(70 days)
The Polymedco Homocysteine Test is intended for the quantitative in vitro determination of total homocysteine in serum and plasma on automated clinical chemistry analyzers. This device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
The Homocysteine Calibrators are a device intended for medical purposes for use with the Polymedco Homocysteine assay to establish points of reference that are used in determination of values in the measurement of homocysteine in human serum or plasma.
The Homocysteine Controls are intended for use as an assayed quality control serum to monitor the precision and accuracy of the laboratory testing procedures for total homocysteinc.
Not Found
The provided text describes an FDA 510(k) premarket notification for the Polymedco Homocysteine Test. However, it does not contain specific details about acceptance criteria, device performance results, sample sizes, ground truth establishment, or study designs (e.g., MRMC, standalone).
Therefore, I cannot populate the table or answer the questions with the requested information based on the provided document. The document is primarily an FDA clearance letter and an "Indications for Use" statement, not a detailed study report.
Information NOT available in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts and their qualifications for establishing ground truth for the test set.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers with/without AI assistance.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
The document only states the device's intended use and FDA clearance, implying that studies were conducted to support the substantial equivalence claim, but the details of those studies are not included in this particular set of pages.
§ 862.1377 Urinary homocystine (nonquantitative) test system.
(a)
Identification. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.(b)
Classification. Class II.