
The definition of an IVD generally involves devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The e.p.t. Pregnancy Test fits this definition perfectly.
N/A
Intended Use / Indications for Use
e.p.t.® Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from first day of missed period and may be used before the expected period.
Product codes
LCX
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
Over-The-Counter Use
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
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the figure. The figure is composed of three curved lines that form the shape of a person with arms raised.
JAN 1 6 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Louise Roberts Regulatory Affairs Manager Unipath Ltd. Priory Business Park Bedford United Kingdom MK44 3UP
Re: K033658
Trade/Device Name: e.p.t. Pregancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system. Regulatory Class: Class II Product Code: LCX Dated: January 6, 2004 Received: January 9, 2004
Dear Ms. Roberts:
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,
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, D.V.M. 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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K033658 510(k) Number (il known):_
e.p.t.® Pregnancy Test Device Name:
Indicalions For Use:
. .
e.p.t.® Pregnancy Test is an over-the-counter urine hCG test which is intended for the e.p.t.l.® Pregnancy Test is an over-inclicated for use from first day of missed period and
detection of pregnancy. The test is indicated for use from traceted period detection of pregnancy. The test is mellared before the expected period.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Carol C Benson for Jean Cooper, DVM | |
|---|---|
| Division Sign-Off |
Office of In Vitro Diagnostic Device
Evaluation and Safety
| 510(k) | K033658 |
|---|---|
| -------- | --------- |
| Prescription Use (Per 21 CFR 801 109) | OR | Over-The-Counter Use
(Optional Format 1-2-96)
X |
| --------------------------------------- | ---- | ------------------------------------------------------- |
|---|