The Ovulation Tester is an over-the-counter device intended to detect the most fertile days of a woman's menstrual cycle by the direct visualization of the characteristic peri-ovulatory ferning pattern seen in dried saliva. This ferning occurs due to increased levels of estrogen.

Device Description

The Ovulation Tester is a complete system for identifying the most fertile day(s) of a woman's menstrual cycle using a direct saliva sample. These fertile days are detected through the observation of distinctive crystallization or ferning patterns seen on a glass slide. The test is selfadministered and is completely portable. The system requires no reagents nor specific storage conditions, can be performed with relative ease, and results may be interpreted within approximately 10 minutes of saliva application. The test is intended for over-the-counter (OTC) use.

The Ovulation Tester Kit consists of:

the Ovulation Tester device (see below for further details) with tracking disk
an extra tracking disk
the saliva brush applicator
the Instruction Booklet
a marking pencil
the storage bag

The Ovulation Tester device consists of

the black microscope eyepiece
the rubber eve cup (shown installed over the black eyepiece)
the tracking disk (stored in the unit)
the battery (already in place)
the light source (already in place)

The Ovulation Tester is a hand-held, circular shaped "minimicroscope" containing four sets of five miniaturized microscope slides in a plastic case. The slides are made from optical glass, and are placed on a round tracking disk; the disk serves as the platform for viewing the dried saliva patterns. One tracking disk may be used for several months. The device also includes a small built-in light (light emitting diode [LED]) as its light source for viewing the slides, a replaceable battery (1.5 volt) and electronic circuitry.

The system is designed to perform sequential testing over five consecutive days; the testing days are based on the woman's expected cycle length. To perform the test, a woman places a thin coat of saliva on a slide by means of the saliva brush applicator. After the saliva has been allowed to air-dry, the tracking disk is rotated so that the day-specific slide lines up at the proper opening. The device is brought in close proximity to the viewing eye, and a black button on the back of the device is pushed: this activates the green light to allow viewing of the dried saliva patterns. The preovulatory days are characterized by ferning patterns, while, on other days, the slides will appear with "debris-like" substances such as dots, circles, or cells.

AI/ML Overview

Acceptance Criteria and Device Performance Study for TCI Ovulation Tester™

The provided document describes the TCI Ovulation Tester™, an over-the-counter device intended to detect the most fertile days of a woman's menstrual cycle by visualizing ferning patterns in dried saliva. The summary presents clinical and consumer study data to demonstrate its performance.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for accuracy or readability. Instead, it presents performance metrics from studies as evidence of the device's capability. Based on the provided text, the implied acceptance is based on demonstrating equivalence to an existing urinary LH kit and acceptable readability by untrained users.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Accuracy (identifying impending ovulation)	Comparable to a urinary LH kit	93% accurate compared to a urinary LH kit (identifying salivary ferning within 48 hours pre or post the first day of the LH surge)
Readability by untrained consumers	High level of readability by untrained users	93% readability (consumers identified ferning on at least one day when a trained reader identified it)
Consumer identification of ferning	High success rate for consumers to identify ferning around ovulation	92% of the time, consumers could identify their ferning during the five days around ovulation

2. Sample Size and Data Provenance

Test Set Sample Sizes:
- Clinical Studies (Accuracy): 166 premenopausal women
- Consumer Studies (Readability): 163 untrained women
- Consumer Studies (Identification): The text mentions "another evaluation" with consumers, but the specific sample size for this 92% identification rate is not explicitly stated as distinct from the 163 for readability, though it implies a separate assessment.
Data Provenance: The document does not specify the country of origin for the study data. It also does not explicitly state whether the studies were retrospective or prospective, but clinical and consumer studies for device validation are typically prospective.

3. Number of Experts and Qualifications for Ground Truth

Clinical Studies (Accuracy): The ground truth for identifying impending ovulation was established by comparison to a "urinary LH kit." While the LH kit itself serves as a reference, the document does not specify the number of experts or their qualifications involved in interpreting the LH kit results or confirming the LH surge for the 166 premenopausal women.
Consumer Studies (Readability/Identification): For the readability study, the performance of the untrained consumers was compared against a "trained reader." The number of trained readers is not specified, nor are their specific qualifications (e.g., years of experience, medical background).

4. Adjudication Method

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for establishing the ground truth or resolving discrepancies in either the clinical or consumer studies. The comparison for accuracy was against an LH kit, and for readability, it was against a "trained reader," implying a single point of reference without a multi-reader adjudication process mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is explicitly mentioned. The studies described focus on the standalone performance of the device and its readability by individual consumers compared to a reference (LH kit or trained reader), rather than comparing human readers with and without AI assistance to quantify an effect size.

6. Standalone Performance Study

Yes, a standalone performance study was done.

Accuracy Study: The "clinical studies with 166 premenopausal women" assessed the device's ability to identify impending ovulation (93% accuracy) compared to a urinary LH kit. This is a measure of the algorithm/device's performance in detecting the intended biological event.
Readability Study: The "consumer studies with 163 untrained women" assessed how well untrained users could interpret the device's results (93% readability). This also represents a form of standalone performance, albeit from the user's perspective.

7. Type of Ground Truth Used

Clinical Studies (Accuracy): The ground truth for "impending ovulation" was established by comparison to a urinary LH kit, which detects the midcycle LH surge. This is a biochemical marker/reference standard.
Consumer Studies (Readability/Identification): The ground truth for "ferning" was established by a trained reader (expert interpretation) or by inference from the LH kit results for the timing of ovulation.

8. Sample Size for Training Set

The document does not provide any information about the sample size used for a training set. This suggests that the device's core mechanism for detecting ferning patterns likely relies on optical observation and user interpretation based on instructions, rather than a machine learning model that would require a distinct training set for algorithm development.

9. How Ground Truth for Training Set Was Established

Since no training set is mentioned for an algorithm, there is no information on how ground truth for a training set was established. The device operates on the principle of direct visualization of ferning patterns by the user, guided by the instruction booklet.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for TCI Group. The logo consists of the letters "TCI" in a stylized font, with the letters stacked on top of each other. To the right of the letters is the word "Group" in a larger, bolder font. Below the logo is the text "USA * Switzerland * Czech Republic".

DEC 0 5 2001

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K013323.

Submitter Information (21 CFR 807.92(a)(1))
Submitter:	TCI New York50 Davids DriveHauppage, NY 11788phone: (631) 436-5900 x30fax: (631) 436-5920

Mr. Gerry Rausnitz Contact: President and CEO TCI New York
October 4, 2001 Summary Date:

Name of Device and Classification (21 CFR 807.92(a)(2)) TCI Ovulation Tester™ (Ovulation Tester) Name (trade): luteinizing hormone test system Name (usual):

21 CFR 862.1485, Class 1, CEP (75) Classification:

Identification of Legally Marketed Predicate Device(s) (21 CFR 807.92 (a)(3))

The Ovulation Tester is substantially equivalent to Conceive® Ovulation Predictor (Quidel Corporation, San Diego, CA), cleared under premarket notification K953063.

The Ovulation Tester is identical or similar to its predicate in terms of: intended use, risk to patient, result interpretation (positive or negative for impending ovulation), test availability (OTC), and clinical performance (ability to identify impending ovulation).

50 Davids Drive		Telephone: (631) 436-5900 ext. 301
Hauppauge, NY 11788	Fax:	(631) 436-5920
WebPage: www.tcioptics.com	Email:	grausnitz@tcioptics.com

{1}------------------------------------------------

Description of Device (21 CFR 807.92 (a)(4))

The Ovulation Tester Kit consists of:

1. the Ovulation Tester device (see below for further details) with tracking disk
1. an extra tracking disk
1. the saliva brush applicator
1. the Instruction Booklet
1. a marking pencil
1. the storage bag

The Ovulation Tester device consists of

1. the black microscope eyepiece
1. the rubber eve cup (shown installed over the black eyepiece)
1. the tracking disk (stored in the unit)
1. the battery (already in place)
1. the light source (already in place)

{2}------------------------------------------------

Intended Use (21 CFR 807.92 (a)(5))

Similarities to the Predicate(s) (21 CFR 807.92 (a)(6))

A summary table of the similarities and differences between the Ovulation Tester and the predicate device (Conceive) follows.

Indications foruse	Identify the periovulatory phase ofthe menstrual cycle to help awoman become pregnant	Identify the periovulatory phase of themenstrual cycle to help a womanbecome pregnant
Risk to Patient	None; test is non-invasive. Results(positive or negative) do not leadto critical decisions or outcomes	None; test is non-invasive. Results(positive or negative) do not lead tocritical decisions or outcomes
ResultInterpretation	Qualitative; positive or negativefor impending ovulation	Qualitative; positive or negative forimpending ovulation
TestAvailability	Over-the-counter (OTC)	Over-the-counter (OTC)
Sample matrix	Saliva	Urine
MeasuredEffect orAnalyte	Ferning under the influence ofestrogen (a hormone)	Urinary LH(a hormone)
Result Stability	Dried saliva pattern is stableindefinitely (several months)	LH stick must be interpreted within 5minutes of adding the urine sample

Comparison Table of Characteristics: TCI-31 Lifelong Ovulation Tester™ and Conceive®

{3}------------------------------------------------

Brief Discussion of Nonclinical and Clinical Data (21 CFR 807.92(b)(1,2))

In clinical studies with 166 premenopausal women aged 18 to 40, the Ovulation Tester was 93% accurate in identifying the impending ovulation as compared to a urinary LH kit. Salivary ferning was identified within 48 hours pre or post the first day of the LH surge in 155/166 cycles.

In consumer studies with 163 untrained women, the readability of the Ovulation Tester was 93%. The consumers were able to identify salivary ferning on at least one of the days when a trained reader identified ferning in 152/163 cycles. In another evaluation, it was found that consumers could identify their ferning during the five days around ovulation 92% of the time.

Performance Data - Conclusions (21 CFR 807.92 (b)(3))

The Ovulation Tester is substantially equivalent to the Conceive® Ovulation Predictor. Both methods identify the most fertile days of a woman's menstrual cycle and impending ovulation. Conceive is a urinary LH kit that identifies the midcycle LH surge, and the Ovulation Tester detects the characteristic pre-ovulatory ferning pattern seen in dried saliva. This ferning occurs due to increased levels of pre-ovulatory estrogen.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

Re:

DEC 0 5 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Public Health Service

TCI New York c/o Ms. Erika B. Ammirati Ammirati Regulatory Consulting 575 Shirlynn Court Los Altos, CA 94022

K013323 Trade/Device Name: TCI Ovulation Tester™ Regulation Number: 21 CFR 862.1485 Regulation Name: Luteinizing hormone test system Regulatory Class: Class I Product Code: CEP Dated: October 4, 2001 Received: October 5, 2001

Dear Ms. Ammirati:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{5}------------------------------------------------

Page 2 -

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/odrh/dsma/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

{6}------------------------------------------------

STATEMENT OF INTENDED USE

510(K) Number (if known):

Device Name: TCI Ovulation Tester™

Indications for Use:

The Ovellation Tester is an over the counter device intended to detect the most fertile days of
a woman's menstrual cycle by the direct visualization of the characteristic pe

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	1013323

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE
AS NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	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.