(30 days)
EZ > Sure™ Urine DipStick Pregnancy Home Test is Excel Scientific, Inc.'s name for OTC use of solid phase L Four - Online Diponor Programo Tivitro diagnostic test kit for the qualitative detection of human Chorionic migatory chomalogiaphy in manododay in the CipStick Pregnancy Home Test is based on comparative data with Syntron Quikpac EIA, an assay for human Chorionic Gonadotropin currently being marketed.
EZ > Sure™ Urine DipStick Pregnancy Home Test is Excel Scientific, Inc.'s name for OTC use of solid phase L Four - Online Diponor Programo Tivitro diagnostic test kit for the qualitative detection of human Chorionic migatory chomalogiaphy in manododay in the CipStick Pregnancy Home Test is based on comparative data with Syntron Quikpac EIA, an assay for human Chorionic Gonadotropin currently being marketed.
The Principle of EZ&Sure™ Urine DipStick Pregnancy Home Test is as follows:
- Both the EZ$ Sure™ Urine DipStick Pregnancy Home Test and the QuikStrip (or E.Z. Strip) Pregnancy Home 1. boon the E2 Pour - Smo Dipease regiugated non-enzyme immunoassay. When the EZ $ Sure™ Urine .o.&fick Pregnancy Home Test is placed in a urine test cup containing the urine specimen, the urine will Dipoton Prognanoy Profile Tothe Total Sol-antibody conjugate in the gold sol pad of the EZ $ Sure™ Urine migrate by capillary active to the hCG molecules in the specimen forming an antibody-antigen Dipolon't roghano 110mle 100 the antibody immobilized in the positive reaction zone in the white complox. This complex a rose-pink color band when the hCG concentration is at or greater than 25 millione area and produces of hCG, there is no rose-pink band in the positive reaction zone. The reaction mixture continues to flow through the absorbent device, pass the positive reaction zone, producing a rose-pink color band in the control zone of the white membrane area, demonstrating that the reagents and the device are functioning correctly.
The provided document focuses on the description and comparison of the EZ Sure™ Urine DipStick Pregnancy Home Test and other existing pregnancy tests, primarily for regulatory submission (K970425). It outlines the test's principle, its differences from comparator products, and contact information.
However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed aspects requested in the prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training set details).
Therefore, I cannot provide the requested information based on the given text. The document is a summary of safety and effectiveness, but it lacks the scientific study details required to answer your prompt.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the word "EXCEL" in white letters on a black rounded rectangle. Below the rectangle, the phrase "Commitment to Excellence" is written in a smaller font. The text and shape create a logo or branding element, likely for a company or product named Excel.
Attachment #5
K970425
MAR - 6 1997
Summary of Safety and Effectiveness
EZQ Sure™ Urine DipStick Pregnancy Home Test
EZ > Sure™ Urine DipStick Pregnancy Home Test is Excel Scientific, Inc.'s name for OTC use of solid phase L Four - Online Diponor Programo Tivitro diagnostic test kit for the qualitative detection of human Chorionic migatory chomalogiaphy in manododay in the CipStick Pregnancy Home Test is based on comparative data with Syntron Quikpac EIA, an assay for human Chorionic Gonadotropin currently being marketed.
The Principle of EZ&Sure™ Urine DipStick Pregnancy Home Test is as follows:
- Both the EZ$ Sure™ Urine DipStick Pregnancy Home Test and the QuikStrip (or E.Z. Strip) Pregnancy Home 1. boon the E2 Pour - Smo Dipease regiugated non-enzyme immunoassay. When the EZ $ Sure™ Urine .o.&fick Pregnancy Home Test is placed in a urine test cup containing the urine specimen, the urine will Dipoton Prognanoy Profile Tothe Total Sol-antibody conjugate in the gold sol pad of the EZ $ Sure™ Urine migrate by capillary active to the hCG molecules in the specimen forming an antibody-antigen Dipolon't roghano 110mle 100 the antibody immobilized in the positive reaction zone in the white complox. This complex a rose-pink color band when the hCG concentration is at or greater than 25 millione area and produces of hCG, there is no rose-pink band in the positive reaction zone. The reaction mixture continues to flow through the absorbent device, pass the positive reaction zone, producing a rose-pink color band in the control zone of the white membrane area, demonstrating that the reagents and the device are functioning correctly.
- The Differences Between the EZ$ Sure™ Urine DipStick Pregnancy Home Test and the Syntron's QuikStrip 2. (or E.Z. Strip) Pregnancy Home test are as follows :
| QuikStrip (or E.Z. Strip)Pregnancy Home test | EZ&Sure™ Urine DipStickPregnancy Home Test | |
|---|---|---|
| Specimen Volume | 6 drops | 6 drops of urine |
| Incubation | 5 minutes | 5 minutes |
| Reagent | No | No |
| Step | one step | one step |
| Cutoff | 25 mlU/mL | 25 mlU/mL |
| Urine Cup | Yes | Yes |
- The Differences Between the EZQ Sure™ Urine DipStick Pregnancy Home Test and the Syntron Quikpac 3. EIA Pregnancy Test are as follows :
| Syntron Quikpac EIAPregnancy Test | EZ& Sure™ Urine DipStickPregnancy Home Test | |
|---|---|---|
| Specimen Volume | 3 drops of urine | 6 drops of urine |
| Incubation | 3 minutes with antibody and 3minutes with substrate | 5 minutes |
| Reagent | 2 bottles | No |
| Step | 3 steps | one step |
| Cutoff | 25 mIU/mL | 25 mIU/mL |
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the word "EXCEL" in a bold, sans-serif font, set against a black background with rounded corners. Below the word "EXCEL" is the phrase "Commitment to Excellence" in a smaller, italicized font. The text is likely part of a logo or a slogan, emphasizing a dedication to high standards.
1110
- For questions conceming the safety and effectiveness of the EZ$ Sure™ Urine DipStick Pregnancy Home ಇ. Test, please contact:
Min-Lee Cheng, Ph.D. 23071 E. La Palma Avenue Yorba Linda, CA 92887 Tel: (714) 692-7151
§ 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.