(60 days)
CLEARBLUE EASY DIGITAL PREGNANCY TEST is an over-thecounter qualitative urine hCG test which is intended for the detection of pregnancy. The test has a sensitivity of 50mIU/ml hCG in urine, and can be used from the first day of the missed period.
Not Found
The provided text is a 510(k) summary for the CLEARBLUE EASY DIGITAL PREGNANCY TEST. It primarily covers the regulatory determination of substantial equivalence and does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria in the format requested.
Therefore, I cannot extract the information to fulfill your request. The document is a regulatory letter indicating clearance, not a scientific study report.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY = 2 2003
Ms. Louise Roberts Regulatory Affairs Manager Unipath Limited Priory Business Park Bedford United Kingdom MK44 3UP
Re: K030659
Trade/Device Name: CLEARBLUE EASY DIGITAL 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 28, 2003 Received: March 3, 2003
Dear Ms. Roberts:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 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 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 Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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K030659 -510 (K) NUMBER (IF KNOWN) : CLEARBLUE EASY DIGITAL PREGNANCY TEST DEVICE NAME: INDICATIONS FOR USE:
CLEARBLUE EASY DIGITAL PREGNANCY TEST is an over-thecounter qualitative urine hCG test which is intended for the detection of pregnancy. The test has a sensitivity of 50mIU/ml hCG in urine, and can be used from the first day of the missed period.
Alan Cooley
(Division Sign-Off)
Division of Clinical Laboratory Devices 510(k) Number JA
(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-Use (Optional Format 1-2-96)
§ 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.