(30 days)
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No
The description details a standard immunoassay based on antibody-antigen binding and color change, with no mention of computational analysis, algorithms, or learning processes.
No
This device is an in vitro diagnostic test for the qualitative detection of human chorionic Gonadotropin (hCG) in urine, which is used for diagnostic purposes (pregnancy testing) and not for treating or preventing a disease or condition.
Yes
The device is described as an "in vitro diagnostic test kit" for the qualitative detection of human chorionic gonadotropin (hCG) in urine, which directly indicates its use for diagnosis.
No
The device description clearly outlines a physical dipstick test that utilizes chemical reactions and capillary action to detect hCG in urine. This involves hardware components (dipstick, membrane, reagents) and is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "qualitative detection of human phonic Gonadotropin (hCG) in urine." This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
- Device Description: The description explicitly states it is an "in vitro diagnostic test kit."
- Principle of Operation: The principle describes a "sandwich solid phase dye-conjugated non-enzyme immunoassay," which is a common method used in in vitro diagnostic tests.
- Sample Type: The test is performed on "urine," which is a biological specimen.
- Purpose: The purpose is to detect the presence of hCG, which is a marker used for pregnancy diagnosis.
All of these factors clearly indicate that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Excel OneStep Urine hCG Pregnancy DipStick Test is Excel Scientific, Inc.'s name for professional use of solid Ekol of one of the more regioner in vitro diagnostic test kit for the qualitative detection of human phonic Gonadotropin (hCG) in urine.
Product codes
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Device Description
The Excel OneStep Urine hCG Pregnancy DipStick and the QuikStrip (or E.Z. Strip) Pregnancy Home tests are a sandwich solid phase dye-conjugated non-enzyme immunoassay. When the Excel OneStep Urine hCG Pregnancy DipStick is placed in a urine test cup containing the urine specimen, the urine will migrate by capillary action. The gold sol-antibody conjugate in the gold sol pad of the Excel OneStep Urine hCG Pregnancy DipStick binds to the hCG molecules in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody immobilized in the positive reaction zone in the white membrane area and produces a rose-pink color band when the hCG concentration is at or greater than 25 mIU/mL. In the absence of detectable levels 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
No
Mentions AI, DNN, or ML
No
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
professional 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)
The Excel OneStep Urine hCG Pregnancy DipStick Test is based on comparative data with Syntron Quikpac EIA, an assay for human Chorionic Gonadotropin currently being marketed. The Excel OneStep Urine hCG Pregnancy DipStick Test and the Syntron Quikpac EIA Pregnancy Test both have a cutoff of 25 mIU/mL.
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 rectangle appear to be part of a logo or branding material.
Incubation
Reagent
Step
Cutoff
Urine Cup
Attachment #4
Summary of Safety and Effectiveness
MAR - 6 1997
Excel OneStep Urine hCG Pregnancy DipStick Test
Excel OneStep Urine hCG Pregnancy DipStick Test is Excel Scientific, Inc.'s name for professional use of solid Ekol of one of the more regioner in vitro diagnostic test kit for the qualitative detection of human phonic Gonadotropin (hCG) in urine. Excel OneStep Urine hCG Pregnancy DipStick Test is based on comparative data with Syntron Quikpac EIA, an assay for human Chorionic Gonadotropin currently being marketed.
The Principle of Excel OneStep Urine hCG Pregnancy DipStick Test is as follows:
- Both the Excel OneStep Urine hCG Pregnancy DipStick and the QuikStrip (or E.Z. Strip) Pregnancy Home 1. tests are a sandwich solid phase dye-conjugated non-enzyme immunoassay. When the Excel OneStep Urine hCG Pregnancy DipStick is placed in a urine test cup containing the urine specimen, the urine will migrate by capillary action. The gold sol-antibody conjugate in the gold sol pad of the Excel OneStep Urine hCG Pregnancy DipStick binds to the hCG molecules in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody immobilized in the positive reaction zone in the white membrane area and produces a rose-pink color band when the hCG concentration is at or greater than 25 mIU/mL. In the absence of detectable levels 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.
| Test and the Syntron's QuikStrip (or E.Z. Strip) Pregnancy Home test as shown below : | ||
|---|---|---|
| QuikStrip (or E.Z. Strip) | ||
| Pregnancy Home test | Excel OneStep Urine hCG | |
| Pregnancy DipStick Test | ||
| Specimen Volume | 6 drops | 6 drops of urine |
5 minutes
one step
25 mIU/mL
. . . . . . . . . . . . . . . . . . . . . .
No
Yes
5 minutes
one step
25 mIU/mL
No
Yes
- There is no difference in the testing procedure between the Excel OneStep Urine hCG Pregnancy DipStick 2.
| 3. The differences between the Excel OneStep Urine hCG Pregnancy DipStick Test and the Syntron Quikpa |
|---|
| EIA Pregnancy Test are as follows : |
| | Syntron Quikpac EIA Pregnancy
Test | Excel OneStep Urne hCG
Pregnancy DipStick 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 inside a black rounded rectangle. Below the rectangle, the phrase "Commitment to Excellence" is written in a smaller, italicized font. The text is black against a white background.
- For questions concerning the safety and effectiveness of the Excel OneStep Urine hCG Pregnancy DipStick, 4. please contact:
Min-Lee Cheng, Ph.D. 23071 E. La Palma Avenue Yorba Linda, CA 92887 Tel: (714) 692-7151
Sales (1) 10.
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