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One Step HCG Pregnancy Test 2000 mIU / mL is a qualitative, two sites sandwich immunoassay test device for the determination of human chorionic gonadotropin (HCG) concentration in urine samples with a cutoff of 2000 mIU / mL designed to aid in the detection of pregnancy. This test device is intended for professional central laboratory use only.

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The provided text is a 510(k) premarket notification approval letter for a medical device called "One Step HCG Pregnancy Test 2000 mIU / mL." This document primarily focuses on the FDA's decision regarding substantial equivalence to a predicate device and does not contain the detailed study information needed to answer the specific questions about acceptance criteria and device performance as typically found in a clinical study report.

Therefore, I cannot provide a comprehensive answer to your request based on the given input. The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Information about MRMC comparative effectiveness studies.
6. Details on standalone algorithm performance.
7. Type of ground truth used (beyond implying a "determination of human chorionic gonadotropin (HCG) concentration").
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document states the device is a "qualitative, two sites sandwich immunoassay test device for the determination of human chorionic gonadotropin (HCG) concentration in urine samples with a cutoff of 2000 mIU / mL to aid in the detection of pregnancy." This implies that the device's performance would be evaluated based on its accuracy (sensitivity and specificity) in detecting HCG at or above the 2000 mIU/mL threshold against a known reference method or clinical outcome, but the specific study details are not present.

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