(29 days)
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No
The device is a liquid quality control material for monitoring the performance of critical care analyzers. There is no mention of any computational or algorithmic processing, let alone AI/ML.
No.
The device is a quality control material intended to monitor the measurement of various parameters in critical care analyzers, not to directly treat or diagnose a condition.
No
This device is a quality control material intended to monitor the performance of diagnostic devices, not to diagnose medical conditions itself. It helps ensure that other instruments are working correctly before patient samples are analyzed.
No
The device description clearly states it is a "specially formulated aqueous liquid material" and contains "polystyrene microbeads," indicating it is a physical substance used for calibration and quality control, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For In Vitro Diagnostic Use".
- Intended Use: The device 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." This monitoring is done in vitro (outside the body) on the analytical instruments.
- Purpose: The purpose is to "determine the instrumentation is working properly before the analysis and report of patient specimens, or after any suspicious results have been obtained." This is a core function of quality control materials used in clinical laboratories for diagnostic testing.
- Device Description: The description details a "specially formulated aqueous liquid material intended to for use to monitor all analytes measured by the OPTI." This material is analyzed by the diagnostic instrument.
All of these points align with the definition and purpose of an In Vitro Diagnostic device, specifically a quality control material used to ensure the accuracy and reliability of diagnostic tests performed on patient samples.
N/A
Intended Use / Indications for Use
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.
Product codes
75 JJY
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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 Critical Care Analyzers.
Typical Within-Run (Swr), Between-Dav (Sdd) and Total (ST) precision were determined from two runs per day with 2 replicates per run for 20 days on a single AVL OPTI Critical Care Analyzer. Additionally, 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 and serum collected for routing analysis on existing instrumentation.
All evaluation of measurement imprecision was within manufacturer's stated claims and comparison of measurement between the OPTI Critical Care Analyzer and other instrumentation showed no significant difference (P
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/0 description: The image shows a logo with the letters "NL" in a bold, sans-serif font. Below the logo, there is a handwritten alphanumeric string that reads "K9741822". The logo and the string are both in black and are set against a white background.
510(k) Summary
JAN 2 2 1998
cientific corporat
(a) (1) Submitter's name, address AVL Scientific Corporation 33 Mansell Court Roswell, GA 30076
Contact Person Randy Byrd Quality Assurance Manager (770) 587-4040 x 631
Date of preparation of this summary:
- Device trade or proprietary name: (2)
AVL OPTI-Check Control
8 January 1998
Device common or usual name or classification name
Multi Analyte Control Solution
| CLASSIFICATION | |||
|---|---|---|---|
| PRODUCT NOMENCLATURE | NUMBER | CLASS | PANEL |
| MULTI ANALYTE CONTROL SOLUTION | 75 JJY | I | CHEMISTRY |
(3) Substantial Equivalence
A VL OPTI-check is substantially equivalent in function, safety and efficacy to a number of currently marketed devices known as 'Combi' or 'Multi-Analyte' control solutions, namely:
Multi-Function Blood Gas Control, Bionostics, Inc., K880447
Control for Blood Gases, Electrolytes and Glucose, Bionostics, Inc., K911755
Description of the new device (4)
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.
1
Intended use of the device (ર)
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.
Technological characteristics of the device. (6)
AVL OPTI-check is technologically equivalent to currently marketed products to which substantial equivalence is claimed. It contains a low concentration, 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.
(b) (1) Summary of non-clinical tests submitted with the premarket notification for the device.
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 Critical Care Analyzers.
(b) (2) Summary of clinical tests submitted with the premarket notification for the device.
Typical Within-Run (Swr), Between-Dav (Sdd) and Total (ST) precision were determined from two runs per day with 2 replicates per run for 20 days on a single AVL OPTI Critical Care Analyzer. Additionally, 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 and serum collected for routing analysis on existing instrumentation.
(b) (3) Conclusions drawn from the clinical and non-clinical trials.
All evaluation of measurement imprecision was within manufacturer's stated claims and comparison of measurement between the OPTI Critical Care Analyzer and other instrumentation showed no significant difference (P