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ACE® LDL-C Reagent is intended for use in the quantitative determination of low density lipoprotein cholesterol in human serum.
ACE® LDL-C Reagent is intended for the quantitative determination of LDL cholesterol in serum using the ACE® clinical chemistry system.
LDL-C Calibrator is intended for the calibration of the ACE® LDL-C Assay.
LDL-C Controls are intended to monitor the performance of the ACE® LDL-C Assay.
The measurement of LDL cholesterol is a factor in the pathogenesis of atherosclerosis and coronary artery disease.

The ACE® LDL-C Reagent contains two reagents. An aliquot of serum is added to the first reagent, which contains a unique detergent that selectively solubilizes the non LDL lipoproteins. Enzymes also present in the first reagent consume the cholesterol in a non color forming reaction. The second reagent contains another detergent that releases the remaining LDL lipoproteins. The enzyme reaction with LDL cholesterol, in the presence of a chromogenic coupler, produces color that is directly proportional to the amount of LDL cholesterol in the sample.

The ACE® LDL-C Reagent is intended for the quantitative determination of low density lipoprotein cholesterol in human serum.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are implicitly derived from the performance of the predicate device (Genzyme N-geneous® LDL Cholesterol Reagent) as this is a 510(k) submission seeking substantial equivalence.

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

• Correlation vs. Reference method (Ultracentrifugation): n = 70
• Correlation vs. Immunoseparation method: n = 66
• Data Provenance: Not explicitly stated, but typically for such clinical testing, the data would be laboratory-generated. The document does not specify country of origin or whether it's retrospective or prospective.

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

This information is not provided in the document. The ground truth for the correlation studies was established by widely accepted laboratory methods (Ultracentrifugation and Immunoseparation method, and Friedewald calculation), not by expert consensus in the human interpretation sense.

4. Adjudication Method for the Test Set

This is not applicable as the studies are focused on comparing quantitative measurements from different assays, not on human interpretation or diagnosis 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

This is not applicable. This submission is for a diagnostic reagent, not an AI-assisted diagnostic device that involves human readers interpreting results.

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

This is not applicable in the context of an "algorithm" as commonly used for AI. The study describes the standalone performance of the reagent (a chemical assay) by comparing its measurements to established reference methods.

7. The Type of Ground Truth Used

• Correlation vs. Reference Method: Ultracentrifugation
• Correlation vs. Immunoseparation Method: Immunoseparation method
• Correlation vs. Friedewald Calculation: Friedewald calculation

These methods are well-established laboratory techniques for determining LDL-C and serve as the ground truth or reference methods for comparison.

8. The Sample Size for the Training Set

This information is not provided. As this is a chemical reagent, it does not involve a "training set" in the machine learning sense. The development of the reagent would involve method optimization, but not a distinct "training set" of patient data in the same way an AI algorithm would.

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

This is not applicable for a chemical reagent. The development process would involve analytical chemistry and biochemistry principles to formulate the reagents to achieve the desired performance characteristics.

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ACE T Uptake Reagent is used in the diagnosis and treatment of thyroid disorders. It is intended for the quantitative determination of unsaturated binding sites on the thyroid-binding proteins in serum using the ACE clinical chemistry analyzer.

The ACE T Uptake Regent contains two reagents, and Antibody/Substrate reagent and an Enzyme The assay uses a mixture of enzyme glucose-6-phosphate dehydrogenase Conjugate reagent. conjugated thyroxine (G6PD-T4) and a known amount of exogeneous T4 which is allowed to bind to the thyroxine-binding proteins in the sample. A sample with increased levels of unsaturated thyroxine-binding sites, the exogeneous T4 will bind leaving G6PD-T4 conjugate free. On addition of an anti-thyroxine antibody, the G6PD-T4 conjugate is bound by the antibody and the enzyme activity is inhibited. Conversely, a sample with decreased levels of unsaturated thyroxine-binding sites will leave most exogeneous T4 unbound. Upon addition of anti-T4 antibody, the unbound exogeneous T4 will inhibit the anti-T4 binding to G6PD-T4 conjugate and produce a high G6PD enzyme activity. This phenomenon creates a relationship between unsaturated thyroxine-binding sites concentration (T Uptake) and the enzyme activity. The enzyme G6PD activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.

Acceptance Criteria and Device Performance Study for ACE® T Uptake Reagent (K981375)

This document describes the acceptance criteria and a summary of the performance study for the ACE® T Uptake Reagent, based on the provided 510(k) premarket notification.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ACE® T Uptake Reagent are implicitly defined by its substantial equivalence to the predicate device (Diagnostic Reagents, Inc. T Uptake Enzyme Immunoassay, K951586). The study aimed to demonstrate that the new device's performance characteristics are comparable to, or better than, the predicate device.

Note: The document explicitly states that "Based on these data, the Schiapparelli Biosystems ACE® T Uptake Reagent is substantially equivalent to the predicate device." This implies that meeting or closely matching the predicate's performance metrics served as the acceptance criteria.

2. Sample Size and Data Provenance for the Test Set

• Sample Size (for correlation study): N = 50
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, given that this is a 510(k) submission for a diagnostic reagent, it is highly probable that the data was generated prospectively during a validation study conducted in a clinical laboratory setting, likely within the United States.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: Not applicable. This type of device (reagent for quantitative determination) does not typically involve expert interpretation of results for establishing ground truth in the same way an imaging device might. The "ground truth" for the test set is established through comparison with a recognized reference method or predicate device.
• Qualifications of Experts: Not applicable for this specific type of device and study design.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" is established by the results of the comparative methods (predicate device and Hitachi 717 Assay for T Uptake), not through expert adjudication. Discrepancies would be handled through technical investigation of the assay performance, not by an adjudication panel.

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

• MRMC Study: No. A multi-reader multi-case (MRMC) comparative effectiveness study is not relevant for this type of in vitro diagnostic (IVD) reagent. MRMC studies are typically performed for imaging or interpretation-based diagnostic devices where human readers are involved in the diagnostic process.

6. Standalone (Algorithm Only) Performance

• Standalone Performance Study: Yes, in effect. The performance data presented (Assay Range, Precision, Correlation) directly reflects the standalone performance of the ACE® T Uptake Reagent as an algorithm/reagent system. There is no human-in-the-loop component in the fundamental operation of this quantitative assay. The device itself (ACE® T Uptake Reagent) is the "algorithm" and its performance is evaluated directly.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the performance assessment was established through comparison with a legally marketed predicate device (Diagnostic Reagents, Inc. T Uptake Enzyme Immunoassay) and another commercial assay (Hitachi 717 Assay for T Uptake). Specifically, the correlation study used the results from these established methods as the reference for assessing the accuracy of the proposed device.

8. Sample Size for the Training Set

• Sample Size for Training Set: The document does not provide specific information about a dedicated "training set" sample size. For IVD reagents like this, the development process typically involves internal validation and optimization using various samples, but these are not usually formally termed "training sets" in the same way as machine learning algorithms. The performance assessment data N=50 likely represents a portion of the validation data.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: As mentioned above, the concept of a "training set" and its explicit ground truth establishment is not typically documented in this manner for traditional IVD reagent submissions. The device's methodology (enzyme immunoassay) is based on established biochemical principles. Ground truth for optimizing and calibrating such a reagent would be derived from:
  • Known concentration standards: Using commercially prepared or internally validated standards with defined T Uptake values.
  • Reference materials: Using biological samples with assigned values from reference laboratories or methods.
  • Comparison to existing, validated methods: Initial development and optimization would likely involve running samples in parallel with accepted methods to ensure the new reagent provides accurate and reliable results.

Overall, the study demonstrates substantial equivalence to the predicate device by showing comparable assay range, precision, and a strong correlation with both the predicate and another commercial T Uptake assay.

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ACE® T4 Reagent is intended for use in the quantitative determination of thyroxine in human serum.

ACE® T4 Reagent is used in the diagnosis and treatment of thyroid disorders. It is intended for the quantitative determination of thyroxine in serum using the ACE clinical chemistry analyzer.

The ACE® T4 Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Coniugate reagent. The assay uses 8-anilino-1-naphthalene sulfonic acid (ANS) to dissociate thyroxine from the plasma-binding proteins. The dissociated thyroxine in the sample competes with an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled thyroxine for a fixed amount of anti-thyroxine specific antibody binding sites. In the absence of thyroxine from the sample, the thyroxine-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between thyroxine concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ACE® T4 Reagent are implicitly defined by its substantial equivalence to the predicate device, the DRI Thyroxine (T4) Enzyme Immunoassay. The reported device performance is compared directly to the predicate device's performance characteristics.

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

• Test Set Sample Size (Correlation Study):

  • Predicate Device: 108 samples (N=108)
  • Proposed Device: 50 samples (N=50)

• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) submission for an in-vitro diagnostic, it is generally assumed to be prospective clinical studies or laboratory studies conducted in a controlled environment as part of performance validation.

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

This document describes an in-vitro diagnostic (IVD) device for quantitative determination of thyroxine in human serum. For such devices, "ground truth" is typically established by reference methods or validated comparative assays, rather than expert consensus on images or clinical assessments. The comparison is made against existing commercial thyroxine assays (for the predicate) and the Hitachi 717 analyzer (for the proposed device). Therefore, the concept of "experts" to establish ground truth as would be relevant for image-based diagnostic aids does not directly apply here. The expertise lies in the established accuracy and reliability of the comparative analytical methods.

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, the ground truth is established by comparative analytical methods, not by human adjudication of observations.

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 an in-vitro diagnostic reagent, not an imaging device or an AI-assisted diagnostic tool that would involve human readers.

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

Yes, this is effectively a standalone performance study. The device (ACE® T4 Reagent) is an analytical tool that quantitatively determines thyroxine levels. Its performance (precision and correlation) is evaluated directly, without human interpretation of results as part of the primary measurement.

7. The Type of Ground Truth Used

The ground truth for the test set (correlation study) was established by:

• For the predicate device: A "Commercial thyroxine assay."
• For the proposed device: The "Hitachi 717" analyzer, which itself is a widely accepted clinical chemistry analyzer.

This is a form of comparative assay reference method or reference instrument data used to establish equivalency and accuracy for IVDs.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning, as this device is a reagent for an enzyme immunoassay, not an AI software. The performance assessment section focuses on validation data (precision and correlation).
For traditional IVDs, "training" might refer to the development and optimization of the assay itself using various samples, but specific sample sizes for such a "training set" are not typically reported in 510(k) summaries in this manner, nor are they relevant in the same way as for AI/ML models.

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

Not applicable in the context of machine learning. The "ground truth" for developing a chemical assay typically involves using calibrators and control materials with known concentrations, or comparing against established reference methods during the assay development phase. These details are not provided in this 510(k) summary.

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ACE® Theophylline Reagent is intended for the quantitative determination of theophylline in serum using the ACE® clinical chemistry analyzer.

Theophylline is a methylxanthine derivative which is widely used in the treatment of asthma, obstructive lung disease and neonatal apnea. The primary therapeutic effect of theophylline is due to relaxation of bronchial smooth muscle; however, theophylline has a variety of other effects. These include stimulation of the central nervous system and medullary respiratory centers, decreased peripheral vascular resistance, cardiac stimulation, and diuresis. In combination with other clinical data, monitoring serum theophylline levels may provide the physician with useful information to aid in adjusting patient dosage to achieve optimal therapeutic effect while avoiding drug toxicity.

The ACE® Theophylline Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to theophylline and is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD+ to NADH.

Here's an analysis of the provided text, focusing on acceptance criteria and the supporting study, formatted as requested:

Acceptance Criteria and Device Performance Study for ACE® Theophylline Reagent

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary directly compares the proposed device's performance to a predicate device. The acceptance criteria are implicitly defined by the predicate device's performance characteristics, demonstrating substantial equivalence.

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ACE® Valproic Acid Reagent is intended for use in the quantitative determination of valproic acid in human serum.
ACE® Valproic Acid Reagent is intended for the quantitative determination of valproic acid in serum using the ACE® clinical chemistry analyzer.

The ACE® Valproic Acid Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to valproic acid and is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.

The ACE® Valproic Acid Reagent is an enzyme immunoassay intended for the quantitative determination of valproic acid in human serum. The study demonstrated its substantial equivalence to a predicate device, the DRI Valproic Acid Enzyme Immunoassay, based on performance parameters such as assay range, precision, and correlation with another commercial valproic acid assay.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device and showing comparable performance. The performance metrics of the predicate device serve as the de facto acceptance criteria.

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ACE® Primidone Reagent is intended for use in the quantitative determination of primidone in human serum.

ACE® Primidone Reagent is intended for the quantitative determination of primidone in serum using the ACE® clinical chemistry analyzer.

Primidone (Mysoline®) used alone, or in combination with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. In combination with other clinical data, monitoring serum primidone levels will provide physicians with useful information to aid in adjusting patient dosage to achieve optimal therapeutic effect while avoiding drug toxicity.

The ACE® Primidone Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to primidone and is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.

The ACE® Primidone Reagent is intended for the quantitative determination of primidone in human serum using the ACE® clinical chemistry analyzer. The device's performance was assessed by comparing it to a predicate device, the DRI Primidone Enzyme Immunoassay, and through non-clinical test results including within-run and between-run precision, and correlation against a Hitachi 717 analyzer.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" as pass/fail thresholds for precision or correlation. Instead, it presents the performance of the proposed device alongside the predicate device's performance for comparison, implying that performance comparable to or better than the predicate is acceptable.

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ACE® Phenobarbital Reagent is intended for use in the quantitative determination of phenobarbital in human serum.

ACE® Phenobarbital Reagent is intended for the quantitative determination of phenobarbital in serum using the ACE® clinical chemistry analyzer.

The ACE® Phenobarbital Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to phenobarbital and is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD' to NADH.

Here's an analysis of the provided text regarding the ACE® Phenobarbital Reagent, detailing its acceptance criteria and the study that proves its performance:

ACE® Phenobarbital Reagent: Acceptance Criteria and Performance Study

The ACE® Phenobarbital Reagent is an enzyme immunoassay intended for the quantitative determination of phenobarbital in human serum. This 510(k) premarket notification (K973536) demonstrates substantial equivalence to a predicate device, the DRI Phenobarbital Enzyme Immunoassay (K946210).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the comparison to the predicate device and standard performance metrics for such assays. The reported performance of the Proposed Device (ACE® Phenobarbital Reagent) is compared against that of the Predicate Device for substantial equivalence.

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ACE® Phenytoin Reagent is intended for use in the quantitative determination of phenytoin in human serum.
ACE® Phenytoin Reagent is intended for the quantitative determination of phenytoin in serum using the ACE® clinical chemistry analyzer.
Phenytoin is one of the most widely prescribed anti-convulsant drugs for the treatment of epilepsy, particulary grand mal epilepsy (major motor), corticol focal seizures and temporal lobe epilepsy.

The ACE® Phenytoin Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to phenytoin and is based on the competition of an enzyme glucose-o-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.

The provided document describes the ACE® Phenytoin Reagent, an enzyme immunoassay for the quantitative determination of phenytoin in human serum, and its substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission relies on demonstrating substantial equivalence to a predicate device (Diagnostic Reagents, Inc. (DRI) - Phenytoin Reagent [510(k) Number K945725]). The performance parameters below are compared between the proposed device and the predicate device, implying that the predicate's performance serves as the de-facto acceptance criteria for the proposed device to be considered substantially equivalent.

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ACE® Carbamazepine Reagent is intended for use in the quantitative determination of carbamazepine in human serum.

ACE® Carbamazepine Reagent is intended for the quantitative determination of carbamazepine in serum using the ACE® clinical chemistry analyzer.

The ACE® Carbamazepine Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to carbamazepine and is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites . In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.

The ACE® Carbamazepine Reagent is an enzyme immunoassay intended for the quantitative determination of carbamazepine in human serum.

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

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This in vitro diagnostic product is intended for the quantitative determination of HDL cholesterol in human serum.

Numerous studies have shown an inverse relationship between serum HDL cholesterol and the risk of coronary heart disease. HDL cholesterol also has an important role in the pathogenesis of atherosclerosis.

An aliquot of serum is added to the first reagent which contains a mixture of polymers and polyanions that bind to the surface of low-density lipoproteins (LDL), very low-density lipoproteins (VLDL) and chylomicrons. These complexed lipoproteins are stabilized, even in the presence of detergent, which is added as part of the second reagent, together with cholesterol enzymes. HDL particles are not stabilized by the polymers and polyanions and become solubilized by the detergent. As a result, only the HDL cholesterol is subject to measurement.

The ACE™ HDL-C Reagent is intended for the quantitative determination of HDL cholesterol in human serum. The study provided focuses on establishing substantial equivalence to a predicate device (N-geneous™ HDL Cholesterol Reagent) and to a CDC reference method, rather than specifically defining explicit acceptance criteria in a regulatory sense for a single-arm study. The performance assessment compares key metrics to both the predicate device and the CDC reference method.

Here's the breakdown of the information requested based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" in a pass/fail format with specific thresholds. Instead, it presents performance summaries for comparison against a predicate device and a reference method, with the implicit acceptance being that the proposed device performs comparably. The document states that "Based on these data, the Schiapparelli Biosystems ACE™ HDL-C reagent is substantially equivalent to the Centers for Disease Control Reference Method and the predicate device, the Genzyme N-geneous HDL Cholesterol Reagent."

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