(82 days)
Plasma or whole blood collection device where glycolytic inhibition of the specimen is reguired.
Evacuated Blood Collection Tube Gray Stopper
The provided text describes a 510(k) clearance for an Evacuated Blood Collection Tube with a Gray Stopper (K971111). This document states the device is "substantially equivalent" to legally marketed predicate devices, which means it doesn't require a new clinical study to prove safety and effectiveness.
Therefore, the document does not contain any information about:
- Acceptance criteria and reported device performance (in terms of specific metrics like sensitivity, specificity, etc.)
- A study proving the device meets acceptance criteria
- Sample sizes for test or training sets
- Data provenance
- Number of experts or their qualifications for ground truth establishment
- Adjudication methods
- Multi-reader multi-case (MRMC) comparative effectiveness studies
- Standalone algorithm performance studies
- Type of ground truth used
- How ground truth for the training set was established
The document is a regulatory clearance letter, not a clinical study report. It focuses on the legal and regulatory aspects of device marketing, based on the device's equivalence to existing products rather than a new demonstration of performance through a clinical trial.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.