(30 days)
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No
The device description details a standard immunoassay based on antibody-antigen reactions and capillary action, with no mention of computational analysis, algorithms, or learning processes.
No
This device is a diagnostic test kit for qualitative detection of human Chorionic Gonadotropin (hCG), not a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "diagnostic test kit for the qualitative detection of human Chorionic migatory chomalogiaphy".
No
The device description clearly describes a physical diagnostic test kit (dipstick) that utilizes immunoassay principles and capillary action to detect hCG in urine. This involves physical components and chemical reactions, not solely software.
Based on the provided text, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states it is an "In Vitro diagnostic test kit for the qualitative detection of human Chorionic migatory chomalogiaphy in manododay in the CipStick Pregnancy Home Test".
- Device Description: Describes the principle of the test, which involves a "non-enzyme immunoassay" performed on a "urine specimen". This is a classic description of an in vitro diagnostic test.
- Predicate Device: Mentions a "Syntron Quikpac EIA", which is also described as an "assay for human Chorionic Gonadotropin currently being marketed". EIA (Enzyme Immunoassay) is a common type of IVD.
The text clearly indicates that this device is designed to perform a diagnostic test on a biological sample (urine) outside of the body, which is the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
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Device Description
The EZ&Sure™ Urine DipStick Pregnancy Home Test is a solid phase, conjugated non-enzyme immunoassay. When the EZ $ Sure™ Urine is placed in a urine test cup containing the urine specimen, the urine will migrate by capillary active to the hCG molecules in the specimen forming an antibody-antigen complex. This complex produces 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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.
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 DipStick
Pregnancy 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 EIA
Pregnancy Test | EZ& Sure™ Urine DipStick
Pregnancy Home Test |
|-----------------|---------------------------------------------------------|-------------------------------------------------|
| Specimen Volume | 3 drops of urine | 6 drops of urine |
| Incubation | 3 minutes with antibody and 3
minutes 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