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The Hemoglobin Alc assay is used in clinical laboratories for the quantitative in vitro measurement of percent hemoglobin A 1c (NGSP) or HbA1c fraction mmol/mol (IFCC) in human whole blood and hemolysate on the ARCHITECT c 4000 System.

Hemoglobin A1c measurements are used as an aid in the diagnosis of diabetes mellitus, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.

The Hemoglobin Alc Calibrators are for use in the callbration of the Hemoglobin A1c assay on the ARCHITECT e 4000 System.

The Hemoglobin A 1c Controls are used for the estimation of test precision of systematic analytical deviations of the Hemoglobin A1c assay on the ARCHITECT c 4000 System.

The Hemoglobin A1c assay consists of two separate concentration measurements: glycated hemoglobin (HbA1c) and total hemoglobin (THb). The two concentrations are used to determine the percent HbA1c (NGSP units) or the hemoglobin fraction in mmol/mol (IFCC units). The assay utilizes an enzymatic method that specifically measures N-terminal fructosyl dipeptides of the ß-chain of HbA1c. The total hemoglobin is determined by measuring absorbance. The final result is expressed as %HbA1c (NGSP) or mmol/mol HbA1c (IFCC) and is automatically calculated by the system from the HbA1c/THb ratio. The device also includes Hemoglobin A1c Calibrators and Hemoglobin A1c Controls.

This document describes the Hemoglobin A1c Assay, Calibrators, and Controls, a device used for the quantitative in vitro measurement of percent hemoglobin A1c (NGSP) or HbA1c fraction mmol/mol (IFCC) in human whole blood and hemolysate on the ARCHITECT c 4000 System. The information provided primarily focuses on the device's technical specifications, performance evaluation, and substantial equivalence to a predicate device (ARCHITECT Hemoglobin A1c assay, K130255).

I will extract the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a definitive table format with pass/fail thresholds. However, performance studies are conducted with implied expectations for meeting certain analytical standards. I will synthesize the performance data provided across various sections to address the "reported device performance."

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

• Precision Study (Within-Laboratory Precision):
  • Sample Size: Three levels of human whole blood controls and human whole blood panels were tested. Each level was tested a minimum of 2 replicates, twice per day, for 20 testing days.
  • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
• Limit of Blank (LoB) and Detection (LoD) Study:
  • Sample Size: Zero-level samples (minimum 3 replicates), low-level samples (minimum 2 replicates).
  • Data Provenance: Not specified.
• Interferences (Endogenous Substances, Hemoglobin Variants, Drugs, Rheumatoid Factor, Hemoglobin Derivatives):
  • Sample Size: Test and reference samples were tested in a minimum of 12 replicates for endogenous substances, drugs, RF, and hemoglobin derivatives. For hemoglobin variants, the number of samples (n) varied per variant (e.g., HbC: 43, HbD: 40, HbE: 50, HbS: 31, HbA2: 24, HbF: 28).
  • Data Provenance: Not specified.
• Matrix Comparison:
  • Sample Size: Specimens from a minimum of 43 different donors. Each sample tested in a minimum of 2 replicates.
  • Data Provenance: Not specified.
• Linearity:
  • Sample Size: 9 samples (4 commercial linearity levels + 5 prepared samples). Each sample tested in a minimum of 2 replicates.
  • Data Provenance: Not specified.
• Method Comparison and Predicted Bias (against NGSP secondary reference laboratory method):
  • Sample Size: A minimum of 120 human whole blood specimens. Tested in replicates of 2.
  • Data Provenance: Not specified (likely laboratory-based, not patient-derived with demographic context).
• Method Comparison to Predicate Device:
  • Sample Size: A minimum of 120 human whole blood specimens. Tested in replicates of 2.
  • Data Provenance: Not specified.

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)

The document does not mention the use of "experts" in the traditional sense (e.g., radiologists, pathologists) for establishing ground truth. Instead, the ground truth for the method comparison studies was established using NGSP secondary reference laboratory methods for HbA1c measurement. These are highly standardized analytical methods, not dependent on expert interpretation. For calibrators and controls, traceability is to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference method. The qualifications of personnel performing these reference methods are typically certified laboratory technicians or scientists, but this is not detailed.

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

There is no mention of an adjudication method in the context of expert review for establishing ground truth, as the ground truth is based on reference analytical 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 a clinical chemistry assay, not an imaging or diagnostic device that involves "human readers" or "AI assistance" in interpretation in the way a MRMC study would apply. Therefore, no MRMC comparative effectiveness study was conducted or is applicable here. The device automatically provides a quantitative measurement.

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

Yes, the studies presented are standalone performance evaluations of the assay system (reagents + instrument). The device provides a quantitative measurement of Hemoglobin A1c, and its performance (precision, linearity, interference, method comparison) is assessed based on the accuracy and reliability of these measurements against reference methods or established analytical standards. There is no "human-in-the-loop" component for result generation, only for sample handling and result interpretation for clinical decision-making.

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

The ground truth used for performance evaluation, particularly for method comparison, is based on:

• Reference Laboratory Methods: Specifically, an NGSP secondary reference laboratory method (e.g., Tosoh HPLC analyzer) for comparison of patient samples.
• Traceability to International Standards: Calibrators and controls are "value assigned using secondary calibrators that are traceable to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference method."

8. The sample size for the training set

The document describes performance evaluation (test set data) for the device. It does not provide information about a "training set" in the context of machine learning/AI development. This device is a quantitative in vitro diagnostic assay, not an AI/ML-based diagnostic software.

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

Not applicable, as no training set (in the AI/ML context) is described for this in vitro diagnostic device.

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The Hemoglobin A Ic assay is used in clinical laboratories for the quantitative in vitro measurement of percent hemoglobin A le (NGSP) or HbA Ic fraction mmobile blood and hemolysate on the ARCHITECT c 8000 System. Hemoglobin Alc measurements are used as an aid in the diagnosis of diabetes mellinus, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-eem blood glucose control in individuals with diabetes mellitus.

The Hemoglobin Alc Calibrators are for use in the Hemoglobin Alc assay on the ARCHITECT c 8000 System.

The Hemoglobin Alc Controls are used for the estimation and the detection of systematic analytical deviations of the ARCHITECT c 8000 System.

The Hemoglobin A1c Reagent Kit contains Reagent 1 (R1), Reagent 2 (R2), and Diluent (A1cDIL). The Hemoglobin A1c Calibrator Kit contains Calibrator 1 (Cal 1) and Calibrator 2 (Cal 2), which are lyophilized human whole blood containing hemoglobin and glycated hemoglobin. The Hemoglobin A1c Control Kit contains Low Control (Control L) and High Control (Control H), which are lyophilized human whole blood containing hemoglobin and glycated hemoglobin. The assay utilizes an enzymatic method to measure glycated hemoglobin (HbA1c) and total hemoglobin (THb) concentrations, which are then used to calculate percent HbA1c (NGSP units) or HbA fraction (IFCC units). The assay is performed on the ARCHITECT c 8000 System.

Here's a summary of the acceptance criteria and the study details for the Hemoglobin A1c assay:

Acceptance Criteria and Device Performance

Study Details

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

   • Within-Laboratory Precision: Not specified for sample patients, but involved 3 reagent lots, 3 calibrator lots, 1 control lot (L/H), 1 lot of commercial controls (3 levels), human whole blood controls, and human whole blood panels. Tested in 2 replicates, twice per day for 20 days.
   • Limit of Blank (LoB) & Detection (LoD): Zero-level samples (minimum 3 replicates), low-level samples (minimum 2 replicates). Five runs over minimum 3 days.
   • Interferences (Endogenous, Drugs, Hb Variants, RF, Hb Derivatives): Minimum of 12 replicates for test and reference samples.
     • Hb Variants specific:
       • HbC: n=21
       • HbD: n=20
       • HbE: n=20
       • HbS: n=20
       • HbA2: n=26
       • HbF: n=19
   • Matrix Comparison: Specimens from a minimum of 43 different donors. Each sample tested in a minimum of 2 replicates.
   • Linearity: 9 samples (commercially available linearity sets + 5 prepared by combining them). Tested in a minimum of 2 replicates.
   • Method Comparison and Predicted Bias: Minimum of 120 human whole blood specimens. Tested internally in replicates of 2. Tested over a minimum of 5 days.
   • Data Provenance: Not explicitly stated for all studies (e.g., country of origin). However, the "human whole blood specimens" and "human whole blood controls" suggest these are human samples. Studies were performed in-house at Abbott Laboratories. All studies are retrospective in the sense that they are laboratory performance evaluations on collected samples, not prospective patient trials.

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

   • Not applicable as this is an in vitro diagnostic (IVD) device for quantitative measurement. The ground truth for the method comparison study was established using an NGSP secondary reference laboratory method (Tosoh HPLC analyzer), which is a recognized standardized method for HbA1c.

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

   • Not applicable. The ground truth was established by comparison to a recognized reference method or by preparing samples with known concentrations/characteristics.

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 IVD device, not an imaging AI device that involves human readers.

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

   • Yes, the performance studies described (Precision, LoB/LoD, Interferences, Linearity, Method Comparison) are all standalone performance evaluations of the device and its reagents. The device operates as an automated system measuring HbA1c concentrations.

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

   • For Method Comparison: A National Glycohemoglobin Standardization Program (NGSP) secondary reference laboratory method (Tosoh HPLC analyzer) was used as the comparator (reference) method. This is a highly standardized and traceable ground truth for HbA1c measurements.
   • For Precision, LoB/LoD, Linearity, Interferences: Ground truth was established by:
     • Using calibrators traceable to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference method.
     • Using controls with value-assigned concentrations (traceable to IFCC reference method and NGSP units).
     • Creating samples with known concentrations (e.g., "zero-level," "low-level," linearity sets, spiked interference samples, samples with known Hb variants).

7. The sample size for the training set:

   • Not applicable. This is an IVD device based on an enzymatic methodology, not a machine learning or AI algorithm that requires a "training set" in the traditional sense. The device's performance is based on its chemical and enzymatic reactions, and the calibration process uses a dedicated calibrator kit, not a "training set" of patient data for model learning.

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

   • Not applicable, as there is no "training set" for a machine learning model. The device's calibration involves calibrators that are value-assigned using secondary calibrators traceable to the IFCC reference method.

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CONE-TROL Hemoglobin A1c Control Set is intended for use as quality control material to monitor the performance and precision of Hemoglobin A 1 c determination methods.

The CONE-TROL Hemoglobin A 1c Control Set is prepared from human blood to which chemicals, preservatives, and stabilizers are added. The control is provided in liquid form for user convenience.

The provided documentation describes the acceptance criteria and study for the CONE-TROL Hemoglobin A1c Control Set, a quality control material, primarily focusing on its stability. It is not an AI/ML device, so many of the requested fields (e.g., MRMC studies, human reader improvement, multi-reader consensus) are not applicable.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for the CONE-TROL Hemoglobin A1c Control Set is that the analyte activity (concentration) must fall within ±10% of the initial value at various storage conditions and time points.

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

• Sample Size:
  • For stability studies, the "sample" typically refers to the number of vials or batches tested. The document mentions two vials were assayed in triplicate for value assignment, and data points were collected over several days (minimum 6 data points per level for value assignment). For stability, specific numbers of individual vials tested at each time point are not explicitly stated, but it follows a standard protocol of testing representative aliquots from the prepared control sets.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the studies were conducted by the manufacturer, Cone Bioproducts, located in Seguin, TX, USA, for regulatory submission to the FDA. The stability studies are prospective, as they track the product over time.

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

Not applicable. This device is a quality control material whose "truth" is its chemical concentration, determined by analytical instrumentation. It does not involve human interpretation or expert opinions to establish ground truth in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set

Not applicable. Ground truth for this chemical control is established through objective analytical measurements, not through adjudication of expert opinions.

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 not an AI/ML device.

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

Yes, in a sense, the performance of the control material is assessed in a "standalone" manner. Its stability and value assignment are determined purely through analytical measurements on laboratory instruments (Tosoh G7 HPLC Analyzer). There is no "human-in-the-loop" component in determining the performance of the control material itself; it's an objective measurement of its chemical properties over time.

7. The Type of Ground Truth Used

The ground truth used is the measured concentration of HbA1c in the control material, determined by objective analytical methods using the Tosoh G7 HPLC Analyzer. This is a form of measurement data/analytical truth.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. As above, there is no training set for this type of device. The "ground truth" for the control material's initial value (value assignment) is established by assaying Levels 1 and 2 in triplicate on the applicable instrument system, with a minimum of 6 data points for each level. The mean, standard deviation, and coefficient of variance are then determined.

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ACE® Hemoglobin A1c (HbA1c) Reagent is intended for the quantitative determination of hemoglobin A1c (umol/L) and total hemoglobin (g/dL) in human EDTA whole blood for the calculation of percent hemoglobin A 1 c using the ACE clinical chemistry system. This test is intended for use in clinical laboratories or physician office laboratories to monitor long term blood glucose control in individuals with diabetes mellitus. For in vitro diagnostic use only.

The umol HbA1c and total hemoglobin (THb) values generated are intended for use in the calculation of the HbA1c/THb ratio and cannot be used individually for diagnostic purposes.

Hemoglobin A1c Calibrators are intended for use in the performance of both a multi-point calibration for hemoglobin A1c and a single-point calibration of total hemoglobin on the ACE® clinical chemistry system, for the quantitative determination of percent (%) hemoglobin A1c in whole blood. For in vitro diagnostic use only.

Hemoglobin Alc Controls are intended to reliably monitor the accuracy and precision of quantitative determinations of hemoglobin A1c on the ACE® clinical chemistry system. For in vitro diagnostic use only,

ACE® Hemoglobin A1c (HbA1c) Reagent is provided as a single kit and consists of four bottles containing a hemoglobin denaturant, a total hemoglobin reagent, a HbAlc agglutinator reagent and a HbA1c antibody reagent.

The ACE Hemoglobin Alc Calibrators are provided as a single kit and contain ready-to-use liquid calibrators, one of each of six levels.

The ACE Hemoglobin A1c Controls are provided as a single kit and contain lyophilized controls with normal and elevated levels of HbA1c and a reconstitution fluid. The controls are prepared from human whole blood, which has been tested and found negative for antibody to Human Immunodeficiency Virus (anti-HIV) Types 1 and 2, antibody to Hepatitis C (anti-HCV) and for Hepatitis B Surface Antigen (HBsAg) by FDA recommended (approved/licensed) tests.

The document, K063306, describes the Alfa Wassermann, Inc. ACE® Hemoglobin A1c Reagent, Hemoglobin A1c Calibrators and Hemoglobin A1c Controls device. This device is intended for the quantitative determination of hemoglobin A1c and total hemoglobin in human EDTA whole blood for the calculation of percent hemoglobin A1c using the ACE clinical chemistry system.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a table format with pass/fail thresholds. However, it presents performance data against which the device's efficacy can be judged, particularly in comparison to a predicate device. The implied acceptance is that the device's performance metrics are comparable to or within acceptable limits relative to established methods, as evidenced by successful correlation and precision studies.

• Regression Equation: y = 1.052x + 0.23
• Correlation Coefficient: 0.975
• Standard Error of the Estimate: 0.49
• Confidence Interval Slope: 1.000 to 1.104
• Confidence Interval Intercept: -0.20 to 0.67
  POL Labs (n=20 samples per lab):
• Lab A: y = 0.940x + 0.41, R=0.9762, SEE=0.46, CI Slp=0.871-1.009, CI Int=-0.16-0.99
• Lab B: y = 1.102x - 0.04, R=0.9818, SEE=0.47, CI Slp=1.032-1.172, CI Int=-0.63-0.55
• Lab C: y = 1.035x + 0.38, R=0.9844, SEE=0.41, CI Slp=0.974-1.095, CI Int=-0.89-0.13 |

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

• Precision Studies:
  • Main Study: For the ACE clinical chemistry system, two patient samples (one normal, one elevated) were used for determining within-run and total CVs. The number of replicates or days for this specific part is not explicitly stated, but it followed CLSI/NCCLS EP5-A2 which outlines such protocols.
  • POL Sites: Three EDTA whole blood samples with varying HbA1c levels were run in triplicate on five different days at each of the three POL sites.
• Measuring Range Study: One whole blood sample was used, which was serially diluted.
• Accuracy (Correlation) Studies:
  • Main Correlation Study: The document does not specify the exact number of samples for the main correlation study against the Tosoh Bioscience's A1c 2.2 Plus Automated Glycohemoglobin Assay. It refers to "patient samples" but no count.
  • POL Labs: Each of the three POL labs ran 20 EDTA whole blood samples in duplicate in four different runs (total of 80 measurements per lab, 240 measurements across all POL labs for accuracy comparison).
• Data Provenance: The document does not explicitly state the country of origin for the data. Given the submitter's address (West Caldwell, NJ, USA) and FDA submission context, it is highly probable the data was gathered in the United States. The studies appear to be prospective in nature, designed specifically for this submission.

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

• For this type of in-vitro diagnostic device (quantitative measurement of a biomarker), "experts" in the sense of human readers (like radiologists) are not typically used to establish ground truth.
• The ground truth is established by a predicate device or reference method, which is considered the gold standard. In this case, the Tosoh Bioscience's A1c 2.2 Plus Automated Glycohemoglobin Assay was used as the predicate device against which the accuracy of the ACE Hemoglobin A1c kit was evaluated. The performance characteristics of the predicate device are the "ground truth" here.
• There is no mention of a specific number of human experts or their qualifications for establishing ground truth, as the ground truth itself is an established laboratory method.

4. Adjudication Method for the Test Set

• Adjudication methods (like 2+1, 3+1) are common in studies where human interpretation or subjective assessment plays a role in establishing ground truth (e.g., image-based diagnostics).
• For a quantitative in-vitro diagnostic device like the ACE Hemoglobin A1c kit, which relies on chemical reactions and automated measurement, adjudication by human experts is not applicable or performed. The "adjudication" is inherent in the direct comparison of the device's quantitative output against the quantitative output of the predicate device. Discrepancies are handled through statistical analysis (e.g., linear regression, correlation).

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

• No, an MRMC comparative effectiveness study was not done.
• MRMC studies are typically used to assess the impact of an AI system (or new diagnostic tool) on human reader performance, especially in fields like radiology where human interpretation of images is critical.
• This device is an automated, in-vitro diagnostic assay for a chemical biomarker (HbA1c). Its primary function is to provide a quantitative measurement, not to assist human interpretation in a comparative effectiveness study setting.

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

• Yes, this entire study is essentially a standalone performance study.
• The ACE Hemoglobin A1c kit, when used with the ACE clinical chemistry system, operates as an automated system. The performance data presented (precision, measuring range, accuracy against a predicate) represents the performance of the algorithm/reagent system on its own, without human intervention influencing the measurement outcome once the process is initiated. Personnel (even those without formal medical technology education in POL sites) are involved in sample preparation and loading, but the actual analytical measurement and calculation are automated by the device.

7. Type of Ground Truth Used

• The ground truth used for the accuracy studies was the concurrent measurement obtained from a legally marketed and established predicate device: the Tosoh Bioscience's A1c 2.2 Plus Automated Glycohemoglobin Assay. This is a common and accepted method for establishing accuracy for new in-vitro diagnostic devices. It operates as a "reference method" in this context.

8. Sample Size for the Training Set

• The document does not explicitly mention a training set sample size. This device is a reagent/assay kit for a clinical chemistry system, not a machine learning or AI algorithm that typically goes through a distinct "training phase" on a dataset in the same way.
• The methods described (latex agglutination inhibition assay, conversion to alkaline hematin, measurement of absorbance) are biochemical principles. While there might have been internal development/optimization data, it's not described as a formal "training set" in the context of this 510(k) summary. The calibration procedure itself (using calibrators) is a form of "training" the system for accurate measurements, but this is distinct from a dataset used for training an AI model.

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

• As concluded in point 8, a formal "training set" in the AI sense is not described.
• For the calibration process (which could be considered analogous to a system's "learning" or setting up its operational parameters), the Hemoglobin A1c Calibrators are used. These calibrators are presumably manufactured with known, precise concentrations of HbA1c and total hemoglobin, established through rigorous manufacturing and quality control standards. The ground truth for these calibrators would be established through a combination of gravimetric/volumetric preparation and validation against higher-order reference methods and materials (e.g., IFCC reference methods for HbA1c primary calibration). However, this specific process for the calibrators' ground truth is not detailed in this 510(k) summary.

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RNA1c Control for Bayer DCA2000 and DCA2000+ Analyzers is intended to be used to monitor and evaluate the analytical performance of the Bayer DCA 2000 and DCA 2000+ Analyzers that measure HbA1c. The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practice. The two levels of controls allow performance monitoring within the clinically important range.

For In Vitro Diagnostic Use

RNA1c Hemoglobin A1c Control for Bayer DCA2000 and DCA2000+ Analyzers is a two-level, aqueous liquid control solution consisting of a synthetic peptide identical to the HbA1c epitope in a non-biological aqueous solution with dye to provide the appropriate total hemoglobin value. The concentration of dye and peptide are optimized for use on the Bayer DC A 2000 and DCA 2000+ Analyzers to provide measurement values for HbA1c equivalent to the predicate device, Bayer DCA 2000 Hemoglobin A1c Normal and Abnormal Control Kit.

RNA1c Hemoglobin A1c Control for Bayer DCA2000 and DCA2000+ Analyzers provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. The product is packaged in a plastic bottle with dropper tip for application of the solution to the test cartridge.

RNA1c Hemoglobin A1c Control for Bayer DCA2000 and DCA2000+ Analyzers is a non-hazardous aqueous solution containing no biological materials and requires no reconstitution prior to use.

The provided text describes the 510(k) summary for the "RNA1c Hemoglobin A1c Control for Bayer DCA2000 and DCA2000+ Analyzers" device. It outlines the device's characteristics, intended use, and a comparison to a predicate device to establish substantial equivalence. However, it does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets those criteria with statistical data.

The document states that "Tests were conducted to verify specific performance requirements: a) Closed bottle stability, b) Stability after opening, c) Correlation to predicate device, d) Test precision and range." It also notes that "Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence."

This document is a regulatory submission for substantial equivalence based on comparison to an existing device, rather than a detailed report of a performance study with specific acceptance criteria and outcome data. Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

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

The document does not explicitly state acceptance criteria in a quantitative manner or report specific performance metrics against such criteria. It generally states that the device provides "measurement values for HbA1c equivalent to the predicate device."

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

Not provided in the document.

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)

Not applicable, as this is a quality control material and the "ground truth" would be established by the analytical performance of the device it controls, not by human expert assessment. The document does not describe the specific methodology for evaluating the "correlation to predicate device" or "test precision and range."

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

Not applicable.

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, as this is a quality control material, not an AI diagnostic device for human interpretation.

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

The device itself is a control solution, which is used to assess the performance of an analyzer (Bayer DCA 2000 and DCA 2000+ Analyzers). The "standalone" performance here refers to the control's ability to produce consistent results on those analyzers. The document indicates tests were done for "Correlation to predicate device" and "Test precision and range," which implies standalone performance evaluation, but no specific data or methodology is provided.

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

For a quality control material, the "ground truth" for its performance would typically be the assigned value of the control, established through rigorous testing against reference methods or by comparison to an established predicate. The document states the new device is optimized "to provide measurement values for HbA1c equivalent to the predicate device," suggesting the predicate device's performance provides a reference point.

8. The sample size for the training set

Not applicable, as this is a physical control solution, not a machine learning algorithm that requires a training set.

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

Not applicable.

Summary of available information regarding acceptance criteria and study:

The document describes the device as a quality control material intended to monitor the analytical performance of HbA1c analyzers. The "study" mentioned consists of non-clinical tests to verify performance requirements through comparison to a predicate device.

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Liquid Human Glycosylated Hemoglobin (A1C) Control is intended for use in the laboratory to monitor the precission and accuracy of Glycosylated Hemoglobin (A1C) assay procedures for the methods listed in the package insert. The routine use of quality control materials is an integral part of ensuring the accuracy and precision of laboratory analyses.

Not Found

The provided text is a government letter concerning the substantial equivalence determination for a medical device called "Glycosylated Hemoglobin A1C Control Normal and Elevated." It informs the manufacturer that they can market the device.

However, the document does not contain any information about acceptance criteria, device performance, a specific study, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The letter is solely an administrative notification of regulatory clearance.

Therefore, I cannot provide the requested table and study details based on the input text.

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The Hemoglobin A1c Control contains both Normal and Abnormal level Controls. They are intended for use as a quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.

The Hemoglobin A1c Control contains both Normal and Abnormal level Controls. They are intended for use as a quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation. They are prepared from normal adult human blood The source blood is tested and found to be non-reactive for Hepatitis B surface antigen, Hepatitis C antibody, antibodies against human immunodeficiency virus (HIV) types 1 & 2, and Syphilis (RPR and TPHA). The Abnormal Level Control is prepared by controlled glycation of normal non-diabetic hemolysate. The controls are reconstituted with distilled water or a reconstitution solution comprising the biocide sodium azide (0.09%). The reconstitution volume is between 0.25 mL and 0.5 mL. The controls reconstitute in 15 minutes with occasional swirling, and are stored at 2° - 8°C.

This is a 510(k) summary for a Hemoglobin A1c Control device, which is a quality control material used to monitor the precision of laboratory testing procedures for HbA1c quantitation. It is not an AI/ML device for diagnosis or treatment. The provided text refers to a traditional in vitro diagnostic device. Therefore, many of the typical questions for AI/ML device studies (like expert consensus, adjudication methods, multi-reader multi-case studies, and AI effect size) are not applicable to this type of submission.

The "study" here is a comparison of technological characteristics and performance between the new device and a legally marketed predicate device to demonstrate substantial equivalence, rather than a clinical study evaluating diagnostic accuracy.

Here's the breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for a quality control device typically revolve around its stability, composition, and its ability to perform similarly to predicate devices across different measurement methods. The reported performance is primarily a comparison against a predicate device.

The "study" demonstrating these meet the criteria is presented as a "Comparison of Technological Characteristics with Predicate Device" shown in the table. The primary evidence for acceptance is the demonstration of substantial equivalence to the predicate device (Lyphochek Diabetes Control Level 1 & 2, Bio-Rad Laboratories, K831478) based on these characteristics.

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

• Sample Size: Not explicitly stated as a "test set" in the context of an AI/ML algorithm. The comparison is based on the characteristics of the manufactured control materials themselves. For quality control materials, "sample size" might refer to the number of lots manufactured and tested or the replicates of aliquots tested to determine stability and target values. This information is not detailed in the provided summary.
• Data Provenance: Not applicable in the sense of patient data. The product is a manufactured in vitro diagnostic control. The source material is normal adult human blood, tested for pathogens. The device is manufactured by Canterbury Scientific Limited in Christchurch, New Zealand.

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

Not applicable. This is a quality control material, not a diagnostic device requiring expert interpretation of images or clinical data to establish a "ground truth" in that sense. The "ground truth" for the control material is its chemical composition and its measured HbA1c values, which are determined by established laboratory methods and validated against known standards, not by expert consensus in a clinical context.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of clinical interpretation requiring adjudication.

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 not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for this device (a quality control material) is its chemical composition, stability, and the target HbA1c values, established through:

• Analytical Testing: Rigorous laboratory testing using recognized methods (e.g., HPLC, latex immunoagglutination inhibition) to determine the precise HbA1c percentage, other hemoglobin fractions, and stability over time.
• Reference Standards: Calibration against international or national reference standards for HbA1c measurement.
• Manufacturing Specifications: Adherence to defined manufacturing processes to ensure consistent product attributes.
• Predicate Device Comparison: Used as a benchmark for performance characteristics.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Ask a specific question about this device

The Roche Hemoglobin A1c Control N and P are in vitro diagnostic devices intended for use as assayed quality control material to monitor the accuracy and precision at normal and pathological levels in quantitative HbA1c assays measuring HbA1c as a fraction of total Hemoglobin.

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This document is a 510(k) clearance letter from the FDA for a medical device called "Roche Hemoglobin A1c Control N and P." It's not a study report or a technical document describing a device and its performance in detail.

Therefore, the requested information regarding acceptance criteria and a study proving device performance cannot be extracted from this document. This letter primarily states that the FDA has found the device "substantially equivalent" to a legally marketed predicate device, allowing it to be marketed. It does not contain the detailed study results or performance metrics you've asked for.

The relevant information in this document is:

• Device Name: Roche Hemoglobin A1c Control N and P
• Intended Use: In vitro diagnostic devices intended for use as assayed quality control material to monitor the accuracy and precision at normal and pathological levels in quantitative HbA1c assays measuring HbA1c as a fraction of total Hemoglobin.
• Regulatory Class: I
• Product Code: JJX
• Date of Clearance: August 6, 1997
• Marketing status: Cleared for marketing based on substantial equivalence.

To answer your questions about acceptance criteria and study data, you would need to access the actual 510(k) submission document (K972721) or any associated clinical/analytical study reports, which are not provided here.

Ask a specific question about this device