(233 days)
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No
The description focuses on immunological reactions and antibody-based detection, with no mention of AI, ML, image processing, or data training/testing sets typically associated with AI/ML devices.
No
This device is a diagnostic tool used to detect pregnancy, not to treat or cure a disease or condition.
Yes
Explanation: The device is a "Home pregnancy test kit" that "detects pregnancy," which is a diagnostic determination. It aims to identify the presence of a specific condition (pregnancy) based on a biological marker (HCG).
No
The device description clearly states it is a "midstream pregnancy test kit" and describes antibodies, indicating a physical, hardware-based diagnostic test.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to detect pregnancy, which is a diagnostic purpose.
- Device Description: It describes an "immunologically reaction" using antibodies to detect HCG, a substance found in the body. This is a characteristic of in vitro diagnostic tests.
- Mechanism: The test works by analyzing a sample (presumably urine, as it's a home pregnancy test) outside of the body to determine a medical condition (pregnancy). This is the definition of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Home pregnancy tests are designed to detect this pregnancy hormone in woman urine.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
One step Best midstream presnancy test kids detect pregnancy by an immunologically reaction. The antibodies are affinity purified Goat anti mouse IgG, affinity purified polyclonal antibody to HCG and affinity purified monoclonal antibody to HCG. .
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
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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 test kit accuracy for pregnant women are 100% in laboratory test. The cross reactivity with LH is negative when LH level is less than 200 mIU/ml.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
accuracy for pregnant women are 100%
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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Summary
Home pregnancy test kits can now be purchased from most drug stores without a prescription. There are approximately more than 10 various kinds of one step home pregnancy test kits available. These tests are virtually the same as the urine pregnancy tests performed in most doctoral office and clinics. The home pregnancy tests are convenient, private, and, if performed properly, can be quite accurate.
During pregnancy a fertilized egg implanted in the uterus wall, A hormone, called human choroinic gonadotropin (HCG) is then produced by the developing placenta and excreted in the urine. The amount of HCG excreted in the urine rises rapidly during the first weeks of pregnancy. Home pregnancy tests are designed to detect this pregnancy hormone in woman urine.
One step Best midstream presnancy test kids detect pregnancy by an immunologically reaction. The antibodies are affinity purified Goat anti mouse IgG, affinity purified polyclonal antibody to HCG and affinity purified monoclonal antibody to HCG. .
The test kit accuracy for pregnant women are 100% in laboratory test. The cross reactivity with LH is negative when LH level is less than 200 mIU/ml.
The data of our test kits compared with "Be sure" one step midstream pregnancy test kits, which were approved by FDA, indicates that the performance of both kits are very similar. Substantial equivalence should be determined.
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