(30 days)
Not Found
Not Found
No
The description focuses on data transfer and storage, explicitly stating the system "does not affect the scientific technology of the CLEARPLAN EASY FERTILITY MONITOR" and that the information presented is analogous to manual recording. There is no mention of AI or ML in the provided text.
No
The device aids in timing intercourse to achieve conception, which is not a therapeutic intervention for a disease or condition. It is an in vitro diagnostic device for fertility monitoring.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The CLEARPLAN EASY FERTILITY MONITOR, an over-the-counter (OTC) in vitro diagnostic device..." This directly identifies the device as a diagnostic device.
No
The device description explicitly states that the CLEARPLAN DATA TRANSFER SYSTEM consists of a "software controlled electronic card reader, a connecting cable, electronic memory cards and user instructions," indicating it includes hardware components in addition to software.
Based on the provided text, the CLEARPLAN EASY FERTILITY MONITOR is explicitly stated to be an in vitro diagnostic device (IVD).
The text describes it as: "The CLEARPLAN EASY FERTILITY MONITOR, an over-the-counter (OTC) in vitro diagnostic device, is intended to be used by women as an aid in the timing of intercourse by identifying those days in a woman's cycle on which intercourse is most likely to lead to conception via a urine test."
The CLEARPLAN DATA TRANSFER SYSTEM is described as an accessory to the CLEARPLAN EASY FERTILITY MONITOR. While it interacts with the data from the IVD, the text states it "does not affect the interpretation of the results of the user's own activities" and "does not affect the scientific technology of the CLEARPLAN EASY FERTILITY MONITOR." This suggests the Data Transfer System itself is not performing an in vitro diagnostic test, but rather managing and displaying data generated by the IVD.
Therefore, the answer is Yes, the CLEARPLAN EASY FERTILITY MONITOR is an IVD. The CLEARPLAN DATA TRANSFER SYSTEM is an accessory to the IVD.
N/A
Intended Use / Indications for Use
The CLEARPLAN EASY FERTILITY MONITOR, an over-the-counter (OTC) in vitro diagnostic device, is intended to be used by women as an addition in the home, by identifying those days in a woman's cycle on which intercourse is most likely to lead to conception via a urine test.
The CLEARPLAN DATA TRANSFER SYSTEM is an accessory to the CLEARPLAN EASY FERTILITY MONITOR which allows the information collected by this product to be transferred to and stored on a computer, and viewed on the computer display or printed out. The CLEARPLAN DATA TRANSFER SYSTEM also allows the time of access of the stored information to be recorded electronically and the data to be collated on the computer.
The target market for the CLEARPLAN DATA TRANSFER SYSTEM is women who have purchased the CLEARPLAN EASY FERTILITY MONITOR, however the device will be of use to Obstetricians, Gynaecologists and Fertility Specialists.
The CLEARPLAN DATA TRANSFER SYSTEM is intended to transfer data which have already been collected by the user of the CLEARPLAN EASY FERTILITY MONITOR. The CLEARPLAN DATA TRANSFER SYSTEM does not affect the scientific technology of the CLEARPLAN EASY FERTILITY MONITOR. The information which is presented to the user of the device is analogous to that which they could have recorded on paper on a daily basis by noting the indications given by the MONITOR. Therefore the CLEARPLAN DATA TRANSFER SYSTEM does not affect the interpretation of the CLEARPLAN EASY FERTILITY MONITOR activities.
Product codes
LHD, CEP
Device Description
The CLEARPLAN DATA TRANSFER SYSTEM consists of a software controlled electronic card reader, a connection cable, electronic memory cards and user instructions.
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
Home use by women; Of use to Obstetricians, Gynaecologists and Fertility Specialists.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
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, within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The logo is black and white.
ﻴﺔ
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 4 1999
Louise Roberts Regulatory Affairs Manager Unipath Limited Priory Business Park Bedford MK44 3UP United Kingdom
Re:
K990223 Trade Name: Modification of Clearplan Easy Fertility Monitor Regulatory Class: I Product Code: LHD, CEP Dated: January 19, 1999 Received: January 25, 1999
Dear Ms. Roberts:
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 ass bated in and the time 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 Eederal 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.
1
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device Under the Clinical Laooratory iniprovement in includes in if it dees, you should contact
may require a CLIA complexity categorization. Toddetermine if it it dees, you should may require a CEIA complexity categoriesation (CDC) at (770)488-7655. -
This letter will allow you to begin marketing your device as described in your 510(k) I his leter will allow you to oegin mailsching your antial equivalence of your device to a premarket notification. The FDA midning of bassification 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 II you desire Specific us from to: 'yo diagnostic devices), please contact the Office of and additionally 809.10 for in Vide ditightly, for questions on the promotion and Compliance at (301) 594-4500. I recutact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket Also, prease note the regulation onlines, " read information on your responsibilities under the nothication (21 CFR 807.97). Outcom of Small Manufacturers Assistance at its toll free Act may be obamod from at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
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
2
K990223/A'
FDA/CDRH/ODE/DMC
FEB 88 -4 03 PH '99
Page
510 (K) NUMBER (LTF (KNOWN) + K990223
DEVICE NAME: MODIFICATION OF THE CLEARPLAN EASY FERTILITY MONITOR
INDICATIONS FOR USE:
The CLEARPLAN EASY FERTILITY MONITOR, an over-the-counter (OTC) in vitro diagnostic device, is case on which The CLEARPLAN EASY FERTILAT I NOTOTCH by identifying those days in a woman's cycle on which intended to be used by women as an addition in the a wise comists of a software-omissted electronic intercourse is most likely to lead to conception via a unne too. "The consumer through pharmacies and drug . .. _ stores.
The CLEARPLAN DATA TRANSFER SYSTEM is an accessory to the CLEARPLAN EASY FIRTILITY The CLEARPLAN DATA TRANSFER CLUPERS by this product to be transferred to and stored on a
MONITOR which allows the information collected by this product to be transfer St MONTOK which allows the intonnation of onews of at . The CLEARPLAN DATA TRANSFER SYSTEM
computer, and viewed on the computer display or provinced the data to be collated on t computer, and viewed on the compact usplay or econded electronically and the data to be collated on the allso allows the lime of accs of the round of the CLEARPLAN EASY FERTILITY MONITOR.
The CLEARPLAN DATA TRANSFER SYSTEM consists of a software controlled electronic card reader, a The CEART DAY DAY DAY PATT TIG LES, electronic memory cards and user instructions.
The target market for the CLEARPLAN DATA TRANSFER SYSTEM is women who have purchased the The target market for the CEEARLEAN DAYAN THE device will be of use to Obstericians, Gynaecologists and Fertility Specialists.
The CLEARPLAN DATA TRANSFER SYSTEM is intended to transfer data which have already The CLEARPLAN DATA TRANSFER STOTEM IS and of the internation which been collected by the user of the CLEAR DAY Dris to that which the they could have recorded on paper on a daily is presented to the user of the device is anales to unit maste and the more is own of the user's own basis by nothig the indications given by the OLD. It a FRANSFER SYSTEM does not affect the interest the interest the CLARD AN activities. Therefore the CLEACEAN DAY DAYA Treatific technology of the CLEARPLAN EASY FERTILITY MONITOR.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER FAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K990223 |
OR
| Prescription Use
(Per 21 CFR 801.109) | Over-The-Counter-Use
(Optional Format 1-2-1) |
| ------------------------------------------ | ------------------------------------------------- |
|---|