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Found 6 results
510(k) Data Aggregation
(37 days)
The Synermed® Direct Billirubin reagent is intended for use in the quantitative determination of conjugated (direct reacting) bilirubin in serum or plasma.
Not Found
I apologize, but the provided text from the FDA 510(k) letter for the Synermed IR750 Direct Bilirubin Reagent does not contain the requested information about acceptance criteria or a study proving the device meets them.
The document is purely an FDA clearance letter, confirming that the device is substantially equivalent to a predicate device and can be marketed. It does not detail the specific performance studies, their methodology, or the results that led to this clearance.
Therefore, I cannot provide the detailed table and study description you requested based on the given input.
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(17 days)
The Synermed® Total Billirubin reagent is intended for use in the quantitative determination of total bilirubin in serum or plasma. The reagent kit is intended for in vitro diagnostic use only.
Elevated serum biliruhin levels are observed in a variety of conditions including hemolytic disorders, biliary obstruction, cholestasis, hepatitis, cirrhosis and decreased conjugation (e.g. neonatal jaundice).
Total Bilirubin Reagent Kit
I am sorry, but the provided text from the FDA letter for the Synermed Total Bilirubin Reagent Kit (K972716) is a clearance letter and does not contain the detailed information required to describe acceptance criteria and a study proving device effectiveness. The letter confirms substantial equivalence to a legally marketed predicate device but does not provide performance data, study design, or ground truth establishment.
Therefore, I cannot extract the following information from the given text:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method for the test set
- Multi Reader Multi Case (MRMC) comparative effectiveness study results or effect size
- Standalone algorithmic performance
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
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(63 days)
The Synermed® IR200™ analyzer is intended for in vitro diagnostic use as a multiparameter biochemistry instrument that sequentially quantitates levels of constituents in serum, plasma or urine. Testing is selective, i.e, only selected tests or profiles or automatic repeats of selected tests are performed on each sample.
The Synermed IR200 analyzer is specifically designed to perform tests with Synermed reagents or reagent applications recommended by Synermed. Consequently, no representation as to the general utility of the Synermed IR200 with other than Synermed reagents or approved applications is made and none should be inferred.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) clearance letter for the SYNERMED IR200 Chemistry Analyzer, indicating that the device has been determined to be substantially equivalent to previously marketed devices. It outlines the indications for use but does not contain detailed performance data, study designs, or acceptance criteria.
The information you are requesting, such as performance metrics, sample sizes, expert qualifications, or details about ground truth establishment, is not present in this regulatory document.
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(250 days)
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(78 days)
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(13 days)
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