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The Atellica® CH Phencyclidine (Pcp) assay is for in the qualitative or semiguantitative analyses of phencyclidine in human urine using the Atellica® CI Analyzer, using a cutoff of 25 ng/mL. The Pop assay provides only a preliminary analytical test result. A more specific alternative chemical must be used to obtain a confirmed analytical result. Gas chromatography-mass spectrometry (GCMS) is the preferred confirmatory method. The semiquantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC-MS) or liquid chromatography/tandem mass spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

The Atellica® CH Vancomycin (Vanc) assay is for in vitro diagnostic use in the quantitative measurement of vancomycin in human serum and plasma (lithium heparin) using the Atellica® CI Analyzer. Vanc test results may be used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.

The Atellica CH Pcp assay is a homogenous enzyme immunoassay based on competition between drug in the specimen and drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. G6PDH activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD+) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically at 340/410 nm. Endogenous G6PDH does not interfere because the coenzyme NAD+ functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.

The Atellica CH Vanc assay is based on a homogeneous particle enhanced turbidimetric inhibition immunoassay (PETINIA) technique which uses a synthetic particle-vancomycin conjugate (PR) and monoclonal vancomycin specific antibody (Ab). Vancomycin present in the sample competes with vancomycin on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of vancomycin in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 545 and 694 nm.

This document describes the analytical performance of two in vitro diagnostic (IVD) assays, the Atellica® CH Phencyclidine (Pcp) assay and the Atellica® CH Vancomycin (Vanc) assay, and does not contain information related to AI/ML clinical studies or multi-reader multi-case (MRMC) comparative effectiveness studies. Therefore, it is not possible to address acceptance criteria and study designs typically found in AI/ML performance evaluations (e.g., sample size for training/test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.).

However, I can extract and present the analytical performance criteria and reported device performance based on the provided text, which are relevant for IVD devices.

Analytical Acceptance Criteria and Reported Device Performance

Atellica® CH Phencyclidine (Pcp) Assay

This assay is for qualitative or semi-quantitative analysis of phencyclidine in human urine. The primary "acceptance" is demonstrated through agreement with a confirmatory method (GC/MS) and robust precision and recovery.

Table 1: Atellica® CH Phencyclidine (Pcp) Assay - Analytical Performance

• Overall POS agreement: 95% (19 true positives + 81 high positives / 108 total positives by Atellica CH)
• Overall NEG agreement: 94% (42 low negatives + 7 negatives / 54 total negatives by Atellica CH)
  Discordant Results (Atellica CI Pcp vs GC/MS cut-off 25 ng/mL):
• Atellica POS, GC/MS NEG: Samples 47 (27 ng/mL vs 18.0 ng/mL), 51 (30 ng/mL vs 24.2 ng/mL), 52 (26 ng/mL vs 24.8 ng/mL) - 3 false positives relative to GC/MS cut-off
• Atellica NEG, GC/MS POS: Samples 53 (21 ng/mL vs 25.8 ng/mL), 54 (20 ng/mL vs 26.7 ng/mL), 56 (22 ng/mL vs 27.6 ng/mL), 57 (24 ng/mL vs 27.8 ng/mL), 58 (24 ng/mL vs 28.5 ng/mL) - 5 false negatives relative to GC/MS cut-off |
  | Precision (Repeatability) | Overall Low CV% (e.g., 2.2% at 18.75 ng/mL, 2.4% at 25 ng/mL, 2.8% at 31.25 ng/mL)
• 0 ng/mL: SD 0.1, N/A CV
• 6.25 ng/mL: SD 0.4, 6.7% CV
• 12.5 ng/mL: SD 0.4, 3.3% CV
• 18.75 ng/mL: SD 0.4, 2.2% CV
• 25 ng/mL (Cutoff): SD 0.6, 2.4% CV
• 31.25 ng/mL: SD 0.9, 2.8% CV
• 37.5 ng/mL: SD 0.9, 2.3% CV
• 43.75 ng/mL: SD 1.1, 2.6% CV
• 50 ng/mL: SD 1.7, 3.3% CV |
  | Precision (Within-Lab) | Overall Low CV% (e.g., 4.4% at 18.75 ng/mL and 25 ng/mL, 5.3% at 31.25 ng/mL)
• 0 ng/mL: SD 0.20, N/A CV
• 6.25 ng/mL: SD 0.6, 10.0% CV
• 12.5 ng/mL: SD 0.6, 5.0% CV
• 18.75 ng/mL: SD 0.8, 4.4% CV
• 25 ng/mL (Cutoff): SD 1.1, 4.4% CV
• 31.25 ng/mL: SD 1.7, 5.3% CV
• 37.5 ng/mL: SD 2.3, 5.9% CV
• 43.75 ng/mL: SD 2.5, 5.8% CV
• 50 ng/mL: SD 3.7, 7.1% CV |
  | Reproducibility (Total) | Overall Low CV% (e.g., 6.1% for Urine QC 1, 5.8% for Urine QC 2, 6.5% for Urine QC 3)
• Urine QC 1 (18 ng/mL): SD 1.1, 6.1% CV
• Urine QC 2 (24 ng/mL): SD 1.4, 5.8% CV
• Urine QC 3 (34 ng/mL): SD 2.2, 6.5% CV |
  | Recovery | Mean Recovery ranging from 90% to 107% across various concentrations.
• 0 ng/mL: 0 ng/mL (N/A %)
• 4 ng/mL: 4 ng/mL (101 %)
• 5 ng/mL: 5 ng/mL (100 %)
• 10 ng/mL: 9 ng/mL (90 %)
• 15 ng/mL: 15 ng/mL (100 %)
• 20 ng/mL: 19 ng/mL (95 %)
• 25 ng/mL: 24 ng/mL (96 %)
• 30 ng/mL: 30 ng/mL (100 %)
• 40 ng/mL: 43 ng/mL (107 %)
• 60 ng/mL: 64 ng/mL (107 %)
• 80 ng/mL: 82 ng/mL (103 %) |
  | Endogenous Substances Interference | No false response relative to the 25 ng/mL cutoff for tested substances (Acetone, Ascorbic Acid, Conjugated bilirubin, Creatinine, Ethanol, Gamma Globulin, Galactose, Glucose, Hemoglobin, Human Serum Albumin, Oxalic Acid, Riboflavin, Sodium Azide, Sodium Chloride, Sodium Fluoride, Urea) at specified concentrations when spiked into control pools (19 ng/mL and 31 ng/mL). |
  | Specificity (Structurally Unrelated Compounds) | No false response relative to the 25 ng/mL cutoff for listed structurally unrelated compounds (e.g., Acetaminophen, Amitriptyline, Caffeine, Ibuprofen, etc.) at specified concentrations when spiked into control pools (19 ng/mL and 31 ng/mL). |
  | Specificity (Structurally Related Compounds - Cross-Reactivity) | Values range from 0.0% to 184.4% for structurally related compounds, indicating varying levels of cross-reactivity. Notably, 1-(1-Phenylcyclohexyl)pyrrolidine (PCPy) showed 154.4% and trans-4-phenyl-4-Piperidinocyclohexanol showed 184.4% cross-reactivity. This typically means these compounds may cause a positive result even if PCP itself is not present, emphasizing the need for confirmatory testing. |
  | Specific Gravity and pH Interference | No interference observed for negative urine pools with specific gravity 1.000–1.030 and pH 3–10, when tested at ±25% of the cutoff concentration. |
  | Standardization Traceability | Traceable to Emit Calibrators/Controls, which are referenced to gravimetrically prepared standards qualified by GC/MS from an independent laboratory (within ±10% of nominal). |

Atellica® CH Vancomycin (Vanc) Assay

This assay is for quantitative measurement of vancomycin in human serum and plasma.

Table 2: Atellica® CH Vancomycin (Vanc) Assay - Analytical Performance

• Serum QC 1 (6.1 µg/mL): SD 0.14, 2.3% CV
• Serum 1 (13.4 µg/mL): SD 0.13, 1.0% CV
• Serum QC 2 (19.5 µg/mL): SD 0.15, 0.8% CV
• Serum QC 3 (32.6 µg/mL): SD 0.34, 1.0% CV
• Serum 2 (46.1 µg/mL): SD 0.54, 1.2% CV |
  | Precision (Within-Laboratory) | Overall Low CV% (e.g., 1.5% - 2.8%).
• Serum QC 1 (6.1 µg/mL): SD 0.17, 2.8% CV
• Serum 1 (13.4 µg/mL): SD 0.20, 1.5% CV
• Serum QC 2 (19.5 µg/mL): SD 0.33, 1.7% CV
• Serum QC 3 (32.6 µg/mL): SD 0.61, 1.9% CV
• Serum 2 (46.1 µg/mL): SD 0.89, 1.9% CV |
  | Reproducibility (Total) | Overall Low CV% (e.g., 1.8% - 4.0%).
• Serum QC 1 (6.0 µg/mL): SD 0.24, 4.0% CV
• Serum 1 (13.4 µg/mL): SD 0.27, 2.0% CV
• Serum QC 2 (19.7 µg/mL): SD 0.38, 1.9% CV
• Serum QC 3 (32.9 µg/mL): SD 0.62, 1.9% CV
• Serum 2 (45.9 µg/mL): SD 0.81, 1.8% CV |
  | Assay Comparison (Correlation vs. Predicate) | Correlation coefficient ≥ 0.980 and slope 1.00 ± 0.10.
• Regression Equation: y = 0.97x + 0.3 µg/mL (y = 0.97x + 0.2 µmol/L)
• Correlation coefficient (r): 0.999 (for 107 serum samples in range 4.1–45.9 µg/mL). Meets criteria. |
  | Specimen Equivalency (Serum vs. Plasma (Lithium Heparin)) | Demonstrated equivalency between plasma and serum.
• Regression Equation: y = 1.00x - 0.1 µg/mL (y = 1.00x - 0.7 µmol/L)
• Correlation coefficient (r): 0.996 (for 50 samples in range 4.5–43.9 µg/mL). |
  | Interferences (Hemolysis, Icterus, Lipemia - HIL) | ≤ 10% bias.
• Hemoglobin (1000 mg/dL): 2% and 6% bias at two analyte levels.
• Bilirubin, conjugated (30 mg/dL): 0% and 1% bias.
• Bilirubin, unconjugated (30 mg/dL): -2% and -1% bias.
• Lipemia (Intralipid® 2000 mg/dL): 8% and 6% bias.
• Lipemia (from trig fraction 2000 mg/dL): 6% and 8% bias. *All results meet the

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The Siemens Atellica™ Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.

The Atellica™ A-L YTE Integrated Multisensor (Na, K, Cl) is intended for in vitro diagnostic use in the quantitative determination of sodium, potassium, and chloride (Na, K, Cl) in human serum, plasma, and urine using the Atellica™ CH system. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The Atellica™ CH Albumin BCP Reagent (Alb P) is intended for in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on Atellica™ CH system. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

The Atellica™ IM Thyroid Stimulating Hormone (TSH) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum, and plasma (EDTA and lithium heparin) using the Atellica™ IM system. Measurements of the thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The Atellica™ CH Vancomycin (Vanc) assay is for in vitro diagnostic use in the quantitative measurement of vancomycin in human serum or plasma on the Atellica™ CH System. Vanc test results may be used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.

The Atellica™ Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. The Atellica™ Solution consists of any combination of Atellica Sample Handler component, an Atellica Magline Magnetic Sample Transport system component, Atellica IM and all software and hardware needed to support a customizable array of analyzers. The submission also covers the Atellica™ A-LYTE Integrated Multisensor (Na, K, Cl), Atellica™ CH Albumin BCP Reagent (Alb P), Atellica™ IM Thyroid Stimulating Hormone (TSH) assay, and Atellica™ CH Vancomycin (Vanc) assay, which are reagents/assays used with the Atellica Solution.

The provided document is a 510(k) Premarket Notification from the FDA regarding the Siemens Atellica™ Solution. It details the device's indications for use, its substantial equivalence to predicate devices, and some performance characteristics.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., "The device must achieve a precision CV of X% or less"). Instead, it demonstrates performance by comparing the new Atellica™ Solution (new device) to the predicate devices (Trinidad IM and CH modules) by showing precision and method comparison studies. The implicit acceptance criterion is that the new device's performance should be comparable to the predicate device, as confirmed by the statistical results (slope, intercept, correlation, and precision CVs falling within generally acceptable laboratory ranges).

Given the nature of this 510(k) submission, the "acceptance criteria" are implied by the performance demonstrated and compared to the established performance of the predicate devices. The clinical relevance of the reported performance is tied to the previously cleared predicate devices.

Implicit Acceptance Criteria (Performance should be comparable to predicate):

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The Trinidad CH Vancomycin (Vanc) assay is for in vitro diagnostic use in the quantitative measurement of vancomycin in human serum or plasma on the Trinidad CH System. Vanc test results may be used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.

The Trinidad CH Drug 3 Calibrator (DRUG3 CAL) is intended for in vitro diagnostic use in the calibration of Vancomycin (Vanc) on the Trinidad CH System.

The Trinidad CH Vancomycin (Vanc) assay is based on a homogeneous particle enhanced turbidimetric inhibition immunoassay (PETINIA) technique which uses a synthetic particle-vancomycin conjugate (PR) and monoclonal vancomycin specific antibody (Ab). Vancomycin present in the sample competes with vancomycin on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of vancomycin in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 545 nm and 694 nm.

The Trinidad CH Drug 3 Calibrator (DRUG3 CAL) is a 5 level calibrator product prepared from bovine serum base product.

The Siemens Healthcare Diagnostics Inc. Trinidad CH Vancomycin (Vanc) assay and Trinidad CH Drug 3 Calibrator (DRUG3 CAL) underwent several studies to establish their performance and substantial equivalence to predicate devices. Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with pass/fail thresholds for all metrics. However, it presents the results of various performance studies which implicitly serve as evidence for meeting regulatory requirements for substantial equivalence. The "Acceptance Criteria" column below is inferred from the document's reporting of satisfactory results against established clinical laboratory guidelines (e.g., CLSI documents) or from comparisons to the predicate device.

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

• Detection Limit (LoB/LoD):
  • LoB: 4 samples with no analyte tested (N=5) for 3 days, one run per day, 3 reagent lots. Total reps = 60 to determine rank for non-parametric approach.
  • LoD: 4 low serum samples tested (N=5) for 3 days, one run per day, 3 reagent lots.
• Limit of Quantitation (LoQ): 4 low serum samples processed on three reagent lots for three days, on one instrument. Total of 60 measurements per reagent lot, leading to a total of 180 determinations.
• Linearity Study: 10 samples (prepared by mixing high and low concentration samples). Six replicates were measured for each sample.
• Precision Studies: 80 replicates (n=2 replicates, two times a day for at least 20 days) for controls, serum, and plasma pools.
• Interferences: Conducted using a "paired difference worst case scenario" approach with fresh sample pools containing low or high levels of vancomycin. Specific N not provided for individual interferents.
• Method Comparison: 100 "remnant de-identified samples" (native, spiked, and diluted).
• Matrix Equivalency: 60 matched samples (serum and lithium heparin plasma). Some samples were diluted or spiked.

Data Provenance:

• All studies were "conducted internally by Siemens Healthcare Diagnostic Inc. R&D organization personnel."
• For the Method Comparison, "Remnant de-identified samples were tested. No patient history information was obtained on these samples." This suggests a retrospective data collection from a clinical laboratory or sample bank, likely within the US, given Siemens Healthcare Diagnostics is a US-based entity and the FDA submission is US-centric.

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

The document does not explicitly mention the use of experts to establish a "ground truth" in the sense of clinical interpretation or diagnosis for the test sets.

For quantitative assays like this:

• The "ground truth" for linearity, precision, and detection limits is based on the known concentrations of prepared standards or spiked samples.
• For method comparison, the "ground truth" comes from the measurements generated by the predicate device.
• The personnel conducting the study were "laboratory technicians with training similar to personnel who would conduct the tests in a hospital laboratory setting," and they were "trained on the operation of both the device and the predicate device." These individuals are not referred to as "experts" in the clinical sense of radiologists or pathologists, but rather as trained laboratory professionals.

4. Adjudication Method for the Test Set

Not applicable in the context described. Adjudication methods (like 2+1 or 3+1) are typically used for establishing ground truth in diagnostic studies involving subjective interpretation (e.g., image analysis by multiple radiologists). This submission describes performance studies for a quantitative measurement assay where the "ground truth" is either inherent to the sample preparation (e.g., spiked concentrations) or established by a reference method (the predicate device). No human interpretation requiring adjudication is mentioned.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted, nor is it applicable. MRMC studies evaluate the performance of human readers, often with or without AI assistance, on a set of cases, typically for diagnostic tasks like image interpretation. This submission is for an in vitro diagnostic assay that quantitatively measures vancomycin levels, not for an AI-powered diagnostic imaging device or a clinical decision support system that directly involves human "readers" interpreting cases.

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

This device is a standalone algorithm (an in vitro diagnostic assay) in the sense that its performance is measured directly and quantitatively on biological samples to determine vancomycin concentration. The "algorithm" here is the chemical reaction and measurement process (PETINIA technique) implemented on the Trinidad CH System, which then outputs a numerical value. There is no human "in-the-loop" interpretation component for the direct measurement itself; humans operate the instrument and interpret the final quantitative result. The performance data presented (linearity, precision, detection limits, method comparison) are effectively "standalone" performance metrics of the assay system.

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

The ground truth used for the studies varied by the specific test:

• Detection Limits, LoQ, Linearity: Ground truth was established by known, prepared concentrations of vancomycin in control matrices (e.g., bovine serum base, spiked native serum).
• Method Comparison: Ground truth was established by the measurements from the legally marketed predicate device (Dimension RxL VANC assay), which is considered an accepted method for vancomycin quantification.
• Matrix Equivalency: Ground truth for comparison was the measurements from the new device itself on serum samples to compare against its performance on plasma from the same patient.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI algorithms. As this is a traditional in vitro diagnostic assay based on an immunoassay technique, it is developed and validated through laboratory experiments, not typically "trained" on a dataset in the way an AI algorithm would be. The experiments described (e.g., development of the assay, optimization of reagents, calibration) are analogous to the development phase, but not termed a "training set."

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

As explained above, there isn't a "training set" in the AI sense for this type of IVD device. The development of such an assay involves:

• Careful formulation of reagents (synthetic particle-vancomycin conjugate, monoclonal vancomycin specific antibody).
• Optimization of reaction conditions and measurement parameters.
• Calibration using highly characterized standards (like the Trinidad CH Drug 3 Calibrator, which is prepared from bovine serum base). The calibrators themselves would be assigned values based on precise preparation and analytical verification against reference methods or materials.

The "ground truth" during assay development would stem from known quantities of vancomycin standards and reference materials, used to ensure the assay accurately measures concentrations across its intended range.

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In vitro test for the quantitative determination of vancomycin in serum and plasma on Roche/Hitachi cobas c systems.

A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

The ONLINE TDM Vancomycin Gen.3 is a two reagent assay for the in vitro quantitative determination of vancomycin in human serum or plasma on automated clinical chemistry analyzers. It is a homogeneous microparticle agglutination immunoassay based on the kinetic interaction of microparticles in solution (KIMS). A competitive reaction takes place between the drug conjugate and vancomycin in the serum sample for binding to the vancomycin antibody on the microparticles. The resulting kinetic interaction of microparticles is indirectly proportional to the amount of drug present in the sample.

The provided text details the performance evaluation of the "ONLINE TDM Vancomycin Gen.3" device. Here's a breakdown of the requested information:

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

The document doesn't explicitly state "acceptance criteria" as separate rows but presents performance study results, implying these results are considered acceptable for substantial equivalence. The table below compiles the reported performance data.

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

• Detection Limit (LoB, LoD):
  • LoB: 60 measurements (5-fold determinations per run, 6 runs over 3 days, across one or two instruments) per lot.
  • LoD: 30 samples/measurements (5 serum samples, 6 runs over 3 days, 1-fold or 2-fold determination per run, across one or two instruments) per lot.
  • LoQ: 15 serum samples, tested in two aliquots over 6 runs for 4 days.
• Precision: Not explicitly stated, but "two runs per day for $\geq$ 21 days" were performed. The number of samples for controls (3) and human serum (5) are listed, with replicates per run not specified but implied to be sufficient for precision calculations.
• Linearity: Sixteen levels (dilution series from a human serum sample pool and diluent) were prepared. The process was repeated for plasma samples.
• Matrix Comparison: 67 full tubes and 9 half-filled tubes of serum and plasma from a single donor. (K2-EDTA plasma had 10 half-filled tubes).
• Interferences (H, L, I Indices): Two human serum sample pools spiked with Vancomycin. An 11-step dilution series prepared for each interferent, with 3 aliquots per level tested.
• Interferences (Drugs): Two human serum sample pools spiked with Vancomycin. Tested with 3 replicates.
• Method Comparison to Predicate: 125 single native human serum samples from patients taking Vancomycin. 8 additional native Vancomycin samples were spiked, and 1 sample diluted to cover the range.

The data provenance regarding the country of origin is not specified. All studies appear to be prospective experimental studies conducted in a controlled lab setting, rather than retrospective patient data analysis.

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

This device is an in-vitro diagnostic (IVD) assay for quantitative determination of vancomycin concentration. The "ground truth" for these types of devices is based on established analytical reference methods or assigned values.

• For LoQ, the expected value was determined with Vancomycin LCMS/MS, which is a highly accurate reference method, not expert consensus.
• For Method Comparison to Predicate, the predicate device (ONLINE TDM Vancomycin, K060586) served as the reference standard for comparison, not human experts.
• No human experts were involved in establishing the ground truth for any of these analytical performance studies. These are laboratory-based measurements.

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

Not applicable. This is an IVD device for quantitative measurement, not an imaging or qualitative diagnostic device requiring expert adjudication. The "truth" is determined by analytical reference methods or comparison to a 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

Not applicable. This is an IVD device for quantitative measurement, not an AI-assisted diagnostic tool for human readers.

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

This entire submission describes the standalone performance of the ONLINE TDM Vancomycin Gen.3 assay. The device itself is an automated chemical analyzer system (Roche/Hitachi cobas c systems) that performs the assay, not an AI algorithm. The performance metrics listed (detection limit, precision, linearity, interference, method comparison) are all standalone analytical performance characteristics of the device.

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

The ground truth or reference methods used for evaluation include:

• LCMS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry): Used for determining expected values for the Limit of Quantitation (LoQ).
• Predicate Device (ONLINE TDM Vancomycin, K060586): Used as the comparative reference for the method comparison study.
• Standard Analytical Protocols: Studies like precision, linearity, and interference follow established CLSI guidelines, where the "truth" is defined by the experimental setup (e.g., known concentrations of analytes, spiked interferents).

8. The sample size for the training set

Not applicable. This device is an IVD assay, not a machine learning or AI-based system that requires a "training set" in the conventional sense. The development of such assays involves reagent formulation, optimization, and extensive analytical verification and validation, but not typically "training data" for an algorithm.

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

Not applicable, as there is no "training set" for an AI algorithm here.

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The ARCHITECT i Vancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT i Vancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.

The ARCHITECT i Vancomycin assay is a one-step STAT immunoassay for the quantitative measurement of vancomycin in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex.

Sample, anti-vancomycin coated paramagnetic microparticles, and vancomycin acridinium-labeled conjugate are combined to create a reaction mixture. The anti-vancomycin coated microparticles bind to vancomycin present in the sample and to the vancomycin acridinium-labeled conjugate. After washing, pre-trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of vancomycin in the sample and the RLUs detected by the ARCHITECT i System optics.

The ARCHITECT i Vancomycin assay is a device for the quantitative measurement of vancomycin in human serum or plasma. The device is a chemiluminescent microparticle immunoassay (CMIA) for in vitro diagnostic use, intended to aid in the diagnosis and treatment of vancomycin overdose and in monitoring its levels to ensure appropriate therapy.

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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The ARCHITECT iVancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT iVancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.

The ARCHITECT iVancomycin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of vancomycin in human serum or plasma.

For in vitro diagnostic use.

The ARCHITECT iVancomycin assay is a one-step STAT immunoassay for the quantitative measurement of vancomycin in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex.

Sample, anti-vancomycin coated paramagnetic microparticles, and vancomycin acridinium-labeled conjugate are combined to create a reaction mixture. The antivancomycin coated microparticles bind to vancomycin present in the sample and to the vancomycin acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of vancomycin in the sample and the RLUs detected by the ARCHITECT i System optics.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size used for the clinical performance comparison, nor does it specify the country of origin of the data or whether it was retrospective or prospective. It only states that a "Summary of Clinical Performance" demonstrated "substantially equivalent performance" with a correlation coefficient of 0.996.

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

Not applicable. This is an in vitro diagnostic device for quantitative measurement of vancomycin in human serum or plasma. Ground truth is established by a reference method (the predicate device) or by the inherent accuracy of the chemical measurement itself, rather than by human expert consensus or clinical assessment.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for imaging or diagnostic interpretation tasks where human readers are involved. For an in vitro diagnostic device like this, the comparison is between the new device and a predicate device in terms of analytical performance.

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

Yes, the study described is a standalone performance assessment of the ARCHITECT iVancomycin assay. The device itself performs the quantitative measurement without human interpretation as part of its core function, although human operators are involved in running the assay. The comparison directly evaluates the device's analytical output against that of a predicate device.

7. The Type of Ground Truth Used

The ground truth or reference standard for evaluating the ARCHITECT iVancomycin assay's performance was the AxSYM Vancomycin II assay, which is the legally marketed predicate device. The clinical performance summary indicates a direct comparison of results between the new device and the predicate device.

8. The Sample Size for the Training Set

Not applicable. This device is an immunoassay, not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for such a system involves the development and optimization of the reagent formulations, reaction conditions, and calibration procedures, which are determined during the device development phase, not through a "training set" of patient data as in machine learning.

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

Not applicable. See point 8.

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The IMMULITE® 2000 Vancomycin assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of vancomycin in serum and plasma (EDTA or heparinized), as an aid in monitoring the therapeutic administration of this antibiotic.

The IMMULITE® 2500 Vancomycin assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of vancomycin in serum and plasma (EDTA or heparinized), as an aid in monitoring the therapeutic administration of this antibiotic.

The IMMULITE 2000, IMMULITE 2500 Vancomycin assay is a solid phase competitive chemiluminescent enzyme immunoassay. The solid phase (bead) is coated with ligandlabeled vancomycin. The reagent contains alkaline phosphatase (bovine calf intestine) conjugated to monoclonal murine antivancomycin in the patient sample competes with the ligand-labeled solid phase for vancomycin binding sites on the monoclonal murine anti-vancomycin enzyme conjugate. The excess sample and reagent are removed by a centrifugal wash. Finally, chemiluminescent substrate is added to the bead and signal is generated in proportion to the bound enzyme. The assay includes an automatic on-board predilution of 1/20 prior to immunoreaction. Immunoreaction incubation time is 30 minutes. The sample volume required is 10 µL for the test and 250 uL dead volume. The sample types are serum and plasma (heparin or EDTA).

{
  "acceptance_criteria_study": {
    "1_acceptance_criteria_table": [
      {
        "Criterion": "Reportable Range",
        "Acceptance Criteria": "Not explicitly stated as a separate acceptance criterion, but the reported range is 3.0 µg/mL – 50 µg/mL.",
        "Reported Device Performance": "3.0 µg/mL – 50 µg/mL for both IMMULITE 2000 and IMMULITE 2500 Vancomycin assays."
      },
      {
        "Criterion": "Limit of Blank (LoB)",
        "Acceptance Criteria": "The highest value expected to be seen in a series of results for samples that contain no analyte, based on CLSI guideline EP17-A. Computed as mean CPS - 1.65 * total SDcps, then converted to vancomycin dose.",
        "Reported Device Performance": "0.4 µg/mL for both IMMULITE 2000 and IMMULITE 2500."
      },
      {
        "Criterion": "Limit of Detection (LoD)",
        "Acceptance Criteria": "The actual concentration at which an observed test result is likely to exceed the Limit of Blank (LoB) and may therefore be declared as detected, based on CLSI guideline EP17-A. Formula: LoD = LoB + 1.65 * SD.",
        "Reported Device Performance": "0.9 µg/mL for both IMMULITE 2000 and IMMULITE 2500."
      },
      {
        "Criterion": "Precision (IMMULITE 2000)",
        "Acceptance Criteria": "Intra- and inter-assay CV% over the range of approximately 5 to 47 µg/mL should not be greater than 10.2% and 6.8%, respectively.",
        "Reported Device Performance": "Max statistics across 3 lots show intra-assay CV% not greater than 10.2% and inter-assay CV% not greater than 6.8% over the range of approximately 5 to 47 µg/mL."
      },
      {
        "Criterion": "Precision (IMMULITE 2500)",
        "Acceptance Criteria": "Intra- and inter-assay CV% over the range of approximately 5 to 45 µg/mL should not be greater than 6.1% and 6.0%, respectively.",
        "Reported Device Performance": "Max statistics for one kit lot show intra-assay CV% not greater than 6.1% and inter-assay CV% not greater than 6.0% over the range of approximately 5 to 45 µg/mL."
      },
      {
        "Criterion": "Linearity (Average Recovery)",
        "Acceptance Criteria": "Not explicitly stated as a numerical threshold, but implied to be acceptable for patient samples. The reported value is 96.0%.",
        "Reported Device Performance": "Average recovery for patient samples tested in the IMMULITE 2000/IMMULITE 2500 Vancomycin assay was 96.0%."
      },
      {
        "Criterion": "Spiked Recovery (Average % Recovery)",
        "Acceptance Criteria": "Not explicitly stated as a numerical threshold, but implied to be acceptable. The reported value is 101%.",
        "Reported Device Performance": "Average % recovery for spiked patient samples was 101%."
      },
      {
        "Criterion": "Interfering Substances (Bilirubin)",
        "Acceptance Criteria": "No significant interference (up to a stated concentration) on results within the precision of the assay.",
        "Reported Device Performance": "No significant interference from Bilirubin up to 20 mg/dL."
      },
      {
        "Criterion": "Interfering Substances (Hemoglobin)",
        "Acceptance Criteria": "No significant interference (up to a stated concentration) on results within the precision of the assay.",
        "Reported Device Performance": "No significant interference from Hemoglobin up to 600 mg/dL."
      },
      {
        "Criterion": "Interfering Substances (Triglycerides)",
        "Acceptance Criteria": "No significant interference (up to a stated concentration) on results within the precision of the assay.",
        "Reported Device Performance": "No significant interference from Triglycerides up to 3000 mg/dL."
      },
      {
        "Criterion": "Cross-Reactivity",
        "Acceptance Criteria": "No detectable cross-reactivity to various potential cross-reactants when vancomycin-spiked human serum sample is tested.",
        "Reported Device Performance": "No detectable cross-reactivity to a long list of substances (e.g., Acetaminophen, Amikacin, etc.) at high concentrations (typically 500 µg/mL), or Teicoplanin/CDP-1 at relevant concentrations."
      },
      {
        "Criterion": "Interference (HAMA/RF)",
        "Acceptance Criteria": "No detectable interference from HAMA or Rheumatoid Factor (RF) in tested samples.",
        "Reported Device Performance": "No detectable interference from HAMA (up to 1880 ng/mL) and RF (up to 2330 IU/mL)."
      },
      {
        "Criterion": "Sample Type Correlation (SST Serum vs Serum)",
        "Acceptance Criteria": "High correlation and equivalence between sample types. For SST vs Serum: slope 1.00 (95% CI: 0.96 to 1.05), intercept -0.07 (95% CI: -1.43 to 1.28), r = 0.99.",
        "Reported Device Performance": "Linear Least Squares: Y= 1.00 X - 0.07; slope = 1.00 (95% CI: 0.96 to 1.05); intercept = -0.07 (95% CI: -1.43 to 1.28); r = 0.99. Deming Regression: Y= 1.01 X - 0.28; slope = 1.01 (95% CI: 0.97 to 1.06); intercept = - 0.28 (95% CI: - 1.64 to 1.09)."
      },
      {
        "Criterion": "Sample Type Correlation (Lithium Heparin vs Serum)",
        "Acceptance Criteria": "High correlation and equivalence between sample types. For Lithium Heparin vs Serum: slope 1.02 (95% CI: 0.97 to 1.06), intercept 0.03 (95% CI: -1.25 to 1.30), r = 0.99.",
        "Reported Device Performance": "Linear Least Squares: Y=1.02 X + 0.03; slope = 1.02 (95% CI: 0.97 to 1.06); intercept = 0.03 (95% CI: -1.25 to 1.30); r = 0.99. Deming Regression: Y= 1.02 X - 0.15; slope = 1.02 (95% CI: 0.98 to 1.06); intercept = - 0.15 (95% CI: -1.43 to 1.14)."
      },
      {
        "Criterion": "Sample Type Correlation (EDTA vs Serum)",
        "Acceptance Criteria": "High correlation and equivalence between sample types. For EDTA vs Serum: slope 1.00 (95% CI: 0.96 to 1.04), intercept 0.001 (95% CI: -1.19 to 1.19), r= 0.99.",
        "Reported Device Performance": "Linear Least Squares: Y= 1.00 X + 0.001; slope = 1.00 (95% CI: 0.96 to 1.04); intercept = 0.001 (95% CI: -1.19 to 1.19); r= 0.99. Deming Regression: Y=1.01 X - 0.15; slope =1.01 (95% CI: 0.97 to 1.05); intercept = - 0.15 (95% CI: - 1.35 to 1.05)."
      },
      {
        "Criterion": "Method Comparison (IMMULITE 2000 vs AxSYM Vancomycin II)",
        "Acceptance Criteria": "High correlation (r=0.97) between the platforms and the predicate device, indicating equivalence of assays.",
        "Reported Device Performance": "Linear Least Squares: r = 0.971. Slope = 1.022 (95% CI: 0.983 to 1.061), Intercept = 0.727 (95% CI: 0.060 to 1.394)."
      },
      {
        "Criterion": "Method Comparison (IMMULITE 2500 vs AxSYM Vancomycin II)",
        "Acceptance Criteria": "High correlation (r=0.97) between the platforms and the predicate device, indicating equivalence of assays.",
        "Reported Device Performance": "Linear Least Squares: r = 0.966. Slope = 1.028 (95% CI: 0.985 to 1.071), Intercept = 0.495 (95% CI: -0.236 to 1.226)."
      },
      {
        "Criterion": "Method Comparison (IMMULITE 2500 vs IMMULITE 2000)",
        "Acceptance Criteria": "High correlation (r=0.970) between methods, indicating equivalence of assays.",
        "Reported Device Performance": "Linear Least Squares: r = 0.970. Slope = 0.981 (95% CI: 0.943 to 1.019), Intercept = 0.170 (95% CI: -0.526 to 0.866)."
      },
      {
        "Criterion": "Assay Kit Stability",
        "Acceptance Criteria": "Support a claim of 360 days shelf life when stored at 2-8°C, based on real-time and accelerated stress studies.",
        "Reported Device Performance": "Results of real-time and accelerated stress studies support the claim of 360 days shelf life for the assay kits when stored at 2-8°C."
      }
    ],
    "2_sample_size_and_data_provenance_test_set": {
      "Limit of Blank": {
        "Sample Size": "60 replicates of a zero analyte heparin plasma and serum sample, and the assay zero calibrator. Assayed across 3 IMMULITE 2000 kit lots (with 3 instruments per lot) and 1 IMMULITE 2500 kit lot (with 3 instruments per lot).",
        "Data Provenance": "Not explicitly stated (e.g., country of origin, retrospective/prospective). Implied to be laboratory-generated samples for method validation."
      },
      "Limit of Detection": {
        "Sample Size": "Five different samples with low concentrations of vancomycin (>0.4 ug/mL to 1.6 ug/mL). Assayed using 3 IMMULITE 2000 kit lots (2 instruments per lot) and 1 IMMULITE 2500 kit lot (2 instruments per lot). Eight runs of 2 replicates per sample over 8 separate days.",
        "Data Provenance": "Not explicitly stated (e.g., country of origin, retrospective/prospective). Implied to be laboratory-generated samples for method validation."
      },
      "Precision": {
        "Sample Size": "Two aliquots of each test sample in two runs per day over 20 different days, for a total of 80 replicates per test sample per lot. Three different kit lots on IMMULITE 2000 platform and one lot on IMMULITE 2500, with two instruments used per lot. Precision pools targeted 5, 10, 20, 30, and 45 µg/mL.",
        "Data Provenance": "Not explicitly stated (e.g., country of origin, retrospective/prospective). Implied to be laboratory-generated samples for method validation."
      },
      "Linearity": {
        "Sample Size": "10 patient samples (neat, 4 in 8, 2 in 8 and 1 in 8 dilutions) across the therapeutic range (9 to 46 ug/mL). Each assayed in triplicate.",
        "Data Provenance": "Patient samples. Not explicitly stated (e.g., country of origin, retrospective/prospective)."
      },
      "Spiked Recovery": {
        "Sample Size": "6 patient sample pools spiked with various concentrations of 3 different spiking solutions.",
        "Data Provenance": "Patient samples. Not explicitly stated (e.g., country of origin, retrospective/prospective)."
      },
      "Interfering Substances/Cross-Reactivity/HAMA/RF": {
        "Sample Size": "Varies by substance. Typically, neat normal human serum and human serum spiked with 25 ug/mL vancomycin, spiked with the potential interfering substance. Assayed in 2 replicates. For HAMA/RF, 6 normal human samples for HAMA, 5 RF-positive human samples and 1 normal for RF.",
        "Data Provenance": "Human serum samples. Not explicitly stated (e.g., country of origin, retrospective/prospective)."
      },
      "Alternate Sample Types (Correlation Study)": {
        "Sample Size": "SST vs Serum: N=33. Lithium Heparin vs Serum: N=32. EDTA vs Serum: N=31. Matched sets of human serum, SST, lithium heparin and EDTA samples spiked with various concentrations of vancomycin. Each run in duplicate.",
        "Data Provenance": "Human samples. Not explicitly stated (e.g., country of origin, retrospective/prospective)."
      },
      "Clinical Sample Population (Method Comparison)": {
        "Sample Size": "IMMULITE 2000 vs AxSYM II: N=162 endogenous serum patient samples. IMMULITE 2500 vs AxSYM II: N=162 endogenous serum patient samples. IMMULITE 2500 vs IMMULITE 2000: N=164 endogenous serum patient samples.",
        "Data Provenance": "Endogenous serum from patients being treated with vancomycin. Not explicitly stated (e.g., country of origin, retrospective/prospective)."
      }
    },
    "3_number_and_qualifications_of_experts_ground_truth": "N/A. This document describes the validation of an in vitro diagnostic assay (a laboratory test) for quantitative measurement of vancomycin. The 'ground truth' for this type of device is typically established through analytical methods and comparisons to a predicate device, rather than expert consensus on image interpretation or clinical diagnosis. The predicate device (AxSYM® Vancomycin II) serves as the reference for method comparison.",
    "4_adjudication_method_test_set": "N/A. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective expert review (e.g., radiology diagnosis) to establish ground truth from multiple readers. This document describes analytical performance studies of a quantitative assay, where objective measurements are compared against reference methods or established analytical criteria. No human adjudication is mentioned or implied.",
    "5_mrmc_comparative_effectiveness_study": "No. This document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers. The studies focus on the analytical performance of the device and its comparison to a predicate device, not on human-in-the-loop performance or the effect size of AI assistance for human readers.",
    "6_standalone_performance_study": "Yes. The entire document describes standalone performance studies of the IMMULITE 2000/2500 Vancomycin assays. The reported metrics (e.g., Limit of Blank, Limit of Detection, Precision, Linearity, Spiked Recovery, Interference, Cross-Reactivity, Sample Type Correlation, Method Comparison) represent the algorithm's (assay's) performance without human intervention in the measurement process, beyond initiating the automated assay and interpreting the quantitative result.",
    "7_type_of_ground_truth_used": "The ground truth for the analytical and method comparison studies relies on several approaches:\n\n*   **CLSI Guidelines:** For LoB and LoD, the 'ground truth' calculation methodology is defined by CLSI guidelines (EP17-A). Precision is guided by CLSI EP5-A2.\n*   **Analytical Standards/Spiking:** For linearity, spiked recovery, interfering substances, and cross-reactivity, ground truth is established by preparing samples with known, precise concentrations of vancomycin or potential interferents.\n*   **Predicate Device:** For method comparison and sample type correlation, the predicate device (Abbott AxSYM Vancomycin II) or the serum sample type (for correlation studies) serves as the reference or 'ground truth' method against which the new device's measurements are compared. This demonstrates substantial equivalence.",
    "8_sample_size_training_set": "N/A. For these in vitro diagnostic assays, the concept of a 'training set' in the machine learning sense is not directly applicable. The assay 'learns' and establishes its Master Curve at the site of manufacture using calibrators, which are not provided to customers. The document states that calibrators are used at the site of manufacture to establish the Master Curve. The specific sample size for this manufacturing calibration process is not provided in the document.",
    "9_how_ground_truth_for_training_set_was_established": "N/A. Similar to the training set concept, the 'ground truth' for the manufacturing calibration is established internally by DPC based on their proprietary calibration process using reference materials (Vancomycin adjustors and calibrators). The document states: \"In all IMMULITE platform instruments, calibrators are used at the site of manufacture to establish the Master Curve, which is encoded in the kit barcode label.\" The calibrators themselves are likely traceable to recognized reference standards for vancomycin concentration, establishing their 'ground truth'."
  }
}

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The Dimension Vista™ Acetaminophen (ACTM) Flex® reagent cartridge is a device intended to measure acetaminophen, an analgesic and antipyretic (fever reducing) drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

The Dimension Vista™ Amylase (AMY) Flex® reagent cartridge is a device intended to measure the activity of the enzyme amylase in serum, plasma and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

The Dimension Vista™ Creatine Kinase (CK) Flex® reagent cartridge is a device intended to measure the activity of the enzyme creatine kinase in serum and plasma. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive Duchenne-type muscular dystrophy.

The Dimension Vista™ Cholesterol (CHOL) Flex® reagent cartridge is a device intended to measure cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

The Dimension Vista™ Gamma-glutamyl transferase (GGT) Flex® reagent cartridge is a device intended to measure gamma-glutamyl transferase in human serum and plasma. Gamma-glutamyl transferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.

The Dimension Vista™ Glucose (GLU) Flex® reagent cartridge is a device intended to measure glucose in human serum, plasma, urine and cerebrospinal fluid. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal and idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

The Dimension Vista™ High-Density Lipoprotein Cholesterol (HDLC) Flex® reagent cartridge is intended to measure high-density lipoprotein cholesterol in serum and plasma. Measurements of high-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The Dimension Vista™ Low-Density Lipoprotein Cholesterol (LDLC) Flex® reagent cartridge is intended to measure low-density lipoprotein cholesterol in serum and plasma. Measurements of low-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The Dimension Vista™ Lidocaine (LIDO) Flex® reagent cartridge is a device intended to measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy.

The Dimension Vista™ Magnesium (MG) Flex® reagent cartridge is intended for the measurement of magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

The Dimension Vista™ Pseudocholinesterase (PCHE) Flex® reagent cartridge is a device intended to measure pseudocholinesterase activity in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

The Dimension Vista™ Phosphorus (PHOS) Flex® reagent cartridge is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

The Dimension Vista™ Procainamide (PROC) Flex® reagent cartridge is a device intended to measure procainamide in serum and plasma. Measurements obtained may be used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to ensure appropriate therapy.

The Dimension Vista™ Salicylate (SAL) Flex® reagent cartridge is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human serum. Measurements obtained by this device are used in the diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

The Dimension Vista™ Thyroxine (T4) Flex® reagent cartridge is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

The Dimension Vista™ Tobramycin (TOBR) Flex® reagent cartridge is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in palsma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.

The Dimension Vista™ Triglyceride (TRIG) Flex® reagent cartridge is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device 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 Dimension Vista™ Uric Acid (URCA) Flex® reagent cartridge is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

The Dimension Vista™ Valproic Acid (VALP) Flex® reagent cartridge is a device intended to measure valproic acid, an anti-convulsant drug in serum and plasma. Measurements obtained may be used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.

The Dimension Vista™ Vancomycin (VANC) Flex® reagent cartridge is a device intended to measure vancomycin, an antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Vade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension Vista™ system was previously cleared with seven associated test methods (K 051087). This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system.

The reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the devices.

Here's a breakdown of the acceptance criteria and study information for the Dade Behring Dimension Vista™ Flex® reagent cartridges, based on the provided 510(k) summary:

This device submission is a Special 510(k) for a packaging modification, meaning the core technology and reagents are the same as previously cleared devices. Therefore, the primary goal of the study is to demonstrate substantially equivalent performance after the packaging change, rather than to establish initial performance claims for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria or specific performance metrics (e.g., accuracy, precision values) for each analyte. Instead, it relies on a comparative equivalency approach to a predicate device.

The overarching acceptance criterion is "substantially equivalent performance" to the predicate Dimension® Flex® reagent cartridges.

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

The document states: "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance."

• Sample Size for Test Set: This information is not explicitly stated in the provided summary. The summary refers to a "protocol included in this submission," which would contain these details.
• Data Provenance: This information is not explicitly stated in the provided summary.
• Retrospective or Prospective: This information is not explicitly stated. However, given the nature of in-vitro diagnostic testing for performance comparison, it would typically involve prospective testing on patient samples or spiked samples.

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

This is an in-vitro diagnostic device for quantitative measurement of analytes in human samples (serum, plasma, urine, CSF). The ground truth for such devices is established by:

• Reference Methods: Highly accurate and precise laboratory methods, often gold standards like GC-MS, HPLC, or other well-validated enzymatic or spectrophotometric methods.
• Certified Reference Materials (CRMs): Samples with known, certified concentrations of the analytes.

Therefore, the concept of "experts" in the clinical imaging or diagnostic interpretation sense (e.g., radiologists) is not applicable here. The ground truth is laboratory-based and instrumental.

4. Adjudication Method for the Test Set

Not applicable for this type of in-vitro diagnostic device. Ground truth is established by reference methods or certified materials, not by expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done.
• This device is an in-vitro diagnostic reagent cartridge, not an AI-powered diagnostic imaging tool or a system designed for human interpretation with or without AI assistance. The performance is measured instrumentally.

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

• Yes, the performance evaluated is inherently "standalone" in the context of an automated analytical instrument. The Flex® reagent cartridges are designed to be used on the Dimension Vista™ Integrated system, a "fully automated, microprocessor-controlled, integrated instrument system." The performance of the reagent (device) is measured by its output on this automated system.
• There is no "human-in-the-loop" decision-making component for the measurement process itself, although clinical interpretation of the results by a healthcare professional is expected.

7. The Type of Ground Truth Used

The ground truth for this type of in-vitro diagnostic device would typically involve:

• Reference Method Assays: Using established, highly accurate, and precise laboratory methods (e.g., a recognized primary reference measurement procedure or a well-characterized predicate device itself) to determine the true concentration of the analytes in the test samples.
• Certified Reference Materials: Commercial or internal standards with known, traceable concentrations of the analytes.
• Sample Matrix: Patient samples (serum, plasma, urine, CSF) with concentrations spanning the analytical range.

The summary states "Comparative testing... demonstrates substantially equivalent performance." This strongly implies that the new device's measurements were compared against the measurements obtained by the predicate device on the same samples, which serves as the "reference" or "ground truth" for the equivalence claim.

8. The Sample Size for the Training Set

This device is a reagent cartridge for an in-vitro diagnostic test, not a machine learning or AI algorithm in the contemporary sense that requires a "training set" to learn. The reagents and their chemical reactions are based on established scientific principles.

Therefore, the concept of a "training set" as understood in machine learning is not applicable to this device.

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

As noted above, the concept of a "training set" is not applicable to this device. The ground truth for the performance evaluation (test set) would be established by reference methods or comparison to the predicate device, as described in point 7.

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The QMS® Vancomycin assay is intended for the quantitative determination of vancomycin in human serum or plasma on the Hitachi 717 analyzer.

The results obtained are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.

The QMS® Vancomycin assay is a homogeneous particle-enhanced turbidimetric immunoassay. The assay is based on competition between drug in the sample and drug coated onto a microparticle for antibody binding sites of the vancomycin antibody reagent. The vancomycin-coated microparticle reagent is rapidly aqglutinated in the presence of the anti-vancomycin antibody reagent and in the absence of any competing drug in the sample. The rate of absorbance change is measured photometrically, and is directly proportional to the rate of agglutination of the particles. When a sample containing vancomycin is added, the agglutination reaction is partially inhibited, slowing down the rate of absorbance change. A concentrationdependent classic agglutination inhibition curve can be obtained, with maximum rate of agglutination at the lowest vancomycin concentration and the lowest agglutination rate at the highest vancomycin concentration.

The assay consists of reagents R1: vancomycin monoclonal and R2: vancomycin-coated microparticles. A six-level set of QMS® Vancomycin Calibrators (A through F) i

Here's a summary of the acceptance criteria and study findings for the QMS® Vancomycin assay, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance for QMS® Vancomycin Assay

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined "acceptance criteria" with numerical thresholds for all tests. Instead, it presents study results and implies that the observed performance characteristics were deemed acceptable for substantial equivalence to the predicate device. For the purpose of this table, "Acceptance Criteria (Implied)" are derived from the overall goal of demonstrating equivalency or typical performance expectations for such assays, and "Reported Device Performance" are the results presented in the summary.

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1. For in vitro diagnostic use only. VITROS Chemistry Products VANC Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure vancomycin (VANC) concentration in human serum and plasma. Serum or plasma vancomycin measurements are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.
2. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 11 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of vancomycin (VANC).
3. For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assaved control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and VANC on VITROS Chemistry Systems.

The VITROS Chemistry Products VANC Reagent, VITROS Chemistry Products Calibrator Kit 11, and the VITROS Chemistry Products TDM Performance Verifiers are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS VANC assay. VITROS Chemistry Products VANC Reagent is a dual chambered package containing ready-to-use liquid reagents that are used in a two-step reaction to quantitatively measure vancomycin.

VITROS Chemistry Products Calibrator Kit 11 and TDM Performance Verifiers are packaged and sold separately.

VITROS Chemistry Products Calibrator Kit 11 is a liquid ready to use calibrator set for vancomycin. Each kit contains one bottle each of six (6) levels. The level 1 bottle (zero level) contains 5 milliliters. The level 2 through 6 bottles each contain 2 milliliters.

VITROS Chemistry Products TDM Performance Verifier I, II and III are liguid ready to use controls with assayed values published for each lot. The controls are prepared from bovine serum with therapeutic drugs and preservatives added. The product is sold in separate kits of Level I, II and III. Each kit contains 6 vials (2 mL each).

Here's an analysis of the provided 510(k) summary regarding the VITROS Chemistry Products VANC assay and controls:

1. Acceptance Criteria and Reported Device Performance

The submission uses substantial equivalence to a predicate device as its basis for clearance, rather than defining explicit acceptance criteria with pre-specified thresholds for performance metrics. The primary "acceptance criteria" here are implied by the performance of the predicate device and the demonstration of equivalent performance for the new device.

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

The provided summary mentions "patient samples" were used for correlation studies but does not specify the sample size for the test set used to compare the VITROS VANC assay against the predicate device.
The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective), but it's implied to be retrospective as patient samples were used for correlation against an existing, cleared assay.

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

This information is not applicable as the device is an in vitro diagnostic (IVD) assay for quantitative measurement. Ground truth for quantitative diagnostic assays typically refers to a reference method or a predicate device comparison rather than expert adjudication of images or clinical assessments.

4. Adjudication Method for the Test Set

This information is not applicable for this type of IVD assay. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., imaging studies) where human experts determine ground truth. For a quantitative assay, the comparison is against an established reference method or predicate device.

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

A MRMC comparative effectiveness study was not conducted and is not applicable for this device. This type of study involves human readers interpreting cases with and without AI assistance, which is irrelevant for a standalone quantitative IVD assay.

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

Yes, a standalone performance study was done. The entire evaluation described is a standalone performance study, as it assesses the algorithm (the VITROS VANC assay) directly against a predicate device and other performance characteristics (precision, linearity, specificity) without human-in-the-loop interpretation. The performance metrics reported (correlation coefficient, linear regression) are direct measures of the assay's agreement with the predicate.

7. Type of Ground Truth Used

The ground truth for the comparison was established using a predicate device (SYVA Emit 2000 Vancomycin Assay) and patient samples. This means the new device's measurements were compared against the measurements obtained from an already FDA-cleared, commercially available assay using the same patient samples.

8. Sample Size for the Training Set

The document does not provide information regarding a specific "training set" sample size. For an IVD assay, the development process might involve numerous samples for calibration development and optimization, but these are typically not referred to as a distinct "training set" in the same way as machine learning models. The correlation and performance studies act as the validation.

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

Since a specific "training set" and its ground truth establishment mechanism are not detailed in the provided summary, this information is not available. However, for a chemical assay, the "ground truth" during development (analogous to training) would involve:

• Using known concentration standards to develop calibration curves.
• Testing against reference materials with established vancomycin concentrations.
• Optimization of reagent formulations to achieve desired analytical performance.

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