(34 days)
No
The description focuses on immunochromatographic measurement of LH and does not mention any computational or learning-based methods.
No.
The device is an in vitro diagnostic (IVD) test used to predict ovulation, which aids in conception. It does not directly treat or cure any medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "an aid in conception by accurately and reliably predicting ovulation," and that it is an "in vitro diagnostic use" device. The "Device Description" also reiterates that it 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" and is for "in vitro diagnostic use." These phrases confirm its role in diagnosing or aiding in the prediction of a biological state (ovulation).
No
The device description explicitly states it is a "One-step urine test" and mentions "immunochromatographically," indicating a physical test strip or similar hardware component is involved in the measurement of LH. This is not a software-only device.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The Ovulation Predictor test is intended for use outside the body (in vitro diagnostic use) by women at home."
- Definition of IVD: An IVD is a medical device used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. This device analyzes urine to detect LH, which fits this definition.
- "In vitro diagnostic use" mentioned multiple times: The phrase "in vitro diagnostic use" is repeated in both the "Intended Use" and "Device Description" sections, reinforcing its classification.
N/A
Intended Use / 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.
Product codes
CEP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
women at home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Laboratory and clinical studies tests demonstrate that Ovulation Predictor (stick) provides equivalent performance to the ClearPlan® Easy ovulation test.
Key Metrics
Both devices are 99% accurate.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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):
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.
1
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.
2
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 (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
4
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