EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)

K991386 · Selfcare, Inc. · CEP · May 25, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991386
• Device Name: EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)
• Applicant: Selfcare, Inc.
• Product Code: CEP · Clinical Chemistry
• Decision Date: May 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1485
• Device Class: Class 1

Intended Use

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 Story

In vitro diagnostic test; detects LH surge in urine; immunochromatographic stick format; home use by women; aids in conception; provides qualitative result; no complex processing; visual interpretation by user.

Clinical Evidence

Laboratory and clinical studies demonstrate 99% accuracy, equivalent to the predicate ClearPlan® Easy ovulation test.

Technological Characteristics

One-step immunochromatographic test stick; measures Luteinizing Hormone (LH) in urine; qualitative detection; OTC home-use device.

Indications for Use

Indicated for women at home for qualitative measurement of LH and detection of LH surge in urine to aid in conception by predicting ovulation.

Regulatory Classification

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.

Predicate Devices

• ClearPlan® Easy (K981271)
• ClearPlan® Easy (K894579)

Submission Summary (Full Text)

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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: [phone] [phone] Fax:

## Contact Person:

Carol Adiletto Phone [phone] 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):

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.

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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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Page 2

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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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:

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.

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