(54 days)
The TBD One-Step Ovulation Predictor Test is an at-home in vitro diagnostic use test to be marketed over-the-counter (OTC) to lay consumers. The test device product is intended for the detection of human luteinizing hormone (hLH) in urine as an aid in the prediction of ovulation.
The TBD One-Step Ovulation Predictor Test is a simple to use, plastic stick, in vitro device. The top of the stick is clear to allow the user to visualize the migration of the test reagents. The stick contains a chromatographic test strip which has all the necessary reagents to perform the test. An absorbent tip collects and delivers the urine sample to the reagents on the chromatographic strip. The test is performed by placing the absorbent tip into the urine stream for 5 seconds. Alternatively, the test may be performed by immersing the absorbent tip into a container of urine for 5 seconds. The urine sample from the absorbent tip migrates by capillary action along the chromatographic strip, reconstituting the reagents placed strategically along the strip. Visualization of the test results occurs when the appropriate reagents react producing one or two pink-purple lines which appear in a window in the hull of the test stick. The luteinizing hormone (LH) surge is indicated if the test line is similar to or darker than the reference line. If there is no test line or the test line is lighter than the reference line, then there has been no LH surge.
The provided text describes the TBD One-Step Ovulation Predictor Test and its similarity to a predicate device. However, it does not include detailed acceptance criteria or the specific study that would directly prove the device meets these criteria in the format requested.
Here's an analysis based on the information available in the text, highlighting what is missing for a complete answer to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the TBD One-Step Ovulation Predictor Test was found to have "equivalent performance to that of the predicate device" in a direct laboratory comparison, and in consumer use studies, it was "at least as accurate as the predicate device with regard to consumers' accuracy in performing the test."
Missing Information:
- Specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds).
- Detailed quantitative performance metrics for the TBD One-Step Ovulation Predictor Test.
- Quantitative performance metrics for the predicate device to compare against.
2. Sample Size for the Test Set and Data Provenance:
The document mentions "direct laboratory comparison" and "consumer use studies."
Missing Information:
- Sample Size: The number of participants or samples used in these studies is not specified.
- Data Provenance: The country of origin of the data is not mentioned. It is implied that the studies were conducted by Carter-Wallace, Inc., an American company. The description refers to "consumer use studies," which suggests prospective data collection, but this is not explicitly stated. It's unclear if any retrospective data was used.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not mention the involvement of experts in establishing ground truth for the performance studies. Since it's an at-home ovulation predictor test intended for lay consumers, the "accuracy in performing the test" likely refers to the consumers' ability to correctly interpret the results based on the package inserts, rather than expert interpretation of complex clinical data.
Missing Information:
- Details on expert involvement in establishing ground truth are entirely absent.
4. Adjudication Method:
Given the nature of an at-home ovulation test, the concept of an adjudication method as typically applied to expert review of medical images or complex diagnoses is not directly applicable or described.
Missing Information:
- No adjudication method is mentioned or implied.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study is not relevant to this type of device (an at-home diagnostic test for a single user).
Missing Information:
- An MRMC study was not conducted or described.
6. Standalone Performance:
The "direct laboratory comparison" and "consumer use studies" would likely represent the standalone performance of the device as it would be used by consumers, without human-in-the-loop assistance beyond the consumer following instructions.
Missing Information:
- While implied, the term "standalone performance" isn't explicitly used, and specific metrics for this are absent (as noted in point 1).
7. Type of Ground Truth Used:
The ground truth for an ovulation predictor test would typically involve confirming actual ovulation, likely through other clinical methods (e.g., daily blood hormone levels, ultrasound). However, the document focuses on the prediction of the LH surge and refers to "consumers' accuracy in performing the test." This suggests the ground truth for consumer studies might be tied to how well users followed instructions and achieved a correct reading. For the "direct laboratory comparison," the ground truth for LH levels would be laboratory-measured LH concentrations.
Missing Information:
- The exact method for establishing ground truth (e.g., comparison against a gold standard lab assay, confirmation of actual ovulation through other means) for the performance studies is not explicitly detailed.
8. Sample Size for the Training Set:
The concept of a "training set" applies to machine learning algorithms. This device is a biochemical in-vitro diagnostic test, not an AI or machine learning product. Therefore, there wouldn't be a training set in that context.
Missing Information:
- Not applicable as this is not an AI/ML device.
9. How Ground Truth for the Training Set Was Established:
As above, this is not an AI/ML device, so a training set and its associated ground truth establishment are not applicable.
Missing Information:
- Not applicable as this is not an AI/ML device.
In summary, the provided text serves as a 510(k) summary demonstrating substantial equivalence to a predicate device, focusing on technological characteristics and overall performance claims ("equivalent performance," "at least as accurate"). It lacks the granular detail about specific study designs, acceptance criteria, and quantitative results that would be expected in a comprehensive study report to fulfill all aspects of your requested information.
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September 2, 1997 Page 2
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II. 510(k) Summary
| Submitted by: | Carter-WallaceCarter Products DivisionP.O. Box 1001, Half Acre RoadCranbury, New Jersey 08512-0181(609) 655-6000 | |
|---|---|---|
| Contact Person: | Theresa Sines | |
| Date Submitted: | September 2, 1997 | |
| Proprietary Name: | TBD* One-Step Ovulation Predictor Test*May be marketed under brand names yet to be determined, includingANSWER®, ANSWER QUICK & SIMPLE®, FIRST RESPONSE®, orothers. | |
| Common Name: | At-Home Ovulation Predictor Test | |
| Classification Name: | Luteinizing hormone test system | |
| Predicate Device: | FIRST RESPONSE® Ovulation Predictor Test |
Description of the Device: The TBD One-Step Ovulation Predictor Test is a simple to use, plastic stick, in vitro device. The top of the stick is clear to allow the user to visualize the migration of the test reagents. The stick contains a chromatographic test strip which has all the necessary reagents to perform the test. An absorbent tip collects and delivers the urine sample to the reagents on the chromatographic strip. The test is performed by placing the absorbent tip into the urine stream for 5 seconds. Alternatively, the test may be performed by immersing the absorbent tip into a container of urine for 5 seconds. The urine sample from the absorbent tip migrates by capillary action along the chromatographic strip, reconstituting the reagents placed strategically along the strip. Visualization of the test results occurs when the appropriate reagents react producing one or two pink-purple lines which appear in a window in the hull of the test stick. The luteinizing hormone (LH) surge is indicated if the test line is similar to or darker than the reference line. If there is no test line or the test line is lighter than the reference line, then there has been no LH surge.
The TBD One-Step Ovulation Predictor Test is substantially equivalent to the FIRST RESPONSE® Ovulation Predictor test marketed by Carter Products, Division of Carter-Wallace, Inc.
Intended Use of the Device: The TBD One-Step Ovulation Predictor Test is an at-home in vitro diagnostic use test to be marketed over-the-counter (OTC) to lay consumers. The test device product is intended for the detection of human luteinizing hormone (hLH) in urine as an aid in the prediction of ovulation.
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II. 510(k) Summary (cont'd)
Technological Characteristics: The TBD One-Step Ovulation Predictor Test incorporates the same technological characteristics as the predicate device. It differs from the predicate device by utilizing a plastic stick with an "exposed wick" (the absorbent tip) to collect and deliver the urine sample to the reagents on the chromatographic strip. The First Response® Ovulation Predictor Test utilizes a plastic stick device which encloses the absorbent pad and exposes a Urine Collection area on the under side of the stick. This difference raises no new issue regarding safety or effectiveness of the product.
Another difference of the TBD One-Step Ovulation Predictor Test is the exposure time of the absorbent tip to the urine sample which is 5 seconds. The First Response Ovulation Predictor Test exposure time is 10 seconds. The support data in this submission validate the 5 second urination time. No new issues regarding safety or effectiveness are raised.
In a direct laboratory comparison, the TBD One-Step Ovulation Predictor Test was found to have equivalent performance to that of the predicate device, and in consumer use studies, the TBD One-Step test was at least as accurate as the predicate device with regard to consumers' accuracy in performing the test.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three lines forming the snake and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 2 7 1997
Stephen C. Kolakowsky Director, Regulatory Affairs Carter-Wallace, Inc. Half Acre Road P.O. Box 1001 Cranbury, New Jersey 08512-0181
Re : K973310 TBD One-Step Ovulation Predictor Test Requlatory Class: I Product Code: CEP Dated: September 2, 1997 Received: September 3, 1997
Dear Mr. Kolakowsky:
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 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ನಿ 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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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INDICATIONS FOR USE STATEMENT VI.
510(k) Number (if known):
TBD One-Step ()vulation Predictor Test Device Name:
The TBD One-Step Ovulation Predictor Test is an at-home Indications For Use: ovulation predictor test marketed over-tho-counter (OTC) to lay consumers. The TBD One-Step Ovulation Predictor Test detects the presence of human luteinizing hormone (hLH) in the urine as an aid in the prediction of ovulation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Syrice Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
OR
| Over-The-Counter Use | ✓ |
|---|---|
| ---------------------- | ----------------------------------------- |
(Division Sign-Off)
Division of Clinical Laboratory vices
510(k) K973310
§ 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.