BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT by SYNTRON BIORESEARCH, INC.

BeSure Plus OneStep Ovulation Home predicator test is a solid phase immunoassay in vitro diagnostic test kit. It is intended for over the counter use for the qualitative determination of leutinizing hormone (LH) in urine. This test kit is utilized to determine when the female body will ovulate, the most likely time for conception to occur.

Device Description

BeSure Plus OneStep Ovulation Prediction test is a Syntron Bioresearch, Inc. name for OTC use of solid phase immunoassay in vitro diagnostic test kit for the qualitative determination of Luteinizing Hormone (LH) in urine. BeSure Plus OneStep Ovulation Prediction test is based on comparative data with BeSure OneStep Ovulation Predictor test, a qualitative test for the determination of Luteinizing hormone currently being marketed by Syntron Bioresearch, Inc.

The BeSure Plus OneStep Ovulation Prediction Test is a sandwich solid phase dye-conjugate non-enzyme immunoassay. As the urine specimen is added to the reaction device, the gold-sol-anti-B LH antibody conjugate binds to the LH that exists in the urine specimen forming an antibody-antigen complex. This complex then migrates to the positive reaction zone and a LH antibody that is immobilized there by forming an antibody-antibody dye conjugate sandwich, which produces a rose-pink color band. In the absence of LH, there is no rose-pink color band that appears in the positive reaction zone. The remaining dye continues to flow up the absorbent device by passing through the positive reaction zone. This produces a rose-pink color band in the control reaction zone as immobilized antibody captures the unbound dye conjugate, demonstrating that the reagents and device are functioning correctly. This working principle can also be applied for the BeSure OneStep Ovulation Prediction test.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study detailed in the provided text for the BeSure Plus OneStep Ovulation Prediction test:

1. Acceptance Criteria and Reported Device Performance

The provided document defines the acceptance criterion implicitly through the performance of the predicate device and the comparison to a quantitative lab assay. The device is considered acceptable if its performance correlates highly with a commercially available one-step ovulation test and accurately identifies an LH surge at or above 30 mIU/ml, aligning with a quantitative LH EIA test.

Acceptance Criteria Category	Specific Criterion	Reported Device Performance and Evidence
Correlation with Predicate Device	To demonstrate substantial equivalence to an existing commercially available one-step ovulation test kit (BeSure OneStep Ovulation Predictor Test - K951538). This implies the BeSure Plus OneStep should have comparable accuracy and reliability in detecting LH surges.	"Test results obtained by 100 consumers using BeSure Plus OneStep Ovulation home test showed a 99% correlation with results independently obtained by laboratory technicians using other commercially available onestep ovulation test." The "other commercially available onestep ovulation test" is implicitly the predicate device, K951538, given the context.
Accuracy of LH Surge Detection (Cutoff)	The device should accurately detect an LH surge when the LH concentration in urine is equal to or greater than 30 mIU/ml, and should not show a surge when the concentration is less than 30 mIU/ml. This is based on the established surge cutoff of ≥ 30 mIU/ml for the predicate device and the standard for ovulation prediction.	"The results were further confirmed by having the laboratory technicians assay the patient's urine to determine the amount of LH for every testing day by using Syntron's Quantitative LH EIA test (K871602/A). The data obtained from the LH EIA test (Syntron) indicated that LH concentration equal or greater than 30 mIU/ml exhibits LH concentration less than 30 mIU/ml exhibits no surge in BeSure Plus OneStep ovulation test..." This directly confirms the device's adherence to the 30 mIU/ml cutoff.
User Performance	Non-technical users (consumers) should be able to accurately use the device to detect the onset of the LH surge with precision comparable to that achieved by trained laboratory technicians using a reference immunoassay.	"These results show that nontechnical users of BeSure Plus OneStep home Ovulation Predictor Kits are able to detect the onset of the LH surge with precision comparable to that obtained by a reference immunoassay performed by trained laboratory technicians." This statement directly addresses the user performance aspect based on the 99% correlation obtained by consumers and confirmed by lab assays.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 100 consumers (patient urine samples).
Data Provenance: The text does not explicitly state the country of origin. However, the manufacturer, Syntron Bioresearch, Inc., is based in Carlsbad, CA, USA, suggesting the data is likely from the United States. The study appears to be prospective in nature, as it involved "100 consumers using BeSure Plus OneStep Ovulation home test" and their urine being subsequently assayed by laboratory technicians.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The term "experts" isn't explicitly used for establishing ground truth from the perspective of interpreting results as an expert would for, say, an image. Instead, the ground truth was established by laboratory technicians using a quantitative reference method.

Number of Experts/Technicians: Not specified as a quantity, but referred to in plural as "laboratory technicians."
Qualifications: "trained laboratory technicians." While the specific years of experience or certifications are not provided, the "trained" designation implies they possess the necessary skills and knowledge to accurately perform and interpret the Syntron's Quantitative LH EIA test (K871602/A).

4. Adjudication Method for the Test Set

The adjudication method was essentially a comparison and confirmation process:

Initial user interpretation: 100 consumers used the BeSure Plus one-step test.
Independent commercial test interpretation: Laboratory technicians independently obtained results using "other commercially available onestep ovulation test" (implied to be the predicate device, K951538).
Quantitative confirmation (Ground Truth): Laboratory technicians then assayed the same patient's urine using Syntron's Quantitative LH EIA test (K871602/A) to determine the exact LH concentration. This quantitative assay served as the definitive ground truth for LH levels.

There's no explicit mention of an "X+Y" adjudication method, as the ground truth was derived from a quantitative chemical assay rather than subjective expert interpretation (e.g., of an image). The quantitative EIA test served as the objective measure against which both the consumer results and the independent commercial test results were compared.

Crucially, it notes: "In this study, the laboratory technicians did not know the outcome of the consumer's test results," indicating blinding was employed during the quantitative confirmation to prevent bias.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly done in the context of human readers improving with AI vs. without AI assistance. This study involves a direct comparison of a new OTC device against a predicate device and a quantitative lab assay, focusing on the device's ability to detect an LH surge. The "AI" aspect is not applicable here as it's a simple, qualitative in-vitro diagnostic test.

6. Standalone Performance Study

Yes, a standalone performance study was done for the algorithm/device only without human-in-the-loop performance initially dictating the result interpretation.

The 99% correlation observed between the consumers' use of the BeSure Plus OneStep and the results obtained by lab technicians using another commercial test, followed by confirmation with a quantitative LH EIA test, demonstrates the standalone performance of the BeSure Plus OneStep device in detecting LH surges. The device's ability to produce a rose-pink band at ≥30 mIU/ml LH and no band at <30 mIU/ml LH is its standalone performance characteristic. While consumers perform the test, the "reading" of the rose-pink band is the device's output, which is then interpreted. The study essentially validates the "algorithm" (the immunoassay process within the strip) by showing its output corresponds to the chemical reality.

7. Type of Ground Truth Used

The primary ground truth used was quantitative outcomes data (LH concentration).

Specifically, the "Syntron's Quantitative LH EIA test (K871602/A)" was used to determine the exact amount of LH (in mIU/ml) in each patient's urine sample. This provided an objective, numerical measurement of the LH level, which was then used to definitively identify whether an LH surge (≥ 30 mIU/ml) was present or not.

8. Sample Size for the Training Set

The document does not mention a training set or any machine learning/AI models that would require a distinct training set. This is a descriptive study for an immunoassay device, not an algorithm that learns from data.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or applicable for this type of device, this question is not relevant to the provided information.

Summary

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K9831/3

Attachment 9

Summary of Safety and Effectiveness

The exact differences in reagent between the two protocols are as follows:
	BeSure Plus OneStepOvulation Predictor Test	BeSure OneStepOvulation Predictor Test(K951538)
Specimen Volume	Midstream	4 drops of urine
Reagent	No Reagent	No Reagent
Incubation	5 minutes	5 minutes
Steps	1 Step	1 Step
Surge Cutoff	≥ 30 mIU/ml	≥ 30 mIU/ml

Test results obtained by 100 consumers using BeSure Plus OneStep Ovulation home test showed a 99% correlation with results independently obtained by laboratory technicians using other commercially available onestep ovulation test. The results were further confirmed by having the laboratory technicians assay the patient's urine to determine the amount of LH for every testing day by using Syntron's Quantitative LH EIA test (K871602/A). The data obtained from the LH EIA test (Syntron) indicated that LH concentration equal or greater than 30 mIU/ml exhibits LH concentration less than 30 mIU/ml exhibits no surge in BeSure Plus OneStep ovulation test, which is comparable to other commercially available onestep ovulation test kit (K951538). In this study, the laboratory technicians did not know the outcome of the consumer's test results.

These results show that nontechnical users of BeSure Plus OneStep home Ovulation Predictor Kits are able to detect the onset of the LH surge with precision comparable to that obtained by a reference immunoassay performed by trained laboratory technicians. Copies of consumer's reports are attached at the end of this report. The contact person for this Summary of Safety and Effectiveness report is provided by:

Charles Yu Syntron Bioresearch, Inc. 2774 Loker Avenue West Carlsbad, CA 92008 Tel: 760-930-2200 Fax: 760-930-2212

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NOV 1 8 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Charles Yu General Manager Syntron Bioresearch, Inc. 2774 Loker Avenue West Carlsbad, California 92008

K983113 Re : BeSure Plus OneStep Home Ovulation Predictor Trade Name: Test Kit Requlatory Class: I Product Code: CEP Dated: August 26, 1998 Received: September 4, 1998

Dear Mr. Yu:

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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturinq 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 requlatory 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 obliqation 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 requlations.

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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 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

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510(k) Number (if known): K983113

Device Name: BeSure Plus OneStep home Ovulation Predictor Test Kit.

Indication For Use:

am OneStep Ovulation Home predicator test is a solid phase immunoassay in vitro diagnostic test kit. It is intended for over the counter use for the qualitative determination of leutinizing hormone (LH) in urine. This test kit is utilized to determine when the female body will ovulate, the most likely time for conception to occur.

(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 801.109) OR

Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K983113

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.