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CHOLESTEROL: Reagent kit intended for the quantitative determination of Cholesterol in human serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood, of lipid and lipoprotein metabolism disorders.

HDL-Cholesterol: Reagent kit intended for the quantitative determination of high-density lipoprotein in human serum. Measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases.

LDL-Cholesterol: Reagent kit intended for the quantitative determination of low-density lipoprotein in human serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

TRIGLYCERIDES: Reagent kit intended for the quantitative determination of triglycerides (neutral fat) in human serum. Measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

CHOLESTEROL: The Cholesterol Oxidase peroxidase (CHOD-PAP) enzymatic method is used. The cholesterol esterase enzyme catalyzes the hydrolysis of cholesterol and free fatty and free fatty acids. Free cholesterol, including that originally present in the sample, is then oxidized by the enzyme cholesterol oxidase (CHOD) to cholest-4-en-3-one, by using molecular oxygen as the electron acceptor and concurrently producing hydrogen peroxide (H2O2). The H2O2 produced is then used in a subsequent chromogenic oxidative coupling reaction, catalyzed by the enzyme peroxidase, in the presence of a redox indicator system, which leads to the formation of a colored compound, absorbing light at 550 nm. The increase in absorbance is directly proportional to the cholesterol concentration in the sample.

HDL-Cholesterol: The Accelerator Selective Detergent method is applied. The determination of HDL-Cholesterol is based on the following reactions: LDL, VLDL, and chylomicrons are neutralized by the combined action of the enzymes Cholesterol Oxidase, Peroxidase, accelerators and N,N-bis-(4-sulfobutyl)-m-toluidine-disodium (DSBmT). HDL remaining in the sample is disrupted by the action of a selective detergent and cholesterol is converted to △4 Cholestenone by the enzymatic action of Cholesterol Esterase and Cholesterol Oxidase, with the subsequent production of H2O2, which reacts with DSBmT and 4-aminoantipyrine in the presence of Peroxidase to a colored complex that absorbs light at 590 nm. The absorbance measured is proportional to the concentration of HDL-Cholesterol in the sample.

LDL-Cholesterol: The Selective Detergent method is applied. The method is in a two-reagent format and depends on the properties of a unique detergent. The first detergent solubilizes only the non-LDL lipoprotein particles. The cholesterol released is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. The second detergent solubilizes the remaining LDL particles, and a chromogenic coupler allows for color formation. The enzyme reaction with LDL-Cholesterol in the presence of the coupler at 590 nm produces color that is proportional to the amount of LDL cholesterol present in the sample.

TRIGLYCERIDES: The enzymatic glycerol-3-phosphate-peroxidase (GPO-POD) method is used. The method enzymatically hydrolyzes by lipase to free fatty acids and glycerol is phosphorylated by adenosine triphosphate (ATP) with glycerokinase (GK) to produce glycerol-3-phosphate and adenosine diphosphate (ADP). Glycerol-3-phosphate-oxidase oxidizes glycerol-3-phosphate to dihydroxyacetone phosphate and H2O2. The catalytic action of peroxidase (POD) forms quinoneimine from H202, aminoantipyrine, and Dihydrate (N-Ethyl-N-(2hydroxy-3-sulfopropyl)-m-toluidine (TOOS). The absorption change at 550 nm is proportional to the triglycerides concentration in the sample.

Here's a breakdown of the acceptance criteria and the study information for the Medicon Hellas Cholesterol, HDL-Cholesterol, LDL-Cholesterol, and Triglycerides test systems, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by comparison to legally marketed predicate devices and alignment with clinical laboratory guidelines (CLSI). The document presents a clear comparison in the "Device Comparison Table" sections. For this summary, I'll focus on the key performance indicators for each analyte.

CHOLESTEROL

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For the quantitative in vitro determination of Triglycerides in serum. Triglyceride measurements are used in the diagnosis and treatment of diseases involving lipid metabolism and various endocrine disorders e.g Diabetes mellitus, nephrosis and liver obstruction

This in vitro diagnostic device is intended for prescription use only.

The Randox Triglycerides kit assay consists of ready to use reagent solutions.

Here's a breakdown of the acceptance criteria and the study information for the Triglycerides (TRIGS) device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of "acceptance criteria" for the entire device's performance followed by a direct comparison in a single table, but rather describes various performance characteristics and their findings. I will construct a table based on the individual performance criteria and the results presented.

• Sensitivity Pool (13.3 mg/dl): Total CV 13.4%
• Serum Pool 1 (96.4 mg/dl): Total CV 2.1%
• QC 1 (96.5 mg/dl): Total CV 2.3%
• Patient Pool 2 (104 mg/dl): Total CV 2.5%
• Patient Pool 1 (117 mg/dl): Total CV 2.5%
• Serum Pool 2 (237 mg/dl): Total CV 2.1%
• CAL (240 mg/dl): Total CV 2.0%
• QC 2 (259 mg/dl): Total CV 1.5%
• Serum Pool 3 (326 mg/dl): Total CV 1.6%

Lot 2 (RX Daytona Plus):

• Sensitivity Pool (17.7 mg/dl): Total CV 11.6%
• 801UN QC 2 (97.3 mg/dl): Total CV 3.2%
• Serum Pool 1 (111 mg/dl): Total CV 3.6%
• 832UE CAL (235 mg/dl): Total CV 3.0%
• Serum Pool 2 (252 mg/dl): Total CV 2.6%
• 587UE QC 3 (265 mg/dl): Total CV 2.5%
• Serum Pool 3 (326 mg/dl): Total CV 3.7%
• Serum Pool 4 (514 mg/dl): Total CV 2.8% |
  | Linearity/Assay Reportable Range | Deviation from linearity less than 5%. | Linearity: Slope 0.96, Intercept 3.30, r = 1.000.
  Reportable Range: 12.4 – 1000 mg/dl. (The linearity study covered up to approximately 1000 mg/dl, and the device has an auto-dilution feature for samples >1000 mg/dL). |
  | Detection Limit | Not explicitly stated as acceptance criteria, but rather defined properties. | LoD: 3.96 mg/dl (based on 240 determinations, 4 low-level samples)
  LoB: 2.65 mg/dl
  LoQ: 12.4 mg/dl (lowest concentration at which precision is met) |
  | Analytical Specificity (Interference) | Recovery within ±10% of the initial value of Triglycerides concentration of 150mg/dL and 496mg/dL. | Hemoglobin: No significant interference up to 750mg/dL
  Total Bilirubin: No significant interference up to 60mg/dL
  Conjugate Bilirubin: No significant interference up to 60mg/dL
  Ascorbic Acid: No significant interference up to 3.0mg/dL |
  | Method Comparison with Predicate Device | Not explicitly stated as a single numeric criterion for the regression, but the goal is "substantially equivalent" to the predicate. Implied acceptable correlation (r) and agreement (slope, intercept). | Comparison: Y = 0.97x + 1.22
  Correlation coefficient: r = 0.999 (This indicates a very strong positive correlation) |

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

• Precision/Reproducibility:
  • Test Set: Serum-based control material and unaltered human serum samples (some spiked or diluted). Specific numbers of individual patient samples beyond "Pool 1, Pool 2, Pool 3, Pool 4" are not given. For each sample type, 2 replicates per run were performed, twice daily for 20 non-consecutive days, using 2 reagent lots and 2 systems.
  • Data Provenance: Not explicitly stated, but implies laboratory testing with control materials and human serum samples. Given the manufacturer is based in the UK, it's likely the testing was done there, but this is not confirmed. It is a prospective study design for precision.
• Linearity:
  • Test Set: 11 levels prepared from low and high serum pools, each run in replicates of five.
  • Data Provenance: Not explicitly stated, but implies laboratory testing with serum pools. Prospective study design.
• Detection Limit:
  • Test Set: 240 determinations were made, including 4 low-level samples, to determine LoD, LoB, and LoQ.
  • Data Provenance: Not explicitly stated, implies laboratory testing. Prospective study design.
• Analytical Specificity (Interference):
  • Test Set: Spiked interferent samples with corresponding control solutions. Specific number of samples not provided. Triglycerides concentrations of 150 mg/dL and 496 mg/dL were examined.
  • Data Provenance: Not explicitly stated, implies laboratory testing. Prospective study design.
• Method Comparison:
  • Test Set: 109 serum patient samples spanning the range 14.2 to 986 mg/dl. Each tested in singlicate.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but states "serum patient samples." Implies retrospective collection of samples or prospective collection for this study.

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

This device (Triglycerides assay) is an in-vitro diagnostic device for quantitative chemical analysis. The "ground truth" for these types of devices is established through analytical reference methods or highly characterized reference materials, not typically by expert consensus of human readers.

• No mention of human experts or their qualifications for establishing ground truth for the test set.

4. Adjudication Method for the Test Set

Not applicable for this type of quantitative analytical assay. Adjudication is typically used in image-based diagnostic studies involving human interpretation.

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

No, an MRMC comparative effectiveness study was not done. This type of study involves assessing the performance of human readers, sometimes with and without AI assistance, and is not relevant for a quantitative chemical assay.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies described (precision, linearity, detection limit, analytical specificity, method comparison) represent the standalone performance of the device/system (RX Daytona plus analyzer with Randox Triglycerides reagent) without human intervention in the analytical measurement process beyond sample loading and general operation.

7. The Type of Ground Truth Used

• Precision/Reproducibility, Linearity, Detection Limit, Analytical Specificity: The "ground truth" or reference for these studies refers to the true concentration of triglycerides in the samples (control materials, spiked samples, diluted samples) as determined by a highly accurate method or known values of reference materials.
• Method Comparison: The "ground truth" is the results obtained by a legally marketed predicate device (Randox Triglyceride Assay, K923508). For calibrators within the system, Randox Calibration Serum Level 3 is stated to be traceable to the Triglycerides reference method ID-GC/MS. This indicates a high-accuracy chemical method is the ultimate ground truth for calibration.

8. The Sample Size for the Training Set

This document describes a medical device (an in-vitro diagnostic reagent/system) for which "training sets" are not typically applicable in the same way as for AI/machine learning algorithms. The device's performance characteristics are inherent to its chemical formulation and the analytical instrument. There is no mention of a "training set" for an algorithm.

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

Not applicable, as there is no specific "training set" for an algorithm mentioned in the context of this device.

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The ADVIA® Chemistry Triglycerides 2 assay (TRIG 2) is intended for in vitro diagnostic use in the quantitative measurement triglycerides in human serum and plasma on the ADVIA® Chemistry systems. Measurements of triglycerides are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

The Triglyceride 2 reagent is a ready-to-use liquid reagent packaged for use on the automated ADVIA 1800 Chemistry system. It is supplied as a 358 tests/wedge. 4 wedges/Kit with a 38 mL fill in a 40 mL wedge size.

Existing Siemens Set-Point Chemistry calibrator (classified under CFR 862.1150 - calibrator, multi-analyte mixture, product code JIX), cleared under 510k K030169, is used to calibrate the assay on the ADVIA Chemistry systems.

Here's a breakdown of the acceptance criteria and study information for the ADVIA® Chemistry Triglycerides 2 Reagents (TRIG 2) device, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the ADVIA® Chemistry Triglycerides 2 assay appear to be established by comparison with a predicate device and adherence to CLSI guidelines for various performance characteristics. Specific quantifiable acceptance criteria are often implied by "acceptable results" or meeting certain thresholds, but the document primarily reports the performance observed.

Study Details

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

   • Precision: 80 replicates for each of the two serum controls and two serum pools. The data provenance is not explicitly stated (e.g., country of origin); however, the context of in vitro diagnostic testing in a 510(k) submission generally implies laboratory testing under controlled conditions, likely in the US by the manufacturer (Siemens Healthcare Diagnostics, Inc., Tarrytown, NY). The data is prospective as it was generated specifically for this submission.
   • Linearity: Not explicitly stated how many samples/replicates were used, but it involved mixing low and high serum pools to create 12 levels (9 intermediate, 3 low-end).
   • LoB, LoD: 320 determinations, comprising 160 blank and 160 low-level sample replicates.
   • Method Comparison (Serum): 101 serum samples.
   • Method Comparison (Plasma Matrices): 60 plasma samples (Lithium Heparin) and 60 plasma samples (Potassium EDTA).
   • Analytical Specificity: Not explicitly stated, but involved testing samples with varying concentrations of interferents and triglycerides.

2. 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):

   • For this type of in vitro diagnostic device (chemical assay), the "ground truth" is typically established by the reference method (the predicate device) or by known concentrations of analytes in calibrators and control materials, rather than by human expert consensus or pathology. No human experts are mentioned for establishing ground truth in this context.

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

   • Adjudication methods like "2+1" or "3+1" are characteristic of studies involving human interpretation (e.g., imaging studies). This information is not applicable to a chemical assay where results are quantifiable values based on instrument 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:

   • No MRMC comparative effectiveness study was done. This type of study is not relevant for an automated chemical assay.

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

   • Yes, this is a standalone device in the sense that the assay itself generates the quantitative results without direct human intervention in the result determination. The performance characteristics described are "algorithm only" or "device only" performance. Humans operate the instrument and interpret results, but the measurement itself is automated.

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

   • The ground truth for performance evaluation (e.g., method comparison) is based on the predicate device (Dimension Clinical Chemistry Triglycerides FLEX reagent cartridge, K010871) and known concentrations for controls, calibrators, and linearity pools. For traceability, the assay is referenced to NIST SRM909c, a certified reference material.

7. The sample size for the training set:

   • This is a traditional IVD assay, not a machine learning or AI-based device. Therefore, there is no "training set" in the context of data used to train an algorithm. The development of the reagent and its parameters would have involved R&D studies, but these are not analogous to training data for AI.

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

   • Not applicable, as there is no training set for an AI/ML algorithm.

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The ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum and lithium heparin plasma using the ACE Axcel Clinical Chemistry System. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE HDL-C Reagent is intended for the quantitative determination of high density lipoprotein cholesterol (HDL-C) concentration in serum and lithium heparin plasma using the ACE Axcel Clinical Chemistry System. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE LDL-C Reagent is intended for the quantitative determination of low density lipoprotein cholesterol (LDL-C) concentration in serum and lithium heparin plasma using the ACE Axcel Clinical Chemistry System. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Triglycerides Reagent is intended for the quantitative determination of triglyceride concentration in serum and lithium heparin plasma using the ACE Axcel Clinical Chemistry System. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Cholesterol Reagent is composed of a single reagent bottle. The reagent contains 4-aminoantipyrine, p-hydroxybenzoic acid, cholesterol oxidase, cholesterol esterase and peroxidase.

The HDL-C Reagent assay utilizes two reagent bottles, the second containing a unique detergent. This detergent solubilizes only the HDL lipoprotein particles, thus releasing HDL cholesterol to react with the cholesterol esterase and cholesterol oxidase, in the presence of a chromogen to produce color. The detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL and chylomicron lipoproteins by adsorbing to their surfaces. The amount of chromogen formed, determined by measuring the increase in absorbance bichromatically at 592/692 nm, is directly proportional to the HDL cholesterol concentration in the sample.

In the ACE LDL-C Reagent assay, detergent 1 solubilizes non-LDL lipoprotein particles (HDL, VLDL and chylomicrons) and releases cholesterol. The cholesterol is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. In a second reaction, detergent 2 solublizes the remaining LDL particles and forms peroxide, via the enzymes cholesterol esterase and cholesterol oxidase. The peroxide, in the presence of peroxidase and two peroxidase substrates, 4-aminoantipyrine and DSBmT, results in a purple-red color. The amount of color formed, determined by measuring the increase in absorbance bichromatically at 544/692 nm, is directly proportional to the LDL cholesterol concentration in the sample.

In the ACE Triglycerides Reagent assay, triglycerides in serum are hydrolyzed by lipase to form glycerol and free fatty acids. In the presence of adenosine triphosphate (ATP) and glycerol kinase, the glycerol is converted to glycerol-1-phosphate and the ATP to adenosine diphosphate. Glycerol-1-phosphate is oxidized by glycerol phosphate oxidase to yield hydrogen peroxide. The hydrogen peroxide then acts to oxidatively couple p-chlorophenol and 4-aminoantipyrine in a reaction catalyzed by peroxidase, producing a red colored quinoneimine complex which absorbs strongly at 505 nm. The amount of chromogen formed, determined by measuring the increase in absorbance bichromatically at 505 nm/692 nm, is directly proportional to the triglycerides concentration in the sample.

The provided text describes a 510(k) submission for the ACE Axcel Clinical Chemistry System and its associated reagents for Cholesterol, HDL-C, LDL-C, and Triglycerides. The submission focuses on demonstrating substantial equivalence to a predicate device (K113262) by showing that the new device has "Same" intended use, instrument platform, basic principle, and reagent composition, with the only difference being the expanded sample type (serum and lithium heparin plasma for the candidate device vs. serum only for the predicate device).

The acceptance criteria are implicitly defined by the performance characteristics demonstrated in the study, which aim to show that the expanded sample type (lithium heparin plasma) does not negatively impact the accuracy and precision of the measurements compared to serum. The study largely relies on analytical performance data rather than clinical outcomes or expert consensus on interpretations.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document; instead, the study intends to demonstrate comparable performance to the predicate device and acceptable analytical characteristics. The reported device performance for precision and matrix comparison is provided below, which implicitly became the "accepted" performance for the expanded sample type.

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

• Precision/Reproducibility Study (Test Set):
  • For each analyte (Cholesterol, HDL-C, LDL-C, Triglycerides), for both serum and plasma, 3 levels of samples were used.
  • Each level was tested with 2 replicates, twice a day, on 5 separate days, yielding a total of 20 replicates per level (3 levels * 2 sample types * 20 replicates/level = 120 total measurements per analyte category, e.g., Cholesterol on Serum).
  • Data Provenance: Not explicitly stated, but typically these studies are conducted in a laboratory setting, likely in the US (given the FDA submission). It is a prospective analytical study designed to evaluate device performance under controlled conditions.
• Matrix Comparison Study (Test Set):
  • Cholesterol: 54 paired serum and lithium heparin plasma specimens.
  • HDL-C: 53 paired serum and lithium heparin plasma specimens.
  • LDL-C: 54 paired serum and lithium heparin plasma specimens.
  • Triglycerides: 55 paired serum and lithium heparin plasma specimens.
  • These specimens covered the assay's dynamic range.
  • Data Provenance: Not explicitly stated, but likely from a clinical laboratory setting, potentially within the US. The samples are retrospective specimens collected for analytical comparison.

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

This type of submission for in vitro diagnostic reagents does not typically involve human experts establishing "ground truth" through interpretation. The "ground truth" for the test set is established by comparative measurements against a reference method or the predicate device, and by the inherent chemical/physical properties of the samples used in reproducibility studies. No information about experts or their qualifications is provided or relevant in this context.

4. Adjudication method for the test set

Not applicable. This is an analytical performance study for laboratory reagents, not a clinical study involving human interpretation that would require an adjudication method.

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/imaging device, nor does it involve human readers or case interpretations. It is an in vitro diagnostic reagent.

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

This is an analytical device, and its performance is inherently standalone in terms of generating a quantitative result. The results are then interpreted by clinicians in the overall diagnostic process. The study evaluates the standalone performance of the reagents on the ACE Axcel Clinical Chemistry System.

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

The "ground truth" for this type of analytical validation is established by:

• Reference methods and/or the predicate device: For the matrix comparison, the serum measurements on the candidate device (which is substantially equivalent to the predicate) serve as the reference against plasma measurements. The predicate device's performance also implicitly serves as a benchmark for comparison.
• Known concentrations: For precision studies, samples are "clinically relevant decision levels" meaning they have known or well-characterized concentrations of the analytes. These concentrations are typically determined by highly accurate laboratory methods.

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device that requires a training set. The reagents are chemical formulations, and the system is an automated analyzer.

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

Not applicable, as there is no training set for this type of device.

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ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE HDL-C Reagent is intended for the homogeneous, quantitative determination of HDL cholesterol (HDL-C) in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE LDL-C Reagent is intended for the quantitative determination of low density lipoprotein cholesterol (LDL-C) in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE Triglycerides Reagent is intended for the quantitative determination of triglycerides in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

In the ACE Cholesterol Reagent assay, cholesterol esters in serum or heparin plasma are completely hydrolyzed by cholesterol esterase to free cholesterol and free fatty acids. The cholesterol liberated by the esterase, plus any endogenous free cholesterol, are both oxidized by cholesterol oxidase to yield hydrogen peroxide. The hydrogen peroxide then acts to oxidatively couple p-hydroxybenzoic acid and 4-aminoantipyrine in a reaction catalyzed by peroxidase, producing a red colored quinoneimine complex which absorbs strongly at 505 nm. The amount of chromogen formed, determined by measuring the increase in absorbance, bichromatically at 505 nm/647 nm, is directly proportional to the cholesterol concentration in the sample.

The HDL-C Assay utilizes two reagents, the second containing a unique detergent. This detergent solubilizes only the HDL lipoprotein particles, thus releasing HDL cholesterol to react with the cholesterol esterase and cholesterol oxidase, in the presence of a chromogen to produce color. The detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL and chylomicron lipoproteins by adsorbing to their surfaces. The amount of chromogen formed, determined by measuring the increase in absorbance bichromatically at 592/692 nm, is directly proportional to the HDL cholesterol concentration in the sample.

In the ACE LDL-C Reagent assay, detergent 1 solubilizes non-LDL lipoprotein particles (HDL, VLDL and chylomicrons) and releases cholesterol. The cholesterol is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. In a second reaction, detergent 2 solublizes the remaining LDL particles and forms peroxide, via the enzymes cholesterol esterase and cholesterol oxidase. The peroxide, in the presence of peroxidase and two peroxidase substrates, 4-aminoantipyrine and DSBmT, results in a purple-red color. The amount of color formed, determined by measuring the increase in absorbance bichromatically at 544/692 nm, is directly proportional to the LDL cholesterol concentration in the sample.

In the ACE Triglycerides Reagent assay, triglycerides in serum or heparin plasma are hydrolyzed by lipase to form glycerol and free fatty acids. In the presence of adenosine triphosphate (ATP) and glycerol kinase, the glycerol is converted to glycerol-1-phosphate and the ATP to adenosine diphosphate. Glycerol-1-phosphate is oxidized by glycerol phosphate oxidase to yield hydrogen peroxide. The hydrogen peroxide then acts to oxidatively couple p-chlorophenol and 4-aminoantipyrine in a reaction catalyzed by peroxidase, producing a red colored quinoneimine complex which absorbs strongly at 505 nm. The amount of chromogen formed, determined by measuring the increase in absorbance bichromatically at 505 nm/692 nm, is directly proportional to the triglycerides concentration in the sample.

Here's a breakdown of the acceptance criteria and study details for the Alfa Wassermann ACE Cholesterol Reagent, ACE HDL-C Reagent, ACE LDL-C Reagent, and ACE Triglycerides Reagent, based on the provided 510(k) summary:

The studies presented are "matrix comparison data" studies, aiming to demonstrate substantial equivalence between using serum and lithium heparin plasma samples with the new ACE reagents on the ACE and ACE Alera Clinical Chemistry Systems. The performance is assessed by comparing quantitative measurements from paired serum/plasma samples.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on demonstrating strong correlation and agreement between serum and plasma measurements, specifically looking for regression equations close to y=x (slope near 1, intercept near 0) and high correlation coefficients. The provided confidence intervals for slope and intercept also serve as an implicit measure of acceptance.

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

• ACE Cholesterol Reagent (ACE Clinical Chemistry System): 102 paired samples (serum and lithium heparin plasma). 5 samples spiked.
• ACE Cholesterol Reagent (ACE Alera Clinical Chemistry System): 100 paired samples (serum and lithium heparin plasma). 6 samples spiked.
• ACE HDL-C Reagent (ACE Clinical Chemistry System): 101 paired samples (serum and lithium heparin plasma).
• ACE HDL-C Reagent (ACE Alera Clinical Chemistry System): 100 paired samples (serum and lithium heparin plasma).
• ACE LDL-C Reagent (ACE Clinical Chemistry System): 99 paired samples (serum and lithium heparin plasma). 4 samples spiked.
• ACE LDL-C Reagent (ACE Alera Clinical Chemistry System): 99 paired samples (serum and lithium heparin plasma). 4 samples spiked.
• ACE Triglycerides Reagent (ACE Clinical Chemistry System): 101 paired samples (serum and lithium heparin plasma). 5 samples spiked.
• ACE Triglycerides Reagent (ACE Alera Clinical Chemistry System): 101 paired samples (serum and lithium heparin plasma). 5 samples spiked.

Data Provenance: The data provenance is described as "paired samples drawn from the same patients." There is no explicit mention of the country of origin of the data, but the context of an FDA 510(k) submission for commercialization in the USA suggests it would likely be from a US-based or internationally recognized clinical setting. The studies are prospective in nature, as they involve drawing paired samples for direct comparison. Spiking of some samples was done to extend the measurement range.

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

This type of study does not involve "experts" establishing a ground truth in the traditional sense of medical image interpretation or clinical diagnosis. Instead, the ground truth for each measurement type (Cholesterol, HDL-C, LDL-C, Triglycerides) is the quantitative value obtained from the serum sample, which serves as the established reference matrix. The performance of the devices is then compared against this reference when using plasma samples. Therefore, no external experts were used for this purpose; the "ground truth" is the instrumental measurement itself.

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative laboratory test performance study, not an expert-driven adjudication of medical findings. The comparison is statistical (Deming regression) between instrument measurements from two different sample matrices (serum vs. plasma).

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 study evaluating the performance of in-vitro diagnostic reagents and systems, not an AI-assisted diagnostic device involving human readers.

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

This study evaluates the standalone performance of the reagent and instrument system when used with different biological matrices (serum vs. plasma). There is no "human-in-the-loop" component in the interpretation of the numerical results beyond standard laboratory quality control and reporting procedures. The results provided are direct numerical outputs from the analytical instruments.

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

The "ground truth" used in these studies is the quantitative measurement of the analytes (Cholesterol, HDL-C, LDL-C, Triglycerides) obtained from serum samples using the same ACE and ACE Alera Clinical Chemistry Systems. Serum is generally considered the standard matrix for these assays. The purpose of the study is to demonstrate that lithium heparin plasma samples yield comparable results to serum samples.

8. The sample size for the training set

Not applicable. This is a performance validation study for a medical device (reagents and instrument system), not a machine learning model that requires a distinct training set. The "training" in this context would refer to the development and optimization of the reagents and assay protocols, which typically occurs during the R&D phase and doesn't involve a formal "training set" as understood in AI/ML.

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

Not applicable, as there is no training set in the context of machine learning. The reagents are developed to specifically measure the target analytes based on well-established biochemical principles (enzymatic reactions). The "ground truth" for the development of such assays would involve chemical standards, certified reference materials, and comparison to established reference methods, but this is part of the assay development, not a "training set" for the reported performance studies.

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ELITech Clinical Systems TRIGLYCERIDES SL is intended for the quantitative in vitro diagnostic determination of triglycerides in human serum and plasma on ELITech Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

ELITech Clinical Systems CHOLESTEROL SL is intended for the quantitative in vitro diagnostic determination of cholesterol in human serum and plasma on ELITech Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the ELITech Vital Scientific Selectra/Flexor Analyzers.

ELITech Clinical Systems ELITROL I & ELITROL II are multiparametric control sera for use in quality control of ELITech Clinical Systems methods on ELITech Vital Scientific Selectra/Flexor Analyzers.

The device for this submission is available as kit only. It consists of 1 reagent, "R". Reagent R contains: Pipes buffer, p-chlorophenol, ATP, Amino-4-antipyrine (4-AAP), Lipoprotein lipase (bacterial), Glycerol kinase (bacterial), Glycerol-3-phosphate oxidase (microorganisms), Peroxidase (horseradish), Potassium ferrocyanide, Magnesium (Mg2+) and Sodium azide.

The device for this submission is available as kit only. It consists of 1 reagent, "R". Reagent R contains: Pipes buffer, 4-Aminoantipyrine (4-AAP), Cholesterol esterase (CHE bacterial), Cholesterol oxidase (CHO microorganisms), Peroxidase (POD horseradish), Sodium cholate, Phenol and Sodium azide.

ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

Here's a summary of the acceptance criteria and the studies for the ELITech Clinical Systems TRIGLYCERIDES SL reagent, ELITech Clinical Systems CHOLESTEROL SL reagent, ELICAL 2 calibrator, and ELITROL I/ELITROL II controls, based on the provided documents.

ELITech Clinical Systems TRIGLYCERIDES SL Reagent

1. Table of Acceptance Criteria and Reported Device Performance

For TRIGLYCERIDES SL, the acceptance criteria are not explicitly stated as distinct numerical targets; instead, the performance is demonstrated through comparison with a predicate device. The implied acceptance is that the device performs comparably to the predicate or within clinically acceptable ranges for the specified parameters.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not explicitly state the sample size used for the test set for precision and method comparison studies.
• Data Provenance: Not specified in the provided text. It is a submission by SEPPIM S.A.S. from FRANCE, suggesting data could be of French origin or from other regions. Studies are generally retrospective as they are performance evaluations of an existing reagent formulation.

3. Number of Experts and Qualifications

This information is not applicable. The studies are laboratory-based analytical performance evaluations of a diagnostic reagent, not interpretations by medical experts.

4. Adjudication Method

This information is not applicable for this type of analytical performance study.

5. MRMC Comparative Effectiveness Study

• This information is not applicable. This is an analytical performance study of a diagnostic reagent, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Performance Study

• Yes, the performance data presented (measuring range, precision, method comparison, limitations) are for the standalone performance of the ELITech Clinical Systems TRIGLYCERIDES SL reagent on the ELITech Vital Scientific Selectra/Flexor analyzers.

7. Type of Ground Truth Used

• For precision and linearity, the "ground truth" refers to laboratory controls and reference materials with known concentrations, or samples run repeatedly to establish variability.
• For method comparison, the "ground truth" is established by comparing the device's results to those obtained using the legally marketed predicate device (ABX PENTRA TRIGLYCERIDES CP). The predicate device's results serve as the reference for comparison.

8. Sample Size for Training Set

• This information is not applicable. This is a chemical reagent, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set was Established

• This information is not applicable.

ELITech Clinical Systems CHOLESTEROL SL Reagent

1. Table of Acceptance Criteria and Reported Device Performance

For CHOLESTEROL SL, similar to TRIGLYCERIDES SL, acceptance is implied by comparison to the predicate device and being within clinically acceptable ranges.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not explicitly state the sample size used for the test set for precision and method comparison studies.
• Data Provenance: Not specified in the provided text. It is a submission by SEPPIM S.A.S. from FRANCE, suggesting data could be of French origin or from other regions. Studies are generally retrospective as they are performance evaluations of an existing reagent formulation.

3. Number of Experts and Qualifications

This information is not applicable. The studies are laboratory-based analytical performance evaluations of a diagnostic reagent, not interpretations by medical experts.

4. Adjudication Method

This information is not applicable for this type of analytical performance study.

5. MRMC Comparative Effectiveness Study

• This information is not applicable. This is an analytical performance study of a diagnostic reagent, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Performance Study

• Yes, the performance data presented (measuring range, precision, method comparison, limitations) are for the standalone performance of the ELITech Clinical Systems CHOLESTEROL SL reagent on the ELITech Vital Scientific Selectra/Flexor analyzers.

7. Type of Ground Truth Used

• For precision and linearity, the "ground truth" refers to laboratory controls and reference materials with known concentrations, or samples run repeatedly to establish variability.
• For method comparison, the "ground truth" is established by comparing the device's results to those obtained using the legally marketed predicate device (ABX PENTRA CHOLESTEROL CP). The predicate device's results serve as the reference for comparison.

8. Sample Size for Training Set

• This information is not applicable. This is a chemical reagent, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set was Established

• This information is not applicable.

ELITech Clinical Systems ELICAL 2 Calibrator

1. Table of Acceptance Criteria and Reported Device Performance

For ELICAL 2, the primary acceptance criteria revolve around format, stability, and handling being comparable to the predicate, and traceability being established.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not specified for stability studies.
• Data Provenance: Not specified. From SEPPIM S.A.S. (FRANCE). Studies are for characterization of the calibrator's properties.

3. Number of Experts and Qualifications

Not applicable.

4. Adjudication Method

Not applicable.

5. MRMC Comparative Effectiveness Study

• Not applicable.

6. Standalone Performance Study

• Yes, the stability and handling characteristics are for the standalone performance of the ELICAL 2 calibrator.

7. Type of Ground Truth Used

• For stability, the "ground truth" involves testing the calibrator's analyte concentrations over time under specified storage conditions and comparing them against initial established values or specified ranges. For traceability, it refers to documentation linking the analyte values to international reference methods or materials.

8. Sample Size for Training Set

• Not applicable.

9. How Ground Truth for Training Set was Established

• Not applicable.

ELITech Clinical Systems ELITROL I and ELITROL II Controls

1. Table of Acceptance Criteria and Reported Device Performance

For ELITROL I and ELITROL II, the acceptance criteria focus on comparable format, levels, handling, and stability to the predicate.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not specified for stability studies.
• Data Provenance: Not specified. From SEPPIM S.A.S. (FRANCE). Studies are for characterization of the control materials' properties.

3. Number of Experts and Qualifications

Not applicable.

4. Adjudication Method

Not applicable.

5. MRMC Comparative Effectiveness Study

• Not applicable.

6. Standalone Performance Study

• Yes, the stability and handling characteristics are for the standalone performance of the ELITROL I and ELITROL II controls.

7. Type of Ground Truth Used

• For stability, the "ground truth" involves testing the control's analyte concentrations over time under specified storage conditions and comparing them against initial established values or specified ranges. The control materials are "assayed," meaning their analyte concentrations are determined using reference methods or established analytical procedures.

8. Sample Size for Training Set

• Not applicable.

9. How Ground Truth for Training Set was Established

• Not applicable.

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The S-Test Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum or heparin plasma using the S40 Clinical Analyzer. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test High Density Lipoprotein Reagent is intended for the quantitative determination of HDL concentration in serum or heparin plasma using the S40 Clinical Analyzer. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Triglycerides Reagent is intended for the quantitative determination of triglyceride concentration in serum or heparin plasma using the S40 Clinical Analyzer. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Cholesterol (CHO), S-Test HDL Cholesterol (HDL) and S-Test Triglycerides (TG) reagent cartridges, used with the S40 Clinical Analyzer, are intended for quantitative in vitro diagnostic determination of CHO, HDL, and TG concentrations in serum or heparin plasma based on a photometric test measuring the formation of reddish purple complexes in coupled enzymatic reactions.

The provided text describes the 510(k) summary for the S-Test Cholesterol (CHO), S-Test High Density Lipoprotein Cholesterol (HDL), and S-Test Triglycerides (TG) reagent cartridges for use with the S40 Clinical Analyzer. This summary outlines the performance data for each test.

Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The studies described are primarily analytical performance studies conducted by Alfa Wassermann Diagnostics Technologies, LLC, both in-house and at Physician Office Laboratory (POL) sites. These studies evaluated precision, accuracy, detection limits, and matrix comparisons (serum vs. plasma).

Additional Information on the Study:

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

   • S-Test CHO:

     • Accuracy (correlation study): 98 samples (range: 31 to 335 mg/dL).
     • Accuracy (POL sites): Sample sizes not explicitly stated, but refers to "patient correlation studies."
     • Serum vs. Plasma: 29 paired samples.

   • S-Test HDL:

     • Accuracy (correlation study): 94 samples (range: 15 to 116 mg/dL).
     • Accuracy (POL sites): Sample sizes not explicitly stated, but refers to "patient correlation studies."
     • Serum vs. Plasma: 36 paired samples.

   • S-Test TG:

     • Accuracy (correlation study): 87 samples (range: 24 to 584 mg/dL).
     • Accuracy (POL sites): Sample sizes not explicitly stated, but refers to "patient correlation studies."
     • Serum vs. Plasma: 30 paired samples.

   • Data Provenance: The studies were conducted by the manufacturer, Alfa Wassermann Diagnostic Technologies, LLC, both in-house ('in-house over five days') and at three separate Physician Office Laboratory (POL) sites. The text does not specify the country of origin of the data, but the 510(k) owner is based in West Caldwell, NJ, USA. The data appears to be prospective in nature, as indicated by controlled experiments like "testing three CHO levels for 22 days."

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

   • This is an analytical performance study for an in vitro diagnostic (IVD) device, not an interpretative imaging or diagnostic test requiring human expert adjudication for ground truth.
   • The "ground truth" or reference method for accuracy studies was a "comparative method (x)." The specific identity or nature of this comparative method is not detailed, but for IVDs, this typically refers to a well-established, often FDA-cleared, reference assay run on another analyzer or a gold standard method. No human experts are described as establishing ground truth in this context.

3. Adjudication method for the test set:

   • Not applicable. This is an analytical performance study comparing the device's quantitative measurements against a comparative method. There is no human adjudication process involved as would be seen in image interpretation or clinical diagnosis studies.

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 analytical performance study of an in vitro diagnostic (IVD) assay, not an AI-assisted diagnostic imaging or interpretative tool. There are no human readers or AI involved in the interpretation of results in this context.

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

   • Yes, the performance data presented are for the standalone analytical performance of the S-Test reagent cartridges on the S40 Clinical Analyzer. This represents the "algorithm only" or device-only performance for quantitative measurements of cholesterol, HDL, and triglycerides. There is no mention of a human-in-the-loop component in the direct measurement process.

6. The type of ground truth used:

   • The "ground truth" for the accuracy studies was established by a "comparative method (x)." This means the new device's measurements were compared against another existing, presumably validated, method for measuring cholesterol, HDL, and triglycerides. This is a common practice for demonstrating analytical accuracy for IVD devices, comparing to a "reference standard" or "predicate device" method.

7. The sample size for the training set:

   • Not applicable. This is an analytical performance study of a reagent system, not a machine learning or AI model that requires a training set. The device's performance is characterized through experiments.

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

   • Not applicable, as there is no training set mentioned in the context of this analytical performance study.

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For the quantitative measurement of triglycerides in serum. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus. nephrosis, liver obstruction and other diseases involving lipid metabolism or various endocrine disorders. For in-vitro use only.

For the quantitative measurement of Total cholesterol in serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. For in-vitro use only.

Not Found

This document is a 510(k) premarket notification acceptance letter from the FDA for medical devices: "Cholesterol Oxidase JAS" and "Glycerol Kinase Triglycerides." This type of document does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a summary of safety and effectiveness (SSE). The 510(k) essentially states that the FDA has reviewed the submission and found the device substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

Therefore, I cannot extract the requested information from the provided text because it is not present in this regulatory acceptance letter. This document is not a study report.

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The Vitalab Triglycerides Reagent, the Vitalab Calibrator and the Vitalab Selectra Analyzer are intended for use as a system for the quantitative determination of triglycerides in serum and plasma. Triglycerides results may be used for the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver diseases involving lipid metabolism, various endocrine disorders, or for assessing of the risk of developing cardiovascular diseases.

The Vitalab Triglycerides Reagent, the Vitalab Calibrator and the Vitalab Selectra Analyzer are used as a system for the quantitative analysis of triglycerides in serum and plasma. The Vitalab Triglycerides Reagent determines triglycerides using the lipase/GPO enzymatic assay procedure coupled to a Trinder indicator reaction. The resulting increase in absorbance at 505 nm is proportional to the triglycerides concentration of the sample.

This response is based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

(Note: The "Acceptance Criteria (Implied)" column contains interpretations of what would generally be considered acceptable performance for such a device in comparison to a predicate, as explicit criteria are not always stated but inferred from the study design and conclusion of substantial equivalence.)

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

• Linearity/Recovery: n = 44 (This sample size likely refers to dilution factors or individual measurements across the range). Provenance: Not explicitly stated, but likely laboratory-prepared standards or spiked samples.
• Precision:
  • Serum 1: 60 replicates
  • Serum 2: 60 replicates
  • Serum 3: 60 replicates
    Provenance: Commercially available control serum.
• Method Comparison:
  • Serum samples: 59 specimens
  • Heparinized plasma samples: 60 specimens
    Provenance: Collected from adult patients. Country of origin not specified, but the submission is to the FDA, implying studies likely conducted in the US or internationally to US standards. Retrospective or prospective design is not explicitly stated, but the description "were collected from adult patients and were assayed for triglycerides" often implies a prospective or at least recently collected set of samples for the purpose of the study.
• Minimum Detection Limit: 30 replicate measurements of normal saline. Provenance: Laboratory materials.
• Onboard Reagent Stability & Calibration Stability: Not explicitly stated beyond "serum controls."
• Reconstituted Calibrator Stability: Not explicitly stated beyond "calibrators of increasing ages."

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

• This device is a quantitative clinical chemistry assay. The "ground truth" for such assays is typically established by reference methods or comparison to a legally marketed predicate device, rather than expert consensus on individual cases.
• In this case, the "ground truth" for the method comparison study was the results from "another commercially available method," which served as the reference standard for comparison. The predicate device, the Beckman Trighycerides Reagent Kit and Synchron Multi-Calibrator, also serves as a benchmark for substantial equivalence.
• Therefore, traditional "experts" like radiologists establishing ground truth for images are not applicable here. The "expertise" lies in the validated performance of the reference method and the established accuracy of commercially available control sera.

4. Adjudication Method for the Test Set:

• Not applicable. This is a quantitative chemical assay, not a subjective interpretation task that would typically involve adjudication by multiple experts. The comparison is statistical (Deming regression) between the new device and a reference method.

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 standalone in-vitro diagnostic (IVD) device for quantitative measurement of triglycerides, not an AI-assisted diagnostic tool that involves human readers interpreting results. Therefore, no MRMC study with human readers was conducted, and the concept of "improvement with AI vs without AI" does not apply.

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

• Yes, this entire submission describes standalone performance studies for the Vitalab Triglycerides Reagent and Calibrator on the Vitalab Selectra Analyzer. The performance metrics (linearity, precision, method comparison, detection limit, stability) are all intrinsic to the device system itself, operating without direct human interpretive input influencing the quantitative result. The device outputs a numerical value for triglyceride concentration.

7. The Type of Ground Truth Used:

• Reference Method Comparison: For the method comparison studies, the "ground truth" was established by analyzing patient samples with "another commercially available method" (presumably a validated and accepted diagnostic method for triglycerides).
• Known Concentrations/Standards: For linearity and detection limit, the ground truth was based on known concentrations of standards or normal saline (effectively 0 mg/dL).
• Certified Control Sera: For precision and stability studies, commercially available control serum with established target values was used.

8. The Sample Size for the Training Set:

• This submission describes performance validation studies for an IVD reagent and calibrator. It does not mention any "training set" in the context of machine learning or AI algorithms. The assay procedure is based on a well-established lipase/GPO enzymatic reaction coupled to a Trinder indicator, not a statistical model that requires a training set.

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

• Not applicable, as there is no mention of a training set for an AI/machine learning algorithm.

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The Piccolo Triglycerides Test System used with the Piccolo Point-of-Care Chemistry Analyzer is intended for the in vitro quantitative determination of triglycerides in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders.

The Piccolo® Lipid Panel Reagent Disc (which contains the Piccolo® Triglycerides Test System) is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analvzer. Alternately, the disc mav also be used with serum.

This document describes the regulatory submission for the Abaxis Piccolo® Triglycerides Test System. The device is a laboratory test system designed to measure triglyceride levels in blood samples.

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

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined set of thresholds. Instead, it presents performance characteristics of the new device and compares them to those of a legally marketed predicate device (Bayer Triglycerides-RA Assay). The underlying acceptance criterion for regulatory approval in this context is "substantial equivalence" to the predicate device, meaning the new device performs as safely and effectively. The tests conducted (linearity, precision, sample type comparison, and method comparison) are standard ways to demonstrate this equivalence for in vitro diagnostic devices.

Below is a table summarizing the reported device performance and comparing it to the characteristics of the predicate device, which implicitly defines the 'acceptance' for a substantially equivalent device.

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

• Linearity Study: The sample size for the linearity study is not explicitly stated in terms of number of patient samples, but the results for slope, intercept, and correlation coefficient are provided.
• Precision Study:
  • Sample Size: n = 160 for both within-run and total precision for each serum level tested (Serum 1 and Serum 2). This appears to be 160 replicates per serum level, not 160 distinct patient samples.
  • Data Provenance: Not specified, but generally, such studies use commercially available control sera or pooled patient samples.
• Sample Type Comparison Study:
  • Sample Size: Samples from 20 different patients. Each sample type (serum, heparinized plasma, heparinized whole blood) was tested in quadruplicate.
  • Data Provenance: Not specified, presumed to be clinical samples.
• Method Comparison Study:
  • Sample Size: n = 172 data points. The document clarifies: "number of patient samples = n/2", meaning 86 unique patient samples were run in duplicate.
  • Data Provenance: Not specified, but these are patient samples tested against a predicate device, presumably from a clinical setting. Retrospective or prospective is not specified, but given the nature of the study, it's likely a mix or prospective collection for comparison purposes. No country of origin is mentioned.

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

This information is not provided in the document. For in vitro diagnostic devices like this, the "ground truth" for the test set (patient samples) is typically established by the reference method (the predicate device, in the case of method comparison) or by highly accurate laboratory methods, rather than by human expert consensus or adjudication.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are common in image-based diagnostic studies where human readers interpret results which are then reconciled. For quantitative laboratory tests, the result is a numerical value, and "adjudication" in the traditional sense is not performed on the test results themselves. Method comparison studies statistically compare the new device's numerical results to those of the predicate device.

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 information is not applicable and therefore not provided. MRMC studies are specific to diagnostic tools that involve human interpretation, often in imaging. The Abaxis Piccolo® Triglycerides Test System is an automated in vitro diagnostic device for quantitative chemical analysis, not an AI-assisted diagnostic tool that involves human reader interpretation for primary diagnosis.

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

Yes, the studies presented (Linearity, Precision, Sample Type Comparison, Method Comparison) represent the standalone performance of the Abaxis Piccolo® Triglycerides Test System. The device is designed to operate as an automated system producing a quantitative result without direct human interpretation influencing the measurement itself (beyond sample collection and loading). The studies assess the device's inherent analytical performance.

7. The Type of Ground Truth Used:

For the method comparison study, the predicate device's measurement (Bayer Triglycerides-RA Assay) served as the de facto "ground truth" for comparison to establish substantial equivalence. For linearity, precision, and sample type comparison, the "ground truth" is typically established by the inherent analytical capabilities of the device itself and its ability to consistently and accurately measure known concentrations or produce reproducible results.

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided. The Abaxis Piccolo® Triglycerides Test System is a chemical analyzer, not a machine learning or AI-based system that requires a "training set" in the computational sense. Its reagents and methods are developed through biochemical and analytical chemistry principles, not by training an algorithm on a dataset.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable due to the nature of the device (see point 8).

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