Search Results

The Piccolo® Potassium Test System, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of potassium, in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

The potassium assay is used for the quantitation of potassium in human heparinized whole blood, heparinized plasma, or serum. Potassium measurements are used in the diagnosis and treatment of renal glomerular or tubular disease, adrenocortical insufficiency, diabetic ketoacidosis, excessive intravenous potassium therapy, sepsis, panhypopituitarism, in vitro hemolysis, hyperaldosteronism, malnutrition, hyperinsulinism, metabolic alkalosis and gastrointestinal loss.

The Piccolo® Potassium Test System is a single-use, disposable system used with the Piccolo Xpress® chemistry analyzer for the in vitro quantitative determination of potassium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Piccolo® Potassium Test System is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternatively, the disc may also be used with serum.

The Piccolo Xpress® chemistry analyzer (previously cleared under K942782) is a portable clinical chemistry system designed to run only Piccolo test rotors. The instrument interacts with the rotor to move fluid across the sensors and generate quantitative results. Specimens are identified by scanning a barcode or by manually entering the information via the touchscreen. The Piccolo Xpress® chemistry analyzer has slots to accommodate the cartridges discs. The analyzer will determine the configuration of the system by detecting which discs are installed.

The Piccolo® Potassium Test System will be used with previously cleared rotor systems in a clinical laboratory setting or point-of-care location.

The Piccolo® Potassium Test System, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended for the in vitro quantitative determination of potassium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

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

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

Ask a specific question about this device

Dimension Vista® MMB Assay:
The MMB method is an in vitro diagnostic test for the quantitative measurement of mass creatine kinase MB isoenzyme in human serum and plasma on the Dimension Vista® System for confirmation of acute myocardial infarction.

Dimension Vista® 1500 System:
The Siemens Healthcare Diagnostics Dimension Vista® 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista® chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use.

Dimension Vista® MMB Assay:
The MMB method is a homogeneous sandwich chemiluminescent immunoassay based on LOCI® technology. LOC10 reagents include two synthetic bead reagents and a biotinylated antimass creatine kinase MB isoenzvme monoclonal antibody fragment. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. The second bead reagent (Chemibeads) is coated with a second anti-mass creatine kinase MB isoenzyme monoclonal antibody and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a beadmass creatine kinase MB isoenzyme-biotinylated antibody sandwich. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex by light at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the mass creatine kinase MB isoenzyme concentration in the sample.

The Dimension Vista® 1500 System:
The Dimension Vista® 1500 System is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged Flex reagent test cartridges to measure a variety of analytes in human body fluids. The system is a multi-functional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric, turbidimetric, chemiluminescence, nephelometric, and integrated ion selective multisensor detection technologies for clinical use. The Dimension Vista® 1500 System can analyze up to 1500 tests/hour (typical, depending on the method mix) using a variety of analytical detection capabilities. Dimension Vista® 1500 System detection technologies are: Photometric, Turbidimetric, Chemiluminescent, Nephelometric, Multisensor, ion selective technology

The Siemens Healthcare Diagnostics Dimension Vista® MMB Assay is an in vitro diagnostic test for the quantitative measurement of mass creatine kinase MB isoenzyme in human serum and plasma for confirmation of acute myocardial infarction. The K143720 submission describes the modification of the Dimension Vista® 1500 System with a new photomultiplier tube (PMT) and its impact on the MMB assay.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it presents performance characteristics (method comparison, precision, linearity, LoB, LoD, LoQ) for the modified system and implicitly assumes that these demonstrate substantial equivalence to the predicate device. For this response, I will interpret the performance data provided as the "reported device performance" and infer the implied "acceptance criteria" based on the comparison to the existing predicate and typical performance expectations for such devices.

Ask a specific question about this device

The CSAE method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista® system. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.

The Dimension Vista® CSAE Flex® reagent cartridge is a pre-packaged in-vitro diagnostic test method (assay) that is specifically designed to be used on the 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 (K051087). This Special 510(k) is submitted for a packaging modification to the Dimension® Cyclosporine Extended Range (CSAE) Flex® reagent cartridge (K052017), an in-vitro diagnostic device that has 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 modifications also include a change in method parameters (sample size and reagent volume) but the final concentration of sample/reagent ratio in test milieu remains the same.

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

The CSAE method uses an immunoassay technique in which free and CSA bound antibody-enzyme species are separated using magnetic particles. The CSAE Flex® reagent cartridge contains a pretreatment reagent, B-galactosidase-CSA antibody conjugate, CSA immobilized on chromium dioxide particles, chlorophenol red B-dgalactopyranoside (CPRG) substrate, and diluent to hydrate the tablets. To perform the CSAE assay, a sample cup containing the whole blood sample to be analyzed and a CSAE Flex® reagent cartridge are placed appropriately on the Dimension Vista® system. The Dimension Vista® system mixes and lyses the whole blood sample. The lysed sample is then mixed with the antibody conjugate reagent. The CSA present in the sample is bound by the CSA antibody conjugate reagent. Magnetic particles coated with cyclosporine A are added to bind free (unbound) antibody-enzyme conjugate. The reaction mixture is then separated magnetically. Following separation, the supernatant containing the CSA antibody-enzyme complex is transferred to a cuvette and mixed with the substrate. B-galactosidase catalyzes the hydrolysis of CPRG (chlorophenol red B-dgalactopyranoside) to produce CPR (chlorophenol red) that absorbs light maximally at 577mm. The change in absorbance at 577nm due to the formation of CPR is directly proportional to the amount of CSA in the patient's sample and is measured using a bichromatic (577, 700nm) rate technique.

Here's a breakdown of the acceptance criteria and study information for the Dimension Vista® CSAE Flex® reagent cartridge, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document defines acceptance criteria implicitly through the demonstration of "substantial equivalence" to a predicate device. The primary performance metric presented is the method comparison study results.

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

• Sample Size: 116 transplant samples.
• Data Provenance: Not explicitly stated, but the samples were human "transplant samples." No information on country of origin or whether they were retrospective or prospective.

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

• Not Applicable. This study is a method comparison between two in-vitro diagnostic devices, not a study evaluating human interpretation against a ground truth established by experts. The "ground truth" for comparison is the measurement obtained from the predicate device.

4. Adjudication Method for the Test Set

• None. This was a quantitative method comparison study between two instruments. Adjudication is typically used when human interpretation or subjective assessments are involved.

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

• No. This study is a technical comparison of an in-vitro diagnostic assay on a new instrument platform against an established assay on an older platform. It does not involve human readers or assess the effectiveness of AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Yes, in essence. The entire evaluation is a standalone performance assessment of the Dimension Vista® CSAE Flex® reagent cartridge's ability to quantitatively measure Cyclosporine A. There is no human-in-the-loop component for the measurement process itself, as it's an automated in-vitro diagnostic method. The algorithm here refers to the instrument's measurement and calculation process.

7. Type of Ground Truth Used

• Comparison to a Legally Marketed Predicate Device. The "ground truth" for this study is the analytical measurement obtained from the Dimension® CSAE Flex® reagent cartridge (K052017), which is the legally marketed predicate device. The study aims to show that the new device's measurements are substantially equivalent to the predicate.

8. Sample Size for the Training Set

• Not applicable / Not explicitly stated. This document describes a Special 510(k) for a packaging and platform modification, not the development of a novel algorithm that requires a "training set" in the machine learning sense. The assay chemistry and fundamental technology are consistent with the predicate device. If there was any internal development or optimization, the details of a "training set" are not provided in this regulatory summary.

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

• Not applicable. As a Special 510(k) for a modified existing device, there isn't a "training set" in the context of a new algorithm development. The core methodology and reagents are the same as the predicate device, which would have undergone its own qualification and validation studies when it was initially cleared.

Ask a specific question about this device

The HDLC method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension Vista® system. Measurements of HDL-C are used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.

Dimension Vista® HDCL Flex® reagent cartridge is a pre-packaged in-vitro diagnostic test method (assay) that is specifically designed to be used on the Dimension Vista® Integrated system, a floor model, fully automated microprocessor-controlled, integrated instrument system. The reagents contained in the Dimension Vista® Flex® reagent cartridges are the same as those manufactured for the Dimension® clinical chemistry analyzers. The packaging modification does not affect the fundamental scientific technology of the device. The HDLC assay measures serum HDL cholesterol levels directly without the need for sample pretreatment or separation steps, using a two reagent format. In the first reaction, lipoproteins are precipitated with dextran sulfate in the presence of magnesium sulfate. These complexes are resistant to the polyethylene glycol (PEG)-modified cholesterol esterase (CE) and cholesterol oxidase (CO) that react with HDL cholesterol. In the second reaction, in the presence of oxygen, the HDL cholesterol is oxidized to A-4-cholestenone and hydrogen peroxide. The generated hydrogen peroxide then reacts with 4-aminoantipyrine (4-AAP) and N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxyaniline (HSDA) in the presence of peroxidase. The resulting quinoneimine dye is measured using a bichromatic (600/700 nm) technique. The color intensity of the dye is directly proportional to the serum HDL-C concentration.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical targets in a formal table outside of the comparison, but it implies that the performance of the new device (Dimension Vista® HDLC Flex® reagent cartridge - K3408A) must be "substantially equivalent" to the predicate device (Dimension® AHDL Flex® reagent cartridge - K073072). The comparison table below highlights key identical features and performance aspects. The "Conclusion" section explicitly states that "Comparative testing also demonstrates substantially equivalent performance."

Table of Acceptance Criteria (Implied Equivalence) and Reported Device Performance:

Note on Differences (Not Acceptance Criteria but Design Changes):

• Reagents Cartridge: Predicate uses 6-well plastic Flex® cartridges; New device uses 12-well plastic Flex® cartridges.
• Total Tests per Cartridge: Predicate provides 30 tests; New device provides 120 tests.
• Sample Size: Predicate uses 3 µL; New device uses 1.3 µL.

Study Information:

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence rather than a detailed clinical trial report. As such, specific study details are limited.

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

   • The document states "Comparative testing also demonstrates substantially equivalent performance." However, it does not explicitly state the sample size used for this comparative testing or the data provenance (e.g., country of origin, retrospective/prospective).
   • Given the nature of an in-vitro diagnostic device for cholesterol measurement, it would typically involve human serum/plasma samples, but the specifics are not provided.

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

   • Not applicable/Not mentioned. For this type of in-vitro diagnostic device, ground truth is typically established through a reference method or comparison to a predicate device's established performance, rather than expert interpretation of results. The device and its predicate were "Evaluated by and met the certification criteria of the Cholesterol Reference Method Laboratory Network (CRMLN)," which implies adherence to a highly standardized and validated reference method for ground truth.

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

   • Not applicable/Not mentioned. Adjudication methods are typically used in imaging or clinical interpretation studies where there is subjective assessment. This is an IVD device measuring a quantitative analyte.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is an in-vitro diagnostic device for quantitative measurement of High-Density Lipoprotein Cholesterol (HDL-C), not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.

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

   • Yes, implicitly. The device itself is an automated assay system (Dimension Vista® Integrated system) designed for quantitative measurement. Its performance, as demonstrated by "comparative testing," refers to the algorithm's ability to accurately measure HDL-C concentrations on the new system compared to the predicate, in a standalone fashion without human intervention in the measurement process itself. Human involvement would be in operating the instrument and interpreting the numerical results, not in the direct measurement by the device.

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

   • The ground truth is established through adherence to the Cholesterol Reference Method Laboratory Network (CRMLN) certification criteria. This indicates that the device's measurements are traceable to a highly accurate and standardized reference method for cholesterol, which serves as the "gold standard" for quantitative cholesterol measurement.

7. The sample size for the training set:

   • Not applicable/Not mentioned. This device is not an AI/machine learning device that requires a separate "training set" in the conventional sense. It's a new formulation/packaging of an existing chemical reagent for a known analytical method. The development would involve analytical validation rather than machine learning training.

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

   • Not applicable. As noted above, there's no "training set" in the context of machine learning. The analytical performance (accuracy, precision) is validated against established reference methods (CRMLN).

Ask a specific question about this device

The IGG method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G in human serum, heparinized plasma and cerebrospinal fluid (CSF) on the Dimension Vista® System. Measurements of IgG aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista System for: a1-Acid Glycoprotein (A1AG), a1-Antitrypsin (A1AT), B2-Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG) [serum/plasma] and Immunoglobulin G (IGG-C) [cerebrospinal fluid], Immunoglobulin G Subclass 1 (IGG1), Immunoglobulin G Subclass 2 (IGG2), Immunoglobulin G Subclass 3 (IGG3), Immunoglobulin G Subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), soluble Transferrin Receptor (STFR), Transferrin (TRF).

PROT3 CON is an assayed, low level intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the determination of a1-Microglobulin (A1MIC), specialty Albumin (sALB), Immunoglobulin G (IGG -C) and Microalbumin (MALB). * For Cerebrospinal fluid (CSF)

Dimension Vista® System Immunoglobulin G Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista® System Protein 1 Calibrator: PROT1 CAL is a multi-analyte, liquid human serum based product containing: α₁-Acid Glycoprotein, α₁-Antitrypsin, β₂-Microglobulin, C3 Complement, C4 Complement, Ceruloplasmin, Haptoglobin, Hemopexin, Homocysteine, Immunoglobulin A, Immunoglobulin E, Immunoglobulin G, Immunoglobulin G Subclass 1, Immunoglobulin G Subclass 2, Immunoglobulin G Subclass 3, Immunoglobulin G Subclass 4, Immunoglobulin M, Prealbumin, Retinol Binding Protein, soluble Transferrin Receptor, Transferrin.

Dimension Vista® System Protein 3 Control: PROT3 CON is a multi-analyte, lyophilized, polygeline and rabbit albumin based product containing: a -Microglobulin, Immunoglobulin G, Albumin.

The provided text is a 510(k) summary for the Dimension Vista® System Immunoglobulin G Flex® Reagent Cartridge, Dimension Vista® System Protein 1 Calibrator, and Dimension Vista® System Protein 3 Control. This document primarily focuses on demonstrating substantial equivalence to previously cleared devices for adding Cerebrospinal Fluid (CSF) as a sample matrix for IgG measurement. It does not contain specific acceptance criteria, performance data, or details of a comprehensive study as typically requested for AI/ML device evaluations.

Therefore, many of the requested items (sample size, data provenance, expert qualifications, adjudication methods, MRMC study, training set details) are not applicable or not available in this type of submission. This 510(k) is for an in-vitro diagnostic (IVD) test, which typically has different evaluation criteria and reporting compared to AI/ML devices for image analysis or other diagnostic tasks involving human readers.

However, I can extract the information that is present and indicate where information is missing based on the context of the document.

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

The document does not explicitly state acceptance criteria in a quantitative table format or report performance against such criteria. Instead, it states that "The studies included in this submission demonstrate correlation to and equivalent performance between the predicate N Antisera to Human IGG for CSF sample matrix." This implies that the performance (likely accuracy, precision, and linearity for CSF samples) was deemed equivalent to the predicate, but the specific numerical values for performance or acceptance criteria are not provided.

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

This information is not provided in the 510(k) summary. Given the nature of a 510(k) summary for an IVD test, such detailed study design specifics are often contained in the full 510(k) submission and not in the public summary.

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 information is not applicable for this type of IVD device. The "ground truth" for a quantitative IVD test like this would typically involve reference methods, calibrator values, and quality control materials, not expert consensus on interpretations.

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

This information is not applicable for this type of IVD device. Adjudication methods are typically used in studies involving human readers or AI output where there can be discretionary interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable for this type of IVD device. This is a laboratory diagnostic test for quantitative measurement of a marker, not an AI-assisted diagnostic tool for human readers interpreting images or complex data.

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

This information is not applicable in the context of an AI/ML algorithm. This device is an automated IVD test system. Its standalone performance is inherent to its function, but it's not an "algorithm only" in the way an AI model is, as it relies on reagent chemistry and instrument mechanics. The summary implies "standalone" performance was demonstrated through "correlation" and "equivalent performance" studies against a predicate device.

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

For a quantitative diagnostic assay of Immunoglobulin G in CSF, the ground truth would be established by:

• Reference methods: Highly accurate and precise laboratory methods (e.g., nephelometry, turbidimetry, or potentially a gold standard method if available) used to determine true concentrations in samples.
• Calibrators: Materials with known, assigned concentrations of the analyte (IgG) used to establish the measurement curve of the assay. The Dimension Vista® System Protein 1 Calibrator is mentioned for this purpose.
• Quality Control materials: Materials with known, assigned ranges of analyte concentration used to monitor the assay's performance and ensure accuracy and precision. The Dimension Vista® System Protein 3 Control is mentioned for this purpose.

The summary itself does not detail how the ground truth for the specific 'studies' was established, but these are the general principles for such assays.

8. The sample size for the training set

This information is not applicable for this type of IVD device. The Dimension Vista® system and its reagents are based on established immunochemical principles (light scattering) and are calibrated, not "trained" in the machine learning sense. There is no training set in the context of AI/ML.

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

This information is not applicable for this type of IVD device, as there is no "training set" in the AI/ML sense. Calibration is performed using materials with established concentrations (as outlined in point 7).

Ask a specific question about this device

The DRUG 1 CAL is an in vitro diagnostic product for the calibration of Digoxin (DIG), Lithium (LI), Phenobarbital (PHNO), Phenytoin (PTN) and Theophylline (THEO) methods on the Dimension Vista™ System.

DRUG 1 CAL is a liquid, multi-analyte, human serum based product containing digoxin, lithium, phenobarbital, phenytoin, and theophylline. 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). This same product, the Dimension VistaTM System Drug 1 Calibrator (KC410), was previously cleared (K051087) for the calibration of the Phenobarbital (PHNO) method on the Dimension Vista™ System. The calibrator formulation has not changed. However, additional analytes are being assigned values and included in the intended use. The volume in the vials has also changed from 2.0 mL to 2.5 mL and the claim for punctured vial shelf life is reduced to one day.

This document describes the Dimension Vista™ System Drug 1 Calibrator (DRUG 1 CAL - KC410), which is an in vitro diagnostic product used for the calibration of Digoxin, Lithium, Phenobarbital, Phenytoin, and Theophylline methods on the Dimension Vista System. The information provided focuses on the performance characteristics, particularly stability and traceability, rather than a clinical study involving human patients or complex AI algorithms. Therefore, some of the requested information types (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance for an algorithm, training set details) are not directly applicable to this type of device and study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The main performance characteristic discussed is shelf-life stability.

Additional Stability Claims:

• Target Shelf Life: 12 months (determined by real-time data on file at Dade Behring, Inc.)
• Punctured Vial (on instrument): 1 day
• Open Vial (recapped, refrigerated): 31 days

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

• Test Set (for stability testing): The document states that for stability testing, "The method is calibrated from this stored material. The 4°C material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined."
  • For the main shelf-life study, specific sample sizes (e.g., number of calibrator vials or measurements) are not explicitly stated in the provided text. However, for the bottle value assignment, it mentions "N = 45 replicates per level" for verifying the final assigned values of a commercial lot. This is for manufacturing quality control rather than a clinical test set.
• Data Provenance: The studies are internal performance evaluations conducted by Dade Behring Inc. for regulatory submission. Details on country of origin are not specified, but it's an industry setting. It is a prospective study in the sense that they are testing the stability of newly manufactured calibrator lots over time.

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

This section is not applicable. For a calibrator, the "ground truth" for the analyte concentrations is established through traceability to recognized standards and gravimetric preparation, not through expert interpretation in the way it would be for a diagnostic image or clinical case.

4. Adjudication Method for the Test Set

This section is not applicable as there is no expert adjudication process for calibrator stability and value assignment. The assessment is based on quantitative measurements against pre-defined criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The device is a calibrator, not an AI-powered diagnostic device, and therefore, an MRMC study and AI performance metrics are not relevant.

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

This section is not applicable, as this is a calibrator (a consumable chemical reagent) and not an algorithm or software.

7. The Type of Ground Truth Used

The ground truth for the calibrator values is established through traceability to reference materials and gravimetric preparation:

• Analyte Source: Digoxin, Phenobarbital, Phenytoin, Theophylline are traced to USP (United States Pharmacopeia) reference materials. Lithium is traced to NIST SRM (National Institute of Standards and Technology Standard Reference Material) 924.
• Master Pool and Stock Solution Preparation: Made by "weighing in" or "adding reference materials gravimetrically" to drug-free normal human serum.
• Verification: Master Pool values are compared against "previously approved Master Pool values," and stock solution values are verified against "previously approved Master Pool values."

8. The Sample Size for the Training Set

This section is not applicable. This device is a calibrator, not a machine learning model, so there is no "training set" in the context of AI or algorithm development. The manufacturing process involves controls and verification, which is distinct from training an algorithm.

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

This section is not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The AMON method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension Vista™ System.

The Dimension Vista™ Ammonia (AMON) Flex® reagent cartridge is an in vitro device intended to measure ammonia levels in plasma. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Dade 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 (K051087). This Special 510(k) is submitted for a packaging modification to the Dimension® Ammonia (AMON) Flex® reagent cartridge (K863840), an in-vitro diagnostic device that has been cleared under the 510(k) process. The packaging change is to allow use on the Dimension Vista™ system.

The reagents contained in the Dimension Vista™ Ammonia (AMON) Flex® reagent cartridges are the same as those contained in the Ammonia (AMON) 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 device, nor does it alter the fundamental scientific technology of the device.

The provided text is a 510(k) summary for a medical device (Dimension Vista™ Ammonia (AMON) Flex® reagent cartridge). It focuses on establishing substantial equivalence to a predicate device, rather than presenting a standalone study with detailed acceptance criteria and performance data for a new device.

Therefore, much of the requested information cannot be found in the provided text. The document is about a packaging change for an already cleared device, allowing it to be used on a new instrument system. The "study" mentioned is comparative testing to demonstrate substantially equivalent performance to the predicate device.

However, I can extract what is available:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative sense for performance as it's a submission for a packaging change and not a new diagnostic algorithm. The primary "criterion" for this submission is substantial equivalence to the predicate device.

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

• Sample size: Not specified in the provided text. The document mentions "comparative testing described in the protocol included in this submission," but the protocol details (including sample size) are not part of this summary.
• Data provenance: Not specified (e.g., country of origin of data, retrospective or prospective).

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

This information is not applicable and not provided in the context of this 510(k) submission. This submission is for an in vitro diagnostic device (a reagent cartridge), whose "ground truth" would typically refer to the accuracy of its measurement capability against known standards or reference methods. The evaluation here is for chemical measurement performance, not expert-interpreted images or clinical decisions.

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

This information is not applicable and not provided. Adjudication methods like 2+1 are typically used for expert consensus in image interpretation or clinical outcomes, which is not the nature of this device's evaluation.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable as the device is an in vitro diagnostic reagent cartridge for chemical analysis, 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 is not applicable. The device itself is the "algorithm" (the chemical assay). The performance is inherent to the assay and the instrument system it runs on. The "standalone" performance is its ability to accurately measure ammonia levels. The document states "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance" regarding this, but the specific performance metrics (e.g., accuracy, precision) are not detailed in the summary.

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

The "ground truth" for an in vitro diagnostic for ammonia levels would typically be:

• Reference methods for ammonia measurement.
• Known concentration standards.
• Correlation with clinically relevant ammonia levels in patient samples, often compared to an existing, cleared diagnostic device (the predicate).

While not explicitly stated as "ground truth," the comparison to the Dimension® AMON Flex® reagent cartridge (K863840) serves as the primary reference point (predicate device) for establishing equivalent performance.

8. The sample size for the training set:

This is not applicable as this is not an AI/machine learning device with a training set.

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

This is not applicable as this is not an AI/machine learning device with a training set.

Ask a specific question about this device

The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (URCA) methods on the Dimension VistaTM System

CHEM 1 CAL is a liquid, multi-analyte, bovine serum albumin based product containing calcium, cholesterol, creatinine, glucose, lactic acid, magnesium, thyroxine, urea nitrogen and uric acid. 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.

The provided document includes a section on "Performance Characteristics" specifically addressing the stability of the Dimension Vista™ System Chemistry 1 Calibrator. This section details the acceptance criteria for shelf-life stability and reports on how the device meets these criteria through a specific study design.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document also specifies acceptance criteria for on-board and open-vial stability:

• On-board stability: One day.
• Open vial (recapped and refrigerated): 30 days.

The reported performance for these is implied by the statement "A vial punctured by the instrument and stored on board has a stability claim of one day" and "An open vial not on instrument, but recapped and stored in a refrigerator has a stability claim of 30 days." This suggests that testing was conducted and demonstrated compliance with these claims.

Study Proving Device Meets Acceptance Criteria:

The study described is a shelf-life stability study for the Dimension Vista™ Chemistry 1 Calibrator.

• Study Design/Methodology:
  • Objective: To determine the target shelf life (12 months) of the calibrator and validate its stability under various conditions (long-term storage, on-board, and open-vial).
  • Long-Term Shelf Life: Results of the product stored at 4°C are compared with a control stored at -20°C. The method is calibrated using the -20°C stored material, and the 4°C material values are recovered against this calibration. The percent change over time is monitored against the allowable shelf-life percent change criteria for each analyte. "Real-time data on file at Dade Behring, Inc." is used for the final shelf-life assignment.
  • On-Board and Open-Vial Stability: Vials are opened/punctured on day zero. A sufficient quantity for multiple calibrations is removed. The vials are then recapped and stored at 2-8°C. These opened/punctured vials are tested on days 0, 8 hours, 2, 8, and 31, and their performance is compared against freshly opened vials.

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

• Test Set Sample Size: The document does not explicitly state the total number of individual calibrator vials or batches used in the stability studies. For bottle value assignment, it mentions "N = 45 replicates" tested using multiple instruments. This refers to the assignment of final values to commercial lots, which is a part of quality control and verification, but not necessarily the sample size for the long-term stability testing itself. The sample size for the stability portion is not precisely quantified in the provided text, but it implies a longitudinal study over time.
• Data Provenance: The document does not specify the country of origin of the data. The study is prospective in nature, as it involves monitoring the performance of the calibrator over time under controlled storage conditions to establish shelf life and stability claims.

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

This information is Not Applicable in this context. The device is a calibrator, and its performance (stability and value assignment) is assessed against analytical standards and reference materials (traceability to NIST SRMs, USP, CDC Abell-Kendall method), rather than expert interpretation of results on patient samples.

4. Adjudication Method for the Test Set

This information is Not Applicable. As the ground truth is based on analytical standards and reference methods, there is no need for expert adjudication.

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

This information is Not Applicable. No MRMC study was done, as this is a calibrator for an in vitro diagnostic chemistry system, not an imaging or diagnostic algorithm requiring human reader interpretation or comparison.

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

This information is Not Applicable in the typical sense of an "algorithm." The calibrator itself is a physical product. Its performance is evaluated through a standalone stability study, where the calibrator's values are measured by instruments and compared against established analytical criteria, without human intervention in the result generation itself beyond the operation of the instrument and data analysis.

7. Type of Ground Truth Used

The ground truth for the performance (stability and value assignment) of the calibrator is based on:

• Analytical Standards and Reference Materials: Traceability to various certified reference materials such as:
  • NIST SRM (National Institute of Standards and Technology - Standard Reference Material) for BUN, CA, CREA, GLU, MG, URCA, CHOL.
  • CDC (Centers for Disease Control) Abell-Kendall reference method for CHOL.
  • Lactic acid – lithium salt A-Grade for LA.
  • USP (United States Pharmacopeia) for T4.
• Calculated Value: For TU.
• Previously Approved Master Pool/Standard Values: Used for verification of Master Pool/Standard values and stock solution values.

8. Sample Size for the Training Set

This information is Not Applicable. This product is a calibrator, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for the calibrator is its manufacturing process to meet specific constituent concentrations, verified against reference materials.

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

This information is Not Applicable. As above, there is no "training set." The "ground truth" for the calibrator's composition and assigned values is established through gravimetric additions of reference materials to stock solutions and base matrices, followed by verification against primary standard materials, Master Pools, and previously approved Master Pool/Standard values, all traceable to the analytical standards listed in point 7. The final bottle values are assigned and verified by testing 45 replicates on multiple instruments against these established standards.

Ask a specific question about this device

The CSA method is an in vitro diagnostic test for the quantitative measurement of Cyclosporine A (CSA) in human whole blood on the Dimension Vista™ System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.
The Dimension Vista™ Cyclosporine (CSA) Flex® reagent cartridge is an in vitro device intended to quantitatively determine cyclosporine concentrations in human whole blood. Measurements of CSA are used as an aid in the management of heart, liver, and kidney transplant patients receiving therapy with this drug.

Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Dade 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 (K051087). This Special 510(k) is submitted for a packaging modification to the Dimension® Cyclosporine (CSA) Flex® reagent cartridge (K023065), an in-vitro diagnostic device that has been cleared under the 510(k) process. The packaging change is to allow use on the Dimension Vista™ system. The reagents contained in the Dimension Vista™ CSA Flex® reagent cartridges are the same as those contained in the CSA 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 device, nor does it alter the fundamental scientific technology of the device.

The provided text describes a 510(k) Special submission for a packaging modification of a device, the Dimension Vista™ Cyclosporine (CSA) Flex® reagent cartridge. This submission is primarily about demonstrating that the modified device (for use on the Dimension Vista™ system) is substantially equivalent to an existing predicate device (the Dimension® Cyclosporine (CSA) Flex® reagent cartridge, K023065).

The information provided focuses on the comparison between the new device and the predicate device, rather than a detailed study proving the new device's performance against specific acceptance criteria. The core of the submission is that the reagents and fundamental scientific technology are the same, and the packaging change does not affect its intended use.

Therefore, the study supporting this submission is not a typical clinical trial with detailed performance metrics against a defined ground truth, but rather a comparative study demonstrating substantial equivalence based on the device's characteristics and functionality.

Here's an analysis based on the provided text, addressing your questions where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria in this context are not explicitly stated as numerical performance targets (e.g., specific sensitivity/specificity values). Instead, the acceptance is based on demonstrating substantial equivalence to the predicate device. This means showing that the new device performs comparably to the predicate device and that any differences do not raise new questions of safety or effectiveness.

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

The document does not explicitly state the sample size used for any specific testing to demonstrate substantial equivalence, nor does it specify data provenance (country of origin, retrospective/prospective). Given that this is a Special 510(k) for a packaging modification with the same reagents, the focus would likely be on analytical performance aspects (e.g., precision, accuracy using control materials or spiked samples) rather than a large-scale clinical study with patient samples. The only stated change with a potential impact on sample requirements is the "Sample Size" of 1.9 µL for the new device vs. 5 µL for the predicate. This would require validation that the reduced sample volume does not compromise performance.

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

Not applicable for this type of submission. The ground truth for in vitro diagnostic devices like this is typically established by reference methods or validated control materials, not expert consensus in the way a diagnostic imaging device might use radiologists.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the validation focuses on analytical performance characteristics of the assay rather than a subjective interpretation needing expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro diagnostic reagent cartridge; it does not involve human readers or AI in the context of interpretation of medical images or other clinical data.

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

The device itself is a standalone assay system once integrated onto the Dimension Vista™ analyzer. Performance is measured by the accuracy and precision of the quantitative cyclosporine measurement. The "study" mentioned here is the comparison to the predicate device to demonstrate substantial equivalence, which would involve assessing the quantitative output of the device.

7. The Type of Ground Truth Used

The ground truth for this type of in vitro diagnostic quantitative assay would typically be established using:

• Reference materials/calibrators: Materials with a known, accurately assigned concentration of cyclosporine.
• Split samples: Comparing results from the new device with results from the predicate device (or another validated method) on the same patient samples.
• Spiked samples: Samples (e.g., whole blood matrix) to which a known amount of cyclosporine has been added, allowing for recovery studies.

The document does not specify the exact type of ground truth used, but these are standard practices for IVD validation.

8. The Sample Size for the Training Set

Not applicable. This device is a reagent cartridge for a quantitative assay; it does not employ machine learning or AI models that require a "training set" in the conventional sense. Its performance is based on the chemical reactions and optical measurement principles of the assay.

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

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

Ask a specific question about this device

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

The HAIC assay used on the Dimension Vista™ integrated system is an in-vitro diagnostic assay for the quantitative determination of percent hemoglobin A1c(HbA1c) in anticoagulated whole blood. Measurements of percent hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.

The AMPH Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of amphetamines in human urine using a cutoff of either 300, 500, or 1000 ng/mL. Measurements obtained with the AMPH method are used in the diagnosis and treatment of amphetamines use or overdose. The AMPH method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The BARB Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of barbiturates in human urine. Measurements obtained with the BARB method are used in the diagnosis and treatment of barbiturates use or overdose. The BARB method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The BENZ Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of benzodiazepines in human urine. Measurements obtained with the BENZ method are used in the diagnosis and treatment of benzodiazepines use or overdose. The BENZ method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The COC Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of benzoylecgonine (cocaine metabolite) in human urine using a cutoff of 150 or 300 ng/mL. Measurements obtained with the COC method are used in the diagnosis and treatment of cocaine use or overdose. The COC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The EXTC Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of methylenedioxymethamine (MDMA), and closely related drugs in human urine using a cutoff of either 300 or 500 ng/mL. Measurements obtained with the EXTC method are used in the diagnosis and treatment of ecstasy use or overdose. The EXTC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The METH Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of methadone in human urine. Measurements obtained with the METH method are used to detect methadone use or overdose and to determine compliance with methadone maintenance treatment. The METH method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The OPI Flex® reagent cartridge (300 ng/mL cutoff) used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semi-quantitative determination of opiates in human urine. Measurements obtained with the OPI method are used in the diagnosis and treatment of opiates use or overdose. The OPI method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The PCP Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of phencyclidine in human urine. Measurements obtained with the PCP method are used in the diagnosis and treatment of phencyclidine use or overdose. The PCP method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The THC Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of cannabinoids in human urine. Measurements obtained with the THC method are used in the diagnosis and treatment of cannabinoids use or overdose. The THC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Dade Behring Dimension Vista™ Flex® reagent cartridges and the HA1C kit are prepackaged Dade Behring products that are specifically designed to be used on the Dade 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 (K051087). 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 calibrator included in the Dimension Vista™ HAIC kit is the same product (unchanged) as that used in the Dimension® HA1C Kit. The packaging modification, does not affect the intended use of the devices. nor does it alter the fundamental scientific technology of the devices.

Please find the requested information regarding the acceptance criteria and study details below.

1. Table of Acceptance Criteria and the Reported Device Performance

The provided document describes a 510(k) submission for new reagent cartridges and a kit for the Dimension Vista™ system, which are essentially packaging modifications of existing, previously cleared devices for use on a new analyzer system. The core scientific technology and reagents remain the same.

The document mainly focuses on demonstrating substantial equivalence to predicate devices rather than establishing new performance criteria. Therefore, the "acceptance criteria" are implied to be performance comparable to the predicate devices, and the "reported device performance" is framed in terms of achieving this equivalence.

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

The document states, "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for these comparative tests.

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

This information is not provided in the document. As this is an in-vitro diagnostic device for quantitative and qualitative measurements, the "ground truth" would likely be established through reference methods (e.g., GC/MS for drug screens, or an established method for CKMB and HbA1c) rather than expert consensus on images or clinical cases.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided in the document. Given the nature of these in-vitro diagnostic tests, adjudication methods like 2+1 or 3+1, which are common in image interpretation or clinical expert review, are not applicable. Instead, the performance would be compared against a reference method or predicate device.

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

No MRMC comparative effectiveness study was done, nor is it applicable to this submission. The device involves in-vitro diagnostic reagent cartridges for automated analyzer systems, not an AI-assisted interpretation or diagnostic tool for human readers.

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

Yes, this describes a standalone performance evaluation in the context of an in-vitro diagnostic device. The Dimension Vista™ system is described as a "floor model, fully automated, microprocessor-controlled, integrated instrument system." The reagents are designed for use on this automated system. The comparative testing would confirm the analytical performance of the reagents on the new system, without human interpretation of the raw data beyond standard laboratory procedures.

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

For the drug screens (Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Ecstasy, Methadone, Opiates, Phencyclidine, Cannabinoids), the "Indications For Use" sections explicitly state: "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method." This indicates that GC/MS is the ground truth or gold standard against which the screening tests are compared.

For Creatine Kinase MB Isoenzyme (CKMB) and Hemoglobin A1c (HA1C), while not explicitly stated as GC/MS, the "ground truth" would be established by comparison to accepted reference methods or the performance of the predicate devices themselves, as the submission aims to demonstrate substantial equivalence to these existing methods.

8. The Sample Size for the Training Set

The document is a 510(k) submission for modifications to existing products for use on a new instrument system. It focuses on comparative testing to establish substantial equivalence. It does not describe a "training set" in the context of machine learning or algorithm development. The reagents and their fundamental scientific technology are stated to be unchanged from previously cleared devices.

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

As noted in point 8, there is no mention of a "training set" in the context of algorithm development or machine learning in this document. The device's underlying technology is based on established biochemical assays, not a learnable algorithm requiring a training set.

Ask a specific question about this device