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The AVL OPTI Critical Care Analyzer is intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, glucose, urea (BUN), 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 is a small [4.9 x 14.3 x 9.8 in, 10 lbs], instrument using optical fluorescence for the measurement of pH, PCO2, sodium, potassium, ionized calcium, choride. glucose and urea (BUN) of whole blood, plasma, serum or dialysate as appropriate. In addition, it uses scattering 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.

The provided text describes the AVL OPTI Critical Care Analyzer, focusing on its substantial equivalence to other marketed devices and its technological characteristics. However, it does not explicitly state specific acceptance criteria (e.g., performance thresholds like "accuracy must be within X%") in a table format, nor does it provide a detailed study that proves the device meets such criteria with quantitative results in the way you've requested.

Instead, the document focuses on:

• Demonstrating substantial equivalence: By comparing the AVL OPTI to existing devices and stating that there was "no significant difference in mean values (P

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The AVL OMNI™ Analyzer is intended to be used for the measurement of pH , pCO2, pCO2 , sodium, potassium, ionized calcium, chloride, hematocrit and total hemoglobin and the hemoglobin derivatives: OzHb, COHb, MetHb, HHb, SulfHb and metabolites; glucose, lactate and urea nitrogen in samples of whole blood, serum, plasma, aqueous solutions as appropriate, in a clinical laboratory setting by personnel minimally qualified to perform and to report these results.

The AVL OMNI™ Analyzer is a fully-automatic, microprocessor-controlled system that can perform up to 17 tests per sample.

Here's a breakdown of the acceptance criteria and study information for the AVL OMNI™ Modular Analyzer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a typical pass/fail format with specific thresholds. Instead, it implicitly defines acceptance through the concept of "substantial equivalence" to predicate devices and the demonstration of "no significant difference in mean values" and "correlation" during clinical trials. The "reported device performance" is largely described qualitatively.

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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

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.

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:

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The AVL OPTI Critical Care Analyzer is intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, total hemoglobin content and oxygen saturation in samples of whole blood, serum, and plasma 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 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 and potassium of whole blood, plasma or serum 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 7 tests on a single sample, determined by the type of disposable cassette used.

The AVL OPTI Critical Care Analyzer is a medical device intended for measuring pH, PCO2, PO2, sodium, potassium, total hemoglobin content, and oxygen saturation in blood, serum, and plasma samples. The device uses optical fluorescence for some measurements and optical reflectance for others.

Here's a breakdown of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: **"In all evaluations, there was no significant difference in mean values ( P

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AVL OPTI-check assayed control is intended to be used to monitor the measurement of pH, PCO2, PO2, sodium, potassium, total hemoglobin content and oxygen saturation in the AVL OPTI Critical Care Analyzer, as well as other devices measuring the same parameters and ionized calcium and chloride.

For In Vitro Diagnostic Use

The determination of acid-base status, and concentration of carbon dioxide, oxygen, electrolytes, total hemoglobin and oxygen saturation is an important adjunct to patient monitoring for a variety of clinical conditions described in the labeling for those devices used for these purposes. Since therapeutic regimes are often determined by the results obtained in patient samples, the instruments used for these analyses must meet stringent requirements for accuracy and precision of measurement. It should be the goal of the quality control program in institutions performing these analyses to determine the instrumentation is working properly before the analysis and report of patient specimens, or after any suspicious results have been obtained.

OPTI-check is a specially formulated aqueous liquid material intended to for use to monitor all analytes measured by the OPTI. It contains a stable suspension of polystyrene microbeads which reflect and partially absorb red and infrared light similar to erythrocytes, allowing true simulation of the measurement of tHb and SO2 in exactly the same manner as these analytes are determined in whole blood by the AVL OPTI Critical Care Analyzer. The three control levels contain three different concentrations of microbeads to simulate low, medium, and high hematocrit blood samples. OPT-check provides a convenient method of performing daily QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program.

While the product is optimized for performance on the AVL OPTI Critical Care Analyzer, it may be used to monitor the measurement of blood gas and electrolyte values in conventional instrumentation. OPTI-check contains clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, ionized calcium and chloride, and suitable concentrations of microbeads to simulate clinically relevant values of tHb and oxygen saturation.

The provided document describes the AVL OPTI-check Control, a multi-analyte control solution. The acceptance criteria and the study proving the device meets these criteria are outlined as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

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The AVL OMNI™ Analyzer is intended to be used for the measurement of pH , pCO2, pCO2 , sodium, potassium, ionized calcium, chloride, hematocrit and total hemoglobin and the hemoglobin derivatives: OzHb, COHb, MetHb, HHb,SulfHb and metabolites; glucose and lactate in samples of whole blood, serum, plasma, aqueous solutions as appropriate, in a clinical laboratory setting by personnel minimally qualified to perform and to report these results.

The AVL OMNI™ is a modular Critical Care Analyzer intended to be used for the measurement of pH, PCO2, PO2, ctHb, HHb, O2Hb, COHb, MetHb, SulfHb, Nat, K+, CI, ionized Ca*, Hematocrit, glucose and lactate in whole blood, serum, plasma, dialysate and QC materials as appropriate by minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting.

The AVL OMNI™ Analyzer is a fully-automatic, microprocessor-controlled system that can perform up to 16 tests per sample.

The provided text describes the AVL OMNI™ Combi Analyzer and its intended use, but it does not contain a specific section detailing the acceptance criteria and a study proving the device meets those criteria in a structured table or comprehensive study report. The document describes non-clinical tests for precision and linearity for Glucose and Lactate as additions to previous submissions, and clinical tests to demonstrate correlation with legally marketed predicate devices.

However, based on the provided text, I can infer details regarding the "Precision" and "Linearity" tests for the added Glucose and Lactate analytes, which are key performance indicators for this type of device.

Here's an attempt to construct the requested information, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for precision or linearity. Instead, it describes how precision and linearity were determined and then concludes that there was "no significant difference in mean values (P

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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.

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 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. 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. 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.

Here's a breakdown of the acceptance criteria and study information for the AVL 9181 Electrolyte Analyzer, based on the provided text:

AVL 9181 Electrolyte Analyzer: Acceptance Criteria and Study Details

The provided document describes the AVL 9181 Electrolyte Analyzer as an improved design of the existing AVL 9180 Electrolyte Analyzer [K961458], with the primary addition of an Autosampler. The studies presented focus on demonstrating that this new feature, and the overall device, performs equivalently to the predicate devices and existing manual methods.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined "acceptance criteria" in the format of specific thresholds for accuracy, precision, etc. Instead, it describes performance characteristics that were evaluated and concluded to be comparable to predicate devices and manual methods. The general acceptance criterion appears to be "no significant difference" (p wr), Between-Day (Sdd), and Total (ST) Precision determined. Tests performed in manual and automated modes. Conclusion: "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 (N.I.S.T. SRM 956a) | Strong correlation (R-value close to 1) and low Syx. | 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, Syx 0.0067
(Note: This demonstrates linearity, but a direct comparison to an acceptance threshold isn't stated.) |
| Linearity (Serum) | Equivalent linearity to predicate methods; no significant difference (p

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The AVL COMPACT 3 pH / Blood Gas Analyzer is intended to be used for the measurement of pH, PCO2 and PO2 in samples of whole blood.

The AVL COMPACT 3 pH / Blood Gas Analyzer is a fully automatic, microprocessor-controlled medical instrument that measures pH, PCO2 and PO2. Communication to the device is accomplished simply with the use of a keypad. The analyzer communicates to the user through a 4-line alphanumeric display with 20 characters per line and with a thermal printer using heat sensitive paper to output measured values, calibration reports, electrode voltages and other information.

Here's an analysis of the provided text, focusing on acceptance criteria and the study that proves the device meets those criteria:

Device: AVL COMPACT 3 pH/Blood Gas Analyzer

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating that the AVL COMPACT 3 is substantially equivalent to its predecessor (COMPACT 2) and that the changes made (numeric keypad, optimized sample volume requirements) do not introduce significant differences in performance. The acceptance criteria are implicitly derived from the existing performance of the COMPACT 2 and the statistical comparison to the "gold standard" methods (tonometry and AVL OMNI).

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