(127 days)
Indications : The ABL800 FLEX with RADIANCE v2.5 modification is intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry paramenters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO₂Hb, FCOHb, FMetHb, FHHb and FHbF). In addition, the ABL800 Flex with RADIANCE v2.5 modification is intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2. The ABL800 FLEX with RADIANCE v2.5 modification includes an AutoCheck Module to perform automated analysis of quality control fluids.
RADIANCE v2.5 is a Windows-based software application that runs on an independent server and, when added to ABL800 FLEX, enables remote data entry and control of compatible blood-gas analyzers connected to a laboratory information system (LIS) and/or a hospital information system (HIS).
This 510(k) summary (K050869) describes a software modification (RADIANCE v2.5) to an existing blood gas analyzer (ABL800 FLEX). The submission claims substantial equivalence to the predicate device (ABL800 FLEX K041874) based on having the "same intended use and the same fundamental scientific technology," with "Design control information" ensuring substantial equivalence.
This document package does not contain information about acceptance criteria or specific studies to prove that the device meets acceptance criteria. It is a software modification to an existing device, and the primary focus of the 510(k) notice is on functionality, rather than new performance claims that would require extensive clinical studies. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." This implies that the device is considered equivalent based on its technical specifications and intended use matching a previously cleared device, rather than new, independent performance studies demonstrating specific acceptance criteria.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and detailed study information because that information is not present in the provided text.
Specifically, the following information is not present in the provided document:
- A table of acceptance criteria and the reported device performance: This document does not describe measurable acceptance criteria for the RADIANCE v2.5 software or present performance data against such criteria.
- Sample size used for the test set and the data provenance: Not applicable as a performance study for the software itself is not described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multicase (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a blood gas analyzer software, not an AI diagnostic tool involving human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set in the conventional sense.
- How the ground truth for the training set was established: Not applicable.
The submission is for a software update that enables remote data entry and control of compatible blood-gas analyzers, expanding the functionality of an already cleared device. The "Design control information" is cited as the basis for ensuring substantial equivalence, suggesting that internal validation and verification activities, rather than large-scale clinical performance studies, were deemed sufficient for this type of modification.
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.