(107 days)
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No
The device description and intended use indicate a standard immunoassay test kit, and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is an in vitro diagnostic test kit for qualitative determination, not for treating a disease or condition.
Yes
The device is described as an "in vitro diagnostic test kit" for the "qualitative determination of human chorionic gonadotropin in urine," which directly indicates its function as a diagnostic tool.
No
The device description explicitly states it is a "solid phase chromatographic immunoassay in vitro diagnostic test kit," which is a physical hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: It explicitly states "qualitative determination of human chorionic gonadotropin in urine." This is a diagnostic test performed on a sample taken from the body (urine) to determine a medical condition (presence of hCG, which indicates pregnancy).
- Device Description: It describes itself as a "solid phase chromatographic immunoassay in vitro diagnostic test kit". This directly identifies it as an IVD.
The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to perform tests on samples such as blood, urine, or tissue, taken from the human body to detect diseases, conditions, or infections. This device fits that definition perfectly.
N/A
Intended Use / Indications for Use
the professional use of solid phase chromatographic immunoassay in vitro diagnostic test kit for the qualitative determination of human chorionic gonadotropin in urine.
Product codes
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Device Description
The Excel OneStep Urine hCG Pregnancy Module Test is a sandwich solid phase dye-conjugate non-enzyme chromatographic immunoassay. As the specimen flows through the absorbent device via capillary action, the labeled antibody dye conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody immobilized on the positive reaction zone and produces a pink-rose color band when the hCG concentration in the specimen is equal to or greater than 25 ml Uml. In the absence of hCG, no colored line will appear in the positive reaction zone. The reaction mixture continues to flow through the absorbent device past the positive reaction zone and produce a pink-rose color band in the control zone, demonstrating that the reagent and 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
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)
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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 the word "EXCEL" in large, bold, white letters against a black background. The background is a rounded rectangle shape. Below the word "EXCEL" is the phrase "Commitment to Excellence" in a smaller font size. The text is centered below the black rectangle.
Attachment #4
K96323
Summary of Safety and Effectiveness
JEC - 4 1995
Excel OneStep Urine hCG Pregnancy Module Test
Excel OneStep Urine hCG Pregnancy Module Test is Excel Scientific, Inc.'s name for the professional use of solid phase chromatographic immunoassay in vitro diagnostic test kit for the qualitative determination of human chorionic gonadotropin in urine. The exact differences between the Excel OneStep Urine hCG Pregnancy Module Test and the Syntron QuikPac I enzyme immunoassay, an assay for human chorionic gonadotropin currently being marketed are as follows :
- The Syntron QuikPac I ElA protocol is a classical sandwich enzyme immunoassay where endogenous hormone 1. hCG, is first bound by antibody covalently linked to a solid membrane. A second enzyme linked antibody is then reacted to the membrane to form antibody-hCG-antibody-enzyme complex is reacted with a suitable substance to produce a visible "+" positive when the hCG concentration is greater than 25 mIU/mL; and " " negative on the center of the membrane indicates the absence of detectable levels of hCG.
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- The Excel OneStep Urine hCG Pregnancy Module Test is a sandwich solid phase dye-conjugate non-enzyme chromatographic immunoassay. As the specimen flows through the absorbent device via capillary action, the labeled antibody dye conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody immobilized on the positive reaction zone and produces a pink-rose color band when the hCG concentration in the specimen is equal to or greater than 25 ml Uml. In the absence of hCG, no colored line will appear in the positive reaction zone. The reaction mixture continues to flow through the absorbent device past the positive reaction zone and produce a pink-rose color band in the control zone, demonstrating that the reagent and device are functioning correctly.
| | Syntron QuikPac OneStep
hCG Pregnancy Test | Excel OneStep Urine hCG
Module Pregnancy Test |
|-----------------|-------------------------------------------------|--------------------------------------------------|
| Specimen Volume | 5 drops urine | 4 drops of urine |
| Reagent | 2 bottles | None |
| Pre-incubation | 6 minutes | None |
| Step | one step | three steps |
| Cutoff | 25 mIU/mL | 25 mIU/mL |
differences between the two protocols :
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- For questions related to the performance and safety of the Excel OneStep Urine I.C. Pregnancy Module Test, please contact :
Min-Lee Cheng, Ph.D. Requlatory Affairs Excel Scientific, Inc. 23071 E. La Palma Avenue Yorba Linda. CA 92887 TEL: (714) 692-7151 FAX: (714) 692-7153
- For questions related to the performance and safety of the Excel OneStep Urine I.C. Pregnancy Module Test, please contact :