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CR-E reagent, when used in conjunction with SYNCHRON® Systems, UniCel® DxC Systems and SYNCHRON® Systems AQUA CAL 1 and 2 and SYNCHRON CX® Calibrator Level 1 and 2, is intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine (urine is not available on the SYNCHRON CX PRO Systems).

Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

CR-E reagent is used to measure the creatinine concentration by an enzymatic method. This enzymatic creatinine method utilizes a multi-step approach ending with a photometric end-point reaction.

The SYNCHRON Enzymatic Creatinine (CR-E) Reagent is designed for optimal performance on the SYNCHRON LX, UniCel® DxC 600/800, and SYNCHRON CX® PRO Clinical Systems. The reagent kit contains two 200-test cartridges that are packaged separately from the associated calibrator.

Here's an analysis of the provided text regarding the SYNCHRON® Systems Enzymatic Creatinine (CR-E) Reagent, structured according to your request:

Acceptance Criteria and Device Performance Study for SYNCHRON® Systems Enzymatic Creatinine (CR-E) Reagent

1. Table of Acceptance Criteria and Reported Device Performance

Note: The primary acceptance criterion highlighted in the document is the successful extension of the Limit of Detection (Analytical Sensitivity) for serum samples to 0.1 mg/dL, replacing the previous 0.2 mg/dL. The urine sample LoD remained unchanged and met the existing criterion. The overall performance is implicitly tied to demonstrating "substantial equivalence" to the predicate device.

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

The document states: "Performance data from validation testing supports equivalency." However, it does not explicitly provide the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). This information is typically found in the detailed validation reports submitted to the FDA, but is not included in this summary.

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

The document does not provide information on the number of experts used or their qualifications to establish ground truth. For in vitro diagnostic devices like this, ground truth is typically established by comparing the device's results to a recognized reference method or to results from a legally marketed predicate device, rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for a test set. This type of method is usually applied in studies involving subjective interpretation (e.g., imaging studies) rather than quantitative chemical assays. For this device, the "ground truth" would be the result from a reference method or the predicate device, and the comparison would be statistical.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices where human readers interpret observations (e.g., radiology AI). The SYNCHRON® Systems Enzymatic Creatinine Reagent is an automated in vitro diagnostic device, where the measurement is quantitative and performed by the instrument.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was done. The SYNCHRON® Systems Enzymatic Creatinine (CR-E) Reagent is an automated assay run on the SYNCHRON LX, UniCel® DxC 600/800, and SYNCHRON CX® PRO Clinical Systems. The "performance data from validation testing" that "supports equivalency" would inherently be a standalone evaluation of the reagent's analytical performance on these instruments. There is no human interpretation component where the results are subsequently re-evaluated by a human to influence the device's performance.

7. Type of Ground Truth Used

The type of ground truth used is comparison to a legally marketed predicate device (K091742) and, implicitly, to established analytical methods for creatinine measurement. The validation testing would involve comparing the CR-E reagent's results against a gold standard or a well-characterized reference method, likely by linearity, precision, and accuracy studies, or by demonstrating concordance with the predicate device. The primary change here is an extended Limit of Detection for serum, which would have been validated against samples with known low creatinine concentrations.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. For an in vitro diagnostic reagent, there isn't typically a "training set" in the machine learning sense. Instead, the reagent's formulation and assay parameters are developed and optimized through extensive R&D and early validation studies using various concentrations of known analytes and patient samples. The "training" is part of the product development and optimization process, not a distinct "training set" as understood in AI/ML validation studies.

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

As explained in point 8, the concept of a "training set ground truth" isn't directly applicable in the same way it would be for an AI/ML algorithm. However, throughout the development and optimization of the reagent, the "ground truth" for determining assay parameters and performance would have been established by:

• Reference Methods: Using highly accurate and precise reference methods (e.g., isotope dilution mass spectrometry) to determine the true creatinine concentration in control materials and patient samples.
• Known Concentrations: Preparing solutions with precisely known concentrations of creatinine.
• Comparison to Predicate: Benchmarking performance against the legally marketed predicate device (Beckman Coulter SYNCHRON Systems Enzymatic Creatinine (CR-E) reagent, K091742) during development and optimization.

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CR-E reagent, when used in conjunction with SYNCHRON® Systems, UniCel® DxC Systems and SYNCHRON® Systems AQUA CAL 1 and 2 and SYNCHRON CX® Calibrator Level 1 and 2, is intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine (urine is not available on the SYNCHRON CX® PRO Systems). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

CR-E reagent is used to measure the creatinine concentration by an enzymatic method. This enzymatic creatinine method utilizes a multi-step approach ending with a photometric end-point reaction. The SYNCHRON Enzymatic Creatinine (CR-E) Reagent is designed for optimal performance on the SYNCHRON LX®, UniCel® DxC 600/800, and SYNCHRON CX® PRO Clinical Systems. The reagent kit contains two 200-test cartridges that are packaged separately from the associated calibrator.

The provided [K091742](https://510k.innolitics.com/search/K091742) document describes the SYNCHRON® Systems Enzymatic Creatinine (CR-E) Reagent. The acceptance criteria and the study that proves the device meets them are summarized below.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for slope, intercept, R-value, or %C.V. for its performance metrics. Instead, it presents the results of its performance studies (method comparison and precision studies) which are then compared to a legally marketed predicate device (SYNCHRON Systems Creatinine (CR-S) Reagent) to demonstrate substantial equivalence. For the purpose of this response, "reported device performance" refers to the values obtained in the studies.

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

• Method Comparison Studies:

  • Serum (CX7 PRO Platform): N = 78 samples
  • Serum (DxC800 Platform): N = 80 samples
  • Urine (DxC800 Platform): N = 66 samples
  • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it is a premarket submission for a medical device to the FDA, it is highly likely these were prospective studies conducted to demonstrate equivalence for regulatory approval.

• Precision Studies:

  • CX7 PRO Platform: N = 80 for each of the 4 sample levels/pools (Level 1, Level 2, Level 3, Human Pool) for both within-run and total imprecision.
  • DxC800 Platform (Serum): N = 80 for each of the 4 sample levels/pools for both within-run and total imprecision.
  • DxC800 Platform (Urine): N = 80 for each of the 2 urine sample levels/pools for both within-run and total imprecision.
  • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is implied these were prospective studies.

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

The ground truth in this submission is established through comparison to a predicate device (SYNCHRON Systems Creatinine (CR-S) Reagent), which is a legally marketed device often used as a reference method in clinical laboratories. This is not a ground truth established by human experts, but rather by an accepted analytical method. Therefore, the concept of "experts" as in radiologists reading images is not applicable here.

4. Adjudication Method for the Test Set

Not applicable. The ground truth is established by a predicate analytical method, not human interpretation that would require an adjudication method.

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 imaging interpretation where human readers (e.g., radiologists) evaluate cases. This submission concerns an in vitro diagnostic reagent for quantitative chemical analysis, which relies on instrument readings rather than human interpretation.

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

Yes, this entire study represents a standalone performance evaluation of the SYNCHRON® Systems Enzymatic Creatinine (CR-E) Reagent. The device (reagent used on automated analyzers) produces quantitative creatinine measurements directly, without human interpretation of results as part of its primary function. The data presented are direct outputs from the synchronized clinical systems.

7. The Type of Ground Truth Used

The type of ground truth used for the method comparison studies is comparison to a legally marketed predicate device's performance, specifically the SYNCHRON Systems Creatinine (CR-S) Reagent. This is implicitly considered a well-established and accepted method for creatinine determination. For precision, the ground truth is statistical assessment of reproducibility around the measured mean.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. This product is a chemical reagent for an enzymatic assay, not an AI or machine learning algorithm that requires a separate training phase with a distinct dataset. Clinical chemistry assays often involve calibration, internal quality control, and validation studies but do not typically concept of a "training set" for an algorithm. The reported studies are for validation/testing of the device's performance.

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

As noted above, the concept of a "training set" is not applicable to this type of device. The performance validation studies (method comparison and precision) demonstrate the accuracy and reliability of the CR-E reagent against a predicate method and statistical standards for precision.

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