# K111188: Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack, Roche Combitrol Plus B

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: May 14, 2012 after 383 days
- Product code: CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph)
- Device class: 2
- Regulation: 21 CFR 862.1120
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K940918 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032311: Roche Diagnostics Omni S Analyzer, Roche Diagnostics Corp. (2003) Summary page 7.
- K921661: Boehringer Mannheim/ Hitachi 911 Analyzer, Boehringer Mannheim Corp. (1992) Summary page 7.
- K060373: Cobas 6000 Series System, Roche Diagnostics (2006) Summary page 7.
- K032453: Roche Combitrol and Autotrol Plus B Multi Analyte Control, Bionostics, Inc. (2003) Summary page 7.

## Recalls of this device
- Sep 3, 2015 · Class II · Z-1077-2017: under specific settings, an issue may occur during simultaneous Sensor Cartridge and Fluid Pack change on the cobas b 123 <2> POC system and cobas b 123 <4> POC system. The issue occurs when the softw
- Jul 14, 2015 · Class II · Z-2446-2015: Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused by a calibration issue with the PO2 parameter. This issue may not be detected since QC results can be belo
- Jul 14, 2015 · Class II · Z-2447-2015: Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused by a calibration issue with the PO2 parameter. This issue may not be detected since QC results can be belo
- Nov 14, 2012 · Class II · Z-0522-2013: It has been determined that cobas b 123 Fluid Pack COOX cuvettes for lot numbers 21426121 and 21426171, exhibit a significant increase in the out-of-box failure rate caused by a change in the thicknes

## Indications for use
The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na', K*, iCa2* (ISE), hematocrit (Hct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2 Hb, HHb, COHb, MetHb), and oxygen saturation (SO 2) In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory. The integrated AutoQC module and the oximeter module are available as an option. PH, P02 and PCO 2 : PH, P0 2 and PCO 2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances. Sodium (Na 4 ): sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance. Potassium (K1 ): potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Calcium (Ca 2"): calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). Hematocrit (Het): hematocrit measurements are used to distinguish normal from abnormal states of whole blood, such as anemia and erythrocytosis (an increase in the number of red cells). Glucose (Glu): glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemnia, and of pancreatic. islet cell carcinoma., Lactate (Lac): Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood.) Total Hemoglobin (tHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia. O2Hb: oxyhemoglobin as a fraction of total hemoglobin. COHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning. Meti-b: methemoglobin as a fraction of total hemoglobin. HHb: reduced hemoglobin as a fraction of total hemoglobin. SO 2 : oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin. The cobas b 123 AutoQC pack Tni-Level is a multi-analyte control intended for use as control material to monitor the measurement of PH, PCO2 , P0 2 , SO2 , Nat, K+, iCa2+, Hct, tHb and Hb derivatives as well as glucose and lactate on cobas b 123 systems with an AutoQC module. The cobas b 123 AutoCVC Pack is a multi-analyte control, intended for use in calibration verification of the measuring range established by the cobas b 123 POC system for PH, PCO2 , P0 2 , SO2 , Nat, K+, iCa 2 +,Hct, tHb and Hb derivatives as well as glucose and lactate on cobas b 123 systems with an AutoQC module. COMBITROL PLUS B is a multi-analyte control intended for use as control material to monitor the measurement of pH, PCO2 , P0 2 , SO 2, Nat; Kt., CE, iCa 2 +,Uct, ti-b and Hb derivatives as well as glucose, lactate, urea/BUN and bilirubin on Roche OMNI S or cobas b 221 analyzers with an oximeter module, and cobas b 123 analyzers (except urea/BUN, chloride, and bilirubin). COMBITROL PLUS B control material is not intended for use with analyzers from other manufacturers.

Source page: https://510kreport.com/device/K111188
Methodology: https://510kreport.com/methodology