(26 days)
The Stat-Site® M Hgb System is for in-vitro diagnostic use only. The Stat-Site® M Hgb Test Card is intended for the quantitative determination of hemoglobin in whole blood. It is intended for use with the Stat-Site® M Hgb meter.
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The provided text is a 510(k) cleared document for the Stat-Site® M *** System Whole Blood Hemoglobin Assay. It does not contain the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods.
The document is a clearance letter and an "Indications for Use Statement". It confirms that the device is substantially equivalent to a legally marketed predicate device and outlines its intended use. It does not include the technical study results or performance data against specific acceptance criteria.
Therefore, I cannot fulfill your request for:
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§ 864.7500 Whole blood hemoglobin assays.
(a)
Identification. A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.(b)
Classification. Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.