The Ovulation Predictor test is used for the qualitative measurement of LH and the detection of LH surge in a woman's urine as an aid in conception by accurately and reliably predicting ovulation. The Ovulation Predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. The Ovulation Predictor test is an over the counter (OTC) device that will be sold under the name Inverness Medical Early Ovulation Predictor, an under various private labels as One Step Ovulation Predictor or Ovulation Predictor.

Device Description

AI/ML Overview

The provided text describes the K991386 submission for the Early Ovulation Predictor (stick), One Step Ovulation Predictor (stick), and Ovulation Predictor (stick). Here's a breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
99% accuracy	99% accuracy

Explanation: The document explicitly states, "Both devices are 99% accurate," referring to the new device and the predicate device. This establishes the 99% accuracy as the critical performance metric for substantial equivalence.

Study Information:

1. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified. The document generally refers to "clinical studies tests" without providing specific numbers for the test set.
Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. The document does not describe the nature of clinical studies in enough detail to determine how ground truth was established, nor does it mention experts.

3. Adjudication method for the test set:

Not specified. There is no information regarding any adjudication process for the test set.

4. 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:

No, an MRMC study was not done. This device is an in-vitro diagnostic (IVD) for home use, which typically does not involve human readers in the same way an imaging AI device would. The core claim is about the device's ability to detect LH levels, not about assisting human interpretation of complex medical data.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Yes, by nature. The device is a "One-step urine test that measure LH immunochromatographically," intended for home use by women. It provides a direct result (qualitative measurement of LH), meaning its performance is inherently standalone, without a "human-in-the-loop" to interpret an algorithm's output. The comparison is between the new device and a predicate device, both operating as standalone tests.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Implied ground truth related to LH detection. While not explicitly stated, the ground truth would likely be established through a validated laboratory method for measuring Luteinizing Hormone (LH) levels in urine. This would serve as the reference standard against which both the new device and the predicate device's results are compared to determine their "accuracy" in detecting LH surge.

7. The sample size for the training set:

Not specified. The document only mentions "Laboratory and clinical studies tests" without detailing training sets.

8. How the ground truth for the training set was established:

Not specified. As the training set size and characteristics are not provided, the method for establishing its ground truth is also unknown. It would presumably involve similar laboratory methods for LH detection as the ground truth for the test set.

In summary, the provided submission focuses on establishing substantial equivalence to a predicate device (ClearPlan® Easy ovulation test) based on identical technological characteristics and demonstrated equivalent performance (99% accuracy) through laboratory and clinical studies. However, detailed methodological information regarding sample sizes, ground truth establishment, and study design elements common in more complex AI/imaging device submissions is largely absent.

Summary

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K991386

Section 5 - revised

510(k) SUMMARY (Summary of Safety and Effectiveness)

Submitted by:

Carol Adiletto Director of Clinical Affairs Selfcare, Inc. 200 Prospect Street Waltham, MA 02453-3457 USA Phone: (781) 647-3900 (781) 647-3939 Fax:

Contact Person:

Carol Adiletto Phone (781) 647-3900 x124

Summary Prepared:

April 19, 1999

Name of the device:

Early Ovulation Predictor (stick) One Step Ovulation Predictor (stick) Ovulation Predictor (stick)

Classification name(s):

Ovulation Predictor (stick) is a Class I device (21 CFR § 862.1485) for home use

Classification of predicate device(s):

The Ovulation Predictor test is not materially different from the predicate ClearPlan® Easy ovulation tests that are manufactured by Unipath. Ltd., Bedford, UK. and were cleared for use in the United States by K981271 and K894579. Section 6 contains information comparing the new device Ovulation Predictor , to the predicate device, ClearPlan® Easy.

Description of the device/intended use(s):

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Statement of How the Technological Characteristics of the Device Compare to the Predicate device:

The technological characteristics are the same because both devices are One-step urine tests that measure LH immunochromatographically, and have the same safety and effectiveness. They have the same intended use, i.e. use by women as an aid in conception. The new device is intended to be used for the qualitative measurement of LH and the detection of LH surge in a woman's urine. The Ovulation Predictor is intended for use by women outside the body (in vitro diagnostic use) as an aid to conception.

Summary of Performance Data:

Laboratory and clinical studies tests demonstrate that Ovulation Predictor (stick) provides equivalent performance to the ClearPlan® Easy ovulation test.

Both devices are 99% accurate.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

MAY 25 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Carol Adiletto Director of Clinical Affairs SELFCARE, INC. 200 Prospect Street 02453-3457 Waltham, MA

Re: K991386 Trade Name: Early Ovulation Predictor (stick) One Step Ovulation Predictor (stick) Ovulation Predictor (stick) Regulatory Class: I Product Code: CEP Dated: April 20, 1999 Received: April 21, 1999

Dear Ms. Adiletto:

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 QS 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

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

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Section 4- revised

Indications for Use Statement

510(k) Number (if known): _ K 991386

Early Ovulation Predictor (stick) Device Name: One Step Ovulation Predictor (stick) Ovulation Predictor (stick)

Indications for Use:

Dean Coogen

(Division Sign-Off)
Division of Clinical
510(k) Num K 991386

(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 801.019) OR

Over-The-Counter Use

Regulation Number and Section

§ 862.1485 Luteinizing hormone test system.

(a)
Identification. A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.