(26 days)
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No
The summary describes a standard over-the-counter pregnancy test that detects hCG in urine, with no mention of AI, ML, image processing, or complex data analysis typically associated with AI/ML devices.
No.
The device is described as a pregnancy test, which is used for detection and not for treating or preventing any disease or condition.
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 identifies a specific condition or state.
No
The description clearly states it is a urine hCG test, which is a physical test kit, not a software-only device.
Yes, based on the provided information, the e.p.t.® Pregnancy Test 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 diagnose a condition (pregnancy).
- Over-the-Counter Use: While it's for over-the-counter use, 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 description 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 detection of pregnancy. The test is indication for ass in associed period.
Product codes
LCX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of an eagle with three stylized wings.
MAR - 8 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
K040329 Re:
Trade/Device Name: e.p.t. ® Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: February 9, 2004 Received: February 11, 20034
Dear Ms. Roberts:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered pror to ritty 2017 11:37 accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Costinetter recept rety the device, subject to the general controls provisions of the Act. The r ou may, mercere, mailies of the Act include requirements for annual registration, listing of general controls provisions 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 If your device is clusiness (600 as controls. Existing major regulations affecting your device can may or suizyoet to base of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA oc found in Title 21, occouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act that 1171 has intatutes and regulations administered by other Federal agencies. You must or any I edetar statuates and states and the mot limited to: registration and listing (21
1
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and it your finding of substantial equivalence of your device to a legally premits to the licated 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 I ou inay 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.
Yean 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
2
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K040329
Device Name:___e.p.t.® Pregnancy Test
Indications For Use:
e.p.t.® Pregnancy Test is an over-the-counter urine hCG test which is intended for the e.p.t.® Pregnancy Test is an over including of use from first day of missed period and
detection of pregnancy. The test is indicated for use from first day of missed period detection of pregnancy. The test is indication for ass in associed period.
Carol Benson
Division of Off
Office of In Vitro Diagnostic
Device evaluation and Safety
510(k) K040329
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use
X
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)