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 pressures of carbon dioxide; pCO2 .
partial pressure of oxygen pO2 .
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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).

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.

AI/ML Overview

The provided text describes the Rapidlab 1200 System Series, an in vitro diagnostic device for quantitative testing of whole blood samples. However, it does not contain a study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary for a premarket notification to the FDA. It declares the device is "substantially equivalent" to predicate devices based on technological characteristics, device performance, and intended use. This means it relies on the established safety and effectiveness of the predicate devices rather than presenting new, detailed performance studies for specific acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. I also cannot provide sample sizes, data provenance, number of experts, adjudication methods, details of MRMC studies, standalone studies, or how ground truth was established, as this information is not present in the provided text.

Based on the available information, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

Not available in the provided document. The document states that the Rapidlab 1200 systems are "similar in technological characteristics, device performance and intended use" to predicate devices (Rapidlab 800 and Rapidpoint 400 analyzers). This implies that a detailed new performance study against specific acceptance criteria for the Rapidlab 1200 is not presented, but rather a claim of equivalence to already approved devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not available in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not available in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not available in the provided document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not available. This device is an analyzer for blood gases, electrolytes, metabolites, and CO-oximetry, not an AI-assisted diagnostic imaging device that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device is a standalone analyzer. Its performance is measured directly, not in conjunction with human interpretation in the way AI algorithms are. However, specific performance metrics are not provided in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated in the provided document. For in vitro diagnostic devices like blood gas analyzers, the ground truth would typically be established by validated reference methods or highly accurate laboratory instruments. This information is usually detailed in performance studies, which are not included in this 510(k) summary.

8. The sample size for the training set

Not applicable/Not available. This device is based on electrochemical, biochemical, and optical phenomena, not on machine learning or AI models that require a training set.

9. How the ground truth for the training set was established

Not applicable/Not available. As above, this device does not utilize a training set in the AI/machine learning sense.

Summary

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DEC 1 7 2003

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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, RACNPT Regulatory Affairs Manager
Address:	Bayer Healthcare, LLCBayer Corporation63 North StreetMedfield, 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, Metaboliteand CO-oximetry
	Classification Name:	Blood gases and blood pH test system
	Classification Number:	pH -pCO2 -p02 -Calcium -Chloride -Potassium -Sodium -Glucose -Lactate -CO-oximetryParameters	21 CFR 862.1120, Class II21 CFR 862.1120, Class II21 CFR 862.1120, Class II21 CFR 862.1145, Class II21 CFR 862.1170, Class II21 CFR 862.1600, Class II21 CFR 862.1665, Class II21 CFR 862.1345, Class II21 CFR 862.1450, Class II21 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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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.

Chloride. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

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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.

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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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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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.

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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).

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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) .

(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)

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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)

Over-The-Counter Use (Optional Format 1-2-96)

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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)

Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 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.