(35 days)
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No
The summary describes a simple enzymatic test device that provides a qualitative result based on a chemical reaction. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML.
No.
This device is a test device used for the rapid detection of alcohol in saliva or urine, providing a qualitative result for the presence of alcohol. It is a diagnostic tool, not a therapeutic one as it does not treat or cure any condition.
Yes
This device is used to detect the presence of alcohol (ethanol) in saliva or urine, which is a form of qualitative diagnostic testing to identify if alcohol is present.
No
The device description explicitly states it is a "self contained, disposable enzymatic test device" and includes "all reagents and supplies necessary to perform the test," indicating it is a physical device with chemical components, not software only.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for the detection of alcohol (ethanol) in biological samples (saliva or urine). This is a key characteristic of an IVD, which is used to examine specimens taken from the human body to provide information for diagnostic purposes.
- Device Description: It's a "self contained, disposable enzymatic test device" that provides "rapid detection of alcohol." This describes a test kit designed to be used outside of the body to analyze a sample.
- Anatomical Site: It uses samples from "saliva or urine," which are human biological specimens.
- Performance Studies: The document includes details about performance studies (Accuracy, Precision, Sensitivity) conducted to evaluate the device's ability to detect alcohol in samples. This is a standard requirement for IVDs to demonstrate their reliability.
- Predicate Device: The mention of a "Predicate Device(s)" is common in regulatory submissions for IVDs, where a new device is compared to an already approved device.
The fact that it's for "professional use only" and provides a "qualitative" result does not exclude it from being an IVD. Many IVDs are designed for professional use and provide qualitative or semi-quantitative results.
N/A
Intended Use / Indications for Use
ON•SITE Alcohol is recommended for professional use only and is not intended for overthe-counter sale to the general public. Professional use includes applications in healthcare, corrections and drug treatment.
ON•SITE Alcohol yields only a "qualitative" result. A positive result indicates that alcohol (ethanol) is present at a concentration of approximately 0.02% when performed according to the instructions.
Confirmation of ON•SITE Alcohol results using gas chromatography is recommended if quantitative results are desired.
Product codes
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Device Description
ON•SITE Alcohol is a self contained, disposable enzymatic test device that provides rapid detection of alcohol in saliva or urine. It includes all reagents and supplies necessary to perform the test.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
saliva or urine
Indicated Patient Age Range
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Intended User / Care Setting
Professional use includes applications in healthcare, corrections and drug treatment.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy and precision of the current and modified device was compared by running twenty replicates of three ethanol controls (0.008%, 0.02% and 0.032% w/v). Tests were timed and results were read at exactly 2 minutes. Results were reported as either positive or negative. In addition, reaction times for each test (i.e., time required to produce an observable positive result) were recorded. The mean, standard deviation and coefficient of variations were calculated and compared.
Results confirmed the desired shift in reaction time and detection levels as follows:
- % w/v EtOH 0.008: current (No. of Positives 13, Mean Reaction Time 111 sec, Coefficient of Variation 10.3%), modified (No. of Positives 0, Mean Reaction Time 147 sec, Coefficient of Variation 8.2%)
- % w/v EtOH 0.020: current (No. of Positives 20, Mean Reaction Time 81 sec, Coefficient of Variation 8.3%), modified (No. of Positives 12, Mean Reaction Time 115 sec, Coefficient of Variation 8.8%)
- % w/v EtOH 0.032: current (No. of Positives 20, Mean Reaction Time 61 sec, Coefficient of Variation 7.9%), modified (No. of Positives 20, Mean Reaction Time 100 sec, Coefficient of Variation 6.7%)
The sensitivity of the current and modified device were also compared. Ten replicates of eight controls were tested using both devices. Reaction times were compared. Again, results confirmed the targeted shift in reaction times.
- % w/v EtOH 0.005: current (Mean Reaction Time 1 min 47 sec), modified (Mean Reaction Time 2 min 41 sec), Difference (54 sec)
- % w/v EtOH 0.0075: current (Mean Reaction Time 1 min 33 sec), modified (Mean Reaction Time 2 min 14 sec), Difference (41 sec)
- % w/v EtOH 0.01: current (Mean Reaction Time 1 min 19 sec), modified (Mean Reaction Time 2 min 10 sec), Difference (51 sec)
- % w/v EtOH 0.0125: current (Mean Reaction Time 1 min 21 sec), modified (Mean Reaction Time 1 min 53 sec), Difference (32 sec)
- % w/v EtOH 0.015: current (Mean Reaction Time 1 min 19 sec), modified (Mean Reaction Time 1 min 42 sec), Difference (23 sec)
- % w/v EtOH 0.0175: current (Mean Reaction Time 1 min 12 sec), modified (Mean Reaction Time 1 min 47 sec), Difference (35 sec)
- % w/v EtOH 0.02: current (Mean Reaction Time 1 min 6 sec), modified (Mean Reaction Time 1 min 41 sec), Difference (35 sec)
- % w/v EtOH 0.0225: current (Mean Reaction Time 1 min 6 sec), modified (Mean Reaction Time 1 min 29 sec), Difference (23 sec)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity, Accuracy, Precision
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3040 Alcohol test system.
(a)
Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.(b)
Classification. Class II.
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510(k) SUMMARY
| 1. | Submitter: | ANSYS, Inc. |
|---|---|---|
| Address: | 2 Goodyear | |
| Irvine, CA 92618 | ||
| Telephone: | (714) 770-9381 Ext. 7915 | |
| Contact Person: | Lorna Gamboa | |
| Date Prepared: | 7/9/96 | |
| 2. | Trade Name : | ON•SITE Alcohol |
| Common Name: | Alcohol Test System | |
| Classification: | Class II |
3. Predicate Device Information:
The modified ON.SITE Alcohol test is being compared to its predecessor, the current ON.SITE Alcohol, both manufactured by ANSYS, Inc.
4. Description of the Device:
ON•SITE Alcohol is a self contained, disposable enzymatic test device that provides rapid detection of alcohol in saliva or urine. It includes all reagents and supplies necessary to perform the test.
5. Intended Use:
ON•SITE Alcohol is recommended for professional use only and is not intended for overthe-counter sale to the general public. Professional use includes applications in healthcare, corrections and drug treatment.
ON•SITE Alcohol yields only a "qualitative" result. A positive result indicates that alcohol (ethanol) is present at a concentration of approximately 0.02% when performed according to the instructions.
Confirmation of ON•SITE Alcohol results using gas chromatography is recommended if quantitative results are desired.
1
Comparison of technological Characteristics: 6.
The modified ON•SITE Alcohol uses the same technology as its predecessor. The only difference is in the formulation of one of its reagents. It has been modified to increase the reaction time, thus slightly raising the limit of detection.
Performance Characteristics and Supportive Data: 7.
Accuracy and Precision
Accuracy and precision of the current and modified device was compared by running twenty replicates of three ethanol controls (0.008%, 0.02% and 0.032% w/v). Tests were timed and results were read at exactly 2 minutes. Results were reported as either positive or negative. In addition, reaction times for each test (i.e., time required to produce an observable positive result) were recorded. The mean, standard deviation and coefficient of variations were calculated and compared.
Results confirmed the desired shift in reaction time and detection levels as follows:
| % w/v
| EtOH | No. of Positives | Mean Reaction Time | Coefficient of Variation | |||
|---|---|---|---|---|---|---|
| current | modified | current | modified | current | modified | |
| 0.008 | 13 | 0 | 111 sec | 147 sec | 10.3% | 8.2% |
| 0.020 | 20 | 12 | 81 sec | 115 sec | 8.3% | 8.8% |
| 0.032 | 20 | 20 | 61 sec | 100 sec | 7.9% | 6.7% |
Sensitivity
The sensitivity of the current and modified device were also compared. Ten replicates of eight controls were tested using both devices. Reaction times were compared. Again, results confirmed the targeted shift in reaction times.
| % w/v | Mean Reaction Time | Difference | |
|---|---|---|---|
| EtOH | current | modified | sec |
| 0.005 | 1 min 47 sec | 2 min 41 sec | 54 |
| 0.0075 | 1 min 33 sec | 2 min 14 sec | 41 |
| 0.01 | 1 min 19 sec | 2 min 10 sec | 51 |
| 0.0125 | 1 min 21 sec | 1 min 53 sec | 32 |
| 0.015 | 1 min 19 sec | 1 min 42 sec | 23 |
| 0.0175 | 1 min 12 sec | 1 min 47 sec | 35 |
| 0.02 | 1 min 6 sec | 1 min 41 sec | 35 |
| 0.0225 | 1 min 6 sec | 1 min 29 sec | 23 |