(35 days)
No
The document describes a microprocessor-based instrument using ion-selective electrodes and an autosampler. It mentions software modifications for the autosampling feature but does not mention any AI or ML algorithms for data analysis, interpretation, or decision-making. The performance studies focus on precision, linearity, and correlation with predicate devices, not on AI/ML-specific metrics.
No
Explanation: The device is an analyzer used for measuring electrolytes in various bodily fluids and QC materials. It is intended for diagnosis and management, not for directly treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "commonly used in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders." This clearly indicates its role in aiding diagnosis.
No
The device is a physical instrument (analyzer) that uses ion-selective electrodes and an autosampler to measure analytes in various sample types. While it has software components, it is fundamentally a hardware device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used for the measurement of analytes in various biological samples (whole blood, serum, plasma, urine) and QC materials. These measurements are used in the "diagnosis and management of patients." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease or other conditions.
- Clinical Laboratory Setting: The intended user is described as "minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting." This indicates the device is intended for use in a clinical environment for diagnostic purposes.
- Analytes Measured: The analytes measured (sodium, potassium, chloride, ionized calcium, and lithium) are commonly used in clinical diagnostics to assess various physiological states and disorders.
- Performance Studies: The document describes both nonclinical and clinical performance studies, which are typical for IVD devices to demonstrate their accuracy and reliability for clinical use.
The device description further supports this by detailing the use of ion-selective electrodes to measure these analytes in different sample types, which is a common method for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The AVL 9181 Electrolyte Analyzer is intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in whole blood, serum or plasma, urine, dialysate solutions, or QC materials as appropriate by minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting.
These analytes are commonly used in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders and, as such, have come to be among those which are considered by the American Association of Clinical Chemistry to have the potential of being life threatening if left uncontrolled.
Product codes (comma separated list FDA assigned to the subject device)
JFP, CGZ, JIH, CEM, JGS
Device Description
The AVL 9181 Electrolyte Analyzer is a microprocessor-based instrument using ionselective electrodes for the measurement of sodium, chloride, ionized calcium and lithium. The user is able to select any one of the measurement modes: whole blood, serum, urine, standard, OC material, acetate or bicarbonate dialysate, depending on the sample type to be analyzed. The analyzer automatically processes the sample through the necessary steps, then prints and displays the results. The 9181 is an improved design of the existing 9180 Electrolyte Analyzer with the addition of an Autosampler to allow automatic sampling of up to 18 sample cups.
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
Minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting.
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)
Precision Study:
Typical Within-Run (Swr) Between-Day (Sdd) and Total (ST) Precision was determined from 2 runs per day with 2 replicates per run for 20 days on two model AVL 9181 analyzers in each of its three main configurations using samples of each of the specimen types suitable for measurement on the 9181. Tests were performed in manual measurement mode (some solutions) and in automated measurement (all solutions) to demonstrate no significant difference in performance exists between the 9181 in automated and manual measurement modes; and between the 9181 and its predecessor, the AVL 9180.
Linearity in N.J.S.T. Standard Reference Material:
Evaluation of linearity of Sodium, Potassium and Lithium was made in accordance to recommendations by NCCLS' using N.I.S.T. SRM 956a Electrolyte in Human Serum.
Results: Sodium Slope 1.0134, Intercept -2.5307, Correlation Coefficient 0.99988, Syx 0.2709. Potassium Slope 1.0133, Intercept -0.0230, Correlation Coefficient 0.99996, Syx 0.0166. Lithium Slope 0.9717, Intercept 0.0482, Correlation Coefficient 0.99998, Sy*x 0.0067.
Linearity in Serum:
Linearity in serum was evaluated between manual and automated measurement modes. All samples were analyzed in pairs on each of two of AVL 9181 instruments in each configuration: Na/K/Cl, Na/K/iCa and Na/K/Li. and in pairs on each of several instrument types for comparison to various methods, and measurement in both manual and automated modes of operation were compared. Linearity to measurement in serum compared to predicate methods evaluated is equivalent, and there is no significant difference in measurement results obtained in either mode of measurement (p
§ 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.
0
AUG 20 1997
Image /page/0/Picture/1 description: The image shows a logo with the letters "AVL" in a bold, sans-serif font. Above the letters, there is some illegible text that appears to be handwritten. The letters are large and take up most of the image, with the "A" and "V" connected at the top and the "V" and "L" connected at the bottom. The logo is black and white.
510(k) Summary
- Submitter's name, address (a) (1)
AVL Scientific Corporation 33 Mansell Court Roswell, GA 30076
Contact Person Randy Byrd Quality Assurance Manager (770) 587-4040 x 631
14 July 1997
Device trade or proprietary name: (2)
Date of preparation of this summary:
AVL 9181 Electrolyte Analyzer
Device common or usual name or classification name
Ion-specific electrolyte analyzer for sodium, potassium and chloride or ionized calcium or lithium.
| Product Nomenclature | Classification | Number | Class | Panel |
|---|---|---|---|---|
| ELECTRODE, ION-SPECIFIC, CALCIUM | 75 | JFP | II | CHEMISTRY |
| ELECTRODE, ION-SPECIFIC, CHLORIDE | 75 | CGZ | II | CHEMISTRY |
| FLAME PHOTOMETER, LITHIUM | 75 | JIH | II | TOXICOLOGY |
| ELECTRODE, ION-SPECIFIC, POTASSIUM | 75 | CEM | II | CHEMISTRY |
| ELECTRODE, ION-SPECIFIC, SODIUM | 75 | JGS | II | CHEMISTRY |
Substantial Equivalence (3)
The AVL 9181 is an improved design of our existing 9180 Electrolyte Analyzer [K961458] with the addition of an Autosampler to allow automatic sampling of up to 18 sample cups. The 9181 is exactly equivalent to the AVL 9180 with the exception of this single, additional feature. Additionally, for Sodium, Potassium and Lithium the AVL 9181 is substantially equivalent to the I.L. Model 943 Flame Emission Photometer and for Chloride, to the Labconco Digital Chloridometer. The Autosampler used as accessory to the 9181 is the same as already marketed by AVL with the 988-4 Electrolyte Analyzer [K943702] and other 98X version instruments also marketed by AVL.
Description of the new device (4)
The existing 9180 Electrolyte analyzer was designed for the eventual addition of this automated sampling feature. The electronics necessary to the control the automatic needle mechanism and sampler were already incorporated in existing circuitry. The 9180 cabinet was initially designed to receive the AVL 988-4 needle mechanism and sampler, so further modification to the 9180 is minimal. Because the 9181 Electrolyte Analyzer is composed of hardware modules from existing devices (9180 and 988-4) minimum risk was taken in terms of function or reliability.
The manual needle mechanism of the 9180 was replaced with the automated needle mechanism from the AVL 988-4. The electronic circuitry to control the needle mechanism are incorporated into the 9180 display board. The sampler is taken from the 988-4 without modification except that the connector is changed to a smaller type. The 9180 main board already incorporated the controller for the sampler.
Image /page/0/Picture/17 description: The image contains a drawing of the number 18 enclosed in a circle. The number 1 is on the left side and the number 8 is on the right side. The circle is drawn around the number, and it appears to be hand-drawn.
1
The 9180 software was modified to add the automatic sampling feature. Calibration and measurement sequences are taken without alteration from the 9180 (sample volume, timing and algorithms). Once the sample probe is positioned in the sample cup, aspiration, measurement, wash and recalibration sequences are identical to the 9180. This not only eliminates any effects to the measurement between automated and manual sampling, but ensures good correlation of measurement to the predicate devices: 9180 and 988-4.
The AVL 9181 Electrolyte Analyzer is a microprocessor-based instrument using ionselective electrodes for the measurement of sodium, chloride, ionized calcium and lithium. The user is able to select any one of the measurement modes: whole blood, serum, urine, standard, OC material, acetate or bicarbonate dialysate, depending on the sample type to be analyzed. The analyzer automatically processes the sample through the necessary steps, then prints and displays the results.
In the blood, serum and QC measuring modes, the results for sodium and potassium are reported by default as flame photometry equivalent; chloride, ionized calcium and lithium are reported as ISE direct potentiometric values. The urine mode allows for the measurement of prediluted urine samples for sodium, potassium and chloride. The acetate, bicarbonate and standard modes allow for the measurement of aqueous standards and dialysate solutions and reports as ISE direct potentiometric values.
(ട) Intended use of the device.
The AVL 9181 Electrolyte Analyzer is intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in whole blood, serum or plasma, urine, dialysate solutions, or QC materials as appropriate by minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting. These analytes are commonly used in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders and, as such, have come to be among those which are considered by the American Association of Clinical Chemistry to have the potential of being life threatening if left uncontrolled.
Technological characteristics of the device. (6)
Principles of Measurement
The principles of measurement used in the AVL 9181 Electrolyte Analyzer are identical to those principles existing in the the electrolyte analyzers to which substantial equivalence is claimed in paragraph (a)(3) above.
Calibration
The AVL 9181 contains software which permits operation in one of six parameter configurations: Na / K / Ca - , Na / K / Ci . Na / K / L - , Na / Li or Li . A 2-point calibration is performed automatically every 4 hours in READY mode, and a 1-point calibration is performed automatically with each measurement.
Image /page/1/Picture/13 description: The image contains a close-up of a handwritten number "14" with a circle around it. The number is written in a simple, slightly slanted style, with the "1" being a straight line and the "4" having a closed top. The circle is not perfectly round and appears to have been drawn quickly around the number.
2
Technical Specifications
Measured Values
| Parameter | Range | Display Resolution | units |
|---|---|---|---|
| whole blood, serum, plasma, dialysate and aqueous solutions | |||
| Sodium | 40 - 205 | 0.1 | mmol/L |
| Potassium | 1.5 - 15 | 0.1 or 0.01 | mmol/L |
| Chloride | 50 - 200 | 0 or 0.1 | mmol/L |
| ionized Calcium | 0.2 - 5.0 | 0.01 or 0.001 | mmol/L |
| Lithium | 0.1 - 6.0 | 0.01 or 0.001 | mmol/L |
| urine | |||
| Sodium | 1-300 | 0 | mmol/L |
| Potassium | 4.5 - 120 | ||
| (60 - 120 with additional dilution) | 0.1 | mmol/L | |
| Chloride | 1 - 300 | 0 | mmol/L |
| Operating Conditions | |||
| Minimum Sample Size: | 95 μL | ||
| Sample Type: | heparinized whole blood, serum, plasma, urine | ||
| aqueous standards and acetate or bicarbonate | |||
| dialysate solutions | |||
| Sample Application: | syringe, capillary or AVL Microsampler, | ||
| collection tube or sample cup | |||
| Sample Input | automatic aspiration | ||
| Ambient Temperature: | +15 - +32 °C (59 - 90 °F) | ||
| Relative Humidity : | 5% to 95% (non-condensing) | ||
| Type of Measurement: | direct potentiometry |
Data Management
| Printout | |
|---|---|
| Interface | |
| Format 8 bits, no parity, 1 stop bit, ASCII or ASTM (bi-directional) |
Electrical Supply
| · Voltage | 100 - 240 VAC (50-60 Hz) |
|---|---|
| · Power Consumption | 1.4 VA max, 375 max. |
3
Dimensions and Weight
| . Height x width x depth 13.2 x 12.4 x 12.0 inches (33.5 x 31.5 x 29.5 cm) | |
|---|---|
| Weight | 13 lb. (6 kg) |
Classifications
| · Safety category | I |
|---|---|
| · Device type | B (according to ÖVE-MG/EN 60601-1, IEC 601-1) |
| · Mode of operation | continuous operation |
| · Protection classification | IP 20 |
| · Explosion protection | the device is not designed for operation |
| in explosive environments | |
| · Approvals | CSA, IEC 1010 (TÜV/GS), CE |
(b) (1) Summary of nonclinical tests submitted with the premarket notification for the device. Precision
Typical Within-Run (Swr) Between-Day (Sdd) and Total (ST) Precision is determined from 2 runs per day with 2 replicates per run for 20 days on two model AVL 9181 analyzers in each of its three main configurations using samples of each of the specimen types suitable for measurement on the 9181. Tests were performed in manual measurement mode (some solutions) and in automated measurement (all solutions) to demonstrate no significant difference in performance exists between the 9181 in automated and manual measurement modes; and between the 9181 and its predecessor, the AVL 9180.
Linearity in N.J.S.T. Standard Reference Material
Evaluation of linearity of Sodium, Potassium and Lithium was made in accordance to recommendations by NCCLS' using N.I.S.T. SRM 956a Electrolyte in Human Serum:
| Parameter | Slope | Intercept | Correlation
Coefficient | Sy*x |
|-----------|--------|-----------|----------------------------|--------|
| Sodium | 1.0134 | -2.5307 | 0.99988 | 0.2709 |
| Potassium | 1.0133 | -0.0230 | 0.99996 | 0.0166 |
| Lithium | 0.9717 | 0.0482 | 0.99998 | 0.0067 |
Linearity in Serum
Linearity in serum was evaluated between manual and automated measurement modes. All samples were analyzed in pairs on each of two of AVL 9181 instruments in each configuration: Na/K/Cl, Na/K/iCa and Na/K/Li. and in pairs on each of several instrument types for comparison to various methods, and measurement in
1 NCCLS. Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard. NCCLS Document C29-A. NCCLS, 771 East Lancaster Avenue, Villanova, Pennsylvania 19085, 1995.
4
both manual and automated modes of operation were compared. Linearity to measurement in serum compared to predicate methods evaluated is equivalent, and there is no significant difference in measurement results obtained in either mode of measurement (p 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.
9
adrenal gland or other diseases involving electrolyte imbalance.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.
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 ciagnosis 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.
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 diarrhea, 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.
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 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
10
AVL 9181 Analyzer 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 acid-base regulation and losses of protein and albumin, which gives a clear advantage to monitoring calcium status by ionized calcium measurements.
Patients with renal disease 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 for accurately monitoring calcium status in renal disease.
Ionized calcium is important for diagnosis or monitoring of: hypertension management, parathyroidism, renal diseases, inadequate calcium intake, vitamin D monitoring, dialysis patients, cancer, pancreatitis, effect of diuretics, malnutrition, kidney stones, multiple myeloma and diabetes mellitus.
Lithium
Lithium is a monovalent alkali metal which is usually absent in the human body. It is used in the treatment of manic depression psychosis. The drug has proven highly effective in its intended use but some clinically significant complications have been associated with its use. Lithium binding to the plasma proteins is less than 10% and its half life is 7 - 35 hrs. It is mainly eliminated from the body by urine (95%).
Lithium has a very narrow therapeutic range. Initial dosing is aimed at between 0.80 to 1.20 mmol/L and the long-term maintenance level is 0.60 to 0.80 mmol/L. The concentration of lithium in serum during therapy is closely monitored, because lithium is acutely toxic with concentrations that are slightly higher than the above therapeutic range.
Urine Electrolytes
The electrolytes present in the human body and also ingested daily from food are excreted from the body in a natural circulation via the renai system, into the urine. Measurement of electrolytes in excreted urine gives important information about the efficiency of the kidneys and other
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.
11
pathological situations. Urine examinations can be made on a random urine sample or for a quantitative determination on a 24 hour collected urine sample. The quantity of electrolytes excreted per day can be determined by multiplying the measured concentration (mmol/L) with the total quantity of urine excreted in one day.
Dialysate Electrolytes
In the dialyzer arterial blood and suitable dialysate liquids are led to a dialysis membrane in opposite directions. The structure of the membrane is such that it prevents the diffusion of proteins and red blood cells through the membrane. Since the composition of the blood and the dialysate are different, a gradient will be formed at the membrane and thus smaller molecules are activated to diffuse through the membrane. This method is effectively used to remove substances like urea, uric acid which are unable to excrete from the blood because of renal insufficiency.
When the concentration of the electrolytes between the blood and dialysate liquid deviates significantly, the electrolytes diffuse in the direction towards the lower concentration (i.e. from blood into the dialysis liquid or vice versa). Analysis of electrolytes in dialysis is of immense clinical significance and provides useful information to the clinician. The use of ISE's in dialysis are:
- · To control the patient's electrolyte balance before, during and after the dialysis for fast recognition of deviations and also for making early corrections.
- · To control the electrolyte concentrations in the dialysis liquid. Normally they are prepared by mixing appropriate concentrations of the substances with a defined quantity of distilled water.
Moore for Q. Montgomery
(Division Sign-Off)
ision of Clinical Laboratory Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)