The Stat Profile Critical Care Xpress Analyzer is intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2%, Hematocrit (Hct), Ca++, total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Reduced Hemoglobin (HHb), Oxygen content (O2Ct), and Oxygen capacity (02Cap) in heparinized whole blood; Nat, K+, C1-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for the "Stat Profile Critical Care Xpress Analyzer." This device performs quantitative determinations of various analytes in blood. The document details the device's indications for use and clinical utility for each analyte.

However, the letter does not contain the specific information requested regarding acceptance criteria and the study that proves the device meets those criteria.

Specifically, the following information is missing from the provided text:

A table of acceptance criteria and the reported device performance: The document only lists the analytes and their clinical utility, not specific performance metrics or acceptance criteria for accuracy, precision, etc.
Sample size used for the test set and the data provenance: There is no mention of study design, sample sizes for test sets, or data origin (e.g., country, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and their qualifications: The document is a regulatory clearance letter, not a study report. It does not detail how ground truth was established for any performance testing.
Adjudication method for the test set: No information on adjudication is present.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: MRMC studies are typically for imaging devices with human interpretation components. This device is an in vitro diagnostic analyzer, and such studies are not applicable.
If a standalone (algorithm only without human-in-the-loop performance) was done: This is an IVD analyzer; its performance is inherently "standalone" in its measurement function, but no specific performance data or study details are provided.
The type of ground truth used: Given it's an IVD device, the "ground truth" would typically be established by a reference method or laboratory standard, but this is not discussed.
The sample size for the training set: Training set information is relevant for machine learning algorithms. While the analyzer might use algorithms internally, this document doesn't detail any machine learning component or its training. However, if "training set" refers to calibration or method development, the information is not present.
How the ground truth for the training set was established: See point 8.

Conclusion:

The provided FDA 510(k) clearance letter for the Stat Profile Critical Care Xpress Analyzer does not contain the detailed study results, acceptance criteria, or information about ground truth establishment for performance testing. This type of information would typically be found in the 510(k) submission summary or a separate clinical/technical study report, neither of which is part of the provided text. The letter primarily confirms substantial equivalence to a predicate device based on the information submitted by the manufacturer.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/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 lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.

NOV 2 2 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Paul W. MacDonald Director of Quality Assurance/Regulatory Affairs Nova Biomedical 200 Prospect Street Waltham, MA 02454-9141

Re: K022746 Trade/Device Name: Stat Profile Critical Care Xpress Analyzer Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (Pcc2, P22) and blood pH test system Regulatory Class: Class II Product Code: CHL: JGS: CEM: JFP; CGZ: CGL; CFA: CGA; KHP; CDS; JKS; JPI; GKR; GHS; JIX; JPK; JJS Dated: October 30, 2002 Received: October 31, 2002

Dear Mr. MacDonald:

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. Iisting 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).

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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). Other general information on your responsibilities under the Act may be obtained 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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Indications for Use

510(k) Number: K022746

Device Name: Stat Profile Critical Care Xpress Analyzer

Indications for Use:

Intended Use

Clinical Utility 1.2

The following list includes the clinical utility information for each of the analytes measured on the STP Critical Care Xpress Analyzer.

Blood Gases: (PCO2, PO2, and pH)

Whole blood measurement of blood gases is used in the diagnosis and treatment of Irfethreatening acid-base disturbances in critically ill patients with numerous metabolic and pulmonary diseases.

Oxygen Saturation (SO2)

Used to assess the oxygenation of hemoglobin and the adequacy of tissue oxygenation in the evaluation of pulmonary function. Also used in the diagnosis and treatment of cyanosis.

Hematocrit (Hct)

Whole blood measurement of hematocrit is used to estimate that red blood cells are present in sufficient quantity to carry oxygen and carbon dioxide.

Hemoglobin (Hb)

Oxygen is carried from the lungs throughout the body by hemoglobin present in red blood cells. Measurement of hemoglobin (tHb) provides the clinician with information regarding the evaluation of chronic and acute anemias and also with information pertaining to the potential oxygen transport capability of the hemoglobin.

Oxyhemoglobin (O2Hb)

The fraction of total hemoglobin combined with oxygen. O2Hb is used to assess pulmonary function. Also used in the diagnosis and treatment of cyanosis.

Carboxyhemoglobin (COHb)

Measurement of carboxyhemoglobin indicates if and to what level carbon monoxide has been inhaled by the patient. Because the affinity of hemoglobin for carbon monoxide is approximately 210 times greater than the affinity for oxygen, high levels of carbon monoxide can lead to tissue anoxia and death unless diagnosed early.

Methemoglobin (MetHb)

Elevations in methemoglobin concentration can be due to congenital methemoglobinemia or from the ingestion of nitrates, chlorates, or any other drug or chemical that can cause methemoglobin formation. Methemoglobin cannot bind with oxygen. Cyanosis and eventually death may occur if left untreated.

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Sodium (Na+)

Measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.

Potassium (K+)

Measurement of potassium is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.

Chloride (Cl-)

Measurement of chloride is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Ionized Calcium (Ca++)

Used in the diagnosis and treatment of hypertension, renal disease, and vitamin D related disorders. Also useful in the diagnosis and treatment of patients with increased total protein and/or albumin levels, as in dehydration.

Ionized Magnesium (Mg++)

Measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high leve)s of magnesium).

Creatinine (Creat)

Measurement of creatinine is used in the diagnosis and treatment of certain renal conditions and is used for monitoring adequacy of dialysis, for example, peritoneal dialysis and peritoneal equilibration testing.

Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism Glucose disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Measurement of lactic acid (lactate) in whole blood, serum, and plasma is used to evaluate the Lactate acid-base status of patients suspected of having lactic acidosis.
Urea Nitrogen (BUN) Measurement of urea nitrogen is used in the diagnosis and treatment of certain renal and metabolic diseases.

Ref. 1. Tietz, N.W. ed. 1986. Textbook of Clinical Chemistry. W. B. Saunders Co

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Sean Cooper

on Sign-Off

(Optional Format 3-10-98)

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.