# K031560: Bayer Rapidlab 1200 System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare, LLC
- Decided: Dec 17, 2003 after 212 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: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K946206 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934907: 860 Measurment System, Ciba Corning Diagnostics Corp. (1994) Summary page 1.
- K946206: Ciba Corning 8-- Series CO-Oximeter, Ciba Corning Diagnostics Corp. (1995) Summary page 1.
- K002738: Bayer Rapidpoint 400 System, Bayer Corp. (2000) Summary page 1.
- K020616: Bayer Rapidpoint 405 System, Bayer Diagnostics Corp. (2002) Summary page 1.

## Most influential descendants
- K113216: Rapidpoint 500 Blood Gas Analyer (2012), 0 descendants of its own

## Recalls of this device
- Jul 16, 2018 · Class II · Z-2930-2018: Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may
- Jul 16, 2018 · Class II · Z-2929-2018: Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may
- Apr 10, 2017 · Class II · Z-2040-2017: Potential Patient Demographic Error with Blank Patient ID Field
- Aug 11, 2016 · Class II · Z-2801-2016: There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
- Aug 11, 2016 · Class II · Z-2800-2016: There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
- May 6, 2015 · Class II · Z-1961-2015: D50 and D51 Diagnostic error codes are not functional.
- Sep 17, 2012 · Class II · Z-0106-2014: RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misiden
- Sep 17, 2012 · Class II · Z-0105-2014: RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misiden
- Apr 4, 2006 · Not classified · Z-1464-06: Invalid CO-oximeter values; Bayer HealthCare determined that under very specific conditions, the RapidLab 1245 or RapidLab 1265 systems may report invalid CO-oximeter values to an LIS, Rapidlink, or R
- Apr 4, 2006 · Not classified · Z-1465-06: Invalid CO-oximeter values; Bayer HealthCare determined that under very specific conditions, the RapidLab 1245 or RapidLab 1265 systems may report invalid CO-oximeter values to an LIS, Rapidlink, or R
- Jan 20, 2006 · Not classified · Z-0682-06: When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab
- Jan 20, 2006 · Not classified · Z-0683-06: When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab
- Jan 20, 2006 · Not classified · Z-0684-06: When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab
- Jan 20, 2006 · Not classified · Z-0685-06: When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab

## Indications for use
The Rapidlab 1200 system series is intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of samples of whole blood for the following parameters: * partial pressure of carbon dioxide * partial pressure of oxygen * pH * sodium * potassium * ionized calcium * chloride * glucose * lactate * CO-oximetry parameters (tHb, FO2Hb, FCOHb, FMetHb, FHHb) The following list includes the indication for use information for each analyte measured on the Rapidlab 1200 System Series: pCO 2, P0 2,pH. Measurements of blood gases (PCO2, P02) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances. Sodium. Sodium measurements obtained by this device 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 antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Potassium. Potassium measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Chloride. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Ionized calcium. 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). Glucose. 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. Lactate. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood). Total hemoglobin. Total hemoglobin measurements are used to determine the hemoglobin content of human blood. Oxyhemoglobin. Oxyhemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia. Carboxyhemoglobin. Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin (the compound formed when hemoglobin is exposed to carbon monoxide) content of human blood as an aid in the diagnosis of carbon monoxide poisoning. Sulfhemoglobin. Sulfhemoglobin measurements are used to determine the sulfhemoglobin (a compound of sulfur and hemoglobin) content of human blood as an aid in the diagnosis of sulfhemoglobinemia (presence of sulfhemoglobin in the blood due to drug administration or exposure to a poison).

Source page: https://510kreport.com/device/K031560
Methodology: https://510kreport.com/methodology