(39 days)
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No
The device description details a standard immunoassay based on chemical reactions and color changes, with no mention of computational analysis, algorithms, or learning processes. The performance study compares the device to other immunoassay tests and a quantitative assay, further indicating a non-AI/ML approach.
No
This device is an in vitro diagnostic test kit used for qualitative determination of Luteinizing Hormone (LH) in urine for ovulation prediction, not for treating or rehabilitating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is an "immunoassay in vitro diagnostic test kit."
No
The device description clearly describes a physical in vitro diagnostic test kit that uses immunoassay technology and produces a visual color band result. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is an "in vitro diagnostic test kit for the qualitative determination of Luteinizing Hormone (LH) in urine." This directly aligns with the definition of an IVD, which are tests performed on samples taken from the human body to detect diseases, conditions, or infections.
- Device Description: The description details a "solid phase immunoassay" and how it works by detecting a specific substance (LH) in a biological sample (urine) using chemical reactions. This is characteristic of many IVD tests.
- Performance Studies: The summary of performance studies describes testing the device against other commercially available ovulation tests and a quantitative LH assay using patient urine specimens. This type of validation is standard for IVD devices to demonstrate their accuracy and reliability.
The fact that it's an "OTC use" and "Home Test Kit" indicates its intended use setting and user, but it doesn't change its classification as an IVD. It's an IVD designed for over-the-counter use by consumers.
N/A
Intended Use / Indications for Use
EZP Sure™ 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
Product codes
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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. This working principle can also be applied for the Concerved Onested Ovulation Prediction Teat.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
OTC use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The performance of EZ9 Sure™ OneStap Ovulation Predictor Home Test Kit Is summarized as fullows:
- 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 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.
- 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.
Key Metrics
- LH concentration between 2:30 mlU/mL in the urine.
- surge cutoff: ≥ 30 mIU/mL
Predicate Device(s)
Conceive® OneStep Ovulation Predictor Less
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
ਸੰ
FAX NO
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,
-
- The exact differences between the EZY Sure™ OneStep Overation Front Kit and Concelve® OneStep Ovulation Prediction Test are as follows:
| | Conceive® OneStep
Ovulation Prediction Test | EZ Sure™ OneStep Ovulation
Predictor 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 |
-
- 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. (714) 692-7151 FAX (714) 692-7153
- For any questions pertaining to this 510(K) application, please contact :