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510(k) Data Aggregation
(10 days)
|---------------------------------------------------|-------------------------------------------|
| 862.3300
cartridge | Dimension® DGTX
Flex® reagent
cartridge | K990251 | II | 862.3300
| Dimension Vista™ Theophylline (THEO) Flex® reagent cartridge | |
| Regulation Number: | 21 CFR§862.3300
The DGTX method is an in vitro diagnostic test for the quantitative measurement of digitoxin in serum and plasma on the Dimension Vista™ System. Measurements of digitoxin are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.
The DIG method is an in vitro diagnostic test for the quantitative measurement of digoxin in serum and plasma on the Dimension Vista™ System. Measurements of digoxin are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.
The GENT method is an in vitro diagnostic test for the quantitative measurement of gentamicin, an aminoglycoside antibiotic, in human serum and plasma on the Dimension Vista™ System. Gentamicin measurements may be used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
The NAPA method is an in vitro diagnostic test for the quantitative measurement of N-acetylprocainamide in serum and plasma on the Dimension Vista™ System. N-acetylprocainamide measurements may be used in therapeutic drug monitoring to maintain adequate procainamide therapy.
The PTN method is an in vitro diagnostic test for the quantitative measurement of phenytoin, (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma on the Dimension Vista™ System. Phenytoin measurements may be used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.
The THEO method is an in vitro diagnostic test for the quantitative measurement of theophylline in human serum and plasma on the Dimension Vista™ System.
Dade Behring Dimension VistaTM 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 VistaTM system was previously cleared with seven associated test methods (K 051087). This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system.
The reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the devices.
The provided text describes a 510(k) submission for several Dimension Vista™ Flex® reagent cartridges intended for diagnostic testing. The core of the submission is to demonstrate substantial equivalence to previously cleared predicate devices, primarily focusing on a packaging modification that allows these reagents to be used on the Dimension Vista™ integrated system. The reagents themselves and their fundamental scientific technology are stated to be the same as the predicate devices.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical "acceptance criteria" or provide a table of "reported device performance" in the typical sense of a clinical study (e.g., sensitivity, specificity, accuracy against a gold standard). Instead, the demonstration of performance relies on comparative testing to show substantial equivalence to the predicate devices. The implicit acceptance criterion is that the performance of the new Dimension Vista™ Flex® reagent cartridges must be substantially equivalent to that of the predicate Dimension® Flex® reagent cartridges.
The text states: "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance." and "Comparative testing also demonstrates substantially equivalent performance."
Since the document is a summary and not the full study protocol, specific performance metrics and their comparison values are not detailed. However, the nature of these in-vitro diagnostic tests typically involves:
- Precision/Reproducibility: Measuring the consistency of results when the same sample is tested multiple times.
- Accuracy/Method Comparison: Comparing the results obtained by the new device against a reference method (in this case, the predicate device results) using patient samples. This often involves statistical methods like regression analysis (e.g., Deming regression) to assess agreement.
- Linearity/Measuring Range: Confirming that the device accurately measures analytes across its claimed analytical range.
- Interference Studies: Assessing the impact of common interfering substances (e.g., hemoglobin, bilirubin, lipids) on the test results.
The key takeaway is that the "acceptance criteria" here are defined by the established performance characteristics of the predicate devices, and the new devices are deemed acceptable if their performance is statistially similar.
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance." However, it does not specify the sample size used for the comparative testing (test set) or the data provenance (e.g., country of origin, retrospective or prospective nature of the samples).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable in the context of this 510(k) submission. For in-vitro diagnostic (IVD) devices measuring specific analytes, the "ground truth" is typically the quantitative concentration of the analyte as determined by a reference method or the predicate device itself, not by expert consensus on qualitative interpretation. No human experts are described as establishing ground truth for the test set.
4. Adjudication Method for the Test Set:
This information is not applicable. Since the submission concerns quantitative measurements of chemical analytes, there is no need for an adjudication method as would be relevant for subjective medical image interpretation or clinical decision-making.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance:
This information is not applicable. The device is an in-vitro diagnostic reagent cartridge for laboratory analysis, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
The entire "device" described here (the reagent cartridges used on an automated analyzer) operates in a standalone (algorithm/system only) manner in terms of its measurement process. The Dimension Vista™ system is described as a "floor model, fully automated, microprocessor-controlled, integrated instrument system." The reagents enable this automated system to perform the quantitative measurements without direct human intervention in the measurement execution. Human involvement is in sample preparation, loading, and interpretation of the numerical results delivered by the automated system.
7. The Type of Ground Truth Used:
The ground truth for the performed comparative testing would have been the quantitative concentration of the specific analyte (Digitoxin, Digoxin, Gentamicin, N-acetylprocainamide, Phenytoin, Theophylline) as measured by the predicate device. Since the reagents themselves are stated to be the same as the predicate and only the packaging is modified for a new instrument system, the primary ground truth is established by the well-characterized performance of the predicate device on its intended system for each analyte.
8. The Sample Size for the Training Set:
This document does not mention a "training set" in the context of an algorithm or machine learning model. This is expected as the device is a reagent cartridge for a chemical assay, not a machine learning-based diagnostic. Therefore, information about the training set size is not applicable.
9. How the Ground Truth for the Training Set Was Established:
As there is no "training set" in the machine learning sense, this information is not applicable. The "training" of such a system involves the development and optimization of the chemical assay reagents and the instrument's detection capabilities during the initial development phases of the predicate devices and the Dimension Vista™ analyzer itself.
Ask a specific question about this device
(189 days)
Antrim United Kingdom, BT29 4QY
K012112 Re: Trade/Device Name: Digitoxin Regulation Number: 21 CFR 862.3300
Randox Laboratories Ltd. Digitoxin Test Kit is an in vitro diagnostic immunoassay for the quantitative determination of digitoxin in serum. Measurements obtained by this device are used in the diagnosis and treatment of digitoxin in the serum and in monitoring levels of digitoxin to ensure appropriate therapeutic levels.
The method includes a suspension of measuring particles coated with digitoxin conjugate. When a sample containing digitoxin is added, the digitoxin in the sample competes with the digitoxin conjugate on the particles for the limited amount of antibody in the reagent. The respective amounts of antibody bound to the digitoxin in the sample and to the digitoxin conjugate on the particles are inversely dependent on the concentration of digitoxin in the sample. The amount of antibody bound to the particles is measured by the agglutination process. When the antibody binds to the particles, agglutination occurs. When digitoxin is present in the sample, partial inhibition of the agglutination process occurs. The degree of agglutination is measured as a change in scattered light as a change in absorbance, proportional to the concentration of digitoxin in the sample.
The provided text is a 510(k) premarket notification letter from the FDA to Randox Laboratories, Ltd. regarding their Digitoxin test system. While it indicates that the device has been found substantially equivalent to a legally marketed predicate device, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. This document is a regulatory approval, not a scientific study report.
Ask a specific question about this device
(57 days)
Kinetic interaction of
microparticles in solution method | DKQ | 862.3300
COBAS INTEGRA Ammonia (NH3): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the ammonia concentration in plasma (test NH3, 0-045).
COBAS INTEGRA aAmylase EPS (AMYLL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of amylase in serum, plasma (test AMY-L, 0998) and urine (test AMY-UL 0-999).
COBAS INTEGRA Cholesterol (CHOLL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of total cholesterol (test CHOLL, 0-001) and HDL cholesterol concentration in serum and plasma in clinical laboratories.
COBAS INTEGRA HDL Cholesterol Application (HDLL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of total cholesterol and HDL - cholesterol (test HDLL, 0-002) concentration in serum and plasma in clinical laboratories.
COBAS INTEGRA Creatinine Enzymatic (CREAE): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the creatinine concentration in serum (test CREAE, 0-014), and urine (test CREEU, 0-114).
COBAS INTEGRA Digitoxin (DIGIT): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of digitoxin in serum or heparinized plasma (test DIGIT 0-259).
COBAS INTEGRA Gamma Glutamyltransferase (GGTL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of GGT, (EC 2.3.2.2; y-glutamyl peptide: amino acid y-glutamyltransferase) in serum and plasma (test GGTL, 0-599).
COBAS INTEGRA Glucose HK Liquid (GLUCL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the glucose concentration in serum, plasma (test GLUL, 0-991), urine (test GLULU, 0-992), and cerebrospinal fluid (test GLULC, 0-993).
COBAS INTEGRA Lipase (LIPL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of lipase in serum and plasma (test LIPL, 0-200).
COBAS INTEGRA Lysergic acid diethylamide (LSD) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the qualitative determination of lysergic acid diethylamide (LSD) in urine (test LSD, 0-001)
COBAS INTEGRA Urea/BUN (UREAL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the urea/BUN (blood urea nitrogen), in serum, plasma (test UREL, 0-003) and urine (test URELU, 0-004).
Roche TDM OnLine Digitoxin Calibrators: are intended for use with the Roche reagents for Digitoxin and the COBAS Chemistry systems for the quantitative determination of digitoxin in serum and plasma.
Roche TDM OnLine Digitoxin Controls: are quality control samples intended for use on COBAS chemistry systems with Roche reagents and calibrators for the quantitative determination of digitoxin assays.
The COBAS INTEGRA test applications contained in this submission are intended for use with the COBAS INTEGRA Analyzer. The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Analyzer utilizes three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The analyzer has a throughput of up to 600 tests per hour with STAT samples prioritized and tested immediately. Random sample access, robotics and a user interface optimize time management and streamline workflow. The COBAS INTEGRA can store up to 68 COBAS INTEGRA Reagent Cassettes on board, 24 hours a day at 2-8℃. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Barcode readers are used to identify newly loaded reagent cassettes, samples for patient identification, and rack inserts and to read calibration and control data from the cassette label. COBAS INTEGRA tests include chemistry, drugs of abuse, immunology, ion selective electrodes, therapeutic drug monitoring, and hematology reagents. Through this submission, it is the intention of Roche Diagnostic Systems to gain clearance for an additional 4 COBAS INTEGRA Reagent Cassettes and 2 ancillary reagents as well as modifications to 7 previously cleared COBAS INTEGRA Reagent Cassettes. These reagents have been modified from granulate to liquid form.
The provided 510(k) summary (K972250) describes the acceptance criteria and study results for several Roche COBAS INTEGRA Reagent Cassettes and ancillary reagents. The studies are primarily focused on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria against a fixed clinical standard. Consequently, the "acceptance criteria" are implied by the results of the comparative studies to be within acceptable analytical performance limits for equivalent devices.
Here's a breakdown of the requested information for each reagent, based on the provided text:
Roche COBAS® INTEGRA Reagent Cassettes & Ancillary Reagents (K972250)
The acceptance criteria are generally implied by the strong correlation and similar performance characteristics (assay range, precision, sensitivity, accuracy/linearity) when compared to the legally marketed predicate devices. The study's goal was to demonstrate substantial equivalence, meaning the new device performs comparably to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for these in vitro diagnostic devices are demonstrated through a comparison of their performance characteristics (Assay Range, Precision, Sensitivity, Accuracy/Correlation Coefficient, and Linear Regression) against legally marketed predicate devices. The "reported device performance" is the performance of the COBAS INTEGRA (Liquid) reagents. The "acceptance criteria" are implied to be within comparable ranges to the predicate devices, indicating substantial equivalence.
Note: For each test, the predicate device's performance is presented alongside the new device's performance, and the linear regression typically shows correlation against the predicate. This comparative approach is the core of the acceptance criteria.
Ammonia (NH3)
| Performance Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (COBAS INTEGRA Ammonia Liquid) |
|---|---|---|
| Assay Range | 0 - 700 U/L (0-2800 U/L with postdilution) | 0 - 700 µmol/L (0-1190 ug/dL) |
| Precision (Level 1) | Mean: ૯દિવ; %CV (within run): 5.7; %CV (total): 8.8 | Mean: 48.8 µmol/L; %CV (w/r): 3.1; %CV (total): 5.2 |
| Precision (Level 2) | Mean: 211; %CV (within run): 1.9; %CV (total): 5.9 | Mean: 226 µmol/L; %CV (w/r): 2.0; %CV (total): 2.5 |
| Sensitivity | 0.0009 AA per µmol/L | 0.76 AA per µmol/L |
| Accuracy (n=164) | Corr. Coefficient (r): 0.992 | Corr. Coefficient (r): 0.997 |
| Lin. Regression | 1.02x + 3.2 µmol/L | 1.03x - 2.8 µmol/L vs. Roche Reagent for Ammonia |
Creatinine (CREAE) - Serum and Plasma
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA Creatinine (Kinetic, Jaffé)) | Reported Device Performance (COBAS INTEGRA Creatinine (Enzymatic, PAP)) |
|---|---|---|
| Assay Range | 0 - 1300 µmol/L (0-13000 µmol/L with post dilution) | 0 - 2000 µmol/L (0-20000 µmol/L with post dilution) |
| Precision (Level 1) | Mean: 85.5 µmol/L; %CV (w/r): 1.5; %CV (total): 1.9 | Mean: 99.4 µmol/L; %CV (w/r): 1.6; %CV (total): 2.2 |
| Precision (Level 2) | Mean: 624 µmol/L; %CV (w/r): 1.1; %CV (total): 1.5 | Mean: 535 µmol/L; %CV (w/r): 0.88; %CV (total): 1.5 |
| Sensitivity | 8.0 X 10^-5 ΔA/min per µmol/L | 2.2 X 10^-4 ΔA per µmol/L |
| Accuracy (n=238) | Corr. Coefficient (r): 0.999 | Corr. Coefficient (r): 0.999 |
| Lin. Regression | 0.87x - 2 µmol/L | 1.08x - 30.6 µmol/L vs. COBAS INTEGRA Creatinine (Jaffé) |
Creatinine (CREAE) - Urine
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA Creatinine (Kinetic, Jaffé)) | Reported Device Performance (COBAS INTEGRA Creatinine (Enzymatic, PAP)) |
|---|---|---|
| Assay Range | 0 - 32.5 mmol/L (0-130 mmol/L with post dilution) | 0 - 40 mmol/L (0-200 mmol/L with post dilution) |
| Precision (Level 1) | Mean: 5.3 mmol/L; %CV (w/r): 1.5 | Mean: 4.1 mmol/L; %CV (w/r): 0.88; %CV (total): 1.1 |
| Precision (Level 2) | Mean: 19 mmol/L; %CV (w/r): 1.0 | Mean: 14.0 mmol/L; %CV (w/r): 0.87; %CV (total): 0.93 |
| Sensitivity | Not specified in labeling | 5.7 X 10^-3 ΔA per mmol/L |
| Accuracy (n=116) | Not specified in labeling | Corr. Coefficient (r): 0.999 |
| Lin. Regression | Not specified in labeling | 0.99x - 0.28 mmol/L vs. COBAS INTEGRA Creatinine (Jaffé) |
Digitoxin (DIGIT)
| Performance Characteristic | Acceptance Criteria (Predicate: Abbott TDx/TDxFLx Digitoxin) | Reported Device Performance (COBAS INTEGRA Digitoxin) |
|---|---|---|
| Assay Range | 2.0 - 80 ng/mL | 2.0 - 65 ng/mL |
| Precision (Level 1) | Mean: 7.5 ng/mL; %CV (w/r): 7.05; %CV (total): 10.61 | Mean: 10.4 ng/mL; %CV (w/r): 6.0; %CV (total): 7.4 |
| Precision (Level 2) | Mean: 15.0 ng/mL; %CV (w/r): 4.87; %CV (total): 7.19 | Mean: 19.5 ng/mL; %CV (w/r): 3.9; %CV (total): 4.5 |
| Precision (Level 3) | Mean: 35.0 ng/mL; %CV (w/r): 4.72; %CV (total): 8.46 | Mean: 37.1 ng/mL; %CV (w/r): 3.6; %CV (total): 3.7 |
| Sensitivity | 2.0 ng/mL | 2.0 ng/mL |
| Accuracy (n=232) | Corr. Coefficient (r): 0.967 | Corr. Coefficient (r): 0.973 |
| Lin. Regression | 1.060 + 0.729 ng/mL | 0.945x + 1.19 ng/mL vs. Abbott TDx/TDxFLx Digitoxin |
Lysergic acid diethylamide (LSD)
| Performance Characteristic | Acceptance Criteria (Predicate: Roche Abuscreen RIA for LSD) | Reported Device Performance (COBAS INTEGRA LSD) |
|---|---|---|
| Assay Range | 0 - 1 ng/mL | 0 - 1 ng/mL |
| Precision (Level 1) | Mean: 0.0; %CV (w/r): 0.6 | Mean (O.D.): 0.978; %CV (w/r): N/A |
| Precision (Level 2) | Mean: 0.25; %CV (w/r): 1.3 | Mean (O.D.): 0.913; %CV (w/r): N/A |
| Precision (Level 3) | Mean: 0.5; %CV (w/r): 1.6 | Mean (O.D.): 0.870; %CV (w/r): N/A |
| Sensitivity | 0.25 ng/mL of LSD at > 99% confidence | 0.10 ng/mL of LSD at > 95% confidence |
| Accuracy | Positive Samples (GC/MS): 21/0; Positive Samples (RIA): 21/0 | Positive Samples (GC/MS): 39/0; Positive Samples (RIA): 39/0 |
Note: For LSD, precision is presented in Optical Density (O.D.) for the new device vs. ng/mL for the predicate, making direct comparison of mean values challenging. However, the %CV for within-run are similar.
α-Amylase (AMYLL) - Serum and Plasma
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA α-Amylase (Granulate)) | Reported Device Performance (COBAS INTEGRA α-Amylase EPS (Liquid)) |
|---|---|---|
| Assay Range | 0 - 2000 U/L (0-20000 U/L with post dilution) | 0 - 2000 U/L (0-10000 U/L with post dilution) |
| Precision (Level 1) | Mean: 143 U/L; %CV (w/r): 1.6; %CV (total): 1.6 | Mean: 76 U/L; %CV (w/r): 1.6; %CV (total): 2.3 |
| Precision (Level 2) | Mean: 277 U/L; %CV (w/r): 1.1; %CV (total): 2.0 | Mean: 498 U/L; %CV (w/r): 1.3; %CV (total): 2.6 |
| Sensitivity | 1.5 X 10^-4 ΔA/min per U/L | 1.9 X 10^-4 ΔA/min per U/L |
| Accuracy (n=114) | Corr. Coefficient (r): 0.992 | Corr. Coefficient (r): 0.996 |
| Lin. Regression | 0.98x - 19 U/L | 0.43x + 4 U/L vs. COBAS INTEGRA α-Amylase (granulate) |
α-Amylase (AMYLL) - Urine
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA α-Amylase (Granulate)) | Reported Device Performance (COBAS INTEGRA α-Amylase EPS (Liquid)) |
|---|---|---|
| Assay Range | 0 - 2000 U/L (0-20000 U/L with post dilution) | 0 - 2000 U/L (0-10000 U/L with post dilution) |
| Precision (Level 1) | Mean: 22 U/L; %CV (w/r): 2.5 | Mean: 183 U/L; %CV (w/r): 1.3; %CV (total): 1.7 |
| Precision (Level 2) | Mean: 302 U/L; %CV (w/r): 0.56 | Mean: 603 U/L; %CV (w/r): N/A; %CV (total): 1.6 |
| Sensitivity | Not specified in labeling | 1.9 X 10^-4 ΔA/min per U/L |
| Accuracy (n=150) | Not specified in labeling | Corr. Coefficient (r): 0.988 |
| Lin. Regression | Not specified in labeling | 0.44x + 0 U/L vs. COBAS INTEGRA α-Amylase (granulate) |
Cholesterol (CHOLL)
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA Cholesterol (Granulate)) | Reported Device Performance (COBAS INTEGRA Cholesterol (Liquid)) |
|---|---|---|
| Assay Range | 0 - 20.7 mmol/L (0-8000 mg/dL with post dilution) | 0 - 18.1 mmol/L (0-7000 mg/dL with post dilution) |
| Precision (Level 1) | Mean: 5.0 mmol/L; %CV (w/r): 1.3; %CV (total): 1.1 | Mean: 5.3 mmol/L; %CV (w/r): 1.3; %CV (total): 2.2 |
| Precision (Level 2) | Mean: 6.3 mmol/L; %CV (w/r): 1.0; %CV (total): 1.2 | Mean: 6.7 mmol/L; %CV (w/r): 1.1; %CV (total): 2.5 |
| Precision (Level 3) | Mean: 8.0 mmol/L; %CV (w/r): 2.0; %CV (total): 1.5 | N/A |
| Sensitivity | 6.4 X 10^-2 ΔA per mmol/L | 8.8 X 10^-2 ΔA per mmol/L |
| Accuracy (n=214) | Corr. Coefficient (r): 0.995 | Corr. Coefficient (r): 0.998 |
| Lin. Regression | 1.04x + 0.1 mmol/L | 0.99x + 0.0 mmol/L vs. COBAS INTEGRA Cholesterol (granulate) |
HDL-Cholesterol Application (HDLL)
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA HDL - Cholesterol Application (granulate)) | Reported Device Performance (COBAS INTEGRA HDL - Cholesterol Application (liquid)) |
|---|---|---|
| Assay Range | 0 - 5.0 mmol/L (0-193 mg/dL) | 0 - 5.0 mmol/L (0-193 mg/dL) |
| Precision (Level 1) | Mean: 0.82 mmol/L; %CV (w/r): 1.2; %CV (total): 2.7 | Mean: 0.20 mmol/L; %CV (w/r): 1.51.3*; %CV (total): 3.0 |
| Precision (Level 2) | Mean: 1.42 mmol/L; %CV (w/r): 0.85; %CV (total): 5.5 | Mean: 1.91 mmol/L; %CV (w/r): 0.26; %CV (total): 1.6 |
| Sensitivity | 6.4 X 10^-2 ΔA per mmol/L | 8.8 X 10^-2 ΔA per mmol/L |
| Accuracy (n=240) | Corr. Coefficient (r): 0.998 | Corr. Coefficient (r): 0.999 |
| Lin. Regression | 0.99x - 0.05 mmol/L | 0.99x + 0.03 mmol/L vs. COBAS INTEGRA HDL - Cholesterol Application (granulate) |
Note: There seems to be a typo for %CV (within run) in Level 1 of the HDLL liquid reagent (1.51.3).
Gamma-Glutamyltransferase (GGTL)
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA GGT (Granulate)) | Reported Device Performance (COBAS INTEGRA GGTL (Liquid)) |
|---|---|---|
| Assay Range | 0 - 700 U/L (0-7000 U/L with post dilution) | 0 - 600 U/L (0-6000 U/L with post dilution) |
| Precision (Level 1) | Mean: 37.9 U/L; %CV (w/r): 0.67; %CV (total): 1.2 | Mean: 21 U/L; %CV (w/r): 0.83; %CV (total): 2.8 |
| Precision (Level 2) | Mean: 345 U/L; %CV (w/r): 0.46; %CV (total): 1.4 | Mean: 428 U/L; %CV (w/r): 0.54; %CV (total): 1.5 |
| Sensitivity | 5.0 X 10^4 ΔA/min per U/L | 6.8 X 10^4 ΔA/min per U/L |
| Accuracy (n=196) | Corr. Coefficient (r): 0.998 | Corr. Coefficient (r): 0.999 |
| Lin. Regression | 1.00x + 0 U/L | 1.00x - 1.2 U/L vs. COBAS INTEGRA GGTL (granulate) |
Glucose (GLUCL) - Serum and Plasma
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA Glucose (Granulate)) | Reported Device Performance (COBAS INTEGRA Glucose (Liquid)) |
|---|---|---|
| Assay Range | 0 - 40 mmol/L (0-400 mmol/L with post dilution) | 0 - 40 mmol/L (0-400 mmol/L with post dilution) |
| Precision (Level 1) | Mean: 5.6 mmol/L; %CV (w/r): 1.2; %CV (total): 1.1 | Mean: 5.3 mmol/L; %CV (w/r): 1.7; %CV (total): 2.6 |
| Precision (Level 2) | Mean: 19.7 mmol/L; %CV (w/r): 0.97; %CV (total): 0.89 | Mean: 33.2 mmol/L; %CV (w/r): 0.72; %CV (total): 1.5 |
| Sensitivity | 9.3 X 10^-2 ΔA per mmol/L | 5.4 X 10^-2 ΔA per mmol/L |
| Accuracy (n=220) | Corr. Coefficient (r): 0.997 | Corr. Coefficient (r): 0.999 |
| Lin. Regression | 0.98x + 0.1 mmol/L | 1.05x - 0.2 mmol/L vs. COBAS INTEGRA Glucose (granulate) |
Glucose (GLUCL) - Urine
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA Glucose (Granulate)) | Reported Device Performance (COBAS INTEGRA Glucose (Liquid)) |
|---|---|---|
| Assay Range | 0 - 16 mmol/L (0-160 mmol/L with post dilution) | 0 - 40 mmol/L (0-400 mmol/L with post dilution) |
| Precision (Level 1) | Mean: 0.27 mmol/L; %CV (w/r): 2.0 | Mean: 1.7 mmol/L; %CV (w/r): 1.7; %CV (total): 4.3 |
| Precision (Level 2) | Mean: 0.48 mmol/L; %CV (w/r): 0.99 | Mean: 37.1 mmol/L; %CV (w/r): 1.8; %CV (total): 2.9 |
| Sensitivity | 2.2 X 10^1 ΔA per mmol/L | 5.4 X 10^2 ΔA per mmol/L |
| Accuracy (n=120) | Not specified in labeling | Corr. Coefficient (r): 0.999 |
| Lin. Regression | Not specified in labeling | 1.01x - 0.02 mmol/L vs. COBAS INTEGRA Glucose (granulate) |
Glucose (GLUCL) - CSF
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA Glucose (Granulate)) | Reported Device Performance (COBAS INTEGRA Glucose (Liquid)) |
|---|---|---|
| Assay Range | 0 - 20 mmol/L (0-360 mmol/L with post dilution) | 0 - 40 mmol/L (0-400 mmol/L with post dilution) |
| Precision (Level 1) | Mean: 4.7 mmol/L; %CV (w/r): 0.57 | Mean: 1.7 mmol/L; %CV (w/r): 1.6; %CV (total): 2.3 |
| Precision (Level 2) | Mean: 10.3 mmol/L; %CV (w/r): 0.23 | Mean: 3.3 mmol/L; %CV (w/r): 1.8; %CV (total): 1.9 |
| Sensitivity | 1.8 X 10^1 ΔA per mmol/L | 5.4 X 10^2 ΔA per mmol/L |
| Accuracy (n=212) | Not specified in labeling | Corr. Coefficient (r): 0.999 |
| Lin. Regression | Not specified in labeling | 1.02x - 0.17 mmol/L vs. COBAS INTEGRA Glucose (granulate) |
Lipase (LIPL)
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA Lipase (Granulate)) | Reported Device Performance (COBAS INTEGRA Lipase (Liquid)) |
|---|---|---|
| Assay Range | 0 - 700 U/L (0-3500 U/L with post dilution) | 0 - 600 U/L (0-3000 U/L with post dilution) |
| Precision (Level 1) | Mean: 116 U/L; %CV (w/r): 1.7; %CV (total): 4.6 | Mean: 126 U/L; %CV (w/r): 1.9; %CV (total): 3.1 |
| Precision (Level 2) | Mean: 550 U/L; %CV (w/r): 2.1; %CV (total): 3.7 | Mean: 515 U/L; %CV (w/r): 1.3; %CV (total): 2.9 |
| Sensitivity | 5.6 X 10^-5 ΔA/min per U/L | 6.4 X 10^-5 ΔA/min per U/L |
| Accuracy (n=198) | Corr. Coefficient (r): 0.976 | Corr. Coefficient (r): 0.976 |
| Lin. Regression | 1.06x - 7 U/L | 0.82x + 16 U/L vs. COBAS INTEGRA Lipase (granulate) |
Urea/BUN (UREAL) - Serum and Plasma
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA Urea/BUN (Granulate)) | Reported Device Performance (COBAS INTEGRA Urea/BUN (Liquid)) |
|---|---|---|
| Assay Range | 0 - 55 mmol/L (0-550 mmol/L with post dilution) | 0 - 40 mmol/L (0-400 mmol/L with post dilution) |
| Precision (Level 1) | Mean: 6.9 mmol/L; %CV (w/r): 0.85; %CV (total): 2.0 | Mean: 4.1 mmol/L; %CV (w/r): 2.3; %CV (total): 3.9 |
| Precision (Level 2) | Mean: 19.9 mmol/L; %CV (w/r): 1.0; %CV (total): 2.3 | Mean: 31.0 mmol/L; %CV (w/r): 0.89; %CV (total): 2.8 |
| Sensitivity | 6.8 X 10^-3 ΔA/min per mmol/L | 2.2 X 10^-2 ΔA/min per mmol/L |
| Accuracy (n=236) | Corr. Coefficient (r): 0.999 | Corr. Coefficient (r): 0.999 |
| Lin. Regression | 1.01x + 0.30 mmol/L | 1.00x + 0.1 mmol/L vs. COBAS INTEGRA Urea/BUN (granulate) |
Urea/BUN (UREAL) - Urine
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA Urea/BUN (Granulate)) | Reported Device Performance (COBAS INTEGRA Urea/BUN (Liquid)) |
|---|---|---|
| Assay Range | 0 - 2200 mmol/L (0-5500 mmol/L with post dilution) | 0 - 2000 mmol/L (0-6000 mmol/L with post dilution) |
| Precision (Level 1) | Mean: 73 mmol/L; %CV (w/r): 0.99 | Mean: 421 mmol/L; %CV (w/r): 1.3; %CV (total): 1.8 |
| Precision (Level 2) | Mean: 345 mmol/L; %CV (w/r): 0.6 | Mean: 679 mmol/L; %CV (w/r): 1.2; %CV (total): 1.8 |
| Sensitivity | Not specified in labeling | 2.0 X 10^-2 ΔA/min per mmol/L |
| Accuracy (n=120) | Not specified in labeling | Corr. Coefficient (r): 0.999 |
| Lin. Regression | Not specified in labeling | 1.0X + 1.3 mmol/L vs. COBAS INTEGRA Urea/BUN (granulate) |
2. Sample sizes used for the test set and data provenance
The sample sizes for accuracy/correlation studies are provided in the tables above under "Sample size (n)". These values range from 114 to 240 for quantitative assays and 39 (positive) for LSD.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, given the context of a 510(k) submission for in vitro diagnostic reagents by Roche Diagnostic Systems, Inc. (located in Somerville, New Jersey, USA), it is highly likely these studies were conducted in a clinical laboratory setting in the USA. The studies are presented as direct comparisons between the new liquid reagents and existing granulate reagents or other legally marketed devices, implying they are prospective comparative studies assessing analytical performance.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
For these chemical assays (e.g., ammonia, creatinine, cholesterol) and therapeutic drug monitoring (digitoxin), "ground truth" is typically established by the quantitative results of the predicate device or a reference method. The document does not mention "experts" in the sense of human readers adjudicating results, as these are quantitative in vitro diagnostic tests. The ground truth is the measured concentration or activity of the analyte as determined by the accepted reference method or predicate device functionality.
For LSD, which involves qualitative detection, the "ground truth" against which the COBAS INTEGRA LSD was compared appears to be GC/MS (Gas Chromatography/Mass Spectrometry), which is a gold standard analytical method for drug detection. The document does not specify the qualifications of individuals performing these GC/MS analyses or interpreting the results, but they would be trained laboratory personnel.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
No adjudication method is mentioned. For these types of quantitative and qualitative analytical tests, "adjudication" by experts in the context of diagnostic imaging or pathology interpretation is not applicable. The comparison is based on numerical results compared to an established method or predicate.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was conducted. This type of study is relevant for medical imaging or pathology devices where human interpretation is a key component, often assisted by AI. The submitted devices are reagents for automated clinical analyzers, where the output is a numerical value or a qualitative positive/negative result, not an image requiring human interpretation. Therefore, there's no mention of AI assistance or human reader improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are effectively standalone performance evaluations of the reagent-analyzer system. These are not "algorithm-only" studies in the modern AI sense, but rather a direct assessment of the analytical performance of the new liquid reagent format on the COBAS INTEGRA Analyzer. The results (e.g., assay range, precision, accuracy) reflect the performance of the integrated system without direct human-in-the-loop interpretation impacting the primary measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth used varies slightly based on the assay, but generally involves:
- Quantitative Assays (Ammonia, Creatinine, Cholesterol, HDL-Cholesterol, GGT, Glucose, Lipase, Urea/BUN): The ground truth for these assays is the quantitative result obtained from the predicate device method. The accuracy is assessed by correlating the results of the new liquid reagents with the predicate (often the granulate version of the same Roche COBAS INTEGRA reagents or another established method like Abbott TDx/TDxFLx for Digitoxin). Linear regression analysis is used to demonstrate agreement.
- Qualitative Assay (LSD): The ground truth for LSD detection is established by a more definitive analytical method, specifically Gas Chromatography/Mass Spectrometry (GC/MS).
8. The sample size for the training set
The document does not explicitly delineate a "training set" in the context of machine learning or AI development. For these chemical assays, the development of the reagents and their formulation would involve extensive R&D and optimization, which could be considered an iterative development process, but it's not described as a distinct "training set" with separate ground truth establishment. The data presented in the tables are for validation or verification of the final product.
9. How the ground truth for the training set was established
As there is no explicitly defined "training set" in the submitted documentation related to AI/ML, there is no description of how ground truth for such a set was established. The development of reagents relies on established chemical and biochemical principles, and performance characteristics are determined through standard analytical validation procedures using reference materials and comparative studies against predicate methods.
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(152 days)
970546
JUL 1 4 1997
Class II Digitoxin Test System, 21 CFR 862.3300
The Chiron Diagnostics ACS:180 Digitoxin Assay is for the quantitative determination of digitoxin in serum or plasma using the Chiron ACS:180 Automated Chemiluminescence System. Monitoring of serum digitoxin concentrations is necessary to maintain therapeutic efficacy and avoid toxicity. Serum digitoxin levels combined with other therapeutic and clinical information provide the clinician with useful information to aid in adjusting patient dosage, achieving optimal therapeutic effect, and avoiding useless subtherapeutic or harmful toxic doses.
The Chiron Diagnostics ACS:180 Digitoxin assay is a competitive immunoassay using direct, chemilumenescent technology. Digitoxin in the patient sample competes with digitoxin, which is covalently coupled to the paramagnetic particles in the Solid Phase for binding to the acridinium ester-labeled monoclonal anti-digitoxin antibody in the Lite Reagent. An inverse relationship exists between the amount of digitoxin in the patient sample and the amount of relative light units (RLUs) detected by the ACS:180® system.
The provided document describes the Chiron Diagnostics ACS Digitoxin assay, comparing its performance to an alternate fluorescence polarization (FPIA) method.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Implied) | Reported Device Performance (ACS Digitoxin) |
|---|---|---|
| Sensitivity | Minimum detectable concentration adequate for clinical use | Measures up to 80 ng/mL, with a minimum detectable concentration of 1.5 ng/mL |
| Accuracy (Correlation to FPIA) | Strong correlation to established method (Predicate Device: TDX Digitoxin Immunoassay, Abbott Laboratories) | Correlation coefficient (r) = 0.83 (for 608 samples from 1.5 to 60 ng/mL) |
| Accuracy (Linear Regression vs. FPIA) | Linear relationship with a reasonable slope and intercept | ACS:180 Digitoxin = 0.79 (alternate method) + 4.9 ng/mL (for 608 samples from 1.5 to 60 ng/mL) |
Note: The document
does not explicitly state "acceptance criteria" values for correlation coefficient, slope, or intercept. These are inferred from the presentation of the data as supporting the device's accuracy and substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 608 samples.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's a submission to the FDA, it's highly likely to be clinical samples, though the specifics are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The "ground truth" for the test set is established by the "alternate fluorescence polarization (FPIA) method," which is itself a diagnostic assay. The document doesn't detail the development or validation of this FPIA method.
4. Adjudication Method for the Test Set
- This information is not applicable/provided in the context of this type of analytical validation. The comparison is against an instrumental method (FPIA), not a human-adjudicated ground truth.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No, an MRMC comparative effectiveness study was not done. This device is an automated immunoassay for measuring a chemical substance (digitoxin concentration) in serum/plasma, not an imaging device or a diagnostic tool requiring human interpretation or AI assistance in that sense.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the performance data presented is for the standalone algorithm (ACS Digitoxin immunoassay). The "accuracy" and "sensitivity" are inherent properties of the assay system itself, not dependent on human interpretation of the assay results in a "human-in-the-loop" setting.
7. The Type of Ground Truth Used
- The "ground truth" (or reference method) for the performance study was an alternate fluorescence polarization (FPIA) method. This is a laboratory diagnostic method.
8. The Sample Size for the Training Set
- The document does not specify a training set sample size. For an immunoassay, the "training set" concept is usually associated with the development and calibration of the assay itself, not a separate, explicitly defined "training set" as might be seen in machine learning applications. The 608 samples are described as involved in the "accuracy" study comparing to the alternate method.
9. How the Ground Truth for the Training Set Was Established
- As a "training set" is not explicitly defined or described in the context of this submission, the method for establishing its "ground truth" is not provided. The FPIA method serves as the reference standard for the performance evaluation.
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