Search Results

The i-STAT CHEM8+ cartridge with the i-STAT 1 System is in the in vitro quantification of total carbon dioxide in arterial or venous whole blood in point of care or clinical laboratory settings.

Carbon dioxide measurements are used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

The i-STAT CHEM8+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for total carbon dioxide (TCO2). The test is contained in a single-use, disposable cartridge. Cartridges require two to three drops of whole blood which are typically applied to the cartridge using a transfer device.

The i-STAT 1 Analyzer is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. The instrument interacts with the cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).

The i-STAT 1 System is comprised of the i-STAT 1 analyzer, the i-STAT test cartridges and accessories (i-STAT 1 Downloader/Recharger, electronic simulator and portable printer). The system is designed for use by trained medical professionals at the patient point of care or in the clinical laboratory and is for prescription use only.

The provided document is a 510(k) Summary for the Abbott Point of Care i-STAT CHEM8+ cartridge with the i-STAT 1 System, which performs in vitro quantification of total carbon dioxide (TCO2) in whole blood.

The acceptance criteria for the device are implicitly demonstrated through the performance characteristics presented, primarily focusing on precision, linearity, limit of quantitation (LoQ), and a method comparison study with a predicate device. The study aims to demonstrate substantial equivalence to the predicate device, SYNCHRON Systems TCO2 Reagent on UniCel DxC 600/800 SYNCHRON Clinical System (K042291).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a table format with specific numerical targets. Instead, performance is presented against standard clinical laboratory guideline (CLSI) expectations and compared to a predicate device. The "acceptance" can be inferred from the reported results meeting generally accepted analytical performance standards for clinical assays and demonstrating substantial equivalence to the predicate.

For this response, I will interpret "acceptance criteria" as the performance metrics evaluated and "reported device performance" as the results obtained from the study.

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

• Precision (Whole Blood):
  • Test Set Size: 279 samples (178 venous, 101 arterial).
  • Data Provenance: Not explicitly stated as retrospective or prospective, but the phrasing "collected across three point of care sites" suggests these were fresh clinical samples collected for the purpose of the study (prospective or near-patient testing).
• Linearity (Whole Blood):
  • Test Set Size: Not explicitly stated as a single number of samples, but involved preparing "whole blood samples of varying analyte levels that spanned the reportable range of the test."
  • Data Provenance: Implied to be laboratory-prepared whole blood samples, likely prospective.
• Limit of Quantitation (LoQ):
  • Test Set Size: Not explicitly stated as a single number of samples, but used "whole blood that was altered to low TCO2." The study was conducted over four (4) days using two (2) cartridge lots.
  • Data Provenance: Implied to be laboratory-prepared whole blood samples, likely prospective.
• Interference:
  • Test Set Size: Not explicitly stated as a single number of samples, but involved "whole blood test samples based on CLSI EP07-A2."
  • Data Provenance: Implied to be laboratory-prepared whole blood samples, likely prospective.
• Method Comparison:
  • Test Set Size: 294 specimens (183 lithium heparin venous whole blood, 111 lithium heparin arterial whole blood). 21 of these (7.14%) were "contrived" (meaning altered or spiked samples to extend the range).
  • Data Provenance: Collected across three point of care sites, suggesting prospective clinical samples. The "contrived" samples are laboratory-prepared.

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

This type of information is generally not applicable for quantitative clinical chemistry assays like the one described. The "ground truth" for TCO2 is established by a reference method or a predicate device. In this case, the predicate device (SYNCHRON Systems TCO2 Reagent on UniCel DxC 600/800 SYNCHRON Clinical System) serves as the comparator or "reference method" for the method comparison study. Clinical experts are not typically involved in establishing the numerical ground truth for such analytes; rather, laboratory professionals operating validated equipment do.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in image-based diagnostic studies where human experts individually interpret results and a consensus process is needed to establish ground truth or resolve discrepancies. For this quantitative clinical chemistry device, the comparison is directly between numerical results from the candidate device and the predicate device/reference method.

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

Not applicable. This device is a fully automated quantitative clinical chemistry analyzer. There are no "human readers" involved in interpreting results from the device in a diagnostic context that would require an MRMC study or AI assistance. The device provides a numerical output for TCO2.

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

Yes, the studies presented are all standalone performance evaluations of the i-STAT CHEM8+ cartridge with the i-STAT 1 System. The device provides a direct quantitative measurement of TCO2 in whole blood without the need for human interpretation or further input once the sample is loaded and the test initiated. The precision, linearity, LoQ, interference, and method comparison studies evaluate the algorithm/device performance directly.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the method comparison study was established by comparison to a legally marketed predicate device, the SYNCHRON Systems TCO2 Reagent on UniCel DxC 600/800 SYNCHRON Clinical System. For analytical performance studies (precision, linearity, LoQ, interference), the ground truth is based on the expected values of control materials or the known concentrations of prepared samples, often traceable to a reference measurement procedure (as mentioned for "Traceability: IFCC Reference Measurement Procedure" in Section 6, though this is for the candidate device, implying its own internal traceability).

8. The Sample Size for the Training Set

Not applicable. This device is a quantitative clinical chemistry analyzer, not a machine learning or AI-based diagnostic tool that typically requires a large "training set" in the conventional sense of AI development. While there is likely internal development and calibration data, the document does not refer to a distinct "training set" for an algorithm in the way it is discussed for AI/ML devices. The "training" for such devices often refers to rigorous calibration and verification procedures in the manufacturing process.

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

Not applicable for the reasons stated in point 8.

Ask a specific question about this device

The GenChem CO2 Acid Reagent when used in conjunction with the GenChem ISE Electrolyte Reference, GenChem Electrolyte Buffer, GenChem CO2 Alkaline Buffer, GenChem Wash Concentrate, and appropriate Calibrators or Calibration Standards is intended for the quantitative determination of Carbon Dioxide in serum and plasma on the Beckman CX3®. Carbon Dioxide results are used in the diagnosis and treatment of numerous and potentially serious disorders associated with changes in the body's acidbase balance.

The Device is a solution containing 0.6 mol/L sulfuric acid, nonreactive surfactants and other ingredients necessary for optimum system operation.

The provided text describes performance characteristics for the GenChem CO2 Acid Reagent, primarily focusing on its analytical performance rather than diagnostic accuracy against a ground truth dataset. Therefore, some of the requested information, particularly regarding expert consensus, MRMC studies, and ground truth establishment for a diagnostic algorithm, is not applicable or cannot be extracted from this document, as it describes a laboratory reagent for quantitative measurement of CO2.

Here's the information that can be extracted and presented according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Precision Study:
  • Sample Size: 60 measurements for each of 3 control sera (2 measurements/day in triplicate over 10 days).
  • Data Provenance: Not explicitly stated, but results are from tests performed on control sera.
• Patient Comparison Study:
  • Sample Size: 80 serum samples and 80 plasma samples.
  • Data Provenance: "Collected from adult patients." No specific country of origin is mentioned. These appear to be retrospective samples used for comparison.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This document describes the performance of a reagent for quantitative CO2 measurement, not a diagnostic algorithm that requires expert ground truth establishment in the traditional sense (e.g., for image interpretation). The "ground truth" for the patient comparison study would be the measurements obtained by the predicate device (Beckman CO2 Reagent on the CX3®). No human experts are mentioned for establishing ground truth for the test set.

4. Adjudication method for the test set

Not applicable. The study involves quantitative measurements of CO2, not subjective interpretations requiring adjudication.

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

Not applicable. This is a submission for a chemical reagent, not an AI-powered diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a submission for a chemical reagent. Its performance is inherently "standalone" in generating a quantitative value, as it's not an algorithm that assists a human.

7. The type of ground truth used

• Precision, Linearity, Sensitivity, Analytical Specificity: These studies use controlled materials with known or expected values as their reference. The "ground truth" is the established chemical and analytical properties of the reference materials.
• Patient Comparison: The "ground truth" for comparison was the measurements obtained by the predicate device (Beckman CO2 Reagent on the CX3®).

8. The sample size for the training set

Not applicable. This is a submission for a chemical reagent, not an AI-powered device that requires a training set. The "development" would involve chemical formulation and validation rather than algorithm training.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned for this type of device.

Ask a specific question about this device

The SYNCHRON LX Clinical Systems are fully automated, computer controlled, clinical chemistry analyzers intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid (sample type is chemistry dependant).

SYNCHRON LX ISE Electrolyte Buffer Reagent, SYNCHRON LX ISE Electrolyte Reference Reagent, and CO2 Alkaline Buffer and Acid Reagent, in conjunction with SYNCHRON LX AQUA CAL 1 and 3, are intended for quantitative determination of carbon dioxide (CO2) in serum or plasma on SYNCHRON LX Systems.

SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1 and 2, are intended for quantitative determination of calcium (CALC) in serum, plasma or urine on SYNCHRON LX Systems.

SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1 and 2, are intended for quantitative determination of chloride (CL) in serum, plasma, urine or cerebrospinal fluid (CSF) on SYNCHRON LX Systems.

SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium (K) in serum, plasma or urine on the SYNCHRON LX System.

SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1, 2 and 3, are intended for the quantitative determination of sodium (NA) in serum, plasma or urine on the SYNCHRON LX System.

The SYNCHRON LX Clinical Systems are fully automated, computer controlled, clinical chemistry analyzers intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid (sample type is chemistry dependent). The analyzers operate in conjunction with reagents, calibrators, and controls designed for use with the system. The instruments feature bar code identification of samples and reagents. Thev automatically dilute samples and deliver them to the associated reaction vessel for each system module (cuvette, cup, or ISE flowcell) along with reagents and reaction constituents. The systems analyze up to 41 analytes per sample.

Major hardware components include a reagent compartment, sample and reagent cranes, cartridge chemistry section, modular chemistry section, sample carousel and crane, hydropneumatics, electronics, and power supplies.

The LX20 PRO is differentiated from the standard LX20 system with the following hardware: LPIA (Large Particle Immunoassay) Module and TS-CTS (Thick Stopper-Closed Tube Sampling) Module

The fixed menu ISE flow cell module is contained in the modular chemistry area. The ISE flow cell contains ISE electrodes for the measurement of Sodium (NA), Potassium (K), Chloride (CL), carbon dioxide (CO2), and Calcium (CALC).

The modified SYNCHRON LX Systems utilize a new ISE (Ion Selective Electrode) sample volume of 40 µL. The prior sample volume was 62µL.

The provided text is a 510(k) Summary for the SYNCHRON LX® Clinical Systems (ISE Module Chemistries). It describes a modification to an existing device rather than a new diagnostic algorithm. Therefore, the traditional "acceptance criteria" and "study" framework for diagnostic devices (especially those involving image analysis or AI) does not directly apply in the same way.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared device, specifically highlighting changes to the ISE sample volume. The performance data mentioned in section 8.0 ("Performance data from validation testing supports equivalency") would relate to verifying that this change does not negatively impact the accuracy, precision, and other operational characteristics of the device, ensuring it still performs as expected for its intended use.

Here's how to interpret the request in the context of this document:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly list numerical acceptance criteria or detailed performance metrics. It generally states that "Performance data from validation testing supports equivalency." For medical devices like these, acceptance criteria would typically involve demonstrating that the modified device's performance (e.g., accuracy, precision, linearity, limits of detection) falls within predefined ranges relative to the predicate device or established clinical standards. Without the full validation report, specific numbers cannot be extracted.

2. Sample size used for the test set and the data provenance:

The document doesn't specify the sample size for the test set or the data provenance (country of origin, retrospective/prospective). This information would usually be found in the detailed validation study report, not typically summarized in the 510(k) summary itself, which focuses on the overall conclusion of substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable to the type of device and study described. This device measures chemical analytes (Sodium, Potassium, Chloride, Carbon Dioxide, Calcium) in bodily fluids. The "ground truth" for these measurements is established through calibrated reference methods, internal laboratory controls, and potentially external quality assessment schemes, not by expert consensus (e.g., radiologists interpreting images).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used when there's subjective interpretation involved, such as in image analysis, where multiple readers might disagree, and a tie-breaking mechanism is needed. For an automated clinical chemistry analyzer, the results are quantitative measurements, and "adjudication" in this sense doesn't occur.

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:

This question is not applicable. The device is a clinical chemistry analyzer, not an AI-powered diagnostic tool for image analysis or other subjective assessments requiring human readers. Therefore, an MRMC study or AI assistance is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:

This question is partially applicable, but rephrased. The SYNCHRON LX Clinical Systems are inherently "standalone" in their measurement function; they are automated instruments that perform the assays without direct human intervention in the measurement process itself. The "algorithm" here would be the instrument's internal logic for sample processing, reagent mixing, detection, and calculation of analyte concentrations. The validation would demonstrate the accuracy and reliability of this automated process. The primary function is to provide an objective measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for this type of device (clinical chemistry analyzer) would be established using:

• Calibrated reference materials: Solutions with known, highly accurate concentrations of the analytes.
• Reference methods: Established, highly accurate laboratory methods (e.g., isotope dilution mass spectrometry for some analytes) against which the device's measurements are compared.
• Internal quality control materials: Samples with established expected ranges that are run regularly to ensure the device is performing correctly.
• Patient samples compared to a predicate device: As this is a modification, a key part of the validation would involve comparing results from the modified device to the predicate device using a range of patient samples.

8. The sample size for the training set:

This question is not applicable in the typical sense of machine learning "training sets." While the instrument's development certainly involved extensive testing and optimization (which could be considered a form of "training" in engineering terms), it's not a machine learning model that learns from labeled data in the way AI algorithms do. The design is based on established electrochemical principles.

9. How the ground truth for the training set was established:

Not applicable for the reasons stated above.

Summary Table based on the provided input (and acknowledging non-applicability):

Ask a specific question about this device

Used to measure carbon dioxide concentrations in serum or plasma on the SYNCHRON CX®3 System.

CO2 Acid Reagent, Procedure Number C7558

This document is a 510(k) Notification for a diagnostic medical device, specifically the Sigma Diagnostics CX®3 CO2 Acid Reagent. It is not based on AI/ML; it's a traditional chemical reagent for measuring carbon dioxide. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, training set details) are not applicable to this type of device and study.

However, I can extract the information relevant to its performance and acceptance criteria based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

to measure carbon dioxide concentrations in serum or plasma on the SYNCHRON CX 3 System

CO2 Alkaline Buffer, Procedure Number C7683

Here is an analysis of the provided text based on your request, focusing on the acceptance criteria and study details for the Sigma Diagnostics CO2 Alkaline Buffer:

This 510(k) premarket notification describes a new device (Sigma Diagnostics CO2 Alkaline Buffer) and demonstrates its substantial equivalence to a predicate device (Beckman CO2 Alkaline Buffer Kit). The study's primary goal is to show that the new device performs as safely and effectively as the existing one.

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

Both electrolyte buffers are used to measure sodium, chloride, potassium, and carbon dioxide concentrations in serum or plasma, sodium, potassium, and chloride concentrations in urine, and chloride concentrations in CSF on the SYNCHRON CX 3 System

The Sigma Diagnostics methods use ion selective electrodes for determining sodium, potassium, and chloride and rate of pH change for determing carbon dioxide on the SYNCHRON CX 3 System.

The provided text describes the summary of safety and effectiveness for the Sigma Diagnostics CX®3 Electrolyte Buffer, Procedure Number E3766. It focuses on demonstrating substantial equivalence to a predicate device (Beckman Electrolyte Buffer Kit, Part No. 443325) through comparison studies, precision, and linearity.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to a predicate device, focusing on correlation coefficients, regression equations indicating agreement, and acceptable levels of precision and linearity.

Ask a specific question about this device

Ask a specific question about this device