(212 days)
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).
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.
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.
§ 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.