YSI 2300 STAT PLUS Glucose and Lactate Analyzer
The YSI 2300 STAT PLUS Glucose and Lactate Analyzer (YSI 2300) was a Class II in-vitro diagnostics (IVD) automated analyser intended that measured glucose in whole blood, plasma or serum; and of L-lactate in whole blood, plasma, or cerebrospinal fluid (CSF). In whole blood or plasma, the instrument could measure glucose and L-lactate simultaneously.[1] The analyzer was discontinued on 22 July 2021.
Prior to its discontinuation, the analyzer was widely accepted as the de facto standard for reference measurements and system calibration by most manufacturers of glucometers for the past 30 years, despite there being no such regulatory requirement.[2][3][4][5][6]
References
- ^ "User's Manual YSI 2300 STAT PLUS Glucose & L-Lactate Analyzer" (PDF). YSI. 2009.
- ^ Bailey, Timothy S.; Klaff, Leslie J.; Wallace, Jane F.; Greene, Carmine; Pardo, Scott; Harrison, Bern; Simmons, David A. (July 2016). "Fundamental Importance of Reference Glucose Analyzer Accuracy for Evaluating the Performance of Blood Glucose Monitoring Systems (BGMSs)". Journal of Diabetes Science and Technology. 10 (4): 872–875. doi:10.1177/1932296816634356. PMC 4928230. PMID 26902794.
- ^ Han, Julia; Heinemann, Lutz; Ginsberg, Barry H.; Alva, Shridhara; Appel, Matthias; Bess, Stephan; Chen, Kong Y.; Freckmann, Guido; Harris, Dennis R.; Hartwig, Matthias; Hinzmann, Rolf; Kerr, David; Krouwer, Jan; Morrow, Linda; Nichols, James; Pfützner, Andreas; Pleus, Stefan; Rice, Mark; Sacks, David B.; Schlueter, Kevin; Vesper, Hubert W.; Klonoff, David C. (May 2020). "The YSI 2300 Analyzer Replacement Meeting Report". Journal of Diabetes Science and Technology. 14 (3): 679–686. doi:10.1177/1932296820911471. PMC 7576944. PMID 32174135.
- ^ "Glucose Analytical Comparability Evaluation of the YSI 2300 STAT Plus™ and YSI 2900D Biochemistry Analyzers" (PDF). YSI.
- ^ Han, Julia; Nichols, James H.; Rice, Mark; Klonoff, David C. (May 2020). "The End of the Road for the YSI 2300 Analyzer: Where Do We Go Now?". Journal of Diabetes Science and Technology. 14 (3): 595–600. doi:10.1177/1932296819886603. PMC 7576956. PMID 31711305.
- ^ Hagvik, Joakim (March 2007). "Glucose Measurement: Time for a Gold Standard". Journal of Diabetes Science and Technology. 1 (2): 169–172. doi:10.1177/193229680700100205. PMC 2771464. PMID 19888402.
Further reading
- YSI 2300 STAT PLUS User's Manual, YSI Inc.
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