# K072018: BS-200 Chemistry Analyzer, Mode BS-200

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Feb 1, 2008 after 193 days
- Product code: CFR (Hexokinase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953239 (1995). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953239: Boehringer Mannheim/Hitachi 917 Analyzer, Boehringer Mannheim Corp. (1995) Summary page 2.
- K000926: Easyelectrolyte Analyzer and Rapidlyte Analyzer, Medica Corp. (2000) Summary page 2.
- K002199: Modification to Liquid Glucose (Hexokinase) Reagent Set, Pointe Scientific, Inc., (2000) Summary page 2.

## Most influential descendants
- K112377: BS-400 Chemistry Analyzer, CLC 720 Chemistry Analyzer (2012), 1 descendant of its own
- K160370: BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer (2016), 0 descendants of its own
- K140690: BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry Analyzer (2014), 0 descendants of its own

## Recalls of this device
- Nov 28, 2012 · Class II · Z-0977-2013: An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.

## Indications for use
The BS-200 Chemistry Analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na+ (sodium), K+ (potassium), Cl-(chloride) in serum, plasma and urine samples and Glucose in serum samples. Additionally, other various chemistry assays may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction. Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Source page: https://510kreport.com/device/K072018
Methodology: https://510kreport.com/methodology