The AVL OPTI Critical Care Analyzer is intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium and chloride, total hemoglobin content and oxygen saturation in samples of whole blood, serum, plasma or dialysate in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.

The AVL OPTI Critical Care Analyzer intended to be used for the measurement of pH, PCO2, PO2, ctHb, SO2, Na', K', Cl' and Ca* in whole blood, serum, plasma and aqueous dialysate solutions as appropriate by minimally trained personnel qualified to perform and to report these values in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.

For Professional Use Only
For In Vitro Diagnostic Use

Device Description

The AVL OPTI Critical Care Analyzer is a small [4.9 x 14.3 x 9.8 in. 10 lbs], instrument using optical fluorescence for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium and choride of whole blood, plasma, serum or dialysate as appropriate. In addition, it uses optical reflectance for the measurement of total hemoglobin and oxygen saturation. A disposable, single-use cassette containing six optical fluorescence sensors is packaged in a sealed foil pouch which bears a bar-coded label with calibration and identification information. The OPTI can perform up to 8 tests on a single sample, determined by the type of disposable cassette used.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the AVL OPTI Critical Care Analyzer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for precision, linearity, or interference. Instead, it describes compliance through comparative studies and general statements of no significant difference. Here's a summary of the reported performance:

Parameter	Acceptance Criteria (explicitly stated)	Reported Device Performance
Precision	Not explicitly stated	"Typical Within-Run (Swr), Between-Day (Sdd) and Total (ST) precision were determined from two runs per day with 2 replicates per run for 20 days on two AVL OPTI instruments using samples: serum, reduced bovine hemoglobin solution and three levels of aqueous quality control solution." (No specific numerical results provided)
Linearity	Not explicitly stated	"Wherever possible, linearity for the OPTI measurement has been established against reference materials or methods. Linearity for pH of whole blood is established by measurement of blood specimens which were tonometered to various CO2 values, and measured on an AVL 995 pH/Blood Gas Analyzer standardized to N.I.S.T. traceable pH buffers, and on OPTI Critical Care Analyzers." (No specific numerical results provided)
Interferences	Not explicitly stated (implied compliance with guidelines)	"Representative samples taken the published guidelines for evaluation of interference substances and identified from literature were evaluated." (No specific numerical results or identified interferences provided)
Clinical Correlation	No significant difference (P<0.05) to predicate devices	"In all evaluations, there was no significant difference in mean values (P<0.05) obtained on measurement by the AVL OPTI from those of the predicate devices."
Safety and Effectiveness	Equivalent to predicate devices	"Analysis of the comparative measurement presented in the 510(k) for this device, together with the linearity and precision data collected during these clinical and non-clinical trials demonstrates that the AVL OPTI Critical Care Analyzer with the additional analytes: chloride and ionized calcium, is safe, effective, and equivalent to those predicate devices to which it is compared."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample sizes used for the precision, linearity, interference, or clinical correlation tests. It mentions "samples: serum, reduced bovine hemoglobin solution and three levels of aqueous quality control solution" for precision and "remnant from patient specimens of both whole blood collected for routine analysis on existing instrumentation" for clinical tests.
Data Provenance: The data appears to be prospective for the clinical tests, as it uses "remnant from patient specimens... collected for routine analysis." The country of origin is not explicitly stated, but given the submitter's address (Roswell, GA) and the FDA submission, it implicitly refers to studies conducted in the United States or under US regulatory guidelines.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish ground truth. For the clinical correlation study, the comparison was made against "predicate devices" operated by "personnel trained to perform and report these analyses." The AVL 995 pH/Blood Gas Analyzer standardized to N.I.S.T. traceable pH buffers was used for linearity of pH as a reference method.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none). The clinical evaluation involved direct comparison to predicate devices, and the statistical analysis focused on the "mean values (P<0.05)."

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. The device is an automated critical care analyzer, not an AI-assisted diagnostic imaging tool that would typically involve human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are essentially standalone performance evaluations of the AVL OPTI Critical Care Analyzer. It is an automated instrument that directly measures analytes, and the studies assess its precision, linearity, interference, and agreement with predicate devices without human interpretation as part of its core function.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance evaluations primarily involved:

Reference Materials/Methods: For linearity, this included "reference materials or methods" and specifically an "AVL 995 pH/Blood Gas Analyzer standardized to N.I.S.T. traceable pH buffers."
Predicate Devices: For clinical correlation, the ground truth was established by the measurements from "predicate devices" (e.g., NOVA Biomedical STAT 5, Chiron 865, AVL 995, etc.).
Quality Control Solutions: For precision, "aqueous quality control solution" was used.

8. The Sample Size for the Training Set

The document does not mention any "training set" or "training data" in the context of machine learning or AI. This device is an automated analyzer based on optical fluorescence and reflectance, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a "training set" or a machine learning component for this device, this question is not applicable.

Summary

{0}------------------------------------------------

DEC 1 1 1998

K984299

Image /page/0/Picture/2 description: The image shows a logo with the letters AVL in a stylized, bold, sans-serif font. The letters are interconnected and appear to be formed by thick, angular lines. The logo is black and stands out against a white background. The overall design is modern and geometric.

510(k) Summary

Submitter's name, address (a) (1) AVL Scientific Corporation 33 Mansell Court Roswell, GA 30076

Date of preparation of this summary:

Contact Person Randy Byrd Quality Assurance Manager (770) 587-4040 x 631

30 November 1998

Device trade or proprietary name: (2)
AVL OPTI Critical Care Analyzer

Device common or usual name or classification name

pH, Blood Gas, Electrolyte, hemoglobin and oxygen saturation analyzer

	CLASSIFICATION
PRODUCT NOMENCLATURE	NUMBER	CLASS	PANEL
ELECTRODE, ION-SPECIFIC, CALCIUM	75 JFP	II	CHEMISTRY
ELECTRODE, ION-SPECIFIC, CHLORIDE	75 CGZ	II	CHEMISTRY
ELECTRODE, ION-SPECIFIC, POTASSIUM	75 CEM	II	CHEMISTRY
ELECTRODE, ION-SPECIFIC, SODIUM	75 JGS	II	CHEMISTRY
ELECTRODE, BLOOD PH	75 CHL	II	CHEMISTRY
BLOOD GASES/PH	75 CHL	II	CHEMISTRY
HEMOGLOBINOMETER, AUTOMATED	81 GKR	II	HEMATOLOGY
OXIMETER, WHOLE BLOOD	81 GLY	II	HEMATOLOGY

(3) Substantial Equivalence

The AVL OPTI is substantially equivalent in function, safety and efficacy to a number of currently marketed devices known as 'Combi Analyzers' and 'Point of Care' analyzers. Specifically: NOVA Biomedical STAT 5 [K874832], Chiron 865 [K946206], AVL 995 [K895317], SenDx 100 [954482], Diametrics IRMA [945240], I-STAT 200 [940918], as well as electrolyte analyzers such as AVL 9181 [972763] and IL 943 Flame Photometer [K823480]. The OPTI Critical Care Analyzer is an improved design of the AVL OPTI 1 pH/Blood Gas Analyzer [K944089, K961161 and K974784].

(4) Description of the new device

{1}------------------------------------------------

(5) Intended use of the device

Technological characteristics of the device. (6)

Principles of Measurement

The OPTI Critical Analyzer uses fluorescence optode technology similar to that used in commercially available products since late 1983 and is unchanged in principle of operation from the originally submitted 510(k) for this device. Additional parameters, sodium and potassium, ionized calcium and chloride are measured by fluorescence and measurement of total Hemoglobin (ctHb) and oxygen saturation (SO2) is accomplished by optical reflectance.

Calibration

A disposable, single-use cassette contains all the elements needed for calibration, QC sample measurement, patient sample measurement and waste containment. Calibration verification is performed with each cassette immediately prior to use. No other calibration is required for the usual operation of this device for the measurement of pH, PCO2, PO2, Na , K , Ca , Cl , tHb and SO2.

(b) (1) Summary of non-clinical tests submitted with the premarket notification for the device.

The AVL OPTI Critical Care Analyzer has been tested and found to comply with EN 50081-1, FCC Class B. EN 50081-2 and IEC 1010-1.

Precision

Typical Within-Run (Swr), Between-Day (Sdd) and Total (ST) precision were determined from two runs per day with 2 replicates per run for 20 days on two AVL OPTI instruments using samples: serum, reduced bovine hemoglobin solution and three levels of aqueous quality control solution.

Linearity

Wherever possible, linearity for the OPTI measurement has been established against reference materials or methods. Linearity for pH of whole blood is established by measurement of blood specimens which were tonometered to various CO2 values, and measured on an AVL 995 pH/Blood Gas Analyzer standardized to N.I.S.T. traceable pH buffers, and on OPTI Critical Care Analyzers.

Image /page/1/Picture/16 description: The image contains a handwritten number 8 inside of a circle. The number 8 is slightly tilted to the left. The circle is drawn with a thick black line.

{2}------------------------------------------------

Interferences'

Representative samples taken the published guidelines for evaluation of interference substances and identified from literature were evaluated.

(b) (2) Summary of clinical tests submitted with the premarket notification for the device.

Clinical testing was conducted to demonstrate the correlation of AVL OPTI Critical Care Analyzer to predicate devices in a clinical setting, operated by personnel trained to perform and report these analyses. Specimens analyzed in these tests were remnant from patient specimens of both whole blood collected for routine analysis on existing instrumentation.

In all evaluations, there was no significant difference in mean values (P<0.05) obtained on measurement by the AVL OPTI from those of the predicate devices.

(b) (3) Conclusions drawn from the clinical and non-clinical trials.

Analysis of the comparative measurement presented in the 510(k) for this device. together with the linearity and precision data collected during these clinical and non-clinical trials demonstrates that the AVL OPTI Critical Care Analyzer with the additional analytes: chloride and ionized calcium, is safe, effective, and equivalent to those predicate devices to which it is compared.

1 NCCLS. Interference Testing in Clinical Chemistry: Proposed Guideline. NCCLS Document EP7-P. NCCLS, 771 East Lancaster Avenue, Villanova, Pennsylvania 19085, 1986.

Image /page/2/Picture/11 description: The image contains a close-up of a mathematical expression, specifically the variable 'x' enclosed in parentheses. The expression appears to be part of a larger equation or formula, but the surrounding context is not visible in the image. The focus is solely on the '(x)' term, suggesting its importance within the broader mathematical context.

{3}------------------------------------------------

Image /page/3/Picture/2 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

DEC 1 1 1998

Mr. Randy Byrd Quality Assurance Manager AVL Scientific Corporation 33 Mansell Court Roswell, Georgia 30076

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

K984299 Re: AVL OPTI Critical Care Analyzer Trade Name: Requlatory Class: II Product Code: JFP, CGZ, JGS, CHL, GKR, GLY Dated: November 30, 1998 Received: December 1, 1998

Dear Mr. Byrd:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{4}------------------------------------------------

Page 2

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

510(k) Number: K984299

AVL OPTI Critical Care Analyzer Device Name:

The AVL OPTI Critical Care Analyzer intended to be used for the measurement of pH, PCO2, PO2, ctHb, SO2, Na', K', Cl' and Ca* in whole blood, serum, plasma and aqueous dialysate solutions as appropriate by minimally trained personnel qualified to perform and to report these values in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.

For Professional Use Only For In Vitro Diagnostic Use

Indications for Use1,2

pH

The pH value of the blood may be the single most valuable factor in the evaluation of the acid-base status of a patient. The pH value is an indicator of the balance between the buffer (blood), renal (kidney) and respiratory (lung) systems, and one of the most tightly controlled parameters in the body. The causes of abnormal blood pH values are generally classified as:

metabolic acidosisprimary bicarbonate deficit
---------------------------------------------------

· primary bicarbonate excess metabolic alkalosis
· primary hypoventilation
respiratory acidosis
· primary hyperventilation respiratory alkalosis

An increase in blood, serum or plasma pH (alkalemia) may be due to increased plasma bicarbonate, or a feature of respiratory alkalosis due to an increased elimination of CO2 due to hyperventilation.

A decrease of pH value (acidemia) in blood, serum or plasma may occur due to an increased formation of organic acids, an increased excretion of H -ions in certain renal disorders, an increased acid intake such as in salicylate poisoning or loss of alkaline body fluids. Respiratory acidosis is the result of a decreased alveolar ventilation and may be acute, as the result of pulmonary edema, airway obstruction or medication, or maybe be chronic, as the result of obstructive or restrictive respiratory diseases.

The composition of serous body fluids: pleural, pericardial, ascitic and cerebrospinal fluid, is similar to serum and plasma in electrolyte content and pH. The AVL OPTI may be used for the analysis of these fluids, limited to a pH in the

1 Tietz, Norbert W., Ed., Clinical Guide to Laboratory Tests, 2nd Ed., (Philadelphia: W.B.Saunders, Co., 1990) p.436.

2 Burtis C, Ashwood E (Eds.), Tietz Textbook of Clinical Chemistry, 2nd Ed., (Philadelphia: W.B.Saunders, Co., 1994) pp.1354-1360,2180-2206.

{6}------------------------------------------------

range between 6.8 and 7.7, as long as care is taken to ensure the specimen to be analyzed is clear of fibrin clots or other debris which may block the sample transport in the cassette.

Pleural fluid3

The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions. Patients with pneumonia may develop effusions when the infectious process extends to the visceral pleura, causing exudation of fluid into the pleural space. Fluids are divided into potentially benign and complicated effusions on the basis of pH. Fluids with a pH greater than 7.30 resolve spontaneously, whereas a pH less than 7.20 is an indication of tube drainage.

PCO2

The PCO2 value of arterial blood is used to assess how well the body eliminates carbon dioxide in relation to the metabolic rate of CO2 production.

An arterial PCO2 below the normal range is termed respiratory alkalosis and indicates hypocapnia, a condition caused by increased alveolar ventilation such as hyperventilation. An arterial PCO2 above the normal range is termed respiratory acidosis and indicates hypercapnia, a sign of hypoventilation and failure, resulting from cardiac arrest, chronic obstructive lung disease, drug overdose, or chronic metabolic acid-base disturbances.

PCO2

The PO2 value of arterial blood has become the primary tool for the evaluation of arterial oxygenation status. Values below the normal arterial PO2 (arterial hypoxemia) are usually caused by pulmonary, circulatory, or respiratory abnormalities (e.g. bronchial obstruction, vascular problems, decrease in cardiac output, increased oxygen demand, anatomical heart defect, low inspired O2 content). Generally, PO2 levels above 100 mmHg do not contribute significantly to the oxygen content since, with normal hemoglobin concentrations, 80 - 100 mmHg, PO2 provides a 97 % saturation level, and a level greater than 100 % cannot be achieved.

Sodium

Sodium is the major cation of extracellular fluid. Its primary functions in the body are to chemically maintain osmotic pressure and acid-base balance and to transmit nerve impulses. Sodium functions at the cell membrane level by creating an electrical potential between different cell membranes causing the transmission of nerve impulses and neuromuscular excitability to be maintained. Sodium is involved in some enzyme catalyzed reactions as a cofactor. The body has a strong tendency to maintain a total base

5 Kaplan LA, Pesce AJ. Clinical Chemistry: Theory, analysis and correlation, 2nd Ed. (St.Louis: C.V.Mosby Co. 1989) p 590-591.

{7}------------------------------------------------

content, and only slight changes are found even under pathologic conditions.

Low sodium values, hyponatremia, usually reflect a relative excess of body water rather than a low total body sodium. Reduced sodium levels may be associated with: low sodium intake; sodium losses due to vomiting or diarrhea with adequate water and inadequate salt replacement, diuretics abuse, or salt-losing nephropathy; osmotic diuresis, metabolic acidosis; adreocortical insufficiency; congenital adrenal hyperplasia, dilution type due to edema, cardiac failure, hepatic failure; and hypothyroidism.

Elevated sodium values, hypernatremia, are associated with conditions with water loss in excess of salt loss through profuse sweating, prolonged hyperpnea, severe vomiting or diarrhea, diabetes insipidus or diabetic acidosis; increased renal sodium conservation in hyperaldosteronism, Cushing's syndrome; inadequate water intake because of coma or hypothalamic diseases; dehydration; or excessive saline therapy.

The sodium value obtained may be used in the diagnosis or monitoring of all disturbances of the water balance, infusion therapies, vomiting, diarrhea, burns, heart and kidney insufficiencies, central or renal diabetes insipidus, endocrine disturbances and primary or secondary cortex insufficiency of the adrenal gland or other diseases involving electrolyte imbalance.

Potassium

Potassium is the major cation in the intracellular fluid and functions as the primary buffer within the cell itself. Ninety percent of potassium is concentrated within the cell, and damaged cells release potassium into the blood. Potassium plays an important role in nerve conduction, muscle function, and helps maintain acid-base balance and osmotic pressure.

Elevated potassium levels, hyperkalemia, can be found in oligouria, anemia, urinary obstruction, renal failure due to nephritis or shock, metabolic or respiratory acidosis, renal tubular acidosis with the K /H exchange and hemolysis of the blood. Low potassium levels, hypokalemia, can be found in excessive loss of potassium through diarrhea or vomiting, inadequate intake of potassium, malabsorption, severe burns and increased secretion of aldosterone. High or low potassium levels may cause changes in muscle irritability, respiration and myocardial function.

The potassium value obtained may be used to monitor electrolyte imbalance in the diagnosis and treatment of infusion therapies, shock, heart or circulatory insufficiency, acid-base imbalance, therapy with diuretics, all kinds of kidney problems, diarrhea and hyper- and hypo-function of adrenal cortex and other diseases involving electrolyte imbalance.

lonized Calcium

Calcium in blood is distributed as free calcium ions (50%) bound to protein, mostly albumin (40%) and 10% bound to anions such as bicarbonate, citrate, phosphate

{8}------------------------------------------------

and lactate. However, only ionized calcium can be used by the body in such vital processes as muscular contraction, cardiac function, transmission of nerve impulses and blood clotting. The OPTI CCA measures the ionized portion of the total calcium. In certain disorders such as pancreatitis and hyperparathyroidism, ionized calcium is a better indicator for diagnosis than total calcium.

Elevated calcium, hypercalcemia, may be present in various types of malignancy, and calcium measurements may serve as biochemical markers. In general, while ionized calcium may be slightly more sensitive, either ionized or total calcium measurements have about equal utility in the detection of occult malignancy. Hypercalcemia occurs commonly in critically ill patients with abnormalities in acidbase regulation and losses of protein and albumin, which gives a clear advantage to monitoring calcium status by ionized calcium measurements.

Patients with renal disese caused by glomular failure often have altered concentrations of calcium, phosphate, albumin, magnesium and pH. Since these conditions tend to change ionized calcium independently of total calcium, ionized calcium is the preferred method of accurately monitoring calcium status in renal disease 19.

Ionized calcium is important for diagnOosis or monitoring of: hypertension management, parathyroidism, renal diseases, malnutrition, kidney stoes, multiple mveloma and diabetes mellitus.

Chloride

Chloride is an anion that exists predominantly in extracellular spaces. It maintains cellular integrity through its influence on osmotic pressure. It is also significant in monitoring acid-base balance and water balance. In metabolic acidosis, there is a reciprocal rise in chloride concentration when the bicarbonate concentration drops.

Decreased levels are found in severe vomiting, severe diarrahea, ulcerative colitis, pyloric obstruction, severe burns, heat exhaustion, diabetic acidosis. Addison's disease, fever and acute infections such as pneumonia.

Increased levels are found in dehydration, Cushing's syndrome, hyperventilation, eclampsia, anemia, cardiac decompensation.

total Hemoglobin concentration (ctHb)

The hemoglobin is the main component of erythrocytes. It serves as the vehicle for transportation of oxygen within the bloodstream and each gram/dL of hemoglobin can carry 1.39 mL of oxygen. The oxygen combining capacity of the blood is directly proportional to the hemoglobin concentration rather than to the number of red blood cells (RBC), because some red cells contain more hemoglobin than the others.

19 Burritt MF, Pierides AM, Offord KP: Comparative studies of total and ionized serum calcium values in normal subjects and in patients with renal disorders. Mayo Clinic Proc. 55:606, 1980.

Image /page/8/Picture/12 description: The image shows the number 16 inside of a circle. The number 16 is written in a handwritten style with thick, black lines. The circle is also drawn with a thick, black line and appears to be hand-drawn as well.

{9}------------------------------------------------

Although oxygen transport is the main function of hemoglobin, it also serves as an important buffer in the extracellular fluid. Decreases in the amount of hemoglobin can come about as a result of a decreased concentration of hemoglobin in the ervthrocytes, or a decreased number of erythrocytes that contain a normal concentration of hemoglobin.

Decreased levels are found in anemia states, hyperthyroidism, severe hemorrhage and hemolytic reactions due to transfusions of incompatible blood, reaction to chemical, infectious and physical agents as well as various systemic diseases. Increased levels are found in hemoconcentration of the blood, chronic obstructive pulmonary disease and congestive heart failure.

CtHb gives valuable information in an emergency situation if interpreted not in an isolated fashion but in conjunction with other pertinent laboratory data.

ctHb is used to screen for disease associated with anemia, to determine the severity of anemia, to follow the response to treatment for anemia and to evaluate polycythemia.

Oxygen Saturation (SO2%)

When each heme group of the hemoglobin molecule is associated with one molecule of oxygen, the hemoglobin is referred to as oxyhemoglobin (O2Hb). The amount of oxyhemoglobin, expressed as a fraction of the total available hemoglobin is termed, hemoglobin oxygen saturation (SO2). The largest portion (about 98%) of blood oxygen content is the oxygen bound to hemoglobin. The reference interval for arterial blood from healthy adults is typically 94 to 98% . Decrease in SO2 below the critical level necessary for tissue oxygen saturation is a grave clinical situation. Low oxygen saturation may be caused by many of the same factors responsible for arterial hypoxemia, as well as from unusually large amounts of non-functional hemoglobins, high concentrations of deoxyhemoglobin, chemically altered hemoglobin or factors affecting the affinity of hemoglobin for oxygen, including: temperature, pH, PCO2, 2,3-DPG concentration and type of hemoglobin. 3

4 Siggaard-Andersen O, Durst RA, Maas AHJ. IFCC/IUPAC approved recommendation (1984) on physicochemical quantities and units in clinical chemistry. J Clin Chem Clin Biochem. 25:369-391. 1987.

Burtis C, Ashwood E (Eds.), Tietz Textbook of Clinical Chemistry, 2nd Ed., (Philadelphia: W.B.Saunders, Co., 1994) pp.1354-1360,2180-2206.

{10}------------------------------------------------

(Division Sign-Off) Division of Clinical Laboratory Pr evices 9 100 ﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ વર્ષિક 510(k) Number _

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use ﺎ (Per 21 CFR 801.109) (Optional Format 1-2-96)

Regulation Number and Section

§ 862.1145 Calcium test system.

(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.