(73 days)
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Not Found
No
The 510(k) summary describes a simple qualitative urine test for hCG, with no mention of AI, ML, image processing, or complex data analysis.
No.
The device is an in vitro diagnostic test used to detect pregnancy, which is a diagnostic purpose, not a therapeutic one. It does not treat or alleviate any condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The CLEARPLAN EASY II 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" and a "urine test," which inherently involves physical components for sample collection and analysis, not solely software.
Yes, based on the provided information, the CLEARPLAN EASY II Home Pregnancy Test is an IVD (In Vitro Diagnostic) device.
The "Intended Use / Indications for Use" section explicitly states:
"The CLEARPLAN EASY II 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 II 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 II Home Pregnancy Test is a qualitative test which detects the hormone human chorionic gonadotrophin (hCG) in urine.
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
women, home
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and a wavy line representing water beneath it. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 6 1999
Ms. Louise Roberts Regulatory Affairs Manager Unipath Limited Priory Business Park Bedford MK44 3UP United Kingdom
K993333 Re:
Trade Name: Clearplan Easy II Home Pregnancy Test Regulatory Class: II Product Code: LCX Dated: September 30, 1999 Received: October 4, 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 OS 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.
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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/cdrl/dsma/dsmamain.html".
Sincerely yours,
steven Sutman
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
K993333 NUMBER (IF KNOWN): 510 (k) CLEARPLAN EASY II HOME PREGNANCY TEST DEVICE NAME: INDICATIONS FOR USE:
The CLEARPLAN EASY II 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 II Home Pregnancy Test is a qualitative test which detects the hormone human chorionic gonadotrophin (hCG) in urine.
Jean Cooper.
Division Sign-Off) Division of Clinica! Laboratory Levices 332 વળ 510(k) Number 4
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-User (Optional Format 1-2