# K071211: Cobas C 111 Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jul 30, 2007 after 90 days
- Product code: CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot)
- Device class: 2
- Regulation: 21 CFR 862.1100
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K781921 (1979). 5 ancestors in all.
1 later device descends from it; 1 cites 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)
- K063744: Cobas Integra C 111, Rochdiag (2007) Summary page 2.

## Most influential descendants
- K102647: Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1 SL/Potassium, Sodium, Chloride... (2011), 0 descendants of its own

## Recalls of this device
- Sep 27, 2016 · Class II · Z-0387-2017: cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20 may encounter the following alarm: 7002: 108000572, A software error occurred. This 
- Oct 18, 2011 · Not classified · Z-0311-2012: Internal investigations have revealed a potential printer malfunction on the Cobas c 111 analyzer, where one or more numbers or characters can be missing on the hard copy result printout, or the print
- Nov 17, 2008 · Not classified · Z-1009-2009: Due to a manufacturing error at the supplier, not all cobas c 111 pinch valve caps are properly glued to the correct position on the pinch valve shaft. Without the glue, the cap can become loose or mi

## Indications for use
The Roche cobas e 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests for professional settings and small laboratories, specialized testing and CLIA-licensed doctor's offices. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride. In vitro test for the quantitative determination of AST in human serum and plasma on the cobas cl II system. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. In vitro test for the quantitative immunological determination of human C-reactive protein in human serum and plasma on the cobas clI II system. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. In vitro test for the quantitative determination of glucose concentration in human serum and plasma on the cobas el 11I system. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia. The chloride electrode for the cobas clI II system is intended for the quantitative determination of chloride in diluted serum, plasma, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. The potassium electrode for the cobas clI II system is intended for the quantitative determination of potassium in diluted serum, plasma; and urine. Measurements of potassium are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. The sodium electrode for the cobas clI II system is intended for the quantitative determination of sodium in diluted serum, plasma, and urine. Measurements of sodium are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretie hormone secretion, or other diseases involving electrolyte imbalance.

Source page: https://510kreport.com/device/K071211
Methodology: https://510kreport.com/methodology