(68 days)
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No
The summary describes a standard immunoassay test kit and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
No
This device is an in vitro diagnostic test kit used for qualitative determination of hCG in urine, indicating it's for diagnosis and not for treating a condition.
Yes
The device is described as an "immunoassay in vitro diagnostic test kit" for the "qualitative determination of human Chorionic Gonadotropin (hCG) in urine," which fits the definition of a diagnostic device.
No
The device is described as a "solid phase 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: The intended use is the "qualitative determination of human Chorionic Gonadotropin (hCG) in urine." This is a test performed on a biological sample (urine) outside of the body to provide information about a person's health status (pregnancy).
- Device Description: The device is explicitly described as a "solid phase immunoassay in vitro diagnostic test kit." This directly states that it is an in vitro diagnostic test.
The definition of an IVD is a medical device that is used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body to detect diseases, conditions, or infections. This device fits that definition perfectly.
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Intended Use / Indications for Use
Platform OneStep pregnancy test is Syntron Bioresearch. Inc. name for OTC use of solid phase immunoassay in vitro diagnostic test kit for the qualitative determination of human Chorionic Gonadotropin (hCG) in urine.
Product codes
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Device Description
Platform OneStep pregnancy test is a sandwich solid phase dye-conjugate nonenzyme immunoassay. As the specimen is added to the reaction device, the gold-solantibody conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a purple-pink color band when hCG concentration is greater than 25 mIU/ml. In the absence of hCG, there is no purple-pink line in the positive reaction zone. The reaction mixture continues to flow through the absorbent device, pass the positive reaction zone, producing a purple-pink color band, demonstrating that the reagents 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
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)
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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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K960117
Platform OneStep Pregnancy Test Summary of Safety and Effectiveness
Platform OneStep pregnancy test is Syntron Bioresearch. Inc. name for OTC use of solid phase immunoassay in vitro diagnostic test kit for the qualitative determination of human Chorionic Gonadotropin (hCG) in urine. Platform OneStep pregnancy test is based on comparative data with Besure OneStep immunoassay, an assay for human Chorionic Gonadotropin currently being marketed.
The Principle of Platform and Besure Pregnancy Test is as follows:
The Platform and Besure pregnancy test is a sandwich solid phase dye-conjugate nonenzyme immunoassay. As the specimen is added to the reaction device, the gold-solantibody conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a purple-pink color band when hCG concentration is greater than 25 mIU/ml. In the absence of hCG, there is no purple-pink line in the positive reaction zone. The reaction mixture continues to flow through the absorbent device, pass the positive reaction zone, producing a purple-pink color band, demonstrating that the reagents and device are functioning correctly.
| Specimen Volume | 6 drops of urine | 4 drops of urine |
|---|---|---|
| Incubation | 5minutes | 5minutes |
| Reagent | No | No |
| Step | 1 Step | 1 Step |
| Cutoff | 25 mIU/ml | 25 mIU/ml |
| Urine Cup | Yes | Yes |