Clearblue Easy Easy Read Pregnancy Test is an over-the-counter urine hCC test which is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine. The test is indicated for use from three days before the expected period.

Device Description

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AI/ML Overview

Here's an analysis of the provided text regarding the Clearblue Easy Easy Read Pregnancy Test, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Claimed Use: Over-the-counter urine hCG test for early pregnancy detection.	The device is cleared for marketing as an over-the-counter urine hCG test.
Indicated Use: From three days before the expected period.	The device's indications for use specifically state "from three days before the expected period."
Accuracy/Sensitivity/Specificity: Not explicitly stated in the provided text.	Not explicitly stated in the provided text. However, the FDA's "substantial equivalence" determination implies that the device meets performance standards comparable to legally marketed predicate devices.

Important Note: The provided FDA clearance letter focuses on establishing substantial equivalence to a predicate device for marketing purposes. It does not detail the specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy percentages) that Unipath Ltd. used in their internal validation studies, nor the detailed results of those studies. The letter only confirms that the FDA reviewed the 510(k) and found the device substantially equivalent.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified in the provided document.
Data Provenance: Not specified in the provided document. The manufacturer is Unipath Ltd. based in the United Kingdom, so the studies could have been conducted there or elsewhere. The document does not indicate if the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not specified in the provided document.
Qualifications of Experts: Not specified in the provided document.

4. Adjudication Method for the Test Set

Not specified in the provided document. This type of detail is typically found in the full 510(k) submission, not the FDA clearance letter.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not Applicable: This device is an in-vitro diagnostic (IVD) pregnancy test, not an imaging device requiring human reader interpretation in the same way an AI-powered diagnostic imaging tool would. Therefore, an MRMC study as typically understood for AI in radiology, for example, would not be relevant. The "human readers" for this device are the users interpreting the visual result (lines/symbols).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, implicitly: As an over-the-counter pregnancy test, the device is designed to be used by individuals without expert human intervention beyond interpreting the visual result. The "algorithm" in a qualitative test like this would be the chemical reaction leading to a visible line, and its performance is evaluated in a standalone manner (i.e., does the test correctly detect hCG in a sample). The 510(k) submission would have included data demonstrating the test's ability to accurately detect hCG levels.

7. The Type of Ground Truth Used

Implicitly, clinical reference methods and/or known hCG concentrations: For a pregnancy test, ground truth would typically be established by:
- Quantitative hCG measurements: Using highly accurate laboratory-based assays to determine the true hCG concentration in urine samples.
- Clinical outcomes: Confirming pregnancy through other diagnostic methods (e.g., ultrasound, follow-up blood tests) to correlate with the test results.
- Known hCG-spiked samples: Testing samples with precisely known concentrations of hCG to assess sensitivity and specificity at various levels.

8. The Sample Size for the Training Set

Not specified in the provided document. This information would be part of the full 510(k) submission. For chemical-based IVDs, the concept of a "training set" in the machine learning sense is not directly applicable. Instead, there would be development and optimization phases where various reagents and designs are tested, and then validation studies on larger, independent sets.

9. How the Ground Truth for the Training Set Was Established

Not specified in the provided document. Similar to point 8, the "training set" concept is different here. However, for the development and optimization of such a test, the ground truth would involve precisely prepared samples with known hCG concentrations and potentially clinical samples with confirmed pregnancy status obtained through reference laboratory methods.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 8 2004

Ms. Louise Roberts Regulatory Affairs Manager Unipath Ltd. Priory Business Park Bedford, United Kingdom, MK44 3UP

Re: K041404

Ko 11-Device Name: Clearblue Easy Easy Read Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: May 20, 2004 Received: May 26, 2004

Dear Ms.Roberts:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrobate) is the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978) as ecordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmette 710 (110) that to hevice, subject to the general controls provisions of the Act. The 1 ou may, dicierore, market the detect coursements for annual registration, listing of general controls provisions of ractice, 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 your device is elabilitied (oss as controls. Existing major regulations affecting your device It may be subject to suen additions come Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in Title 21, ovcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dri brounder of your device complies with other requirements of the Act that I DA has made a acterinaliations administered by other Federal agencies. You must of ally Federal statutes and regulanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice er it rart 807), laboring 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) I his letter will anow you to begin mailoning of substantial equivalence of your device to a legally premaired notincation: "The PDF interessification 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, II you desire specific mionitation association of your device, please contact the Office of of questions on the promotion and Safety at (301) 594-3084. Also, please note the In Viro Diagnostic De reserence to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I bu may other belief general ers, 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,

Sean M. Cooper, MS, DVM.

Jean M. Cooper, MS, D.V.M. 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

510(k) Number (if known):

Ko41404

Clearblue Easy Easy Read Pregnancy Test Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Clearblue Easy Easy Read Pregnancy Test is an over-the-counter urine hCC test which is a Clearbite Easy Easy Read Fregnancy. The test is indicated for use from three days before the expected period.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safetv

K04146

Regulation Number and Section

§ 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.