Search Results

The Compass Bioscience Cardiac Markers Controls are to be used as a quality control material to assess the accuracy and precision of laboratory test methods used to measure the antigens and enzymes contained in the control. It is intended to validate the measurement of these analytes in patient samples.

Three levels of control are provided to allow the performance of the analyte test methods to be monitored within the clinically significant range.

The Compass Bioscience Cardiac Marker Calibration Control Set is used to verify the calibration of various test methods over the measurable range of the test.

Compass Bioscience Cardiac Markers Controls are supplied in three levels, 2 x 1 mL each level per box and as a four Level Calibration Verification set, 2 x 1 mL each level per box. The controls are supplied as a ready-to-use frozen liquid, requiring no reconstitution or dilution. They are prepared in a human EDTA plasma matrix fortified to target levels with human source material and reagent grade chemicals added at different concentrations to achieve the levels. Sodium Azide

Here's a breakdown of the acceptance criteria and the study details for the Compass Bioscience Cardiac Markers Control and Calibration Verification Set, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• 30 days for CK-MB and Myoglobin
• 14 days for Troponin I and BNP | Passed: Achieved 30-day stability for CK-MB and Myoglobin, and 14-day stability for Troponin I and BNP. Testing was conducted by measuring recovery at 7-day intervals. |
  | Consistency Across Lots | No significant difference in performance across multiple lots of product. | Passed: Multiple lots of product were tested with no significant difference in performance. |

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

• Sample Size:
  • For stability testing, "multiple lots of product" were used. The exact number of lots is not specified.
  • For establishing assayed values, "multiple instruments and reagent lots" were used for calculations. The exact number is not explicitly stated.
• Data Provenance: The studies appear to be prospective as they involve real-time and accelerated stability testing of manufactured product lots. The data was generated in-house at Compass Bioscience and through interlaboratory studies. The country of origin of the data is not specified, but the manufacturing company (Compass Bioscience) is based in the USA.

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

• The term "ground truth" isn't directly applicable in the context of control materials in the same way it would be for a diagnostic device identifying disease.
• For establishing "Assayed Values" (which serve as the reference for the control material), values were determined:
  • From assays performed in the Compass Bioscience laboratory using three Triage® MeterPlus readers with specific Triage® panel tests.
  • From interlaboratory data using instrument manufacturers' reagents.
• The text doesn't specify the "number of experts" or their "qualifications" in the traditional sense. Rather, it describes a process of analytical measurement using standard laboratory equipment and interlaboratory comparison.

4. Adjudication Method for the Test Set:

• No specific adjudication method (like 2+1, 3+1, none) is described for the test set or for establishing the assayed values. The values were derived from direct measurement and interlaboratory consensus on those measurements.

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 typically evaluates the improvement in human reader performance (e.g., radiologists interpreting images) with and without AI assistance for diagnostic tasks. This device is a quality control material, not a diagnostic imaging or interpretive AI device.

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

• This question is not applicable to this device. The Compass Bioscience Cardiac Markers Control and Calibration Verification Set is a laboratory reagent (control material), not an algorithm or AI software. Its performance is evaluated based on its stability and its ability to provide consistent, established analyte levels when tested on laboratory instruments.

7. The Type of Ground Truth Used:

• As mentioned in point 3, the concept of "ground truth" as a diagnostic outcome is not strictly applicable.
• The "ground truth" for the control material itself is its established assayed values, which are derived from:
  • Expert consensus/analytical measurement: Assays performed in-house using multiple instruments (Triage® MeterPlus readers) and specific test panels.
  • Interlaboratory data: Data obtained from other laboratories using various instrument manufacturers' reagents.
  • These values form the reference against which other measurements (e.g., during stability testing or routine QC) are compared.

8. The Sample Size for the Training Set:

• This question is not applicable to this device. As a control material, it does not use a "training set" in the context of machine learning or algorithm development. The "training" in this context would refer to the process of establishing the assayed values for the control material, as described in point 7.

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

• This question is not applicable as there is no "training set" for an algorithm. However, if we interpret "ground truth for the training set" as "how the assayed values for the control material were established," then:
  • Assayed values for package inserts were established by:
    • Performing assays in the Compass Bioscience laboratory using three Triage® MeterPlus readers with the Triage® Profiler S.O.B.™ Panel tests, the Triage® CardioProfiler Panel, and the Triage® Cardiac Panel.
    • Collecting and analyzing interlaboratory data using various instrument manufacturers' reagents.
    • Mean values were calculated from multiple instruments and reagent lots.
    • Ranges were determined based on 2 SD - 3 SD of the overall mean values derived from stability and interlaboratory data.

Ask a specific question about this device

The Compass Bioscience Hemoglobin A1c Control is to be used as a quality control material to assess the accuracy and precision of laboratory test methods used to measure Hemoglobin A1c levels. It is intended to validate the measurement of Hemoglobin A1c in patient samples.

Two levels of control are provided to allow the performance of the analyte test methods to be monitored within the clinically significant range.

The Compass Bioscience Hemoglobin A1c Control is supplied as frozen liquid in two levels and consists of a human whole blood matrix adjusted to target concentrations of glycated hemoglobin (HbA1c) and containing preservatives and stabilizers. Assayed values are determined from interlaboratory data.

Hemoglobin A1c Assayed Controls are supplied in two levels, 3 x 1 mL each level per box . The controls are supplied as a ready-to-use frozen liguid, requiring no reconstitution or dilution. They are prepared in a human whole blood matrix adjusted to target concentrations of HbA1c. Stabilizers and preservatives have been added to inhibit microbial growth.

This submission describes a Hemoglobin A1c Assayed Control (K060570) and its substantial equivalence to an existing predicate device for quality control in laboratory settings. The performance criteria and testing focus on product stability rather than diagnostic accuracy as the device is a control material, not a diagnostic test.

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: The document does not specify the exact number of individual samples or vials tested for each stability study. It mentions testing "multiple lots of product" for open vial stability but does not provide a specific number.
• Data Provenance: The studies are described as "accelerated stability studies" and "real-time stability testing." Given the context of a 510(k) submission to the FDA, it is highly likely these studies were conducted in the US (where Compass Bioscience is based). The studies appear to be prospective, as they involve monitoring the product over time under defined storage conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this submission. The device is a quality control material, not a diagnostic device requiring expert interpretation of results. The "ground truth" for the test set (stability studies) is defined by the initial concentration of HbA1c in the control material and its change over time, or by interlaboratory assayed values.

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

This is not applicable to this submission as there is no human interpretation or adjudication of performance based on the type of data presented (stability measurements).

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 quality control material, not an AI-assisted diagnostic tool.

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 control material, not an algorithm.

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

The "ground truth" for the stability studies is primarily:

• Initial test value: The concentration of HbA1c in the control material at the start of the stability study (day 0).
• Interlaboratory data: For assayed values, the ground truth is established collectively from interlaboratory studies using various instrument manufacturers' reagents. This represents a consensus of measured values across different laboratory settings.

8. The sample size for the training set

This is not applicable. The device is a quality control material, not a machine learning model that requires a training set.

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

This is not applicable for the reasons stated in point 8.

Ask a specific question about this device