(212 days)
Not Found
No
The device description focuses on electrochemical, biochemical, and optical measurement technologies, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic (IVD) device used for quantitative testing of blood samples to measure various parameters, which are then used in the diagnosis and treatment of conditions. It does not directly treat or prevent a disease in a living patient, but rather provides information to aid healthcare professionals in making diagnostic and treatment decisions.
Yes
The text explicitly states: "The Rapidlab 1200 system series is intended for in vitro diagnostic use by healthcare professionals..." and further details how the measurements are "used in the diagnosis and treatment" of various conditions.
No
The device description explicitly states the system uses measurement technology based on electrochemical, biochemical, and optical phenomena, and includes a CO-oximetry module utilizing spectral absorption. These are hardware-based measurement methods, not purely software functions.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The very first sentence explicitly states, "The Rapidlab 1200 system series is intended for in vitro diagnostic use by healthcare professionals..."
- Testing of Samples: The device is designed to test samples of whole blood, which is a biological specimen.
- Quantitative Testing: It performs quantitative testing of various parameters in these samples.
- Diagnosis and Treatment: The indications for use for each analyte clearly describe how the measurements are used in the diagnosis and treatment of various diseases and conditions.
- Device Description: The description details the technology used to measure analytes in blood samples.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
The Rapidlab 1200 System is intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of samples of whole blood for the following parameters:
- partial pressures of carbon dioxide; pCO2 .
- partial pressure of oxygen pO2 .
- . ਾਨ
- sodium; Na* .
- potassium; K* .
- ionized calcium; Ca** .
- chloride; Cl .
- 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 Rapidiab 1200 System Series:
pCO2, pO2, pH. Measurements of blood gases (PCO2, PO2) 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), and treathern of alabovenic 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.
lonized calcium. Calcium measurements are used in the diagnosis and treatment of formizou ballorian. Ouronariety 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 Carbonyarate metabliom atceration of pancreatic islet cell carcinoma.
Lactate. Lactic acid measurements that evaluate the acid-base status are used in Lactate. Eachs usid model offentic 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 Oarboxyhemoglobin (the compound formed when hemoglobin is exposed to the carboxynomogrobin (thof 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).
Product codes (comma separated list FDA assigned to the subject device)
CHL, JFP, CGZ, CEM, JGS, CGA, GKR, KHP
Device Description
The Rapidlab 1200 system series is intended for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples.
The 1200 Series System uses measurement technology that is based on electrochemical, biochemical and optical phenomena. The device use potentiometry and amperometry methods for blood gas, electrolytes and metabolites to convert the potential generated by the sensor to an electrical signal which the system then converts to a value that represents that concentration of a specific analyte or substances in recognizable units of measurement.
The Rapidlab 1200 series system CO-oximetry module utilizes spectral absorption by measuring the light from whole blood at several wavelengths. The measurement module detects and quantitates total hemoglobin and other related quantities in the sample.
The Rapidlab 1200 series system will interface with the Rapidlink information management system and/or will provide connect capability to hospital LIS/HIS systems via network interface ports.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
in vitro diagnostic use by healthcare professionals
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K934907, K946206, K002738, K020616
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEC 1 7 2003
K03/560
page 1 of 5
Appendix A Summary of Safety and Effectiveness
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
1. Submitters Information
| Contact person: | Mary E. Gray, RAC
NPT Regulatory Affairs Manager | | |
|------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Bayer Healthcare, LLC
Bayer Corporation
63 North Street
Medfield, MA 02052 | | |
| Phone: | (508) 359-3825 | | |
| e-mail address: | mary.gray.b@bayer.com | | |
| Date Summary Prepared: | December 11, 2003 | | |
| | 2. Device Information | | |
| | Proprietary Name: | Rapidlab 1200 System Series | |
| | Common Name: | Analyzer for Blood Gas, Electrolyte, Metabolite
and CO-oximetry | |
| | Classification Name: | Blood gases and blood pH test system | |
| | Classification Number: | pH -
pCO2 -
p02 -
Calcium -
Chloride -
Potassium -
Sodium -
Glucose -
Lactate -
CO-oximetry
Parameters | 21 CFR 862.1120, Class II
21 CFR 862.1120, Class II
21 CFR 862.1120, Class II
21 CFR 862.1145, Class II
21 CFR 862.1170, Class II
21 CFR 862.1600, Class II
21 CFR 862.1665, Class II
21 CFR 862.1345, Class II
21 CFR 862.1450, Class II
21 CFR 864.5620, Class II |
3. Predicate Device Information
| Name: | Rapidlab 800 Series | Rapidpoint 400 Series |
|---|---|---|
| Manufacturer: | Bayer Healthcare, LLC | Bayer Healthcare, LLC |
| 510(k) Number: | # K934907 | # K002738 |
| # K946206 | # K020616 |
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page 2 of 5
Appendix A Summary of Safety and Effectiveness
4. Device Description
The Rapidlab 1200 system series is intended for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples.
5. Statement of Intended Use
The Rapidlab 1200 System is intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of samples of whole blood for the following parameters:
- partial pressures of carbon dioxide; pCO2 .
- partial pressure of oxygen pO2 .
- . ાન
- sodium; Na* .
- potassium; K* .
- ionized calcium; Ca** .
- chloride; Cl .
- glucose .
- lactate .
- CO-oximetry parameters (tHb, FO2Hb, FCOHb, FMetHb, FHHb) .
6. Statement of Indications for Use
The following list includes the indication for use information for each analyte measured on the Rapidiab 1200 System Series:
pCO2, pO2, pH. Measurements of blood gases (PCO2, PO2) 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), and treathern of alabovenic 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.
lonized calcium. Calcium measurements are used in the diagnosis and treatment of formizou ballorian. Ouronariety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
2
K031560
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Glucose. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal Carbonyarate metabliom atceration of pancreatic islet cell carcinoma.
Lactate. Lactic acid measurements that evaluate the acid-base status are used in Lactate. Eachs usid model offentic 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 Oarboxyhemoglobin (the compound formed when hemoglobin is exposed to the carboxynomogrobin (thof 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).
7. Summary of Clinical Utility
Sunfinal y of Onlined Gillity information for each analyte measured on the Rapidlab 1200 System Series:
pH. Acidosis (low pH) stems from either respiratory failure (high pCO2) or from metabolic causes (including ketoacidosis, lactic acidosis, uremia, severe diarrhea, hypoaldosteronism, renal tubular disease, drug effects, or poisoning from several specific agents). Alkalosis (high pH) stems from hyperventilation (low pCO2) or from metabolic causes (including excessive vomiting, gastric drainage, drug effects, hyperadrenocorticism, potassium depletion, or excessive alkalai intake). Extreme nyperadionooort.client a potentially life-threatening pathophysiologic state that must be corrected promptly.
pCO2. This analyte reflects the overall respiratory status. Thus high pCO2 indicates respiratory suppression or failure, whereas low pCO2 indicates hyperventilation respiratory oupprossion from hypoxia, anxiety, fever, cerebral disease, cirrhosis, or (which ive mechanical ventilation). Extreme abnormalities of pCO2 reflect a excessive fifoshambar venthophysiologic state that must be corrected promptly.
pO2. This analyte reflects the ability of the lungs to deliver oxygen to the blood. Hypoxia (low pO2) may occur despite adequate respiration due to parechymal lung l ripoxia (low pozy may osoar treop, pulmonary edema, and pulmonary fibrosis) due discuses (c.g. phounting of blood. Extremely low pO2 is a potentially life-threatening pathophysiologic state that must be corrected promptly.
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K031560
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Sodium. Abnormal concentrations stem from deficit or overload of total body water Southil. Abhonmar officential from diverse clinical conditions such as congestive of of Souldin Itself. TH00 and ment, renal disease, neuropsychiatric disorders (causing abnormal fluid intake), intravenous fluid therapy, excessive fluid loss (e.g. (Causing abhormal heat stroke), drug therapy (e.g. diuretics), diabetes mellitus (causing osmotic diuresis), and imbalances of hormones (e.g. ADH, mineralcorticoid, (causing osmotio diaroolo)) and odium and water excretion. An extremely abnormal glasoonloola, which concentration may itself directly cause altered mental status, stupor, plasma sodium oonoomiaallyn, brain dehydration leading to cerebral hemorrhage, or, ultimately, death. Thus extreme abnormalities of sodium reflect a potentially lifethreatening pathophysiologic state that must be corrected promptly.
Potassium. High concentrations commonly stem from renal insufficiency (or failure), r otassive potassium replacement, drug effects (including some diuretics), hemolytic disease, or crush injury. Low concentrations stem from gastrointestinal loss, dietary insufficiency, or drug effects (most diuretics). Other metabolic imbalances (acid-Insuminoney, or drag glucocorticoid, insulin effects) also cause abnormal potassium concentrations. An extremely abnormal plasma potassium concentration may itself directly cause neuromuscular paralysis, respiratory failure, cardiac nray itoon alrootiy cardiac arrest. Thus extreme abnormalities of potassium reflect a annymmia, or threatening pathophysiologic state that must be corrected promptly.
Chloride. Assay is used most commonly to distinguish the "high anion gap" acidoses (Ketoacidosis, lactic acidosis, uremia, poisoning from several specific agents) from (Ketodoooni, lactio acidoses (loss of alkalai as in severe diarrhea, hypoaldosteronism, potassium-sparing diuretics, renal tubular acidosis). In the absence of acidosis, changes in plasma choride concentration tend to parallel those of sodium. Thus chloride is high in dehydration and low in overhydrated states.
lonized calcium. Abnormalities typically stem from parathyroid disease, vitamin D imbalance, renal disease, pancreatitis, drug effects, abnormalities of magnesium or inhosphorus, malignancy, or sarcoidosis. An extreme abnormality itself may cause proophords, mallghanoms, tetany, altered mental status, seizures, heart failure, or arrhythmias. Thus extreme abnormalities of ionized calcium reflect a potentially lifethreatening pathophysiologic state that must be corrected promptly.
Glucose. Glucose is elevated in any of the forms of diabetes mellitus, including Type 1, Type 2, Gestational, or any of the 50 "Other Specific Types." More moderate elevations occur in pre-diabetic conditions known as "impaired glucose levels." Clabetics sometimes suffer acute, life-threatening metabolic crises known as "diabetic ketoacidosis" which is typical in Type 1, or "hyperglycemic hyperosmolar alabetic state" which is typical in Type 2. Low glucose levels most commonly stem from insulin overdose, but also from a number of disorders collectively know as "hypoglycemic disorders." Examples of the latter include insulinoma, IGF2-secreting Trypoglycemia, postprandial syndrome, severe hepatic disorders, turner, laokiedo ny pogramment by deficiencies in gluconeogenic hormones, and endoonne alonoraers astric states. Extreme abnormalities of glucose reflect a some post surgiour gathophysiologic state that must be corrected promptly.
Lactate. Elevations are a sign of inadequate delivery oxygen to the peripheral tissues as occurs in respiratory failure, circulatory failure, and clinical shock.
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Kozisto
page 535
Total hemoglobin. Hemoglobin is low in anemia. There are numerous specific types of anemia, but each stems from one of three basic causes: blood loss, destruction of red blood cells, or failure to produce new red blood cells. Hemoglobin is high in polycythemia, which may be primary, secondary to hypoxia, secondary to dehydration, or a complication of over-transfusion. Polycythemia may lead to circulatory complications as a result of increased blood viscosity. Extreme abnormalities of hemoglobin reflect a potentially life-threatening pathophysiologic state that must be corrected promptly.
Oxyhemoglobin. This is the fraction of hemoglobin that is actually delivering oxygen to body tissues.
Reduced hemoglobin. This is the fraction of hemoglobin that could deliver more oxygen to body tissues if pulmonary oxygenation were improved.
Carboxyhemoglobin. This is a fraction of hemoglobin that cannot deliver oxygen to body tissues. It is formed when carbon monoxide is inhaled.
Methemoglobin. This is a fraction of hemoglobin that cannot deliver oxygen to body tissues. It is elevated in certain metabolic diseases.
Sulfhemoglobin. This is a fraction of hemoglobin that cannot deliver oxygen to body tissues. It may be elevated in some patients taking sulfur-containing drugs or with certain infections.
8. Summary of Technological Characteristics
The 1200 Series System uses measurement technology that is based on electrochemical, biochemical and optical phenomena. The device use potentiometry and amperometry methods for blood gas, electrolytes and metabolites to convert the potential generated by the sensor to an electrical signal which the system then converts to a value that represents that concentration of a specific analyte or substances in recognizable units of measurement.
The Rapidlab 1200 series system CO-oximetry module utilizes spectral absorption by measuring the light from whole blood at several wavelengths. The measurement module detects and quantitates total hemoglobin and other related quantities in the sample.
The Rapidlab 1200 series system will interface with the Rapidlink information management system and/or will provide connect capability to hospital LIS/HIS systems via network interface ports.
The Rapidlab 1200 systems are similar in technological characteristics, device performance and intended use therefore are substantially equivalent to the predicate devices, the Rapidlab 800 and the Rapidpoint 400 analyzers.
5
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 17 2003
Ms. Mary E. Gray NPT Regulatory Affairs Manager Bayer HealthCare LLC Diagnostics Division 63 North Street Medfield, MA 02052
Re: K031560 Trade/Device Name: Bayer Diagnostics Rapidlab 1200 System Series Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (Pco2, Po2) and blood pH test system Regulatory Class: Class II Product Code: CHL; JFP; CGZ; CEM; JGS; CGA; GKR; KHP Dated: October 1, 2003 Received: October 2, 2003
Dear Ms. Gray:
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 ic may of our just 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,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Image /page/7/Picture/24 description: The image shows the Bayer company logo. The logo is a circle with the word "BAYER" written vertically inside. The image also contains the text "Page 1 of 3" at the top.
Bayer HealthCare Diagnostics Division
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Bayer Rapidlab 1200 System Device Name: __
Intended 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) .
OR
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE, IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (
Carol Benaim / Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K031560
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
8
Indications for Use:
The following list includes the indication for use information for each analyte measured on the Rapidlab 1200 System Series:
pCO2, pO2, pH. Measurements of blood gases (PCO2, PO2) and blood pH are used in pCO2, pr1. Modedrent of life-threatening acid-base disturbances.
Sodium. Sodium measurements obtained by this device are used in the diagnosis and Soulum. Soulum measurements secretion of the hormone aldosterone), diabetes treatment of aloosteronism (excounts of dilute urine, accompanied by extreme Insibidus (chibhic exoretion of largo n's disease (caused by destruction of the adrenal thirst), adrenar hypertension, Addioon, AddioSic hormone secretion, or other diseases involving electrolyte imbalance.
Potassium. Potassium measurements obtained by this device are used to monitor Potassium. I otassium mododiement of diseases conditions characterized by low or high blood potassium levels.
Chloride. Chloride measurements are used in the diagnosis and treatment of electrolyte Onloride: Onlorido mesa such as cystic fibrosis and diabetic acidosis.
lonized calcium. Calcium measurements are used in the diagnosis and treatment of fomzed canvianni Oulonanian of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Glucose. Glucose measurements are used in the diagnosis and treatment of Glucose. Glaooso moders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE, IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol Benam / Jean Cooper, PRM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K031560
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
9
Lactate. Lactic acid measurements that evaluate the acid-base status are used in the Lactate: Lactio dold measurementomorially 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 oarboxynemoglobin (the compound formed when hemoglobin is exposed to carbon canboxynchnoglobin (the over pood 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 sulfhemoglobin (a compouna of salfaremia (presence of suffhemoglobin in the blood due to drug administration or exposure to a poison).
(Please Do NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE, IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol Benson & Jean Cooper, ARM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k03/560
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)