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Found 15 results
510(k) Data Aggregation
(140 days)
91767
Re: K181553
Trade/Device Name: Immunalysis Ethyl Alcohol Enzyme Assay Regulation Number: 21 CFR 862.3040
| II |
| Classification Regulation: | 21 CFR 862.3040
The Immunalysis Ethyl Alcohol Enzyme Assay is an in vitro diagnostic device for the quantitative analysis of ethyl alcohol (ethanol) in human urine, serum or plasma with automated clinical chemistry analyzers. The measurement of ethanol is used for the diagnosis and treatment of alcohol intoxication and poisoning. This assay is calibrated against ethyl alcohol. This device is intended for prescription use only.
The Immunalysis Ethyl Alcohol Assay is based on the oxidation of ethyl alcohol to acetaldehyde by alcohol dehydrogenase (ADH) and nicotinamide adenine dinucleotide (NAD) reduced to NADH resulting in an absorbance change measured spectrophotometrically at 340nm. The concentration of ethanol in the sample is directly proportional to the ADH activity.
The Immunalysis Ethyl Alcohol Enzyme Assay is an in vitro diagnostic device for the quantitative analysis of ethyl alcohol (ethanol) in human urine, serum, or plasma using automated clinical chemistry analyzers. The measurement of ethanol is used for the diagnosis and treatment of alcohol intoxication and poisoning.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit from Study Design) | Reported Device Performance |
|---|---|---|
| Limit of Blank (LoB) | Calculation from sixty (60) blank measurements of unaltered drug-free negative human urine, serum, and plasma. | Urine: 0.481 mg/dL |
| Serum: 0.668 mg/dL | ||
| Plasma: 0.652 mg/dL | ||
| Limit of Detection (LoD) | Testing of four samples per matrix (urine, serum, plasma) at concentrations in the range LoB to 4xLoB, in replicates of five, on two reagent lots over three days. | Urine: 1.3 mg/dL |
| Serum: 1.7 mg/dL | ||
| Plasma: 1.7 mg/dL | ||
| Limit of Quantitation (LoQ) | Four independent samples of each matrix spiked at the LoQ concentration were tested on two reagent lots, demonstrating suitable accuracy. | All matrices: 2.9 mg/dL (quantitatively determined with suitable accuracy) |
| Linearity/Recovery | Serially diluted samples (from high concentration EtOH to drug-free) covering 3 mg/dL to 600 mg/dL, tested in triplicate. Slope and r² values to demonstrate linearity. Recovery percentages. | Urine: Slope: 0.996, Intercept: -0.172, r²: 0.999 (Recovery 97.5% - 102.6%) |
| Serum: Slope: 0.978, Intercept: 2.869, r²: 0.999 (Recovery 96.6% - 104.8%) | ||
| Plasma: Slope: 0.970, Intercept: 0.307, r²: 0.999 (Recovery 95.1% - 106.1%) | ||
| Precision | Performed for 20 days, 2 runs per day in duplicate (N=80 for each matrix) on drug-free samples spiked with EtOH at 25, 75, 125, 150, 175, 200 mg/dL and calibrators/controls at 50, 100, 300 mg/dL. Spiked concentrations confirmed by GC-FID. CV% values for repeatability, between run, and within-laboratory. | Urine: Within-Laboratory CV% range from 1.5% to 1.8% for spiked samples. |
| Serum: Within-Laboratory CV% range from 2.0% to 3.2% for spiked samples. | ||
| Plasma: Within-Laboratory CV% range from 1.5% to 4.9% for spiked samples. | ||
| Specificity and Cross-Reactivity | Structurally and functionally similar compounds spiked into drug-free urine, serum, and plasma at levels yielding the equivalent of 10 mg/dL and 100 mg/dL EtOH. Verified ability of the device to exclusively determine certain drugs. | Low cross-reactivity for most tested compounds ( |
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(331 days)
|
| Classification: | 21 CFR 862.3040
IN 46555
Re: K121247
Trade/Device Name: Alco-Screen Saliva Alcohol Test Regulation Number: 21 CFR 862.3040
ALCO-SCREEN® is a semi-quantitative screening test used to estimate the Blood Alcohol Concentration (BAC) using human saliva. The test strip estimates BAC at the 0.00%, 0.02%, 0.04%, 0.08% and 0.3% levels. Results are used in the diagnosis of alcohol use or intoxication. For in vitro diagnostic use.
ALCO-SCREEN® is a visually read semi-quantitative test for the detection of alcohol in saliva. The test strip indicates the relative Blood Alcohol Concentration (BAC) at 5 different cut-off levels. The device consists of a box of 24 individually packaged single test strips each designed for single use and to be disposable, and instruction for use.
The Alco-Screen® is a visually read, semi-quantitative test for alcohol detection in saliva, estimating Blood Alcohol Concentration (BAC) at 0.00%, 0.02%, 0.04%, 0.08%, and 0.3% levels.
Here's an analysis of its acceptance criteria and the study proving its performance:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria in a table format with corresponding reported performance values. Instead, it makes a general statement: "Results demonstrate that Alco-Screen® performs as intended and meets all established specifications."
However, based on the Intended Use and the description of the device's function, we can infer the primary performance characteristic would be its ability to accurately estimate BAC at the specified cut-off levels. The "Performance Testing" section further categorizes the types of studies conducted.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Accuracy of BAC estimation at 0.00%, 0.02%, 0.04%, 0.08%, and 0.3% levels. | "performs as intended and meets all established specifications." |
| Precision and Reproducibility | Studies were conducted to determine these characteristics. |
| Analytical Specificity | Studies were conducted to confirm this characteristic. |
| Stability | Studies were conducted to confirm this characteristic. |
| Field Use Performance | Studies were conducted, demonstrating the device's performance with an evidentiary device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any of the performance studies.
Regarding data provenance, the document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The term "field use studies" suggests prospective data collection in a realistic setting.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not specify the number of experts used to establish ground truth or their qualifications. Given that the device is a visually interpreted chemical test, the "ground truth" would likely be established through comparison with a reference method (e.g., a laboratory-based evidentiary alcohol test).
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted, and therefore, no effect size of human readers improving with AI vs. without AI assistance is available. This device is a visually interpreted chemical test, not an AI-assisted diagnostic tool for interpretation by multiple readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
This question is not applicable to the Alco-Screen®. The device is a visually interpreted chemical test; there is no AI algorithm to evaluate in a standalone manner. The "human-in-the-loop" is always required for visual interpretation against a color chart.
7. Type of Ground Truth Used
While not explicitly stated as "ground truth," the description of "field use studies with an evidentiary device" implies that the device's performance was compared against a reference standard, likely a more accurate and validated method for measuring BAC (e.g., a breathalyzer or blood alcohol test used for legal or medical evidence).
8. Sample Size for the Training Set
The document does not mention a training set sample size. As this is a chemical test interpreted visually against a fixed color chart, it does not involve machine learning or a "training set" in the traditional sense of AI/algorithm development.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set" for this type of device. The performance is assessed against established chemical reaction principles and comparison to reference methods.
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(140 days)
Classification Name:
Classification:
Predicate Devices:
Device Description:
Alcohol test system
21 CFR 862.3040
12 2012
Re: K121256 Alco-Screen 02 Saliva Alcohol Test Trade/Device Name: Regulation Number: 21 CFR 862.3040
The ALCO-SCREEN® 02 is a qualitative screening test used to detect the presence of ethyl alcohol in human saliva. The test detects relative Blood Alcohol Concentrations (BAC) greater than or equal to 0.02%. Results are used for the diagnosis of alcohol intoxication. For in vitro diagnostic use. The assay is a disposable test for one-time use.
ALCO-SCREEN® 02 is a visually read qualitative test for the detection of alcohol using saliva. The test strip indicates the relative Blood Alcohol Concentration (BAC) at 0.02%. The device consists of a box of 24 individually packaged single test strips each designed for single use and to be disposable, and instruction for use.
Here's an analysis of the provided text regarding the Alco-Screen® 02 device's acceptance criteria and studies:
Acceptance Criteria and Device Performance
The provided text does not explicitly state quantitative acceptance criteria in a table format with specific metrics. However, it does indicate the device's intended performance.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Detection of ethyl alcohol in human saliva | Qualitatively detects ethyl alcohol in human saliva |
| Detects relative Blood Alcohol Concentrations (BAC) ≥ 0.02% | Detects relative BAC ≥ 0.02% |
| Performs as intended | "Results demonstrate that Alco-Screen® performs as intended and meets all established specifications." |
| Substantially equivalent to predicate device (Orasure Technologies Inc, QED A150 Saliva Alcohol Test) | "Alco-Screen® 02 is substantially equivalent to the predicate device currently marketed under the Food, Drug and Cosmetic Act." |
Study Details
Based on the provided information, the description of the studies is quite limited.
- Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "field use studies with an evidentiary device" but does not provide details on sample size, country of origin, or whether the study was retrospective or prospective.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The device is a visually read qualitative test, not an AI-assisted diagnostic. There is no mention of human readers' performance improvement with or without AI assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is a standalone test strip for visual interpretation. There is no algorithm involved in its direct interpretation; a human visually reads the color change.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated how the "true" BAC levels were determined for the performance tests. Given the nature of a BAC test, it's highly probable that a referencemethod (e.g., blood alcohol analysis or a calibrated breathalyzer) would be used as the ground truth.
- The sample size for the training set: Not applicable. This device is a chemical test strip, not an AI algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.
Summary of "Performance Testing" Section:
The document states:
"The performance characteristics of Alco-Screen® 02 were determined by conducting precision and reproducibility studies, analytical specificity studies, stability studies, and field use studies with an evidentiary device. Results demonstrate that Alco-Screen® performs as intended and meets all established specifications."
This paragraph briefly outlines the types of studies conducted but provides no quantitative results, sample sizes, methodology details, or specifics about the "evidentiary device" used in field studies. The "established specifications" are not detailed in the provided text.
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(218 days)
Trade Name: Easy RA Ethyl Alcohol Reagent, Calibrator, and QC Material Regulation Number: 21 CFR 862.3040
The EasyRA EtOH reagent is intended for the quantitative measurement of Alcohol (EtOH) in human urine, using MEDICA's EasyRA Chemistry Analyzer in clinical laboratories. Alcohol measurements are used for the diagnosis and treatment of alcohol intoxication and poisoning.
The EasyCal Ethanol Calibrator is intended for in-vitro diagnostic use for the calibration of the ethyl alcohol assay on the EasyRA Chemistry Analyzer for the quantitative determination of ethyl alcohol in urine.
The EasyQC Ethanol quality control material is intended for in-vitro diagnostic use for the validation of the ethyl alcohol assay, which is used on the EasyRA Chemistry Analyzer for the quantitative determination of ethyl alcohol in urine.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Medica Corporation regarding their Easy RA Ethyl Alcohol Reagent, Calibrator, and QC Material. It details the regulatory approval of the devices for "quantitative measurement of Alcohol (EtOH) in human urine" and states that "Alcohol measurements are used for the diagnosis and treatment of alcohol intoxication and poisoning."
However, this document does not contain information about specific acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for these devices. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions.
Therefore, I cannot fulfill your request for a description of the acceptance criteria and the study that proves the device meets them based on the provided text.
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(158 days)
Regulation section:
21 CFR 862.3040, Alcohol Test System
-
- Classification: Class II
-
The Teco Saliva Alcohol Test is a semi-quantitative screening test for measuring alcohol in human saliva. This strip specifies the relative Blood Alcohol Concentration (BAC) at 0.0%, 0.02%, 0.04%, 0.08%, and 0.30% cut-off levels. Results can be used for the indication of alcohol intoxication. For in vitro diagnostic use only.
The Teco Saliva Alcohol Test is a screening test for the semi-quantitative detection of the presence of ethyl alcohol in human saliva. The test strip indicates relative Blood Alcohol Concentrations (BAC) at 0.0%, 0.02%, 0.04%, 0.08%, and 0.30% cut-off levels. Results are used for the diagnosis of alcohol intoxication. The test is intended for both prescription and over-the-counter in vitro diagnostic use. The assay is a disposable test for one-time use.
The Teco Saliva Alcohol Test is used to detect the amount of alcohol in the saliva after consumption. This is a semi-quantitative test that is read visually. The test strip determines the relative Blood Alcohol Concentration at 5 cut-off levels (negative, 0.02%, 0.04%, 0.08% and 0.3%). The device consists of a test strip (1 test strip per foil pouch). The resultant color on the test strip is compared to the color blocks printed on the pouch.
The Teco Saliva Alcohol Test is a plastic strip tipped with a reactive pad containing tetramethylbenzidine, alcohol oxidase, and peroxidase. The test is utilizes two coupled enzymatic reactions to create the visual changes in the presence of varying amounts of saliva alcohol. The first reaction consists of an oxidation reaction where the ethanol in the saliva is converted to aldehyde by the alcohol oxidase. The second reaction is the oxidation of TMB, the color indicator substrate, and is catalyzed by the enzyme peroxidase. The color change of the pad corresponds to the amount of present alcohol in the sample. The results are read by comparing the colored pad to the color chart found on the strip package
This document describes the Teco Saliva Alcohol Test, a semi-quantitative screening test for measuring alcohol in human saliva. The device aims to determine relative Blood Alcohol Concentration (BAC) at specific cut-off levels.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format for performance metrics like sensitivity, specificity, or accuracy. It primarily focuses on demonstrating substantial equivalence to a predicate device (ACON Mission Saliva Alcohol Test).
However, it implicitly indicates that the device's performance is acceptable if it can achieve "comparable testing data" to the predicate device and "perform satisfactorily" in conjunction with various studies.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Performance | Comparable testing data to the legally marketable ACON Mission Saliva Alcohol Test. Performance is satisfactory when used appropriately. | Clinical study results indicate that intended users were able to obtain comparable testing data when using the Teco Saliva Alcohol Test and the ACON Mission Saliva Alcohol test. Performance characteristics were verified through method comparison, precision, linearity, shelf life, and stress studies. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Clinical study results indicate that the intended users were able to obtain comparable testing data." 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 nature) for the clinical study.
3. Number of Experts and Qualifications for Ground Truth Establishment
The document does not provide information on the number of experts used to establish ground truth for the test set or their qualifications. The primary ground truth for comparison appears to be the results obtained from the predicate device.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. It mentions comparison with a predicate device, suggesting a direct comparison rather than an expert consensus/adjudication process for the Teco Saliva Alcohol Test's results themselves.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The evaluation focuses on the device's performance compared to a predicate, not on how human readers' performance improves with or without the device's assistance.
6. Standalone (Algorithm Only) Performance Study
The Teco Saliva Alcohol Test is described as a "visually read color change" device with the resultant color compared to color blocks printed on the pouch. This intrinsically involves human interpretation. Therefore, a standalone (algorithm only without human-in-the-loop performance) study is not applicable and not mentioned.
7. Type of Ground Truth Used
The primary "ground truth" used for evaluating the Teco Saliva Alcohol Test is the performance of a legally marketed predicate device (ACON Mission Saliva Alcohol Test). The clinical study aimed to show "comparable testing data" between the two devices. The predicate device itself would have had its own established ground truth (likely laboratory confirmation of BAC levels).
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. This device is a chromogenic assay; it is not a machine learning or AI-based algorithm that typically requires explicit training datasets.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of this device, the question of how its ground truth was established is not applicable.
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(461 days)
Device Name: Randox Ethanol Assay and Randox Ethanol Calibrators and Controls Regulation Number: 21 CFR 862.3040
Randox Ethanol Assay: The Randox Ethanol Assay is an in vitro diagnostic test for the quantitative analysis of Ethanol in human urine and serum on the forme analysers, which includes the JX day to na™ and the Amota™ analysers. The measurement of ethanol is used for the diagnosis and treatment of alcohol intoxication and poisoning. This is an in vitro diagnostic device intended for prescription use only.
Randox Ethanol Calibrator Set: The Randox Ethanol Calibrator Set is intended for the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum on the December analysers which includes the X day to na™ and the 121mona™.
Randox Ethanol Control Set: The Randox Ethanol Control Set is intended for the quality control of the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum on the forme analysers which includes the Aday to na™ and the Mimola™. This is an in vitro diagnostic device intended for prescription use only.
Not Found
The provided text is a 510(k) premarket notification for an in vitro diagnostic device (Randox Ethanol Assay and Calibrators/Controls). It does not contain information about acceptance criteria, device performance, or a study report with details like sample sizes, expert qualifications, or ground truth establishment. This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory compliance.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, adjudication methods, or ground truth types for a test set.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Sample size for the training set or how ground truth was established for it.
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(231 days)
The Mission Saliva Alcohol Test Strip is a screening test used to semi-quantitatively measure alcohol in human saliva. The test strip indicates relative Blood Alcohol Concentration at 0.0%, 0.02%, 0.04%, 0.08%, and 0.30% cut-off levels. Results are used in the diagnosis of alcohol intoxication. For in vitro diagnostic use only.
The Mission Saliva Alcohol Test Strip is a screening test used to semi-quantitatively measure alcohol in human saliva at 0.0%, 0.02%, 0.08%, and 0.30% Blood Alcohol Concentration (BAC). Results are used in the diagnosis of alcohol intoxication. The test is a firm plastic strip with a test pad attached at the tip. The test pad contains chemicals that are highly sensitive to alcohol in saliva reacts with the chemicals to produce a color change on the test pad. The color change depends on the amount of alcohol present. The results are read by comparing the color of the test pad with the color chart. The test gives relative Blood Alcohol Concentration (BAC) from 0.02% to 0.30%.
The Mission Saliva Alcohol Test Strip is a screening test designed to semi-quantitatively measure alcohol in human saliva to assist in the diagnosis of alcohol intoxication.
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with specific numerical targets. Instead, it discusses the device's characteristics and compares them to a predicate device. The performance of the Mission Saliva Alcohol Test Strip was evaluated through laboratory testing and clinical studies to demonstrate its safety, accuracy, ease-of-use, and substantial equivalence to the predicate device.
Table of Device Characteristics and Intended Measurement Range:
| Feature | Specification / Performance |
|---|---|
| Methodology | Chromogenic reaction |
| Specimen | Saliva |
| Measurement Range | Negative, 0.02%, 0.04%, 0.08%, and 0.30% BAC |
| Measuring Units | BAC % |
| Reading Time | 2 minutes |
| Reading Stability | 3 minutes |
| Storage Temperature | 2-27°C (36-80°F) |
| Shelf Life | 12 months |
| Dimensions | 0.5 x 8.0 cm (0.20 x 3.15 inches) |
| Weight | 0.16 g (0.006 oz) |
| Accuracy (Clinical) | Comparable readings by laypersons and technicians |
| Ease of Use | Satisfied laypersons using Instructions for Use |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document does not specify the exact sample size for the clinical study. It only states that "Clinical studies were conducted with laypersons and trained laboratory technicians."
- Data Provenance: Not explicitly stated, but clinical studies were performed in the context of a 510(k) submission to the FDA, implying studies conducted under regulatory guidelines, likely within the US given the submission to the FDA. The study data was compared to an evidentiary breath test, Alco-Sensor IV, a DOT/NHTSA approved device (Conforming Product List of Evidential Breath Alcohol Measurement Devices - FR/Vol 72, No 241/December 2007). The study was likely prospective as it involved evaluating the device's performance in real-time.
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: Not specified.
- Qualifications of Experts: The ground truth for comparison was established using an "evidentiary breath test, Alco-Sensor IV," which is a "DOT/NHTSA approved device." This reference implies that the Alco-Sensor IV results were considered the "expert" or gold standard, likely operated by trained technicians as mentioned in the clinical study description.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set in the traditional sense of multiple human experts reviewing results. The comparison was between the Mission Saliva Alcohol Test Strip (interpreted by laypersons and trained technicians) and the Alco-Sensor IV (operated by trained technicians).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not explicitly described in the provided text. The clinical study aimed to demonstrate that "non-professional, inexperienced laypersons were able to obtain comparable readings when using the Mission Saliva Alcohol Test Strip as compared to the results obtained by the trained technicians." This suggests a comparison of user groups (laypersons vs. trained technicians) with the device, but not a study to evaluate human readers' improvement with AI assistance.
6. Standalone Performance Study
The clinical study described seems to primarily evaluate the standalone performance of the Mission Saliva Alcohol Test Strip. It compares the device's results (whether interpreted by laypersons or trained technicians) directly against an evidentiary breath test device. There is no mention of an "AI" component or human-in-the-loop performance in the context of AI.
7. Type of Ground Truth Used
The ground truth used was established by an objective reference device: an "evidentiary breath test, Alco-Sensor IV," which is a "DOT/NHTSA approved device."
8. Sample Size for the Training Set
The document does not describe separate training and test sets in the typical machine learning context. The studies mentioned (laboratory testing and clinical studies) appear to be for performance evaluation rather than algorithm training. Therefore, the sample size for a "training set" is not applicable or not provided.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a "training set" for an algorithm, these details are not applicable. The context is a diagnostic device that operates based on a chemical reaction, not a machine learning algorithm requiring a training phase with labeled data.
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(52 days)
Regulation section: 21 CFR § 862.3040 Clinical toxicology test system
- 2.
Device Name: Dimension Ethyl Alcohol (ETOH) Flex Reagent Cartridge (DF22) Regulation Number: 21 CFR 862.3040
The ETOH method is an in-vitro diagnostic test for the quantitative measurement of ethyl alcohol (ethanol) in human serum, plasma and urine on the Dimension® System. Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning.
The Dimension® ETOH Flex® reagent cartridge is a prepackaged in-vitro diagnostic test method that is specifically designed to be used on the Dade Behring Dimension® Clinical Chemistry System. The reagents contained in the Dimension® ETOH Flex® reagent cartridge are: Reagent 1 which contains the buffering system and; Reagent 2 which contains alcohol dehydrogenase (ADH), the coenzyme nicotinamide adenine dinucleotide (NAD), buffer, preservatives, and stabilizers.
The provided text describes a 510(k) premarket notification for the Dimension® Ethyl Alcohol (ETOH) Flex® Reagent Cartridge (DF22), asserting its substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving its performance against those criteria as would be found in a clinical trial report.
However, based on the information provided, we can infer some aspects and highlight the lack of others. The core of the submission is to demonstrate substantial equivalence to existing devices.
Here's an attempt to answer your questions based on the provided text, noting where information is explicitly not available in the provided document.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of a table with specific thresholds for performance metrics (e.g., accuracy, precision, limits of detection) that the new device needed to meet. Instead, it relies on demonstrating comparative performance to predicate devices to establish substantial equivalence.
The table below summarizes the comparative features and stated performance that are used to assert equivalence, rather than a direct acceptance criteria table.
| Feature / Performance Aspect | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | Quantitative measurement of ethyl alcohol (ethanol) in human serum, plasma, and urine for diagnosis and treatment of alcohol intoxication and poisoning (similar to predicates). | The ETOH method is an in-vitro diagnostic test for the quantitative measurement of ethyl alcohol (ethanol) in human serum, plasma and urine on the Dimension® System. Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning. |
| Sample Type | Plasma, serum, and urine (similar to predicates). | Plasma, serum, and urine. |
| Measuring Range | Within a clinically acceptable range, comparable to or improving upon predicates (Predicates: 0-300 mg/dL and 10-600 mg/dL). | 3-300 mg/dL |
| Sample Size | Practical and efficient (Predicates: 3 µL and 4 µL). | 9 µL |
| Measurement Principle | Enzymatic reaction using alcohol dehydrogenase (ADH) and NAD (similar to predicates). | Bichromatic rate, based on an enzymatic reaction. |
| Substantial Equivalence | Performance comparable to Dimension® ALC Flex® (K904302) and Syva® Emit® II Plus Ethyl Alcohol Assay (K010960). | "Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance." (Specific data not provided in this summary). |
Note on "Acceptance Criteria": For an in-vitro diagnostic device like this, acceptance criteria would typically involve specific assay characteristics such as:
- Analytical Sensitivity: Limit of Detection (LoD), Limit of Quantitation (LoQ).
- Analytical Specificity: Interference studies, cross-reactivity.
- Precision: Repeatability (within-run) and Reproducibility (between-run, between-lot, between-instrument).
- Accuracy: Method comparison studies against a reference method or legally marketed device, often assessed by regression analysis and bias.
- Linearity/Measuring Range.
- Stability.
This 510(k) summary only states that "Comparative testing demonstrated substantial equivalent performance," implying these types of studies were conducted and met predetermined criteria, but the specific criteria and results are not detailed in the provided text.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text. The document states "Comparative testing described in the protocol included in this submission," but no details about the number of samples or subjects are given.
- Data Provenance: Not specified. There is no information about the country of origin of the data or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of device (clinical chemistry reagent cartridge for ethyl alcohol measurement) typically establishes "ground truth" through:
- Reference methods: Highly accurate and precise laboratory methods (e.g., Gas Chromatography-Mass Spectrometry, enzymatic methods traceable to certified reference materials).
- Legally marketed predicate devices: The new device's results are compared to the results obtained from established, cleared devices.
No human experts are typically involved in establishing "ground truth" for the quantitative measurement of ethanol in this context. The "ground truth" refers to the true concentration of ethyl alcohol, which is determined by analytical methods, not by expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for resolving disagreements among human readers/experts, typically in imaging or clinical assessment where subjective interpretation is involved. Since this device provides a quantitative measurement of alcohol, there is no human interpretation or adjudication process for its primary function.
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 (IVD) device for quantitative measurement, not an AI-assisted diagnostic tool for human interpretation.
- There are no "human readers" interpreting results in the way an MRMC study would evaluate, nor is there any AI component described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence, this device operates as a "standalone" algorithm/system for quantitative measurement. The Dimension® ETOH Flex® Reagent Cartridge is designed to be used on the Dade Behring Dimension® Clinical Chemistry System, which performs the measurement automatically. The output is a numerical concentration of ethyl alcohol. Human involvement is in operating the instrument and interpreting the numerical result in a clinical context, but not in the analytical measurement itself. The "comparative testing" mentioned would have evaluated this standalone performance against predicate devices.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this type of IVD device, the "ground truth" for establishing its analytical performance (accuracy, precision, linearity) would typically be:
- Comparisons to legally marketed predicate devices: The Dimension® ALC Flex® reagent cartridge (K904302) and Syva® Emit® II Plus Ethyl Alcohol Assay (K010960).
- Reference methods: Gold standard analytical methods for measuring ethyl alcohol, if used for calibration or method validation (though not explicitly stated in this summary, it's a standard practice).
It is not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable in the context of this device. This device is a reagent cartridge for a clinical chemistry analyzer, based on an enzymatic reaction. It is not an AI/machine learning model that requires a "training set" of data in the typical sense. The 'training' for such a system would involve validating the chemical reaction, reagent stability, and instrument calibration, which doesn't use a data-driven training set like AI models.
9. How the ground truth for the training set was established
Not applicable. As explained in point 8, there is no "training set" for this type of IVD device.
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(77 days)
Regulation section: 21 CFR § 862.3040 Clinical toxicology test system
- 2.
Trade/Device Name: Dimension Vista ETOH Flex Reagent Cartridge, Model K5022 Regulation Number: 21 CFR 862.3040
The ETOH method is an in-vitro diagnostic test for the quantitative measurement of ethyl alcohol in human serum, plasma and urine. Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning.
The Dimension Vista® ETOH Flex® reagent cartridge is a prepackaged in-vitro diagnostic test method that is specifically designed to be used on the Dade Behring Dimension Vista® System. The reagents contained in the Dimension Vista® ETOH Flex® reagent cartridge are: Reagent 1 which contains the buffering system and; Reagent 2 which contains alcohol dehydrogenase (ADH), the coenzyme nicotinamide adenine dinucleotide (NAD), buffer, preservatives, and stabilizers.
The provided text describes a 510(k) submission for the Dimension Vista® Ethyl Alcohol (ETOH) Flex® Reagent Cartridge. This document is focused on establishing substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics as might be found in an AI/ML device submission.
Therefore, many of the requested elements for an AI/ML device study, such as sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this type of submission.
Here's a breakdown of what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the way an AI/ML device study would. Instead, it demonstrates performance by comparing its features and principles to predicate devices and stating that comparative testing demonstrates substantial equivalent performance. Without specific thresholds or numerical acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity), a direct comparison table as requested cannot be fully generated.
However, we can infer "performance" from the comparison to predicate devices, focusing on areas like measuring range, sample type, and principle.
| Feature / Performance Metric | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Dimension Vista® ETOH Flex®) |
|---|---|---|
| Intended Use | Quantitative measurement of ethyl alcohol in human serum, plasma, and urine; diagnosis and treatment of alcohol intoxication and poisoning. | Meets the same intended use. |
| Sample Type | Supports serum, plasma, and urine. (Predicate 1 also supports supernatants from precipitated whole blood) | Supports plasma, serum, and urine. |
| Measuring Range | Expected to be comparable to or encompass the ranges of predicates (0-300 mg/dL for Predicate 1, 10-600 mg/dL for Predicate 2). | 3 - 300 mg/dL |
| Sample Size | Comparable to predicates (3 µL or 4 µL). | 4 µL |
| Measurement Principle | Enzymatic reaction / alcohol dehydrogenase (ADH) enzymatic procedure. | Based on an enzymatic reaction. |
| Substantial Equivalence | Demonstrated equivalent performance through comparative testing. | Conclusion: Substantially equivalent to predicates based on comparative testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document states "Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance," but does not detail the number of samples or cases used in this testing.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is a chemical assay, and "ground truth" would be established through reference methods or validated laboratory results, not expert consensus in the diagnostic imaging sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As a chemical assay, adjudication methods are not relevant.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a laboratory diagnostic assay, not an AI-assisted diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable in the AI/ML sense. This device is a reagent cartridge for an automated analyzer. Its performance is standalone in that it directly measures ethyl alcohol concentrations. However, this is not an "algorithm-only" performance as traditionally understood for AI/ML devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth for a chemical assay like this would typically be established using reference methods or highly accurate analytical techniques for ethyl alcohol concentration. The document does not explicitly state the specific reference method used but implies that the performance was compared to established predicate devices and internal validation protocols.
8. The sample size for the training set:
Not applicable. This is a chemical reagent cartridge, not a machine learning model that undergoes a "training phase" in the conventional sense. Its development relies on chemical and biological principles and optimization, not data-driven training as in AI/ML.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" in the AI/ML context for this device.
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(22 days)
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| 862.3040
cartridge | Dimension® ALC
Flex® reagent cartridge | K904302 | II | 862.3040
® reagent cartridge Dimension Vista™ Lithium (LI) Flex® reagent cartridge Regulation Number: 21 CFR§862.3040
The ALC method is an in vitro diagnostic test for the measurement of ethyl alcohol in serum on the Dimension Vista™ System. Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning.
The ALP method is an in vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma the Dimension Vista™ System.
The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in serum, plasma, and urine on the Dimension Vista™ System.
The Dimension Vista™ Ethyl Alcohol (ALC) Flex® reagent cartridge is a device intended to measure ethyl alcohol in human serum. Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.
The Dimension Vista™ Alkaline phosphatase (ALP) Flex® reagent cartridge is a device intended to measure alkaline phosphatase in serum and plasma. Measurements of alkaline phosphatase are used primarily in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases.
The Dimension Vista™ Calcium (CA) Flex® reagent cartridge is a device intended to measure the total calcium level in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
The Dimension Vista™ Lactic Acid (LA) Flex® reagent cartridge is a device intended to measure lactic acid in plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
The Dimension Vista™ Lithium (LI) Flex® reagent cartridge is a device intended to measure lithium in serum and plasma. Measurements of lithium are used to assure the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).
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 (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 is a 510(k) Summary for in-vitro diagnostic test cartridges (Dimension Vista™ Flex® reagent cartridges) that measure various analytes like Ethyl Alcohol, Alkaline Phosphatase, Calcium, Lactic Acid, and Lithium. The key point of this submission is a packaging modification to allow these existing, previously cleared reagents to be used with the new Dade Behring Dimension Vista™ Integrated system.
Given that the core reagents and their underlying technology remain the same, and only the packaging is changing to adapt them to a new instrument, the information provided focuses on demonstrating that this packaging change does not negatively impact the performance or intended use of the devices compared to their predicate devices on the older Dimension® clinical chemistry systems.
Therefore, the "acceptance criteria" and "study" are not about demonstrating a new diagnostic capability or a new level of clinical performance for the analytes themselves, but rather about demonstrating substantial equivalence for the cartridges when used on the new Dimension Vista™ system. This means showing that the performance on the Dimension Vista™ system is comparable to the established performance on the Dimension® system for the same reagents.
Based on the provided text, the specific details requested in your prompt regarding acceptance criteria, study design, and ground truth for diagnostic device performance as one might expect for a new AI algorithm or a novel biomarker test are not directly applicable or explicitly stated, because the submission is for a packaging modification of existing, cleared assays.
However, I can infer the "acceptance criteria" for this type of submission to be equivalence in performance to the predicate device, and the "study" would likely be a comparative performance study between the new system and the predicate system using the same reagents.
Here's an interpretation based on the provided text, addressing your points where possible:
Acceptance Criteria and Study for Dimension Vista™ Flex® Reagent Cartridges (Packaging Modification)
The primary acceptance criteria for this 510(k) submission, which concerns a packaging modification for existing in-vitro diagnostic reagents, center on demonstrating that the modified cartridges perform equivalently when used on the new Dimension Vista™ system compared to their predicate versions on the Dimension® clinical chemistry systems.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a packaging modification and not a new diagnostic algorithm, the acceptance criteria would revolve around maintaining the performance characteristics (e.g., accuracy, precision, linearity) that were established and accepted for the predicate devices. The text does not provide a specific table of numerical acceptance criteria or reported performance metrics for each analyte. This kind of detailed performance data is typically found in the full 510(k) submission, not necessarily in the public summary.
However, the implied acceptance criterion is substantial equivalence in performance to the predicate devices. The "reported device performance" would be the demonstration that the assays, when run on the Vista system with the new packaging, yield comparable results to those obtained on the Dimension system with the original packaging.
Implied Acceptance Criteria for Substantial Equivalence:
| Performance Metric (Implied) | Acceptance Criteria (Implied) | Reported Device Performance (Inferred from "Substantial Equivalence") |
|---|---|---|
| Accuracy/Bias | Results on Dimension Vista™ are comparable to predicate Dimension® system. | Demonstrated to be substantially equivalent. |
| Precision | Reproducibility of results on Dimension Vista™ is comparable to predicate Dimension® system. | Demonstrated to be substantially equivalent. |
| Linearity/Range | The measuring range and linearity on Dimension Vista™ are comparable to predicate Dimension® system. | Demonstrated to be substantially equivalent. |
| Interference | Interference profiles on Dimension Vista™ are comparable to predicate Dimension® system. | Demonstrated to be substantially equivalent. |
| Intended Use | The intended use and clinical utility remain unchanged. | Confirmed. |
| Fundamental Technology | No alteration to the fundamental scientific technology of the devices. | Confirmed – "The reagents... are the same." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for any comparative testing or the data provenance (e.g., country of origin, retrospective/prospective). For in-vitro diagnostic devices, testing would typically involve patient samples (often spanning the clinical range of the analyte) and/or control materials.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This question is not applicable in the context of this 510(k) submission. This type of submission is for in-vitro diagnostic (IVD) reagents, which measure specific analytes in biological samples. The "ground truth" for chemical measurements is typically established through reference methods, calibrated standards, or comparative analysis with an established, cleared device (the predicate). It does not involve expert readers assessing images or clinical scenarios for a consensus.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like "2+1" or "3+1" are characteristic of studies involving human interpretation (e.g., radiology image reading), where multiple readers assess a case and a tie-breaking mechanism is needed. For IVD measurements, the comparison is typically quantitative, directly comparing instrument outputs or calculated values, not subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This question is not applicable. MRMC studies are specific to evaluating observer performance, particularly in medical imaging, and assessing the impact of a device (like AI assistance) on human interpretation. This 510(k) is for chemical reagents used on an automated analyzer, not a device intended to assist human readers in, for instance, interpreting images.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable in the sense of an "algorithm" being evaluated for diagnostic output that would otherwise require human interpretation. The devices are chemical reagents that interact with an automated analyzer to produce a quantitative measurement. The analyzer performs the "algorithm" for measuring the analyte. The "standalone performance" is essentially the analytical performance of the combined reagent-instrument system, which is what the comparison to the predicate device would demonstrate.
7. Type of Ground Truth Used
For this type of IVD device, the "ground truth" for the performance evaluation would typically be established by:
- Reference Methods: Highly accurate, standardized methods for measuring the target analyte.
- Certified Reference Materials: Materials with precisely known concentrations of the analyte.
- Comparison to Predicate Device: The performance of the new device (or the modified version) is compared directly to a legally marketed predicate device, which itself has established performance characteristics. This is the most likely "ground truth" used in this specific 510(k) for substantial equivalence.
8. Sample Size for the Training Set
This question is not applicable. These are chemical reagents for an in-vitro diagnostic device. There is no "training set" in the context of machine learning or AI algorithms as the terms are typically used for imaging or predictive diagnostics. The reagents are chemical formulations designed to react with analytes, and the instrument uses established analytical principles, not learned patterns from a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated in point 8.
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