EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT

• K Number: K970467
• Device Name: EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT
• Manufacturer: EXCEL SCIENTIFIC, INC.
• Date Cleared: 1997-03-18 ( 39 days)
• Product Code: CEP
• Regulation Number: 862.1485
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

EZYSure™ OneStep Ovulation Predictor Home Test Kit is Excel Scientific. Inc.'s name for OTC use of solld phase 1. immunoassay in vitro diagnostic test kit for the qualitative determination of Luteinizing Hormone (LH) in urine

Device Description

The EZY Sure™ OneStep Ovulation Prodictor Homo Test Kit is a sandwich solld phase dye-conjugato non-enzyme immunoassay. As the specimen is added to the reaction device, the gold-sol-antibody conjugate binds to the LH in the specimen forming an antibody-antigen complex birds to the anti-LH antibody in the positive reaction zone and produces a rese pink color band when LH concentration is present in the abserve of LH, there is no rosepink line in the postive reaction cultinues to flow through the absorbent device, pass the positive reaction zurie, producing a rose-pink color band, demonstrating that the reagents and device are functioning correctly.

AI/ML Overview

Here's an analysis of the provided text regarding the EZYSure™ OneStep Ovulation Predictor Home Test Kit, structured according to your request:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
LH Surge Detection	Capable of discerning LH concentration between 25-30 mIU/mL	Capable of discerning an LH concentration between 25-30 mIU/mL in the urine. When the LH concentration in the urine is ≥ 30 mIU/mL, it is indicative that LH surge is in progress.
Interference	No interference from homologous hormones (1,000 mIU/mL hFSH or 1,000 µIU/mL TSH)	Not interfered by the presence of homologous hormones (such as 1,000 mIU/mL hFSH or 1,000 µIU/mL TSH).
	No interference from common drugs (acetaminophen, aspirin, atropine, caffeine, gentisic acid, each at 20 mg/dL)	Not interfered by common drugs (such as acetaminophen, aspirin, and, atropine, caffeine or gentisic acid, each at 20 mg/dL).
	No interference from other substances (2 g/dL glucose, 1 mg/dL hemoglobin, 20 mg/dL ampicillin, 20 mg/dL tetracycline)	Not interfered by other substances (such as 2 g/dL glucose, 1 mg/dL hemoglobin, 20 mg/dL ampicillin, or 20 mg/dL tetracycline) in the specimen.
User Performance (Lay User)	Consumers (lay users) should be able to obtain results equivalent to those obtained by trained laboratory technicians.	Consumers (103 female volunteers) were able to obtain results that were equivalent to those obtained by trained laboratory technicians who employed another commercially available one-step ovulation test (Conceive® by Quidel) and a quantitative microtiter EIA LH assay (Medix) on the same patient urine specimens.
Intra- and Inter-Assay Variation	No detectable intra- and inter-assay variation between reagent lots and between different reagent lots.	No detectable intra- and inter-assay variation between reagent lots and between different reagent lots using spiked urine pool or patient specimens with known LH concentrations have been substantiated.
Shelf-Life	Eighteen-month shelf-life.	An eighteen-month shelf-life has been substantiated by the real-time and accelerated stability testing of the sample reagent.

2. Sample size used for the test set and the data provenance

• Sample Size: 103 female volunteers (for the user performance study).
• Data Provenance: The document does not explicitly state the country of origin. It indicates the study used "patient urine specimens," which suggests a prospective collection for the purpose of the study. It refers to a comparison with a quantitative microtiter EIA LH assay (Medix) on the "same patient urine specimens," implying these were freshly collected or used within an appropriate timeframe for LH testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: This test directly compares lay user results to those obtained by "trained laboratory technicians." The document does not specify a number of technicians, nor their specific qualifications (e.g., certification, years of experience), beyond being "trained." The Medix quantitative microtiter EIA LH assay served as the gold standard for LH level determination, which is an objective measurement rather than an expert interpretation of the device itself.

4. Adjudication method for the test set

• The document implies a direct comparison, where the results obtained by the lay users with the EZYSure™ test were compared against the results from the Conceive® test (also read by trained laboratory technicians) and the Medix quantitative EIA LH assay. There’s no explicit mention of an adjudication method (like 2+1 or 3+1 consensus) for discrepancies between readings. The "equivalence" implies statistical comparison rather than a formal adjudication process amongst human readers for the device interpretation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a home test kit for a biochemical marker (LH), not an imaging or diagnostic AI tool. The study involved comparing lay user performance with the device against laboratory technician performance using an existing test and a quantitative assay. It does not involve "AI assistance" or "human readers" in the context of interpretation that would typically necessitate an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, in essence, standalone performance was demonstrated through the inherent design of the test. The EZYSure™ OneStep Ovulation Predictor Home Test Kit is designed as a standalone, qualitative diagnostic device. The performance criteria related to LH surge detection, interference, and intra/inter-assay variation represent the "algorithm only" performance (the chemical reaction and visual readout mechanism) independent of user interpretation, though the final interpretation by the user is part of the "user performance" study. The test kit produces a visual colored band; there is no separate "algorithm" in the modern sense of AI.

7. The type of ground truth used

• The ground truth for LH surge detection and LH concentration was established by objective quantitative measurement: a quantitative microtiter EIA LH assay (Medix) on the same urine specimens.
• For user performance, the ground truth for comparison was the results obtained by trained laboratory technicians using both the comparative Conceive® test and the gold-standard Medix quantitative EIA LH assay.

8. The sample size for the training set

• The document does not explicitly mention a training set sample size. This is common for this type of in-vitro diagnostic device, as "training" often refers to the development and optimization of the chemical reagents and manufacturing process rather than a specific data-driven machine learning training phase. The described studies are primarily validation studies.

9. How the ground truth for the training set was established

• Since a formal "training set" in the context of machine learning is not mentioned, the concept of establishing ground truth for it is not applicable here. The development and optimization of the EZYSure™ OneStep Ovulation Predictor Home Test Kit would have involved internal R&D, likely using characterized urine samples (spiked with known LH concentrations, or verified by established lab methods) to refine the sensitivity, specificity, and visual readout characteristics of the immunoassay. However, the document does not detail this developmental phase or any specific "training set" used therein.

Summary

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ਸੰ

FAX NO

K970467

MAR 18 1997

EXCEL

FRON

Attachment #9

SUMMARY OF SAFETY AND EFFECTIVENESS

EZ ? Sure™ OneStep Ovellation Predictor Home Test Kit

• EZYSure™ OneStep Ovulation Prodictor Home Test Kit is Excel Scientific. Inc.'s name for OTC use of solld phase 1. immunoassay in vitro diagnostic test kit for the qualitative determination of Luteinizing Hormone (LH) in urine, EZP Sure™ OneStep Ovulation Prodictor Hume Test K2 is based on comparative data with Conceive® OneStep Ovulation Predictor Less, a semi-quantitative test for the determination of LH currently being marketed by Quildel Corporation.
  The EZY Sure™ OneStep Ovulation Prodictor Homo Test Kit is a sandwich solld phase dye-conjugato non-enzyme immunoassay. As the specimen is added to the reaction device, the gold-sol-antibody conjugate binds to the LH in the specimen forming an antibody-antigen complex birds to the anti-LH antibody in the positive reaction zone and produces a rese pink color band when LH concentration is present in the abserve of LH, there is no rosepink line in the postive reaction cultinues to flow through the absorbent device, pass the positive reaction zurie, producing a rose-pink color band, demonstrating that the reagents and device are functioning correctly. This working principle can also be applied for the Concerved Onested Ovulation Prediction Teat.

• The performance of EZ9 Sure™ OneStap Ovulation Predictor Home Test Kit Is summarized as fullows: ਹੈ.

  • It is capable to discern an LH curcentration between 2:30 mlU/mL in the urine. When the LH a. concentration in the unne 18230 milUmL, It is indicative that LH surge is in progress.
  • It is not interfered by the presence of homologous homiches (such as 1,000 mlU/mL hFSH or 1,000 µIU/mL TSH), b. womon drugs (such as acetaminophen, acontain, and, atropine, carrene or gentleic add, each at 20 mg/dL), or other substances (such as 2 g/dL glucose, 1 mg/dL hemoglobin, 20 mg/dL ampioillin, or 20 mg/dL tetracycline) in the speciment.
  • Using this test kit, consumers (103 female volunteers) were able to obtain results that were equivalent to those obbined ட். by trained laboratory lectricians who employed another commercially available one-step overlain test (Concoive® by Quidel) and a quantitative microtter ElA LH assay (Medix) on the same patient unine specimens.
  • ન No detectable intra- and inter-assay variation between reagent lots and between different reagent lots using spiked urine pool or patient specimens with known LH concentrations have been substantated.
  • An aghteen-month shell-life has been substantiated by the real-time and accelerated stability testing of the semple . reagent,
• 3. The exact differences between the EZY Sure™ OneStep Overation Front Kit and Concelve® OneStep Ovulation Prediction Test are as follows:

	Conceive® OneStepOvulation Prediction Test	EZ Sure™ OneStep OvulationPredictor Home Test
SPECIMEN VOLUME	3 drops	4 drops
REAGENT	No Liquid Reagent	No Liquid Reagent
INCUBATION	3 Minutes	5 Minutes
STEPS	1 Step	1 Step
SURGE CUTOFF	≥ 30 mIU/mL	≥ 30 mIU/mL

• 4. For any questions pertaining to this 510(K) application, please contact :
     Min-Lee Cheng, Ph.D. Excel Scientific, Inc. 23071 E. La Palma Avenue Yorba Linda, CA 92881 Tel. [phone] FAX [phone]

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.