(70 days)
Not Found
Not Found
No
The summary describes a simple qualitative in vitro diagnostic test for detecting hCG in urine, with no mention of AI, ML, image processing, or complex data analysis that would typically involve such technologies.
No.
The device is an in vitro diagnostic (IVD) device used to detect pregnancy, not to treat a medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The CLEARPLAN EASY Home Pregnancy Test, an over-the-counter (OTC) in vitro diagnostic device, is intended to be used by women to detect pregnancy via a urine test."
No
The device is described as an in vitro diagnostic device that detects a hormone in urine, indicating it is a physical test kit and not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The CLEARPLAN EASY Home Pregnancy Test, an over-the-counter (OTC) in vitro diagnostic device, is intended to be used by women to detect pregnancy via a urine test."
This statement directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CLEARPLAN EASY Home Pregnancy Test, an over-the-counter (OTC) in vitro diagnostic device, is intended to be used by women to detect pregnancy via a urine test. The CLEARPLAN EASY Home Pregnancy Test is a qualitative test which detects the hormone human chorionic gonadotropin (hCG) in urine. The product will be made available over-the-counter through pharmacies and drug stores.
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
women / over-the-counter through pharmacies and drug stores
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/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
Public Health Service
APR 8 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Louise Roberts Regulatory Affairs Manager Unipath Limited Priory Business Park Bedford MK44 3UP UNITED KINGDOM
Re: K990262
Trade Name: CLEARPLAN EASY Home Pregnancy Test Regulatory Class: II Product Code: LCX Dated: March 19, 1999 Received: March 22, 1999
Dear Ms. Roberts:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Steven Putman
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
2
S10(K) NUMBER (IF KNOWN) : K990262 _
CLEARPLAN EASY Home Pregnancy Test DEVICE NAME:
INDICATIONS FOR USE:
The CLEARPLAN EASY Home Pregnancy Test, an over-the-counter (OTC) in vitro diagnostic device, is intended to be used by women to detect pregnancy via a urine test. The CLEARPLAN EASY Home Pregnancy Test is a qualitative test which detects the hormone human chorionic gonadotropin (hCG) in urine. The product will be made available over-the-counter through pharmacies and drug stores.
Jean Cooper
(Division Sign-Off) Division of Clinical Laboratory Devices 11 900260 510(k) Number_
(PLEASE DO NOT MRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGI IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format I