(86 days)
Clearblue® Plus Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period (5 days before the missed period).
Not Found
This FDA 510(k) clearance letter for the Clearblue Plus Pregnancy Test does not contain the detailed scientific study information requested. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than providing the specifics of performance studies, acceptance criteria, or ground truth establishment.
Therefore, most of the requested information cannot be extracted from the provided text.
However, I can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance:
- This information is not present in the provided document. The 510(k) summary (which is a separate document typically submitted with the 510(k) application) would contain this.
2. Sample size used for the test set and the data provenance:
- This information is not present in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not present in the provided document.
4. Adjudication method for the test set:
- This information is not present in the provided document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is a pregnancy test, not an AI-assisted diagnostic device for image interpretation. Therefore, an MRMC study with AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is a pregnancy test; the "algorithm" is the biochemical reaction and visual interpretation. Standalone "algorithm only" performance, in the AI sense, is not applicable and not described. The device's performance is inherently "standalone" in its function as a qualitative diagnostic test.
7. The type of ground truth used:
- This information is not present in the provided document. For a pregnancy test, ground truth would typically be established by laboratory methods for hCG concentration (e.g., quantitative serum hCG).
8. The sample size for the training set:
- This information is not present in the provided document. "Training set" as understood in machine learning contexts is not applicable here.
9. How the ground truth for the training set was established:
- This information is not present in the provided document. "Training set" and its ground truth establishment are not applicable in the context of this regulatory clearance document for a pregnancy test.
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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
MAY 1 2 2011
SPD Development Company Limited c/o Ms. Tanya Fair Regulatory Affairs Manager Stannard Way, Priory Business Park Bedford, Bedfordshire United Kingdom MK44 3UP
Re: K110433
Trade/Device Name: Clearblue Plus Pregnancy Tesst Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX Dated: April 28, 2011 Received: May 03, 2011
Dear Ms. Fair:
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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolli-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours.
C.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known): K110433
Device Name: Clearblue® Plus Pregnancy Test
Indications for Use:
Clearblue® Plus Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period (5 days before the missed period).
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) 、
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k): K110433
Page 1 of 1
§ 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.