(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.
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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.
§ 862.2170 Micro chemistry analyzer for clinical use.
(a)
Identification. A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.