(88 days)
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No
The document does not mention AI, ML, or related terms, and the device description focuses on automated analysis and customizable software, not learning algorithms.
No
The device is an automatic analyzer for in vitro diagnostic testing of blood samples, not a device directly used for therapy.
Yes
The device is described as an "automatic analyzer for in vitro testing of blood gases, electrolytes, metabolites and co-oximetry parameters" in samples of whole blood, which are used to determine the physiological state and health of a patient, serving a diagnostic purpose.
No
The device description explicitly states it is an "automatic analyzer for in vitro testing of blood gases, electrolytes, metabolites and co-oximetry parameters in samples of whole blood," indicating it is a physical hardware device that performs laboratory analysis. While it includes a "new software platform," the core function is tied to the hardware analyzer.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ABL800 FLEX is intended for in vitro testing of samples of whole blood for the parameters..." and "...intended for in vitro testing of samples of expired air for the parameters...".
This clearly indicates that the device is designed to perform tests on biological samples (blood and expired air) outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ABL800 FLEX is intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF). In addition the ABL800 FLEX is intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2. The ABL800 FLEX includes an AutoCheck Module to perform automated analysis of quality control fluids.
Indication for use information for the analytes measured by the ABL800 FLEX:
pH: pH is the indispensable measure of acidemia or alkalemia and is therefore an essential part of the pH/blood gas measurement. The normal function of many metabolic processes requires a pH to be within a relatively narrow range.
pO2: The arterial oxygen tension is an indicator of the oxygen uptake in the lungs.
pCO2: pCO2 is a direct reflection of the adequacy of alveolar ventilation in relation to the metabolic rate.
Potassium (cK*): The measurements of the concentration of potassium ions in plasma are used to monitor the electrolyte balance.
Sodium (cNa*): The measurements of the concentration of sodium ions in plasma are used to monitor the electrolyte balance.
Calcium (cCaf'): The measurements of the concentration of calcium ions in plasma are used to monitor the electrolyte balance.
Chloride (cCI): The measurements of the concentration of chloride ions in plasma are used to monitor the electrolyte balance.
Glucose (cGlu): The glucose measurements measure the concentration of glucose in plasma. The glucose measurements are used to screen for, diagnose and monitor diabetes, pre-diabetes, and hyper- and hypoglycemia.
Lactate (cLac): The lactate measurements measure the concentration of factate in plasma. Lactate measurements serve as a marker of critical imbalance between tissue oxygen demand and oxygen supply.
Bilirubin (ctBil): The bilirubin measure the total concentration of bilirubin in plasma. ctBil is used to assess the risk of hyperbilirubinemia.
Total Hemoglobin (ctHb): ctHb is a measure of the potential oxygen-carrying capacity of the blood.
Oxygen Saturation (sO2): sO2 is the percentage of oxygenated hemoglobin in relation to the amount of hemoglobin capable of carrying oxygen. sO2 allows evaluation of oxygenation.
Fraction of Oxyhemoglobin (FO2Hb): FO2Hb is a measure of the utilization of the potential oxygen transport capacity; that is the fraction of oxyhemoglobin in relation to all hemoglobins present (tHb) including dyshemoglobins.
Fraction of Carboxyhemoglobin (FCOHb): FCOHb is the fraction of carboxyhemoglobin. It is incapable of transporting oxygen.
Fraction of Methemoglobin (FMetHb): FMetHb is the fraction of methemoglobin. It is incapable of transporting oxygen.
Fraction of Deoxyhemoglobin in Total Hemoglobin (FHHb): FHHb is the fraction of deoxyhemoglobin in total hemoglobin. It can bind oxygen then forming oxyhemoglobin.
Fraction of Fetal Hemoglobin (FHbF): Fetal hemoglobin consists of two α-chains and two ß-chains, and has a higher oxygen affinity than adult Hb.
Product codes
CHL, JGS, CEM, JFP, CGZ, CGA, CIG, GHS, KQI, KHP, MQM
Device Description
The ABL800 FLEX is an automatic analyzer for in vitro testing of blood gases, electrolytes, metabolites and co-oximetry parameters in samples of whole blood.
The ABL800 FLEX includes the capability (FLEXMODE) of automatically measuring a reduced number of parameters when there is not enough sample to measure the desired number of parameters. The analyzer further includes a new inlet supporting test tubes and has a new software platform, which makes the user interface fully customizable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The precision (i.e. repeatability or within-run imprecision) and reproducibility (i.e. total imprecision) results for the parameters as well as the linearity/assay reportable ranges were established from a single large-sized non-clinical test. The test was performed as a large comparative in-house study using 11 ABL800 FLEX analyzers and 5 ABL735 analyzers (for reference).
The test comprised all measuring modes of all the configurations of the ABL800 FLEX analyzer on all parameters. The study was performed on samples of whole blood having syringe volumes of 20 ml and 50 ml and capillary volumes of 224 µl. 104 µl. 83 µl. 57 ul, 50 ul and 35ul. 16 different mixtures of heparinized whole blood samples were used in the test.
In the test, a total of approx. 4,700 measurements was performed on the ABL800 FLEX with corresponding ABL735 reference values.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study type: non-clinical test, large comparative in-house study.
Sample size: approx. 4,700 measurements on ABL800 FLEX analyzers, 11 ABL800 FLEX analyzers used, 5 ABL735 analyzers (for reference) used.
Key results: The result of the non-clinical test showed that when looking at repeatability, bias, test range etc. the ABL800 FLEX performed substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for Radiometer Copenhagen. The text "RADIOMETER" is on the top line, and the text "COPENHAGEN" is on the bottom line. There is a horizontal line separating the two lines of text. To the right of the text is a circular logo with a stylized "P" inside.
K041874/Page 1 of 5
OCT 8 - 2004
Submitter: | Radiometer Medical ApS |
---|---|
Address: | Åkandevej 21, DK-2700 Brønshøj, Denmark |
Phone: | +45 3827 3827 or +45 3827 3390 (direct) |
Fax: | +45 3827 2736 |
Contact Person: | Ms. Kirsten Rønø |
Date Summary Prepared: | September 30, 2004 |
Device Trade Name: | ABL800 FLEX |
Common name: | Blood Gas, Co-oximetry, Electrolyte and Metabolite Analyzer |
Classification Name: | Blood gases and blood pH test system |
Predicate Devices
RADIOMETER ABL700 Series Upgrade (K002290) and ABL700 with AutoCheck Module (K992859).
Device Description
The ABL800 FLEX is an automatic analyzer for in vitro testing of blood gases, electrolytes, metabolites and co-oximetry parameters in samples of whole blood.
The ABL800 FLEX includes the capability (FLEXMODE) of automatically measuring a reduced number of parameters when there is not enough sample to measure the desired number of parameters. The analyzer further includes a new inlet supporting test tubes and has a new software platform, which makes the user interface fully customizable.
Intended Use
The ABL800 FLEX is intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF). In addition the ABL800 FLEX is intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2. The ABL800 FLEX includes an AutoCheck Module to perform automated analysis of quality control fluids.
1
Image /page/1/Picture/1 description: The image shows the logo for Radiometer Copenhagen. The text "RADIOMETER" is on the top line, and the text "COPENHAGEN" is on the bottom line. There is a horizontal line separating the two lines of text. To the right of the text is a logo with a circle and the letter R.
K041874/Page 2 of 5
Statement of Indication for Use
Indication for use information for the analytes measured by the ABL800 FLEX:
pH: pH is the indispensable measure of acidemia or alkalemia and is therefore an essential part of the pH/blood gas measurement. The normal function of many metabolic processes requires a pH to be within a relatively narrow range.
pO2: The arterial oxygen tension is an indicator of the oxygen uptake in the lungs.
pCO2: pCO2 is a direct reflection of the adequacy of alveolar ventilation in relation to the metabolic rate.
Potassium (cK*): The measurements of the concentration of potassium ions in plasma are used to monitor the electrolyte balance.
Sodium (cNa*): The measurements of the concentration of sodium ions in plasma are used to monitor the electrolyte balance.
Calcium (cCaf'): The measurements of the concentration of calcium ions in plasma are used to monitor the electrolyte balance.
Chloride (cCI): The measurements of the concentration of chloride ions in plasma are used to monitor the electrolyte balance.
Glucose (cGlu): The glucose measurements measure the concentration of glucose in plasma. The glucose measurements are used to screen for, diagnose and monitor diabetes, pre-diabetes, and hyper- and hypoglycemia.
Lactate (cLac): The lactate measurements measure the concentration of factate in plasma. Lactate measurements serve as a marker of critical imbalance between tissue oxygen demand and oxygen supply.
Bilirubin (ctBil): The bilirubin measure the total concentration of bilirubin in plasma. ctBil is used to assess the risk of hyperbilirubinemia.
Total Hemoglobin (ctHb): ctHb is a measure of the potential oxygen-carrying capacity of the blood.
Oxygen Saturation (sO2): sO2 is the percentage of oxygenated hemoglobin in relation to the amount of hemoglobin capable of carrying oxygen. sO2 allows evaluation of oxygenation.
Fraction of Oxyhemoglobin (FO2Hb): FO2Hb is a measure of the utilization of the potential oxygen transport capacity; that is the fraction of oxyhemoglobin in relation to all hemoglobins present (tHb) including dyshemoglobins.
Fraction of Carboxyhemoglobin (FCOHb): FCOHb is the fraction of carboxyhemoglobin. It is incapable of transporting oxygen.
2
Image /page/2/Picture/1 description: The image shows the logo for Radiometer Copenhagen. The text "RADIOMETER" is on the top line, and the text "COPENHAGEN" is on the bottom line. There is a horizontal line separating the two lines of text. To the right of the text is a circular logo with the letters "PR" inside.
Fraction of Methemoglobin (FMetHb): FMetHb is the fraction of methemoglobin. It is incapable of transporting oxygen.
Fraction of Deoxyhemoglobin in Total Hemoglobin (FHHb): FHHb is the fraction of deoxyhemoglobin in total hemoglobin. It can bind oxygen then forming oxyhemoglobin.
Fraction of Fetal Hemoglobin (FHbF): Fetal hemoglobin consists of two α-chains and two ß-chains, and has a higher oxygen affinity than adult Hb.
Clinical Interpretation
Clinical interpretation for the analytes measured by the ABL800 FLEX:
pH: Common causes of low pH (acidosis) may be A) respiratory acidosis as alveolar hypoventilation or increased metabolic rate or B) metabolic acidosis as circulatory impairment, renal failure, diabetic ketoacidosis or gastro-intestinal loss of bicarbonate. (diarrhea). Common causes of high pH (alkalosis) may be A) respiratory alkalosis as alveolar hyperventilation or B) metabolic alkalosis as diuretics, gastrointestinal loss of acid (vomiting) or hypokalemia (low cK*).
pO2: Common causes of low pQ2 is pulmonary disease, cardiac right to left shunt, low alveolar ventilation and ambient pressure.
pCO2: Common causes of low pCO2 (alveolar hyperventilation - hypocapnia) may be A) aggressive ventilator treatment or psychogenic hyperventilation or B) compensatory to metabolic acidosis, secondary to central nervous system affection or secondary to hypoxia. Common causes of high pCO2 (alveolar hypoventilation - hypercapnia) may be lung disease, central nervous system depression, either primary, or secondary to sedation or analgesics or ventilator treatment, either with strategy of permissive hypercapnia or with too low alveolar ventilation.
Potassium (cK"): Common causes of low cK may be diuretics, diarrhoea, vomiting, respiratory or metabolic baseosis or hyperaldosteronism. Common causes of high cK may be renal failure, metabolic acidosis or toxic acidosis (salicylate, methanol, etc.).
Sodium (cNa ): Common causes of low values of cNa may be water intoxication, renal failure, heart failure, liver failure, increased ADH secretion, diuretics or nephrotic syndrome. Common causes of high values of cNa* may be increased Na-load, steroids, vomiting, diarrhea, excessive sweating or osmotic diuresis.
Calcium (cCaf'): Common causes of low values of cCa2 may be baseosis, renal failure, acute circulatory insufficiency, lack of vitamin D or hypoparathyroidism. Common causes of high values of cCa2+ may be malignancies, thyreotoxicosis, pancreatitis, immobilization or hyperparathyroidism.
3
Image /page/3/Picture/1 description: The image shows the logo for Radiometer Copenhagen. The logo consists of the word "RADIOMETER" in bold, uppercase letters above a horizontal line. Below the line is the word "COPENHAGEN" in bold, uppercase letters. To the right of the text is a circular symbol with a stylized "R" inside.
K041874/Page 4 of 5
Chloride (cCl7): Common causes of low cCl may be primary metabolic acidosis or a secondary metabolic acidotic compensation for respiratory alkalosis. Common causes of high cCI" may be metabolic alkalosis either as primary disorder of as compensation for chronic respiratory acidosis.
Glucose (cGlu): Common causes of low cGlu may be insulin overdose, adrenal insufficiency and extensive liver disease. Common causes of high cGlu may be lack of insulin, acute stress (response to trauma, heart attack, and stroke).
Lactate (cLac): In most situations, elevated blood lactate will be caused by hypoperfusion. severely impaired arterial oxygen supply, or a combination of the two. Decreasing or persistently low levels of blood lactate (cLac) during critical illness signal successful treatment.
Bilirubin (ctBil): Bilirubin is formed as a result of the catabolism of hemoglobin. Typically, the major part of bilirubin in plasma comes from the breakdown of red cells. Neonates have an increased breakdown of hemoglobin, limited hepatic function and low concentrations of albumin. If the concentration of bilirubin in neonates exceeds defined levels it requires specific therapy.
Total Hemoglobin (ctHb): High values of ctHb typically indicate a high blood viscosity, which increases the afterload to the heart and thereby can cause forward failure. In extreme cases, the microcirculation can be impaired. Common causes of high values of ctHb (polycytemia) may be A) polycytemia vera or B) dehydration, chronic lung disease, chronic heart disease, living at high altitude or trained athletes. Low concentrations of total hemoglobin or effective hemoglobin imply a risk of tissue hypoxia because of the lowered arterial oxygen content (ctO2). Common causes of low values ctHb (anemia) may be A) impaired red cell production or B) hemolysis, bleeding, dilution (overhydration) or multiple blood samples (neonates).
Oxygen Saturation (sO2): High (normal) sO2 may be a measure of sufficient utilization of actual oxygen transport capacity. Common causes of low sO2 may be impaired oxygen uptake.
Fraction of Oxyhemoglobin (FO2Hb): High (normal) FO2Hb may be an indication of sufficient utilization of oxygen transport capacity. Common causes of low FO2Hb may be impaired oxygen uptake or presence of dyshemoglobins,
Fraction of Carboxyhemoglobin (FCOHb): FCOHb levels are normally below 2 %, but heavy smokers may have up to 9-10 %. Newborns may present up to 10-12 % of FCOHb because of an increased hemoglobin turnover combined with a less developed respiratory system. In the acute exposition, headache, nausea, dizziness and chest pain occur with 10-30 %. Severe headache, general weakness, vomiting, dyspnea and tachycardia occur at 30-50 %. Above 50 %, seizures, coma and death occur.
Fraction of Methemoglobin (FMetHb): FMetHb levels above 10-15 % can result in pseudocyanosis. Methemoglobinemia may cause headache and dyspnea at levels above 30 % and may be fatal, especially in levels above 70 %.
4
Image /page/4/Picture/1 description: The image shows the logo for Radiometer Copenhagen. The text "RADIOMETER" is on the top line, and the text "COPENHAGEN" is on the bottom line. There is a horizontal line separating the two lines of text. To the right of the text is a circular logo with a stylized "R" in the center.
K041874/Page 5 of 5
Fraction of Deoxyhemoglobin in Total Hemoglobin (FHHb): FHHb is an expression of the amount of hemoglobin not bound to oxygen, but capable of being bound to oxygen if the oxygen supply is increased.
Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin. FHbF is seldom used clinically.
Test
The precision (i.e. repeatability or within-run imprecision) and reproducibility (i.e. total imprecision) results for the parameters as well as the linearity/assay reportable ranges were established from a single large-sized non-clinical test. The test was performed as a large comparative in-house study using 11 ABL800 FLEX analyzers and 5 ABL735 analyzers (for reference).
The test comprised all measuring modes of all the configurations of the ABL800 FLEX analyzer on all parameters. The study was performed on samples of whole blood having syringe volumes of 20 ml and 50 ml and capillary volumes of 224 µl. 104 µl. 83 µl. 57 ul, 50 ul and 35ul. 16 different mixtures of heparinized whole blood samples were used in the test.
In the test, a total of approx. 4,700 measurements was performed on the ABL800 FLEX with corresponding ABL735 reference values.
The result of the non-clinical test showed that when looking at repeatability, bias, test range etc. the ABL800 FLEX performed substantially equivalent to the predicate devices.
Summary of Technological Characteristics
The measuring technology of the ABL800 FLEX includes electrochemical and optical technology. The sensors for measuring blood gases and pH, sodium, potassium, calcium, chloride, glucose and lactate are electrochemical sensors. The electrochemical sensors are based on potentiometric and amperometric methods.
The optical system of the ABL800 FLEX for measuring co-oximetry parameters and bilirubin includes a 128-wavelength spectrophotometer. The system is based on absorbance measurements.
The ABL800 FLEX may be interfaced with the RADIANCE STAT analyzer management system software as well as with the hospital LIS/HIS systems through network interfaces.
The ABL800 FLEX is similar in technological characteristics, device performance and intended use as the predicate devices and is therefore substantially equivalent to the predicate devices.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The eagle is facing to the right. The text is in all capital letters.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 8 - 2004
Ms. Lene Meineche Marnaes Regulatory Affairs Radiometer Medical ApS Åkandevej 21 Brønshøj Denmark DK-2700
Re: K041874
Trade/Device Name: ABL800 Flex Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (pCO2, pO2) and blood pH test system Regulatory Class: Class II Product Code: CHL, JGS, CEM, JFP, CGZ, CGA, CIG, GHS, KQI, KHP, MQM Dated: July 9, 2004 Received: July 12, 2004
Dear Ms. Marnaes:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
6
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, US, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use
K041874 510(k) Number:
ABL800 FLEX Device Name:
Intended Use:
The ABL800 FLEX is intended for in vitro testing of samples of whole blood for the parameters PH, pO2, pO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and copri; pool, poozi porameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FMetHb, FHHb and FHbF). In addition the ABL800 FLEX is intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2. The ABL800 FLEX includes an AutoCheck Module to perform automated analysis of quality control fluids.
Indications For Use: Indication for use information for the analytes measured by the ABL800 FLEX:
pH: pH is the indispensable measure of acidemia or alkalemia and is therefore an essential part of the pH/blood gas measurement. The normal function of many metabolic processes requires a pH to be within a relatively narrow range.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Alberto San G
Division Sign-Off
Page 1 of 3
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K041874
8
pO2: The arterial oxygen tension is an indicator of the oxygen uptake in the lungs.
pCO2: pCO2 is a direct reflection of the adequacy of alveolar ventilation in relation to the metabolic rate.
Potassium (cK*): The measurements of the concentration of potassium ions in plasma are used to monitor the electrolyte balance.
Sodium (cNa*): The measurements of the concentration of sodium ions in plasma are used to monitor the electrolyte balance.
Calcium (cCa2+): The measurements of the concentration of calcium ions in plasma are used to monitor the electrolyte balance.
Chloride (cCI): The measurements of the concentration of chloride ions in plasma are used to monitor the electrolyte balance.
Glucose (cGlu): The glucose measurements measure the concentration of glucose in plasma. Oldoose (OCTa). The grants are used to screen for, diagnose and monitor diabetes, prediabetes, and hyper- and hypoglycemia.
Lactate (cLac): The lactate measurements measure the concentration of lactate in plasma. Lactate (claus). The factories a marker of critical imbalance between tissue oxygen demand and oxygen supply.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Alberts Suts
Office of In Vitro Diagnostic Device Evaluation and
510(k) K041874
Page 2 of 3
9
Bilirubin (ctBil): The bilirubin measurements measure the total concentration of bilirubin in plasma. ctBil is used to assess the risk of hyperbilirubinemia.
Total Hemoglobin (ctHb): ctHb is a measure of the potential oxygen-carrying capacity of the blood.
Oxygen Saturation (sO₂): sO2 is the percentage of oxygenated hemoglobin in relation to the Oxygen Saturation (302). JOE in the proving oxygen. sO2 allows evaluation of oxygenation.
Fraction of Oxyhemoglobin (FO₂Hb): FO₂Hb is a measure of the utilization of the potential FTaction of Oxynemogram () - 2 + + fraction of oxyhemoglobin in relation to all hemoglobins present (tHb) including dyshemoglobins.
Fraction of Carboxyhemoglobin (FCOHb): FCOHb is the fraction of carboxyhemoglobin, It is incapable of transporting oxygen.
Fraction of Methemoglobin (FMetHb): FMetHb is the fraction of methemoglobin. It is incapable of transporting oxygen.
Fraction of Deoxyhemoglobin in Total Hemoglobin (FHHb): FHHb is the fraction of r raction of bobin in total hemoglobin. It can bind oxygen then forming oxyhemoglobin.
Fraction of Fetal Hemoglobin (FHbF): Fetal hemoglobin consists of two α-chains and two βchains, and has a higher oxygen affinity than adult Hb.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Page 3 of 3
Allent Satz
Division Sign-Off
Division Sign-On
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K0411874