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Chem-Chex STAT is intended to be used for verifying the accuracy of i-STAT chemistry analyzers used with i-STAT test cartridges. Chem-Chex STAT is assayed for pH, Na*, Ca**, CIT, K*, BUN, Hgb, Hct, and Glucose.

Chem-Chex STAT is a suspension of stabilized mammalian red blood cells in an aqueous buffered medium. Manufactured in three clinically significant levels, it is packaged in dropper tip polyethylene vials containing 2.0 mL volumes. Closures are injection molded polypropylene screw-top caps. Vials are packaged in polystyrene jars.

This document describes the 510(k) submission for Streck Laboratories, Inc.'s "Chem-Chex STAT (New)" device, a multi-analyte control intended for verifying the accuracy of i-STAT chemistry analyzers.

Here's an analysis of the provided information against the requested categories:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria in a quantifiable manner (e.g., "accuracy must be within X%"). Instead, the "acceptance criteria" appear to be based on demonstrating:

• Reproducibility: The device consistently provides the same results under similar conditions.
• Substantial Equivalence: The device performs similarly to predicate devices (i-STAT Control and the former Chem-Chex STAT (K96115)).
• Stability: The device maintains its performance characteristics over its stated shelf-life.
• Fulfillment of Intended Use: The device effectively verifies the accuracy of i-STAT chemistry analyzers.

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

The document mentions "Three studies" were conducted:

• lot to lot reproducibility
• open and closed vial stability
• site to site comparisons at 4 different locations

However, specific sample sizes for each study or for the overall test set are not provided. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a control solution, it's highly likely these were prospective laboratory studies.

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

This information is not applicable in this context. The device is a "multi-analyte control" for chemistry analyzers. Its "ground truth" (i.e., the expected values for pH, Na+, Ca++, Cl-, K+, BUN, Hgb, Hct, and Glucose) would be established through robust analytical methods, not by expert human interpretation like in diagnostic imaging. The "assayed" nature of the control implies that these values are determined by quality control testing in a laboratory setting using highly accurate reference methods.

4. Adjudication Method for the Test Set:

This information is not applicable. Since the ground truth is established analytically for a control solution, there is no need for human expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiology AI). The Chem-Chex STAT is a quality control material for an automated analyzer, not a diagnostic tool requiring human interpretation.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

This concept is not directly applicable to a chemistry control solution. The "performance" of the Chem-Chex STAT is its ability to provide stable, reproducible, and accurate values for the analytes it contains, which are then used to verify the performance of an automated i-STAT analyzer. The device itself is not an algorithm, but a physical control material. The "testing" involves chemical analysis.

7. The Type of Ground Truth Used:

The ground truth for Chem-Chex STAT is established through analytical assay/measurement of the specific analytes (pH, Na+, Ca++, Cl-, K+, BUN, Hgb, Hct, and Glucose) within the control solution. The term "assayed chemistry control" directly implies this.

8. The Sample Size for the Training Set:

This information is not applicable. The Chem-Chex STAT is a physical control substance, not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable, as there is no "training set" for this device.

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Chem-Chex STAT is intended to be used for verifying the accuracy of i-STAT chemistry analyzers used with 6+ test cartridges. Chem-Chex STAT is assayed for Na " CI K+ BUN, Hab, Hct, and Glucose.

Chem-Chex STAT is a suspension of stabilized human red blood cells in an aqueous buffered medium. Manufactured in two clinically significant levels, it is packaged in dropper tip polyethylene vials containing 2.0 mL volumes. Closures are injection molded polypropylene screw-top caps. Vials are packaged in polystyrene iars.

Here's the analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

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

The provided text does not explicitly state specific quantitative acceptance criteria for the device's performance. It discusses "reproducibility," "substantial equivalence," and "stability," but without numerical targets or thresholds. The reported device performance is qualitative, stating that the device was "consistently reproducible," "substantially equivalent to the predicate product," and "stable for the entire product dating."

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

The document does not explicitly state the sample size used for any of the three studies conducted (lot-to-lot reproducibility, within-lot reproducibility, and stability). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

This information is not applicable to the device described. Chem-Chex STAT is a chemistry control used to verify the accuracy of a measuring instrument. Its "ground truth" would be established by reference methods or validated assay values, not by expert interpretation. Experts are not mentioned in this context.

4. Adjudication method for the test set

This is not applicable. Adjudication methods are typically used in studies involving human interpretation or diagnoses to resolve discrepancies in expert opinions. This device is a chemistry control, and its performance is assessed against established values or methods.

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 is not applicable. The device is a chemistry control, not an AI-powered diagnostic tool, and involves no human "readers" in its primary function. Therefore, no MRMC study or assessment of human improvement with AI assistance would have been conducted.

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

This is not applicable. The device is a physical chemistry control, not an algorithm. Its performance is inherent to its chemical and physical properties.

7. The type of ground truth used

The informal "ground truth" for a chemistry control involves its assigned assay values for the analytes it contains (Na+, Cl-, K+, BUN, Hb, Hct, Glucose). These values are established through rigorous analytical methods using reference materials or highly calibrated instruments. The document states "Chem-Chex STAT is an assayed control," implying that specific values for the analytes are determined and provided. However, the exact methodology for establishing these "ground truth" assay values is not detailed.

8. The sample size for the training set

This is not applicable. Chem-Chex STAT is a physical chemistry control, not a machine learning algorithm. Therefore, there is no "training set."

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

This is not applicable as there is no training set for this device.

Ask a specific question about this device