(29 days)
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No
The summary describes a simple chemical test for pregnancy and lacks any mention of AI, ML, image processing, or complex data analysis typically associated with AI/ML medical devices.
No.
The device is a diagnostic test for pregnancy, not a device used for therapy or treatment.
Yes
The device is intended for the detection of pregnancy, which falls under the definition of diagnosing a condition.
No
The device is described as an over-the-counter urine hCG test, which is a physical test kit, not a software application.
Yes, based on the provided information, the CLEARBLUE EASY device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "detection of pregnancy" using "urine hCG test." This involves testing a sample (urine) taken from the human body in vitro (outside the body) to provide information about a physiological state (pregnancy).
- Sample Type: It uses urine, which is a biological sample.
- Purpose: It's used to diagnose or detect a condition (pregnancy).
These are key characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CLEARBLUE EASY is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test has a sensitivity of 50mlU/ml hCG in urine, and is indicated for use from four days before the expected missed period.
Product codes (comma separated list FDA assigned to the subject device)
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
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.)
sensitivity of 50mlU/ml hCG in urine
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 0 9 2001
Mr. Steven H. Armstrong Assistant General Counsel-Marketing Unilever United States, Inc. Lever House - 390 Park Avenue New York, NY 10022-4698
Re: K013372
Trade/Device Name: Clear Blue Easy Early Result Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: October 8, 2001 Received: October 11, 2001
Dear Mr. Armstrong:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Steven Butman
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
NOV 0 9 2001
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K013372
Device Name: Clear Blue Easy Early Result Pregnancy Test
Indications For Use:
CLEARBLUE EASY is an over-the-counter urine hCG test which is intended for the The test has a sensitivity of 50mlU/ml hCG in urine, detection of pregnancy. detection of pregnancy. The cest nad a benefeling
and is indicated for use from four days before the expected missed period.
(Division Sign-Off) Division of Clinical Laborator
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over the Counter $\swarrow$
(Optional Format 3-10-98)