(139 days)
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No
The summary describes a standard immunoassay kit, which is a chemical test, not a software-based device that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or data sets for training/testing.
No.
This device is an in vitro diagnostic test kit used for the qualitative determination of human chorionic gonadotropin, which is a diagnostic purpose, not a therapeutic one. It analyzes samples for information rather than treating or preventing a disease.
Yes
The device is described as an "in vitro diagnostic 'test kit'" and is intended for the "qualitative determination of human chorionic gonadotropin," which helps in diagnosing pregnancy.
No
The device description explicitly states it is a "solid phase chromatographic immunoassay in vitro diagnostic test kit," which is a hardware-based test.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "qualitative determination of human chorionic gonadotropin in urine or serum." This is a diagnostic test performed on biological samples (urine or serum) outside of the body.
- Device Description: The description further clarifies it as a "solid phase chromatographic immunoassay in vitro diagnostic test kit." The term "in vitro diagnostic test kit" directly identifies it as an IVD.
The information provided clearly indicates that this device is designed to be used in vitro (outside the living body) to diagnose a condition (pregnancy, indicated by the presence of hCG) by analyzing biological samples.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
Excel OneStep Urine/Serum hCG Module Pregnancy 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 or serum.
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)
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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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Summary of Safety and Effectiveness
MAY - 2 1996
Excel OneStep Urine/Serum hCG Module Pregnancy Test
Excel OneStep Urine/Serum hCG Module Pregnancy 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 or serum. The exact differences between the Excel OneStep Urine/Serum hCG Module Pregnancy Test and the Syntron immunoassay, an assay for human chorionic gonadotropin currently being marketed are as follows :
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- The Syntron Quikpac I EIA protocol is a classical sandwich enzyme immunoassay where endogenous hormone 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-enzyme complexes. The 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/Serum hCG Module Pregnancy 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 antibodyantigen complex. This complex binds to the anti-hCG antibody immobilized on the membrane in 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 mIUmL. 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 EIA | Excel OneStep Urine/Serum hCG Module | |
|---|---|---|
| Specimen Volume | 5 drops urine | |
| 3 drops serum | 4 drops urine | |
| 4 drops serum | ||
| Reagent | 2 bottles for either urine or serum | No reagent for urine or serum |
| Incubation | 3 minutes with antibody and 3 minutes | |
| with substrate | No pre-incubation with urine or serum | |
| Steps | three | one |
| Cutoff | 25 mIU/mL | 25 mIU/mL |