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C.f.a.s. (Calibrator for automated systems) HbA1c is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.

C.f.a.s. HbA1c is single-level lyophilized calibrator based on hemolyzed sheep blood and human blood. The concentrations of the calibrator components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers. During use, calibrator dilutions are prepared automatically on-board the analyzer resulting in six levels.

The provided text is a 510(k) summary for a medical device called "C.f.a.s. (Calibrator for Automated Systems) HbA1c". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance data as often seen for diagnostic or therapeutic devices.

Therefore, many of the requested elements for a study proving device performance are not directly available in the provided text. The summary emphasizes the similarities and differences between the new calibrator and its predicate, asserting that these differences do not raise new questions of safety or effectiveness.

Here's a breakdown of what can and cannot be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the document as it would be for a typical performance study. For a calibrator, "performance" is typically related to its stability, accuracy in providing a known concentration, and its ability to enable accurate measurements by the instrument it calibrates. The document asserts that the new device is substantially equivalent to a predicate calibrator.

The "acceptance criteria" for a calibrator like this would typically involve:

• Assigned value accuracy: The calibrator, once reconstituted, must have an accurate and stable assigned value for HbA1c.
• Stability: Meeting the stated stability claims (unopened, reconstituted at different temperatures and durations).
• Method compatibility: Successfully calibrating Roche clinical chemistry analyzers for Roche HbA1c methods, leading to accurate patient sample results.

The document implies these criteria are met by stating substantial equivalence to a predicate device with identical core characteristics. No quantitative performance metrics are provided in this summary.

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

This information is not provided in the document. As a 510(k) summary for a calibrator, it focuses on the device's characteristics and its equivalence to a predicate, not on a clinical trial with a "test set" of patient data.

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

This information is not applicable/not provided. The device is a calibrator, not a diagnostic tool that interprets patient data. Therefore, there's no "ground truth" for a test set of patient cases established by experts in this context. The "ground truth" for a calibrator would be its accurately assigned HbA1c concentration.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. There is no "test set" of patient data that would require expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This information is not applicable/not provided. This type of study is relevant for diagnostic imaging or interpretation devices where human performance is being evaluated, and is not relevant for a calibrator.

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

This information is not applicable/not provided. The device is a calibrator, not an algorithm.

7. The Type of Ground Truth Used

For a calibrator, the "ground truth" would be the assigned value of the analytes (HbA1c in this case) at each level of the calibrator. This value is established through highly accurate reference methods and/or traceability to international reference materials. The document implies this "ground truth" is reliably established, making the calibrator suitable for its intended purpose.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This concept applies to machine learning algorithms, not to a medical calibrator.

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

This information is not applicable/not provided.

In summary: The provided 510(k) summary for the C.f.a.s. HbA1c calibrator is a submission focused on demonstrating substantial equivalence to a predicate device. It highlights the physical, chemical, and functional similarities, and explains the differences (such as handling, levels, and stability conditions) without presenting specific, quantitative performance study data or details on "acceptance criteria" as they might apply to a diagnostic or therapeutic device. The "study" here is the comparison to the predicate device, asserting that the new device performs equivalently for its intended use as a calibrator.

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The CDS Hematology Calibrator for red cell, white cell and platelet counting is a device that resembles red cells, white cells and platelets in whole blood specimens and is intended to serve as a calibration standard for automated hematology analyzers, including Beckman Coulter: S-Plus IV-VI series, STKR, JS, JR, ST and JT series, STKS, MAXM, MD, Counto, OnyX, T series and A . T and A . T diff series analyzers; the Abbott Cell-Dyn 1100, Cell-Dyn 1400, 1500, 1600 and 1700 analyzers; and the Danam EXCEL 16 and EXCEL 22 and Coulter Ac T diff analyzers used to count red cells, white cells and platelets. It is a stable suspension of particles whose size, shape, concentration and other characteristics have been precisely and accurately determined.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for the CDS Hematology Calibrator (CDS CAL). It states that the device is substantially equivalent to legally marketed predicate devices, meaning it can be marketed. However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about performance, sample size, ground truth, or expert qualifications.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory approval based on "substantial equivalence" rather than detailed performance metrics and studies.

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The tHb Cal Standard is intended for use in calibrating the total hemoglobin channel of the IL CO-Oximeters and Oximeters.

The product encompassed by this 510(k) submission is a Class II (81KRZ) In Vitro Diagnostic Solution manufactured by ALKO Diagnostic Corporation. The tHb Cal Standard is intended to serve as direct replacement to like named product manufactured by Instrumentation Laboratory Company. ALKO Product A331-50 (tHb Cal Standard) is equivalent to Instrumentation Laboratory product 33150-50 (Cal Dye and Reference Standard). ALKO uses a similar composition, description and packaging design as that used by Instrumentation Laboratory Company in its products.

Here's a breakdown of the acceptance criteria and study findings for the ALKO Diagnostics Corporation's tHb Cal Standard, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ALKO tHb Cal Standard are implicitly defined by its equivalence to the predicate device, Instrumentation Laboratory's Cal Dye™ Reference Standard, and its ability to consistently calibrate CO-Oximeters and Oximeters within acceptable ranges. The performance metrics reported are precision (as Total and Run-to-Run CV%) and comparative agreement with assayed values and the predicate device.

• Level 1 (Mean 16.9): Total CV% 0.6993, Run to Run CV% 0.3826
• Level 2 (Mean 13.8): Total CV% 0.8340, Run to Run CV% 0.5857
• Level 3 (Mean 7.2): Total CV% 1.0758, Run to Run CV% 0.7435

These CV% values are very low, indicating high precision. |
| Comparative Data (tHb Cal Standard vs. Predicate) | The ALKO tHb Cal Standard should yield total hemoglobin (tHb) values that are effectively equivalent to those obtained with the IL Cal Dye™ Reference Standard when measured on the same IL CO-Oximeters/Oximeters. The mean tHb values, standard deviations, and CV% should be very similar, and the measured range (min-max) should encompass or align closely with the assayed values and the predicate's performance. Consistency across different instrument models (IL 282, IL 482) is also a criterion. | On IL 282:

• IL 33150 (Predicate): Mean 14.7, STD 0.0653, CV% 0.4450, tHb min.-max. 14.6-14.8, Assay Value 14.8
• ALKO A331-50: Mean 15.0, STD 0.0499, CV% 0.3316, tHb min.-max. 15.0-15.1, Assay Value 15.0

On IL 482:

• IL 33150 (Predicate): Mean 14.9, STD 0.0730, CV% 0.4901, tHb min.-max. 14.8-15.0, Assay Value 14.9
• ALKO A331-50: Mean 14.8, STD 0.0442, CV% 0.2993, tHb min.-max. 14.7-14.8, Assay Value 14.8

The mean tHb values, SDs, and CV% are very close between the ALKO and IL products on both instruments, demonstrating strong agreement and comparability. The measured ranges are also consistent with the respective assayed values. |
| Functional Equivalence (with predicate) | When used to calibrate IL CO-Oximeters/Oximeters, the ALKO tHb Cal Standard should enable the instrument to produce mean values for various blood gas parameters (tHb, %O2Hb, %COHb, %MetHb, O2 Ct, %RHb) from control samples that fall within the assayed control ranges and are comparable to results obtained when the instrument is calibrated with the predicate IL Cal Dye™ Reference Standard. | On IL 282 & IL 482: For all three control levels and across all measured parameters (tHb, %O2Hb, %COHb, %MetHb, O2 Ct, %RHb), the mean values obtained when calibrating with ALKO tHb Cal Standard are very similar to those obtained with the IL Cal Dye™ Reference Standard. Critically, these mean values consistently fall within the specified "Assayed Control Values" ranges, which broadens the acceptance window. The results demonstrate that the ALKO calibrator allows the instruments to perform functionally equivalently to calibration with the predicate. |

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

• Precision Test Set: The precision study used three levels of IL CO-OX controls. Each level was analyzed 3 times per run, for 5 runs, after a separate calibration for each run. This totals 15 data points (N=15) for each level for "Total" precision, and 5 data points (N=5) for "Run to Run" precision (representing the 5 runs).
• Comparative Data Test Set: For both the IL 282 and IL 482 analyzers, 15 measurements (N=15) were taken for both the IL predicate product and the ALKO product.
• Functional Tests Test Set: Three levels of IL CO-OX controls were measured in triplicate (meaning 3 measurements per level). This was done after calibrating separately with the ALKO standard and the IL predicate standard. (The exact total number of individual measurements for functional tests across all parameters is not explicitly stated as 'N' in a table, but it implies 3 measurements * 3 levels * 2 calibration methods * number of parameters).
• Data Provenance: The data was generated by ALKO Diagnostic Corporation, 333 Fiske Street, Holliston, MA 01746, USA. This indicates the testing was done in the USA. The study appears to be prospective as it involves direct testing and comparison of the ALKO product against the predicate and control materials with specific measurement protocols.

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

The document does not mention the use of experts to establish ground truth for the test set. Instead, the ground truth is established through:

• Assayed values: For the comparative data and functional tests, "Assay Value" or "Assayed Control Values" are provided, which represent the target or expected values for the control materials. These values are typically established by the control manufacturer using reference methods or multiple laboratory testing, not by ad-hoc experts for this specific study.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method in the context of expert review. The study relies on direct quantitative comparison of instrument readings against established assay values or predicate device performance.

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 as the device is an in-vitro diagnostic solution (calibrator) for an instrument, not an AI-powered diagnostic imaging or decision support tool that is interpreted by human readers.

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

This is standalone performance in the context of an IVD calibrator. The performance of the ALKO tHb Cal Standard is assessed by its direct functional impact on the IL CO-Oximeters/Oximeters, allowing them to accurately measure control samples. There is no "human-in-the-loop" interpretation beyond the operation of the instrument itself. The study objective is to show the calibrator functions on its own to enable accurate instrument readings.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used consists of:

• Assayed Values: These are reference values provided by the manufacturer of the IL CO-OX controls for specific parameters (tHb, %O2Hb, etc.). These are typically established through rigorous analytical testing using reference methods.
• Predicate Device Performance: The performance of the Instrumentation Laboratory Cal Dye™ Reference Standard is used as a direct benchmark, as the ALKO product is intended to be a direct replacement and functionally equivalent. The equivalence to an already marketed and presumably validated product serves as a form of "ground truth" for comparative studies.

8. The Sample Size for the Training Set

This is not applicable. The ALKO tHb Cal Standard is an in-vitro diagnostic reagent (calibrator), not an algorithm or AI model that requires a training set. The "composition, description and packaging design" mention indicates a manufacturing process, not a machine learning process.

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

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

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