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cobas c Acetaminophen Gen.2 assay:
The cobas c Acetaminophen Gen.2 assay is an in vitro diagnostic test for the quantitative determination of acetaminophen in serum and plasma for use in the diagnosis of acetaminophen overdose in serum and plasma on Roche/Hitachi cobas c systems.

ACET2 calibrator:
The ACET2 calibrator is for use in the calibration of the Acetaminophen Gen.2 Roche assay.

The cobas c Acetaminophen Gen.2 assay is based on a homogeneous enzyme immunoassay technique used for the quantitative analysis of acetaminophen in human serum and plasma.
Reagents are packaged in a cassette labeled with their instrument positioning R1 (Reagent 1) and R2 (Reagent 2).
R1 contains anti-acetaminophen antibody (sheep polyclonal), G6P, NAD, bovine serum albumin, preservatives and stabilizers.
R2 contains acetaminophen labeled with bacterial G6PDH, Tris buffer, preservatives, bovine serum albumin, and stabilizers.
The ACET2 calibrator contains a known quantity of acetaminophen. The cobas c 501 analyzer dilutes the ACET2 calibrator on-board the analyzer with NaCl diluent, in order to create five concentration levels, and level 1 is water. This results in a six-level calibrator set, and the calibrator set is then used to establish a standard curve. The ACET2 calibrator contains acetaminophen, phosphate buffer, and preservatives.

The provided document describes the analytical performance of the cobas c Acetaminophen Gen.2 assay and ACET2 Calibrator. It outlines various studies conducted to demonstrate the device's characteristics, which can serve as acceptance criteria.

Here's the requested information:

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

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

• Precision (Repeatability and Intermediate Precision): The study was conducted according to CLSI EP5-A2 requirements using human samples and controls. "n = 84" is mentioned for repeatability. "2 aliquots per run, 2 runs per day, 21 days" for intermediate precision. The document does not specify the country of origin or whether the data was retrospective or prospective.
• Method Comparison to Predicate: Sample size (n) = 105 human serum samples. The document does not specify the country of origin or whether the data was retrospective or prospective.
• Linearity: One batch of reagent, one run, samples measured in triplicate. Two separate dilution series (serum and Li-Heparin plasma) with thirteen levels each. The document does not specify the country of origin or whether the data was retrospective or prospective.
• Detection Limits (LoB, LoD, LoQ):
  • LoB: One analyte-free sample tested in n=5 on two analyzers with three reagent batches for six runs per day across three days.
  • LoD: Five low-analyte samples spiked with acetaminophen measured in singlicate on two analyzers with three reagent batches for six runs per day across three days.
  • LoQ: A low-level sample set of six measured in two aliquots using three reagent batches on one analyzer over at least six days.
    The document does not specify the country of origin or whether the data was retrospective or prospective.
• Analytical Specificity (Cross-Reactivity, Endogenous Substances, Common Drugs): Tested using sample pools (at two target concentrations of acetaminophen) and spiked samples. The specific number of individual samples for each compound/substance is not given, but refers to "two sample pools" or "serum sample pools". The document does not specify the country of origin or whether the data was retrospective or prospective.
• Matrix Comparison: 60 tubes collected per anticoagulant (Lithium-heparin, K2-EDTA, K3-EDTA). This suggests 60 samples for each, so 180 total samples. The document does not specify the country of origin or whether the data was retrospective or prospective.

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 product is an in vitro diagnostic test for the quantitative determination of acetaminophen. The "ground truth" for such assays is typically established by reference methods or spiking known concentrations of analyte into samples. The document does not mention the involvement of medical experts (like radiologists) for ground truth establishment, as it's a quantitative chemical assay, not an image-based diagnostic. It uses USP reference standards for traceability, which represents a highly controlled and recognized standard for chemical concentration.

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

Not applicable. Adjudication methods like "2+1" are typically used in studies involving human interpretation (e.g., radiology for diagnostic accuracy) where there might be disagreement among readers, and a third reader is brought in to resolve discrepancies. This document describes the performance of a quantitative chemical assay, where the output is a numerical value.

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-assisted diagnostic device, nor does it involve human readers interpreting cases. It is a standalone in vitro diagnostic assay.

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

Yes, this is a standalone device. The entire document describes the performance of the assay itself (cobas c Acetaminophen Gen.2 assay and ACET2 calibrator) on the Roche/Hitachi cobas c 501 analyzer, which processes samples and provides quantitative results without human interpretation or algorithm assistance as part of the primary diagnostic function.

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

The ground truth for this chemical assay is primarily based on:

• Known concentrations of analyte: For linearity, detection limits (LoD, LoQ), cross-reactivity, and interference studies, samples were spiked with known concentrations of acetaminophen or interfering substances.
• Reference Methods / Standards: For traceability, the method has been standardized against USP reference standards.
• Comparative Method: The performance was compared to a legally marketed predicate device (Siemens Emit® tox™ Acetaminophen Assay).

8. The sample size for the training set

This document describes the analytical validation of a chemical assay. The concept of a "training set" is typically associated with machine learning or AI models, where data is used to train an algorithm. This document details the performance testing of the device, not the development of a machine learning model. Therefore, a "training set" in the context of an AI algorithm is not applicable here.

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

As explained above, there is no "training set" in the AI/machine learning sense for this type of in vitro diagnostic device. The analytical characteristics are established through various experiments using samples with known properties or references.

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The Lin-Zhi Multiple Analyte Set A, B, and C Urine Drugs of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphelamine, Methadone, 6-acetylmorphine, MDMA, Morphine, Oxazepan, and Secobarbital. The calibrators are designed for prescription use with homogeneous enzyme immunoassays on automated clinical chemistry analyzers.

The Lin-Zhi Multiple Analyte Set A, B, and C Urine Drugs of Abuse Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphelamine, Methadone, 6-acetylmorphine, Oxazepan, and Secobarbital. The controls are designed for prescription use with homogeneous enzyme immunoassays on automated clinical chemistry analyzers.

All of the LZI Multiple Analyte Set A, B, and C Drugs of Abuse Calibrators and Controls are liquid and ready to use. These Calibrators and Controls do not have any especially unique technical characteristics. Each contains a known concentration of a specific drug analyte as a mixture.

The Negative DAU Calibrator is a processed, drug-free human urine matrix in human urine with sodium azide (0.09%) as preservative. The Low. Cutoff. Intermediate, and High Calibrators, as well as the 2 levels of Controls are prepared by spiking known concentrations of drug analyte into the Negative DAU Calibrator matrix. These five calibrators and two controls are sold as individual bottles.

Acceptance Criteria and Device Performance Study

This document describes the acceptance criteria and study proving the performance of the LZI Multiple Analyte Set A, B, and C Drugs of Abuse Calibrators and Controls. These devices are intended for in vitro diagnostic use for the calibration and monitoring of homogeneous enzyme immunoassays for drugs of abuse in human urine.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance was evaluated based on stability, traceability, and value assignment, with the primary acceptance criteria being that the calibrators and controls should not vary by more than ±10% in stability studies and that assigned values are within ±10% of target concentrations.

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

The document does not explicitly state a specific "sample size" for a test set in the traditional sense of patient samples. Instead, the testing involved:

• Stability Studies: Measurements were taken on various calibrator and control sets at multiple temperatures (Cold: 2-8 ℃, Room Temperature, Accelerated: 30 ℃) over a period up to Day 366. The number of individual vials or replicates per concentration for these studies is not specified, but it covered all analytes across Sets A, B, and C.
• Traceability and Value Assignment: This involved
  • One commercial standard stock solution per analyte (purity 99%, verified by GC/MS).
  • Secondary stock solutions (concentration verified gravimetrically).
  • Final calibrator and control products (prepared by spiking into negative urine matrix and verified by GC/MS). The exact number of individual samples for the GC/MS verification is not detailed.

Data Provenance: The study appears to be an internal laboratory study conducted by Lin-Zhi International, Inc. given the context of a 510(k) submission. The data is prospective, generated specifically for this submission to demonstrate substantial equivalence. The country of origin of the data is implicitly the USA, where the company is located.

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

This type of device (calibrators and controls for in vitro diagnostics) does not rely on human expert interpretation or ground truth in the way medical imaging or clinical diagnostic devices would. Instead:

• Ground Truth (Reference Values): The "ground truth" for the calibrators and controls is established by the precisely known concentrations of drug analytes spiked into the negative urine matrix. These concentrations are analytically verified.
• Verification Method: Gas Chromatography/Mass Spectrometry (GC/MS) is cited as the method for verifying the purity of starting materials and the final concentrations in the calibrators/controls. GC/MS is a highly accurate and widely accepted analytical technique for confirming the presence and concentration of substances.

Therefore, no clinical experts (e.g., radiologists) were used. The "experts" in this context would be analytical chemists or lab personnel skilled in performing and interpreting GC/MS results and gravimetric measurements. Their specific qualifications are not detailed, but their work is grounded in established analytical chemistry principles.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is analytically determined by precise spiking and confirmed by GC/MS, not by human interpretation requiring adjudication.

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

No. An MRMC comparative effectiveness study is not applicable to this device. This device is a set of calibrators and controls used to standardize and monitor automated laboratory assays, not an AI or diagnostic tool that involves human interpretation of cases.

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

Yes, in a sense. The "performance" being evaluated is the chemical and physical characteristics of the calibrators and controls themselves (stability, accurate concentration). This evaluation is inherently "standalone" in that it assesses the product's intrinsic properties through analytical methods (spectrometry, gravimetry) without human intervention in the result generation or interpretation of a diagnostic outcome. The calibrators/controls are not an "algorithm," but their performance is objectively measured.

7. The Type of Ground Truth Used

The ground truth used is based on analytical confirmation of spiked concentrations using:

• Gravimetrically prepared concentrations: The known amounts of drug analyte spiked into the urine matrix.
• Mass Spectrometry (GC/MS): An independent analytical method used to verify the purity of starting materials and the final concentrations in the calibrators and controls to ensure they are within ±10% of the target concentration.

This is a form of highly precise reference standard or chemical assay ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is a set of calibrators and controls, not an AI/machine learning algorithm that requires a "training set." Its performance is based on its chemical manufacturing and analytical verification, not on learning from data.

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

Not applicable. As explained in point 8, there is no training set for this type of device.

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For in vitro diagnostic use in the calibration of the Amikacin, Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, Quinidine, Theophylline, Valproic Acid, and Vancomycin human serum and plasma assays on the ARCHITECT cSystems. Lot-specific calibrator for the ARCHITECT cSystems are listed in the TDM MCC Value Sheet, packaged with the calibrator.

For in vitro diagnostic use in the calibration of assays for the detection of Amikacin, Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, Quinidine, Theophylline, Valproic Acid, and Vancomycin in human serum and plasma for use on clinical laboratory analyzers. Lot-specific calibrator values with specific analyzers are provided in the value sheet packaged with the calibrator.

Each TDM Multiconstituent Calibrator set and QMS® TDM Multi-Constituent Calibrator set is packaged in a rectangular cardboard box with a 12-bottle divider, a product insert, and a value sheet. Kits are stored refrigerated at 2-8°C. Each kit contains 6 levels of calibrators with the following configurations. The TDM Multiconstituent Calibrator set and QMS® TDM Multi-Constituent Calibrator set are prepared from a bovine serum matrix and contains the following analytes: amikacin, carbamazepine, digoxin, gentamicin, phenytoin, quinidine, theophylline, theophylline, valproic acid, and vancomycin. Sodium azide at 0.09% and ProClin 300 at 0.1% are present as preservatives. TDM Multiconstituent Calibrator and QMS® TDM Multi-Constituent Calibrator levels are provided in liquid ready to use form and to be stored at 2-8°C until the expiration date on the label. Once opened, the opened bottles are stable for 60 days when capped tightly and stored at 2-8°C.

The provided 510(k) summary describes a calibrator device for in vitro diagnostic use, not an AI/ML device. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, training set sample size, ground truth for training set) are not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the provided "Summary of Testing" table.

Acceptance Criteria and Reported Device Performance

Non-Applicable / Not Provided Information for AI/ML Device Study:

The following information is either not applicable to this type of medical device (a calibrator for IVD assays) or is not provided in the summary document:

• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a calibrator. The testing involves laboratory measurements of the calibrator's performance against defined targets.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" for a calibrator would refer to the true concentrations of the analytes, which are established during its manufacturing and characterization rather than by expert review of patient data.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 calibrator, not an AI-assisted diagnostic tool for human readers.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, the "ground truth" implicitly refers to the accurately assigned target concentrations of the analytes within the calibrator solutions. These are determined through precise chemical analysis and manufacturing processes, not clinical expert consensus or pathology.
• The sample size for the training set: Not applicable. There is no AI/ML model to train.
• How the ground truth for the training set was established: Not applicable.

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The Randox Laboratories Ltd. Methamphetamine Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of Methamphetamine in numan urine at the cut off of 1000ng/ml. The assay is calibrated against methamphetamine. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of Methamine use or overdose. The Randox Methamphetamine Assay has been developed for use on the form analysers, which includes the And the annound " and the annound" This in vitro diagnostic device is intended for prescription use only.

The semi-quantitative mode is for purposes of

• (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS
  or

• (2) permitting laboratories to establish quality control procedures.
  This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatograph/Mass Spectrometry(GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The Randox Multidrug Calibrator Set consists of liquid calibrators containing Methamphetamine, Oxazepam and Methadone. There are 5 levels of calibrator. They have been developed for use in the calibration of Methamphetamine, Benzodiazepines and Methadone assays for use on the Drawn analysers, which includes the _________________________________________________________________________________________________________________________________________________________________ use only.

The Randox Multidrug Controls level 1 and 2 are liquid controls containing Methamphetamine. Oxazepam and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Methamphetamine, Benzodiazepines and Methadone assays for use on the Oxecure analysers, which includes the JX day to na™ and the forman". This in vitro diagnostic device is intended for prescription use only.

Not Found

This document describes K092266, a 510(k) premarket notification for the Randox Methamphetamine Assay, Randox Multidrug Calibrator Set, and Randox Multidrug Controls, Level 1 & 2. However, the provided text does not contain the acceptance criteria or the study data that proves the device meets specific acceptance criteria.

The document primarily focuses on the FDA's clearance of the device as substantially equivalent to legally marketed predicate devices, and outlines the "Indications for Use" for each component of the Randox product suite. It also mentions general regulatory requirements.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them based on the provided text.

To answer your request, I would need a different section of the 510(k) submission, likely a performance study summary or a section detailing verification and validation activities.

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The CEDIA® Multi-Drug OFT Calibrators are intended for use in the calibration of d-Amphetamine, Benzoylecgonine, Morphine and Phencyclidine (PCP) in human Oral Fluid when used with the CEDIA Amphetamine, Cocaine, Opiate, and Phencyclidine (PCP) OFT Assays on the MGC 240 analyzer. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA® Multi-Drug OFT Calibrators are liquid ready-to-use. They are prepared by spiking known quantities of Amphetamine, Benzoylecgonine, Morphine and PCP in to buffer matrix. The Cutoff Calibrator is used as a qualitative cutoff reference for distinguishing "positive" from "negative" samples. The concentration for each drug in the calibrators is listed in table below. Concentrations for each calibrator are confirmed by LC-MS/MS methodology.

The provided text describes a 510(k) submission for the CEDIA® Multi-Drug OFT Calibrators, focusing on its substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

The document primarily focuses on:

• Intended Use: Calibration of specific drugs (d-Amphetamine, Benzoylecgonine, Morphine, Phencyclidine (PCP)) in human Oral Fluid when used with CEDIA OFT Assays on the MGC 240 analyzer.
• Device Description: Liquid, ready-to-use calibrators prepared by spiking known quantities of drugs into a buffer matrix. Concentrations are confirmed by LC-MS/MS.
• Comparison to Predicate Device: Table outlining similarities and differences in intended use, analytes, matrix, form, calibrator levels, and storage temperature.
• Conclusion: Substantial equivalence due to performance testing verifying intended function and satisfaction of design specifications.

Therefore, based on the provided text, I cannot provide answers to the requested information (1-9) as they pertain to performance acceptance criteria and efficacy studies typically found in clinical validation reports for diagnostic devices.

The document states: "Substantial equivalence has been demonstrated through performance testing to verify that the device functions as intended and that design specifications have been satisfied." However, it does not provide any details about this "performance testing," including:

• Specific acceptance criteria: What quantitative thresholds were set for performance?
• Performance results: What were the reported metrics (e.g., accuracy, precision, bias)?
• Study design details: Sample size, data provenance, ground truth establishment, expert involvement, etc.

Without this information, it's impossible to fill in the requested table or answer the subsequent questions about the study. This document appears to be just the 510(k) summary and the FDA's clearance letter, not the detailed performance study report itself.

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The C.f.a.s. DAT Qualitative Plus Clinical calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. The Control Set DAT Clinical is for use as an assayed control in the Roche test system for qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers.

C.f.a.s. DAT Qualitative Plus Clinical calibrators contain a mixture of 10 different drugs, prepared by quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, barbituates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine, and propoxyphene. The calibrator set contains a single level for each drug in a drug mixture. Drug concentrations are verified by gas chromatography/mass spectrometry (GC/MS). Control Set DAT Clinical controls contain a mixture of 10 different drugs, prepared by quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, barbituates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine, and propoxyphene. Drug concentrations are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ±25% of the assay cutoff.

The provided text is a 510(k) summary for the C.f.a.s. DAT Qualitative Plus Clinical and Control Set DAT Clinical devices. It establishes substantial equivalence to previously marketed predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics.

Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, training set details) are not applicable or not provided in this type of submission.

Here's an analysis based on the information available:

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

This document describes calibrators and controls for drug-of-abuse testing, not a diagnostic device with performance metrics like sensitivity and specificity against a clinical condition. Therefore, there are no specific "acceptance criteria" for clinical performance in the sense of a diagnostic test, nor reported device performance in terms of clinical accuracy (e.g., sensitivity, specificity, accuracy).

Instead, the acceptance criteria for these calibrators and controls revolve around their composition, their traceability to GC/MS verification, and their intended use for calibrating and controlling Roche assays. The "performance" is implicitly that they function as intended for these purposes when used with the specified assays.

The table below summarizes the device characteristics rather than performance against acceptance criteria in a clinical study:

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

Not applicable. This is a 510(k) for calibrators and controls based on substantial equivalence, not a clinical study on a device's performance against a test set of patient samples. The verification of drug concentrations is done via GC/MS of the manufactured calibrator/control product itself, not on patient samples.

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

Not applicable. Ground truth for the drug concentrations within the calibrators and controls is established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical method, not by human experts.

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

Not applicable, as no human adjudication of results is involved in establishing the ground truth for these calibrators and controls. The drug concentrations are verified by GC/MS.

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 device is not an AI-assisted diagnostic tool, and no MRMC study or AI-related performance evaluation is relevant or mentioned.

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

Not applicable. This device is a calibrator/control material, not an algorithm.

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

The ground truth for the drug concentrations within the calibrators and controls is established by Gas Chromatography/Mass Spectrometry (GC/MS). This is a highly accurate analytical technique used to verify the precise amount of each drug or drug metabolite added to the drug-free human urine matrix.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this 510(k) submission. These are manufactured chemical reference materials, not machine learning algorithms that require training data.

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

Not applicable. As there is no training set, there is no ground truth establishment for one.

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The ADVIA Chemistry TDM DRUG Calibrator II is for in vitro diagnostic use in the calibration of Carbamazepine 2 (CARB_2), Gentamicin_2 (GENT_2), Tobramycin_2 (TOBR 2), Valproic Acid 2 (VPA 2), and Vancomycin 2 (VANC 2) methods on the ADVIA Chemistry Systems.

ADVIA Chemistry TDM DRUG Calibrator II is a multi-analyte, liquid, bovine serum based product containing multiple analytes. The kit consists of 2 vials of each of 5 calibrator levels which are ready for use (no preparation is required). The volume per vial is 5.0 mL. Tobramycin, Carbamazepine, Valproic Acic, Vancomycin and Gentamicin analytes are value assigned for ADVIA Chemsitry systems.

The provided document is a 510(k) summary for a calibrator device, not a diagnostic device that performs human-in-the-loop analysis or has complex acceptance criteria based on diagnostic performance metrics like sensitivity, specificity, or AUC. Therefore, many of the typical questions for diagnostic devices, especially those involving AI or human readers, are not applicable.

This document describes a submission for demonstrating substantial equivalence of a new calibrator (ADVIA Chemistry DRUG Calibrator II) to a previously cleared predicate calibrator (Dade Behring Dimension Drug Calibrator II). The core of the study is a comparison of characteristics between the new and predicate devices to show they are fundamentally the same for their intended use.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a diagnostic performance study. Instead, the "acceptance" is based on demonstrating substantial equivalence to a predicate device. The comparison table below highlights the key characteristics that were evaluated to demonstrate this equivalence. The "performance" is that these characteristics are largely identical or comparable.

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

This document does not describe a "test set" in the context of clinical samples or patient data being analyzed by the device. The "study" here is a comparison of the characteristics of the new calibrator against a predicate calibrator. The "data provenance" refers to the characteristics and specifications of the calibrator products themselves.

The comparison is based on the inherent properties of the calibrators (e.g., active ingredients, matrix, form, stability specifications) rather than a performance study on a specific dataset.

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

Not applicable. There is no "test set" of clinical cases or images to establish ground truth from experts. The "ground truth" for a calibrator relates to the accuracy of the assigned values of the analytes within the calibrator, which would be established through a rigorous manufacturing and quality control process using recognized reference methods and standards (like USP Traceability mentioned).

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" requiring adjudication.

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

No. This is a submission for a calibrator device, not a diagnostic device that would involve human readers or AI assistance in interpreting results for patient cases.

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

No. This device is a calibrator, a component used to ensure the accuracy of other diagnostic methods (ADVIA Chemistry Systems). It does not involve algorithms or standalone performance analysis in the sense of a diagnostic test. Its performance is tied to its stability and the accuracy of its assigned values, which are verified through manufacturing and quality control.

7. The Type of Ground Truth Used

The "ground truth" for a calibrator typically refers to the certified or assigned values of the analytes within the calibrator itself. This is established through:

• Reference standards: The document states "USP Traceability," indicating that the analyte concentrations are traceable to United States Pharmacopeia reference standards.
• Validated analytical methods: High-precision and accurate analytical methods are used during manufacturing to determine the precise concentration of each analyte in the calibrator levels.
• Quality control processes: Extensive quality control ensures that each batch of calibrators meets the specified concentration ranges.

8. The Sample Size for the Training Set

Not applicable. "Training set" is a concept for machine learning algorithms or AI, which is not relevant to a chemical calibrator device.

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

Not applicable. There is no training set for this device.

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The UDAT CAL is an in vitro diagnostic product for the calibration of Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Methaqualone (MTQ), Opiates (OPI), Phencyclidine (PCP), Propoxyphene (PRX), and Cannabinoids (THC) methods on the Dimension Vista™ System.

UDAT CAL is a liquid, multi-analyte, drug free human urine based product containing: D-methamphetamine, Secobarbital, Lormetazepam, Benzoylecgonine, Methadone, Morphine, Phencyclidine, 11-nor- $\Delta$ 9-THC-9-COOH, Propoxyphene, and Methylqualone. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are ready for use (no preparation is required). The volume per vial is 2.5 mL for Calibrator A and 2.6 mL for Calibrator B. Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.

The provided text describes a 510(k) submission for the Dimension Vista™ System Drugs of Abuse Calibrator (UDAT CAL - KC510). This is a calibrator material, not an AI/ML-driven device, so many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance) are not applicable or directly addressed in the context of typical AI/ML device evaluations.

However, based on the performance characteristics provided for this calibrator material, here's an attempt to structure the information as requested, highlighting where the AI/ML specific criteria do not apply.

Acceptance Criteria and Device Performance for Dimension Vista™ System Drugs of Abuse Calibrator (UDAT CAL - KC510)

1. Table of Acceptance Criteria and Reported Device Performance

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

This is not an AI/ML device testing data set in the traditional sense. The "testing" refers to internal validation studies of the calibrator's performance characteristics like stability and value assignment.

• Sample Size for Test Set: Not explicitly stated as a single "test set" sample size. Stability testing involved multiple vials over time (e.g., punctured vials tested on Day 0, 1, 2, and 8; manually opened vials on Day 32). Bottle value assignment involved testing stock solutions and commercial lots.
• Data Provenance: The data is internally generated by Dade Behring, Inc. as part of their product development and validation. This would be considered prospective in the context of their internal studies for product validation. The country of origin is implicitly the USA, where Dade Behring Inc. is located.

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

This is not applicable as this is not an AI/ML device requiring expert interpretation of output. The "ground truth" for calibrators is established through analytical and metrological methods, primarily using highly pure reference materials (like USP standards and Cerilliant pure substances) and quantitative analytical techniques such as GC/MS. The "experts" involved would be analytical chemists or equivalent personnel qualified in laboratory methods and metrology. Their number and specific qualifications (e.g., years of experience) are not detailed as they are for clinical expert reviews.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication for a calibrator's performance; it's based on objective analytical measurements against defined specifications.

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

No, this is not an AI/ML device or an imaging device, therefore an MRMC study is not relevant or performed for a calibrator.

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

Not applicable. This is a physical calibrator material, not a standalone algorithm.

7. The Type of Ground Truth Used

The ground truth for the analyte concentrations in the calibrator material is established through:

• Reference Materials: Highly characterized chemical reference materials (e.g., USP standards, Cerilliant 99% purity analytes).
• Gravimetric Preparation: Exact weighing of these reference materials into drug-free human urine to create stock solutions and master lots.
• Analytical Verification: Confirmation of concentrations using established analytical methods like Gas Chromatography/Mass Spectrometry (GC/MS), which provides highly accurate and specific quantification.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device; there is no "training set." The product is manufactured and its performance characteristics (stability, accuracy of value assignment) are validated.

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

Not applicable, as there is no training set. The "ground truth" for the calibrator's values is established from the reference materials, gravimetric preparation, and analytical verification methods described in point 7.

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The DRUG 2 CAL is an in vitro diagnostic product for the calibration of acetaminophen (ACTM), carbamazepine (CRBM), digitoxin (DGTX), gentamicin (GENT), lidocaine (LIDO), Nacetylprocainamide (NAPA), procainamide (PROC), tobramycin (TOBR), valproic acid (VALP), and vancomycin (VANC) methods on the Dimension Vista TM System.

DRUG 2 CAL is a multi-analyte, liquid, bovine serum based product containing acetaminophen, carbamazepine, digitoxin, gentamicin, lidocaine, N-acetylprocainamide, procainamide, tobramycin, valproic acid, and vancomycin. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are ready for use (no preparation is required). The volume per vial is 2.5 mL. Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.

Here's the breakdown of the acceptance criteria and study information for the Dimension Vista™ System Drug 2 Calibrator (DRUG 2 CAL - KC420), based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Stability Studies: Not explicitly stated as a single "test set" sample size for the entire study. Instead:
     • For shelf-life stability, the product was stored at 4°C and compared to a control stored at -20°C. The duration was determined to support a 12-month shelf life.
     • For open vial/on-board stability, vials were opened/punctured on day zero and tested on days 0, 1, 2, 8, and 32. The number of vials or samples per time point is not specified beyond "a quantity sufficient for multiple calibrations."
   • Bottle Value Assignment: N = 20 replicates per level were tested for the final bottle value assignment of the commercial lot. The text doesn't specify if these 20 replicates were from one lot or across multiple lots for performance evaluation, but it was for each level of a commercial lot.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be internal validation studies conducted by Dade Behring Inc.

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

   • Ground truth for this device (a calibrator) is established through traceability to reference materials and gravimetric preparation rather than expert consensus on clinical readings.
   • The "experts" in this context would be the analytical chemists or personnel responsible for weighing reference materials (USP and Alltech-Applied Sciences), preparing master pools and stock solutions, and performing calibrations, whose qualifications are not detailed in this summary.

3. Adjudication method for the test set:

   • Not applicable in the traditional sense of human reader adjudication for diagnostic imaging or clinical interpretation. Performance is assessed against quantitative analytical criteria (e.g., percent change, recovery, comparison to reference materials).

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 a calibrator for in vitro diagnostic tests, not an AI-powered diagnostic device requiring human interpretation of results.

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

   • Not applicable. While the Dimension Vista™ System is an automated instrument, this submission is for the calibrator material used by the system, not the system's analytical algorithm itself. The calibrator's performance is standalone in the sense that it meets specifications independent of user intervention once used correctly, but it's not an algorithm.

6. The type of ground truth used:

   • Reference Materials: The primary ground truth for the analytes is established through United States Pharmacopeia (USP) Reference Materials (for most analytes) and Alltech-Applied Sciences Reference Standards (for NAPA). These are highly purified, well-characterized chemical substances used as analytical standards.
   • Gravimetric Preparation: Concentrations of stock solutions and commercial lots are based on precise gravimetric (weighing) additions of these reference materials.
   • Previously Approved Master Pools: For verification steps, comparison against "previously approved Master Pool values" established using the corresponding standard reference material serves as a form of internal ground truth or validated standard.

7. The sample size for the training set:

   • Not applicable. This is a calibrator, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a product involves establishing the manufacturing process, quality control, and ensuring consistency with reference standards.

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

   • Not applicable, as there is no "training set" for this type of device. The accuracy of the calibrator relies on the traceability of its components to internationally recognized reference standards (USP) and carefully controlled gravimetric preparation.

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The Preciset DAT Plus I calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

The Preciset DAT Plus II calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

The Cfas DAT Qualitative Plus calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

Roche Preciset DAT Plus I calibrators contain a mixture of 10 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine and propoxyphene. The calibrator set contains up to six levels for each drug contained in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of each drug in a multi-analyte mixture.

Roche Preciset DAT Plus II calibrators contain a mixture of 4 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, benzodiazepines. cannabinoids, and opiates. The calibrator set contains up to six levels for each drug contained in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of each drug in a multianalyte mixture.

Roche Cfas DAT Qualitative Plus calibrator contains a mixture of 10 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine, and propoxyphene. The calibrator set contains a single level for each drug in a drug mixture.

This 510(k) premarket notification is for calibrators used with drug abuse assays, not a diagnostic device with performance metrics like sensitivity and specificity. Therefore, many of the requested categories (e.g., expert consensus, MRMC studies, standalone performance) are not applicable in the traditional sense for this type of device.

This submission focuses on demonstrating substantial equivalence to already marketed calibrators by Roche. The "acceptance criteria" here are implicitly meeting the performance characteristics and intended use of the legally marketed predicate devices.

Here's an attempt to structure the available information according to your request, with significant caveats for the non-applicability of certain criteria:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

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

• N/A (for traditional diagnostic device testing): This submission is for calibrators, not a diagnostic test that processes patient samples to generate a "test set" in the conventional sense. The "test" here involves comparing the composition and intended use of the new calibrators to existing, cleared predicate calibrators.
• Data Provenance: The calibrators themselves are "prepared by the quantitative addition of drug or drug metabolite to drug-free human urine." This suggests an in-house manufacturing process rather than external data provenance like country of origin or clinical data collection. The submission doesn't specify any external "testing" data from a large population.

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

• Not Applicable: For calibrators, "ground truth" isn't established by expert consensus on clinical images or patient data. The "ground truth" concerning the calibrators' composition is established by the manufacturing process – the quantitative addition of specified drug concentrations to drug-free human urine. Analytical techniques would verify these concentrations during manufacturing and quality control.

4. Adjudication Method for the Test Set

• Not Applicable: There is no clinical "test set" and thus no need for an adjudication method for disagreements among experts, as would be common in diagnostic imaging or clinical assessment studies.

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

• No: MRMC studies are used to assess the impact of a diagnostic device (often AI-based) on human reader performance. This submission is for calibrators, which are reagents used to set the measurement scale for an assay, not a diagnostic tool read by humans.

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

• Not Applicable: Calibrators do not have an "algorithm" or standalone "performance" in the way an AI diagnostic device would. Their function is to provide known reference points for an assay. Their performance is related to their stability, accuracy of stated concentrations, and ability to correctly calibrate the associated assays, which would be validated during manufacturing and quality control, not as a standalone "algorithm."

7. The Type of Ground Truth Used

• Manufacturing Specifications / Quantitative Addition: The "ground truth" for these calibrators is their precisely defined chemical composition. They are "prepared by the quantitative addition of drug or drug metabolite to drug-free human urine." This means the concentration of each drug in each level of the calibrator is precisely known and controlled during the manufacturing process.

8. The Sample Size for the Training Set

• Not Applicable: Calibrators are physical reference materials, not algorithms that require a "training set" of data.

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

• Not Applicable: As above, there is no training set for this type of device.

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