(13 days)
Not Found
Not Found
No
The summary describes a simple immunoassay for detecting hCG in urine, with no mention of AI, ML, image processing, or complex algorithms.
No
The device is a diagnostic test (pregnancy test) used to detect hCG, not to treat a medical condition.
Yes
The device is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine, which is used to diagnose pregnancy.
No
The description clearly states the device is an "over-the-counter urine hCC test which is a qualitative immunoassay". This indicates a physical test kit, not a software-only device.
Yes, based on the provided information, the Clearblue Easy Easy Read Pregnancy Test is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is a "qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine." This describes a test performed in vitro (outside the body) on a biological sample (urine) to diagnose or detect a condition (pregnancy, indicated by the presence of hCG).
- Over-the-counter urine hCG test: This further confirms it's a test performed on a biological sample (urine) and is intended for diagnostic purposes.
The definition of an IVD generally includes devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or for the determination of the state of health. The Clearblue Easy Easy Read Pregnancy Test fits this definition.
N/A
Intended Use / Indications for Use
Clearblue Easy Easy Read Pregnancy Test is an over-the-counter urine hCG test which is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine. The test is indicated for use from three days 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 8 2004
Ms. Louise Roberts Regulatory Affairs Manager Unipath Ltd. Priory Business Park Bedford, United Kingdom, MK44 3UP
Re: K041404
Ko 11-Device Name: Clearblue Easy Easy Read Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: May 20, 2004 Received: May 26, 2004
Dear Ms.Roberts:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed 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 encrobate) is the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978) as ecordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmette 710 (110) that to hevice, subject to the general controls provisions of the Act. The 1 ou may, dicierore, market the detect coursements for annual registration, listing of general controls provisions of ractice, 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 your device is elabilitied (oss as controls. Existing major regulations affecting your device It may be subject to suen additions come Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in Title 21, ovcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dri brounder of your device complies with other requirements of the Act that I DA has made a acterinaliations administered by other Federal agencies. You must of ally Federal statutes and regulanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice er it rart 807), laboring 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 mailoning of substantial equivalence of your device to a legally premaired notincation: "The PDF interessification 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, II you desire specific mionitation association of your device, please contact the Office of of questions on the promotion and Safety at (301) 594-3084. Also, please note the In Viro Diagnostic De reserence to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I bu may other belief general ers, 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,
Sean 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
2
Indications for Use
510(k) Number (if known):
Ko41404
Clearblue Easy Easy Read Pregnancy Test Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Clearblue Easy Easy Read Pregnancy Test is an over-the-counter urine hCC test which is a Clearbite Easy Easy Read Fregnancy. The test is indicated for use from three days before the expected period.
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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safetv
K04146