# K160370: BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Jun 9, 2016 after 120 days
- Product code: JGS (Electrode, Ion Specific, Sodium)
- Device class: 2
- Regulation: 21 CFR 862.1665
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953239 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072018: BS-200 Chemistry Analyzer, Mode BS-200, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2008) Summary page 5.

## Recalls of this device
- Dec 9, 2019 · Class II · Z-0920-2020: The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fing
- Dec 9, 2019 · Class II · Z-0921-2020: The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fing

## Indications for use
The BS-800M/ABS800/BA-800M Chemistry Analyzer is designed for clinical chemistry laboratory use, making direct quantitative measurements of Na+(sodium), K+ (potassium), Cl- (chloride) in serum, plasma and urine samples, and Urea Nitrogen in serum samples. Additionally, other various chemistry tests may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction. The BS-800M/ABS800/BA-800M ISE Kit is for the in vitro quantitative determination of Sodium (Na+), Potassium (K+), and Chloride (Cl-) concentrations in serum, plasma and urine samples on the The BS-800M/ABS800/BA-800M Chemistry Analyzer. Sodium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of disease conditions characterized by, low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders. Urea Nitrogen (BUN) measurements are used to aid in the determination of liver and kidney function and other diseases associated with protein catabolism.

Source page: https://510kreport.com/device/K160370
Methodology: https://510kreport.com/methodology