(31 days)
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No
The device description details a standard immunoassay based on chemical reactions and color band formation, with no mention of AI or ML components.
No
This device is an early pregnancy home test, designed for diagnostic purposes (detection of hCG), not for treating or preventing disease.
Yes
The device is described as being for "qualitative detection of human chorionic gonadotropin (hCG) in urine," which is a diagnostic purpose. It determines the presence or absence of a biological marker (hCG) to indicate a physiological state (pregnancy).
No
The device description clearly outlines a physical immunoassay device that detects hCG in urine through a chemical reaction and color change, not a software-only solution.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "qualitative detection of human chorionic gonadotropin (hCG) in urine." This is a test performed on a biological sample (urine) to provide information about a person's health status (pregnancy).
- Device Description: The description details a "sandwich solid phase dye-conjugate non-enzyme immunoassay." This is a laboratory-based testing method used to detect specific substances in biological samples.
- Mechanism: The device works by detecting the presence of hCG in the urine sample through a chemical reaction that produces a visible result (color band). This is a characteristic of IVD tests.
- Performance Studies: The mention of performance studies comparing the device to a commercially available pregnancy test further indicates its nature as a diagnostic tool.
The fact that it is for "OTC use" and "Home" setting doesn't change its classification as an IVD. Many IVDs are designed for over-the-counter and home use.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The EZESure™ (Excel) Urine Midstream Early Pregnancy Home Test is a sandwich solid phase dye-conjugate and non-enzyme immunoassay. The stream of urine directly enters the absorbent windows of the reaction device. A labeled antibody dye-conjugate binds to hCG in the specimen, forming an antibody-antigen complex. This complex then binds to an antibody in the positive reaction zone, producing a rose-pink color band when hCG concentration is equal to or greater than 25 mIU/mL. If hCG is absent, no line forms in the positive reaction zone. The reaction mixture continues to flow through the device and migrates to the control reaction zone, where it produces a rose-pink color band, indicating correct reagent and device function.
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
Home Test
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 EZESure™ (Excel) Urine Midstream Early Pregnancy Home Test has been found to be greater than 99% in agreement with the Syntron Quikpac II test, which is currently available commercially.
Key Metrics
Agreement > 99%
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.
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Image /page/0/Picture/0 description: The image shows a logo with the word "EXCELL" in bold, white letters against a black, rounded rectangle. Below the rectangle, there is a tagline that reads "Commitment to Excellence" in a smaller font size. The overall design is simple and emphasizes the word "EXCELL" as the primary element.
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Attachment #5
Summary of Safety and Effectiveness
EZESure™ (Excel) Unne Midstream Early Pregnancy Home Test is Excel Scientific, Inc.'s และเลเซ for OTC use of EZ Sure " (EXCB) Office Misstream Cally Pregnally Presher to Exections (Mather dotection of human solo plaso mgraldy Chichaeography mintenses in the Middler am Early Prognancy Home Test is hased Chononic Gonerxive data with Syntron Quiltped II programs test (BeSure Home Test), an assay also for human on comparently being in currently being marketed.
The Pnnciple of EZ $ Sure™ (Excel) Urine Midstroam Early Pregnancy Home Test is as fallows:
- The EZ Sure™ (Excel) Urine Midstream Prognancy Horne Test also is a sendwich solid phase dye-1. r ning at d non-enzyme immunossay. The stream of unine goes directly into the absorbent windows of the reaction device. The laboled antibody dye-conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the antibudy in the positive reaction zone and arnatuce a rose-pink color band when hCG concentration is equal to or greater than 25 mlUmL. In the abseries of hCG, there is no line formation in the positive reaction mixture continues lu flow through the device and migrates to the control reaction zone by producing a rose-pink color band, demonstrating that the reagents and device are functioning corroctly.
- The Quikpec II (or BeSure Home Test) also is a sono phase sandwich dye-wrijugale non-enzymo 2. immunossay As the specimen is added to the reaction device, the lebelod antibody dye conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the anti-RCG antibody in the positive reaction zone and produces a rose-pink color band when hCG currentration is equal to or greater than 25 mILV/mL in the specimen. In the absence of hCG, there is no line formation in the positive reaction zone. The reaction mixture continues to flow through the device and migrates into the control roaction zone by producing a rose-pink rator band control, demonstrating that the reagents and device are functioning correctly.
- 3 The exact difforences between the EZRSure™ (Excel) Urine Midstream Early Programcy Home Tust protocol and the Syntron's Quikpac II pregnancy test (BeSure Horne Test) protocol are as follows :
| | Quikpac II pregnancy test
(BeSure Home Test) | EZ Sure™ (Excel) Urine
Midstream Early
Pregnancy Home Test |
|-----------------|-------------------------------------------------|------------------------------------------------------------------|
| Specimen Volume | 6 drops | Urine stream |
| Incubation | 5 minutes | 5 minutes |
| Reagent | No | No |
| Step | one step | one step |
| Cutoff | 25 mIU/mL | 25 mIU/mL |
| Urine Cup | Yes | No |
- 4 The EZY Sure™ (Excel) Urine Midstream Early Prognancy Home Tosts has been found to be greater than 99% in agreement with and the Syntron Quiliped II test) that is currently available commercially. Comments from consumers also support that the test is simple to perform and the results are fast.
- ה For questions conceming the safety and effectiveness of the EZ9 Sure™ Urine Midstream Early Pregnancy Home Test, please contact:
Min-Lee Cheng, Ph.D. 23071 E. La Palma Avenue Yorba Linda, CA 82887 Tel: (714) 682-7151
25071 E. La Polma Avo, Yorka Linda, CA 82687, U.S.A Tol: (714) 802-7151 Pax: (714) 802-7155