Search Results

The ATAC Direct Bilirubin Reagent Kit, which contains both reagent and calibrator, is intended for use with the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of conjugated bilirubin in serum and plasma. Conjugated bilirubin results are used for the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

The ATAC Direct Bilirubin Reagent Kit, which contains both reagent and calibrator, is substantially equivalent to the Trace Direct Bilirubin Reagent, product UG38 (Trace Scientific, Ltd. of Melbourne, Australia) calibrated with the Sigma Bilirubin Calibrator, Total and Direct, product no. B8652 (Sigma Diagnostics, Inc. St. Louis, MO). The effectiveness of ATAC Direct Bilirubin Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown in the following studies.

The ATAC Direct Bilirubin Reagent determines conjugated bilirubin through its reaction with diazotized sulfanilic acid to form a red-purple complex. The resulting increase in absorbance at 546 nm is proportional to the direct bilirubin concentration in the sample.

This document describes the acceptance criteria and performance of the ATAC Direct Bilirubin Reagent Kit, a device intended for the quantitative determination of conjugated bilirubin in serum and plasma.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in the provided text. However, the reported device performance demonstrates the device's characteristics, which would implicitly meet internal acceptance based on established analytical standards for diagnostic reagents. We can infer the "acceptance" by the fact that these results are presented as evidence of the device's effectiveness and substantial equivalence.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Linearity: n = 18 (for standard factor recoveries).
• Sample Size for Precision: n = 60 for each of the three control serum levels (total 180 assays)
• Sample Size for Method Comparison: n = 96 (after exclusions).
• Sample Size for Detection Limit: 125 results over 25 runs.
• Data Provenance: The document states that mixed serum and plasma specimens were collected from adult patients. The country of origin is not explicitly stated, but the predicate device is from Trace Scientific, Ltd. of Melbourne, Australia, and Sigma Diagnostics, Inc. St. Louis, MO, for the calibrator, suggesting a US/Australian context. The study appears to be prospective in nature, as indicated by the collection of patient specimens for the method comparison and repeated assays for precision and detection limit.

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

This device is an in vitro diagnostic reagent kit for quantitative determination of a biomarker (conjugated bilirubin). The "ground truth" for such devices is typically established through reference methods or highly accurate analytical techniques, not through expert human interpretation of images or clinical cases. Therefore:

• Number of Experts: Not applicable in the context of this type of diagnostic device.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving subjective interpretations (e.g., imaging studies where multiple readers interpret results and discrepancies need to be resolved). For a quantitative chemical assay, the "adjudication" is inherent in the analytical methodology itself, such as repeat measurements, statistical analysis, and comparison to a predicate device or reference method.

• Adjudication Method: Not applicable in the traditional sense. The method comparison study involved comparing the ATAC 8000 results with those from another commercially available method, and statistical analysis (Deming regression) was used to assess agreement. Outliers were excluded based on statistical criteria (poor reproducibility and residuals exceeding 6 standard errors).

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

• Was an MRMC study done? No. This type of study is relevant for devices involving human interpretation of results, such as imaging diagnostics. This is a quantitative chemical assay that provides a numerical output.
• Effect size of human readers improve with AI vs without AI assistance: Not applicable.

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

• Was a standalone study done? Yes, the entire evaluation presented (linearity, precision, method comparison, detection limit, stability) represents the standalone performance of the ATAC Direct Bilirubin Reagent Kit on the ATAC 8000 Random Access Chemistry System. This is an automated system; once the sample is loaded, the measurement is performed by the instrument and reagents without real-time human intervention in the result generation process.

7. The Type of Ground Truth Used

• Ground Truth Type:
  • Reference Standards: For linearity, the ground truth was established by "standard values" which are specific concentrations of conjugated bilirubin used for calibration curves.
  • Commercially Available Control Serum: For precision, the ground truth was the expected range of values for these control sera.
  • Comparison to a Predicate Device/Method: For method comparison, the ground truth was established by "another commercially available method" (the "Competitive Reagent"). This approach demonstrates substantial equivalence, where the predicate serves as the de facto "ground truth" for comparative performance.
  • Diluted Serum Pool: For the detection limit, the ground truth involved a diluted serum pool to assess the lowest measurable concentration.

8. The Sample Size for the Training Set

This document describes the validation of a chemical reagent kit, not a machine learning or AI-based algorithm that typically uses "training sets." The linearity standards, control sera, and patient samples used in the performance studies are for validation/testing, not for "training" the reagent itself.

• Sample Size for the Training Set: Not applicable.

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

As there is no "training set" in the context of this device, this question is not applicable. The device's operational parameters (e.g., absorbance at 546 nm proportional to concentration) are based on established chemical principles, not on a trained algorithm.

Ask a specific question about this device

The ATAC Total Bilirubin Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of total bilirubin in serum and plasma. Total bilirubin results are used for the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block.

This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

The ATAC Total Bilirubin Reagent determines total bilirubin through its reaction with diazotized sulfanilic acid in the presence of dimethylsulfoxide to form a red-purplex. The resulting increase in absorbance at 546 nm is proportional to the total bilirubin concentration in the sample.

The "ATAC Total Bilirubin Reagent Kit" is a device intended for the quantitative determination of total bilirubin in serum and plasma. The following information outlines its acceptance criteria and the studies performed to demonstrate its effectiveness.

1. Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set for Linearity: n = 18 (for the linear regression of standard factors). The data provenance is not explicitly stated as country of origin, but it is for "linearity standards," implying laboratory-prepared standards.
• Test Set for Precision: n = 36 for each of the three serum samples tested (total of 108 replicates). The data provenance is "commercially available control serum."
• Test Set for Method Comparison: n = 107. The data provenance is "Mixed serum and plasma specimens, collected from adult patients." The country of origin is not specified. It is likely prospective for the purpose of the study.
• Test Set for Detection Limit: 30 replicates of a diluted serum pool.

3. Number of Experts and Qualifications for Ground Truth

• This document describes the performance characteristics of an in-vitro diagnostic reagent kit (ATAC Total Bilirubin Reagent Kit) and does not involve image analysis or clinical interpretation by human experts to establish ground truth in the typical sense for a medical device that outputs diagnoses or classifications.
• The ground truth for the performance studies (linearity, precision, method comparison, detection limit, stability) is based on:
  • Known concentrations for linearity standards.
  • Assigned values for commercially available control serum.
  • Results from a "commercially available method" (predicate device or similar) for method comparison.
• Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth as it applies to image interpretation or clinical diagnosis does not directly apply here. The "experts" are the analytical chemists and laboratory professionals who establish the values of standards and controls, and run the comparative assays.

4. Adjudication Method

• Adjudication methods like 2+1 or 3+1 are typically used in studies where there is subjective human interpretation involved (e.g., radiologists reviewing images).
• For the performance studies of this in-vitro diagnostic reagent, the "ground truth" or reference values are established through quantitative chemical analysis and metrological traceability. Therefore, an adjudication method in the human consensus sense is not applicable. Discrepancies would be resolved through re-testing, calibration verification, or investigation of analytical errors, not expert consensus.

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

• An MRMC study is not mentioned and is not applicable to the evaluation of an in-vitro diagnostic reagent kit like the ATAC Total Bilirubin Reagent Kit. These studies are relevant for devices that assist human readers in tasks like image interpretation or clinical decision-making.

6. Standalone Performance

• Yes, this document primarily reports on the standalone performance of the ATAC Total Bilirubin Reagent Kit when used with the ATAC 8000 Random Access Chemistry System. The results presented (linearity, precision, detection limit, stability) are measures of the algorithm's (reagent kit's) performance independent of human-in-the-loop diagnostic interpretation.
• The "method comparison" study essentially compares the standalone performance of the ATAC kit to another standalone, commercially available method.

7. Type of Ground Truth Used

The types of ground truth used are:

• Reference Standards/Known Concentrations: For linearity and stability studies, the performance is evaluated against solutions with established concentrations of total bilirubin.
• Assigned Values of Control Materials: For precision studies, the device's repeatability and reproducibility are measured against commercially available control sera with pre-determined mean values.
• Results from a Legally Marketed Predicate/Comparative Device: For method comparison, the results from the ATAC Total Bilirubin Reagent are compared against those obtained from the "Beckman Synchron Total Bilirubin Reagent, product 442745" or another "commercially available method," which serves as the reference ground truth for agreement.

8. Sample Size for the Training Set

• This document describes validation studies of a chemical reagent kit, not a machine learning or AI model. Therefore, the concept of a "training set" in the context of AI is not applicable. The development of the reagent itself would involve formulation, optimization, and initial testing, but these are not referred to as "training sets."

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

• As the concept of a "training set" for an AI model is not applicable here, the question of how its ground truth was established is also not relevant. The studies focus on verifying the analytical performance of the finished reagent kit against established laboratory and regulatory standards.

Ask a specific question about this device

The ATAC Calibrator Kit is intended for use with the ATAC Clinical Systems to establish points of reference that are used in the determination of albumin, calcium, cholesterol, creatinine, glucose, magnesium, phosphorus, total bilirubin, total protein and urea in human specimens. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

The ATAC Calibrator Kit is intended to calibrate the ATAC Clinical Systems for the quantitative determination of albumin, calcium, cholesterol, creatinine, glucose, magnesium, phosphorus, total protein and urea nitrogen.

The provided document describes the ATAC Calibrator Kit and its performance in demonstrating substantial equivalence to a predicate device. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for the regression statistics (e.g., specific ranges for slope and y-intercept). However, the implicit acceptance criterion is that the regression statistics demonstrate substantial equivalence to the comparative method, indicating accurate calibration.

Additionally, for reconstituted stability:

• Acceptance Criteria (Implicit): Statistically insignificant changes or changes less than round-off error/minimal clinical significance.
• Reported Device Performance:
  • Changes in albumin, magnesium, bilirubin, and total protein over 3 days at 2°C to 8°C were statistically insignificant or less than the round-off error of the assay.
  • Observed change for phosphorus over three days was less than 0.2 mg/dL.

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

• Test Set Sample Size:
  • Albumin: 59 sera
  • Magnesium: 55 sera
  • Phosphorus: 58 sera
  • Total Bilirubin: 54 sera
  • Total Protein: 52 sera
• Data Provenance: The data provenance is not explicitly stated (e.g., country of origin). The studies appear to be prospective in nature, as they involve assaying "at least 50 sera" for comparison with existing methods. It does not indicate the data is retrospective.

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

This type of study does not involve "experts" establishing ground truth in the way a medical imaging study might. Instead, the "ground truth" for the calibrator's performance is established by comparing its calibration results to those obtained using established, commercially available comparative methods with their respective calibrators and reagents. The document does not specify the qualifications of the individuals who performed these laboratory assays, but it would typically be trained laboratory personnel.

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative laboratory calibration study comparing results to established methods, not a subjective interpretation task requiring adjudication by multiple readers.

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 calibration study for an in vitro diagnostic device, not a study involving human readers or AI assistance.

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

Yes, this study essentially demonstrates the "standalone" performance of the ATAC Calibrator Kit in the context of the ATAC 8000 Random Access Chemistry System. It assesses the calibrator's accuracy by comparing results from the ATAC system (calibrated with the ATAC Calibrator) against established laboratory methods.

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

The ground truth used is the results obtained from established, commercially available comparative methods (e.g., Hitachi 704, Beckman Synchron CX reagents) which themselves are calibrated with their respective, validated calibrators. This serves as the reference standard for evaluating the accuracy of the ATAC Calibrator Kit.

8. The Sample Size for the Training Set

Not applicable. This is a calibration and method comparison study, not a machine learning study that typically involves distinct training and test sets in the same way. The calibrator itself (ATAC Calibrator Kit) is used to establish reference points, and its accuracy is then validated against other calibrated methods. There isn't an "algorithm" being trained in the conventional sense.

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

Not applicable, as there isn't a "training set" in the context of a machine learning algorithm. The "ground truth" for the overall system's performance is established by the well-defined, validated methodologies of the comparative reference instruments and reagents.

Ask a specific question about this device

The ATAC Calcium Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitation of calcium in serum and plasma. Calcium results are for the diagnosis and treatment of parathyroid disease, a variety of bone disease and tetany (intermittent muscular contractions or spasms).

The ATAC Calcium Reagent Kit is intended for the quantitative determination of calcium in serum and plasma. Calcium results are for the diagnosis and treathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The ATAC Calcium Reagent determines calcium through binding by o-cresolphthalein complexone at alkaline pH. The resulting increase in absorbance at 578 nm is proportion al to the calcium concentration of the sample.

The provided text describes the ATAC Calcium Reagent Kit and studies demonstrating its performance. However, it does not explicitly define "acceptance criteria" as a set of specific thresholds for the reported performance metrics. Instead, it presents the results of various validation studies and implicitly suggests that these results are deemed acceptable for the device's intended use and demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information, framed to address your request for acceptance criteria and the supporting study, even if the "acceptance criteria" are implied rather than explicitly stated.

Interpretation of Acceptance Criteria:

Given that this is a 510(k) submission, the "acceptance criteria" are implicitly tied to demonstrating substantial equivalence to a predicate device (HiChem™ Calcium Reagent Kit) and proving that the device performs safely and effectively for its intended use. While explicit numerical cut-offs aren't listed as "acceptance criteria," the reported performance metrics in the studies are implicitly deemed acceptable by the manufacturer for this purpose.

1. Table of Acceptance Criteria and Reported Device Performance

Note: As explicit "acceptance criteria" are not provided, the table below lists the performance parameters evaluated and their reported results. The implied acceptance is that these results are clinically acceptable and demonstrate substantial equivalence to the predicate device.

Ask a specific question about this device

The ATAC PAK Magnesium Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of magnesium in serum and plasma. Magnesium results are used for the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

The ATAC PAK Magnesium Reagent determines magnesium through its selective binding by xylidyl blue to form a red-purple chelate. The resulting increase in absorbance at 510 nm is proportional to the magnesium concentration in the sample.

The provided text describes the ATAC PAK Magnesium Reagent Kit, its intended use, and studies demonstrating its performance and substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabulated format. However, it presents performance metrics that implicitly serve as acceptance criteria by demonstrating equivalence to a legally marketed device and adequate performance for its intended use. Based on the provided data, the implicit acceptance criteria and the device's performance are summarized below:

Study Information:

1. Sample sizes used for the test set and the data provenance:

   • Linearity Study: n = 36 (for regression analysis of standards). The document does not specify the country of origin but implies laboratory-prepared standards.
   • Precision Study: n = 60 replicates for each of the three serum samples. The control serum is commercially available, but its origin and whether the testing was prospective or retrospective are not specified.
   • Method Comparison Study: n = 110 mixed serum and plasma specimens. These were collected from adult patients, implying a clinical setting. Country of origin not specified, and whether it was prospective or retrospective is not explicitly stated.
   • Detection Limit Study: n = 30 replicates of a diluted serum pool.
   • Stability Studies: Serum controls were assayed, but the specific number of samples or replicates for these studies is not provided beyond "average changes."

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

   • This device is a quantitative assay for magnesium in serum and plasma, not an AI or imaging device that typically requires expert interpretation for a "ground truth" label.
   • For the linearity study, the "ground truth" is the known concentration of the linearity standards.
   • For the precision study, the "ground truth" is the mean concentration of the commercially available control serum.
   • For the method comparison study, the "ground truth" is established by the results obtained from the legally marketed predicate device (Beckman Synchron Magnesium Reagent). No human experts are involved in establishing this "ground truth" in the context of this type of analytical method validation.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials involving subjective interpretation (e.g., radiology reads) where multiple human readers resolve disagreements. This product is an in-vitro diagnostic reagent, where results are quantitative measurements.

4. 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 an in-vitro diagnostic (IVD) reagent kit, not an AI or imaging device where human readers interact with AI assistance. The study compares the new reagent's performance against a predicate device and its own analytical characteristics.

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

   • Yes, the studies described are standalone performance evaluations of the ATAC PAK Magnesium Reagent Kit when used with the ATAC 8000 Random Access Chemistry System. This is a chemical assay, and its performance is assessed directly through its analytical capabilities without human-in-the-loop interaction for result generation. The human "in-the-loop" would be the laboratory personnel operating the instrument and interpreting the numerical results.

6. The type of ground truth used:

   • Reference standards/known concentrations for linearity.
   • Assigned values/agreement with the predicate device for precision and method comparison.
   • Experimental observation (e.g., standard deviation of replicates) for detection limit.

7. The sample size for the training set:

   • Not applicable. This is a chemical reagent kit, not an AI algorithm that requires a "training set" in the machine learning sense. The "development" of the reagent would involve chemical formulation and optimization, not data training.

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

   • Not applicable, as there is no "training set" in the context of an IVD reagent.

Ask a specific question about this device

The ATAC PAK Albumin Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of albumin in serum and plasma. Albumin results are used for the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

The ATAC PAK Albumin Reagent Kit is intended for the quantitative determination of albumin in serum and plasma. Albumin results are used for the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. The ATAC PAK Albumin Reagent determines albumin by the selective binding of bromcresol green. The resulting increase in absorbance at 630 nm is proportional to the albumin concentration in the sample.

The ATAC PAK Albumin Reagent Kit is intended for the quantitative determination of albumin in serum and plasma. The study presented demonstrates its substantial equivalence to the Roche Albumin Reagent Kit (product no. 1970569).

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The ATAC PAK Phosphorus Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of inorganic phosphorus in serum and plasma. Phosphorus results are used for the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

The ATAC PAK Phosphorus Reagent determines phosphorus through its reaction with molybdate to form a phosphomolybdate complex. The resulting increase in absorbance at 340 nm is proportional to the phosphorus concentration in the sample.

Here's a breakdown of the acceptance criteria and the study details for the ATAC PAK Phosphorus Reagent Kit, based on the provided text:

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

Ask a specific question about this device

The ATAC Creatinine Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of creatinine in serum, plasma and urine. Creatinine results are used in the diagnosis and treatment of renal dialysis and as a calculation basis for measuring other urine analytes.

The ATAC PAK Creatinine Reagent Kit is intended for the quantitative determination of creatinine in serum, plasma and urine. Creatinine results are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis and as a calculation basis for measuring other urine analytes. The ATAC PAK Creatinines creatinine through the reaction of creatinine with alkaline picrate. The initial rate of absorbance increase at 510 nm is proportional to the creatinine concentration of the sample.

The provided text describes the ATAC PAK Creatinine Reagent Kit and its performance characteristics. This is a medical device for in vitro diagnostic use, specifically a reagent kit for measuring creatinine levels. The information presented is typical for a 510(k) submission, demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of in vitro diagnostic device (reagent kit), regulatory acceptance criteria typically revolve around accuracy, precision, linearity, and stability, often in comparison to a legally marketed predicate device. The document does not explicitly state "acceptance criteria" but rather presents the results of studies designed to demonstrate the device's performance.

Ask a specific question about this device

The ATAC PAK BUN Reagent Kit is intended for the quantitative determination of urea nitrogen in serum, plasma and urine. Urea nitrogen results are used in the diagnosis and treatment of certain renal and metabolic diseases.

The ATAC PAK BUN Reagent determines urea nitrogen through the enzymatic action of urease and glutamate delydrogenase. The resulting decrease in absorbance at 340 nm is proportional to the urea nitrogen concentration of the sample.

This document focuses on the ATAC PAK BUN Reagent Kit, an in-vitro diagnostic device designed for the quantitative determination of urea nitrogen. The provided text describes the device's performance characteristics and how they demonstrate substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The ATAC Direct LDL Reagent Kit, the ATAC Direct LDL Calibrator and the ATAC 8000 Random Access Chemistry System are intended for the quantitative determination of LDL-cholesterol in serum and plasma. LDL-cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.

The ATAC Direct LDL Reagent determines LDL-cholesterol through a two step reaction, which specifically consumes non-LDL cholesterol in a series of reactions without producing color. In the second reaction step, the chromogen is added, and a second detergent solubilizes the LDL-cholesterol, allowing it to react with cholesterol oxidase, cholesterol esterase and peroxidase in the reagent to produce a color that is proportional to the amount of LDL-cholesterol in the sample.

Here's a breakdown of the acceptance criteria and the study details for the ATAC Direct LDL Reagent Kit, ATAC Direct LDL Calibrator, and ATAC 8000 Random Access Chemistry System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device