(28 days)
The ImmuTest Multi-Drug Screen is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at the following cutoff concentrations:
| Test | Calibrator | Cut-off (ng/ml) |
|---|---|---|
| AMP | d-Amphetamine | 1000 |
| BAR | Secobarbital | 300 |
| BUP | Buprenorphine | 10 |
| BZO | Oxazepam | 300 |
| COC 150 | Benzoylecgonine | 150 |
| COC | Benzoylecgonine | 300 |
| MDMA | 3,4-methylenedioxymethamphetamine | 500 |
| MET 500 | d-Methamphetamine | 500 |
| MET | d-Methamphetamine | 1000 |
| MTD | dl-Methadone | 300 |
| OPI 300 | Morphine | 300 |
| OPI | Morphine | 2000 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | 11-nor-A9-THC-9-COOH | 50 |
The ImmuTest Multi-Drug Screen consists of three test formats: card, cassette and cup. The configurations of the ImmuTest Multi-Drug Screen consist of any combination of the drugs listed above. The ImmuTest Multi-Drug Screen is used to obtain a visual, qualitative result and is intended for professional use only.
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmation methods.
The Ameditech ImmuTest Multi-Drug Screen is a lateral flow immunoassay intended for professional (prescription) use only. The device is used for the qualitative determination of parent compound and/or major metabolites of drugs in human urine specimens, and results are read visually. The device will be made available in three formats that use identical test strips: Dipcard, Cassette, and Cup. The modified device contains up to seventeen (17) assays that can include up to thirteen (13) different drugs at various cutoff concentrations. The assays detect different illicit drugs and medications that are commonly abused. Once the urine sample is administered, negative results can be read as soon as 1 minute and positive results should be read between 5 to 10 minutes. The presence of the line on the test region indicates a negative result for the drug and the absence of a line on the test region indicates a positive result for the drug. A visible line is also present at the control region of the test strip. This line should always appear, regardless of the presence of drugs or metabolites in the urine sample. This means that a negative urine sample will produce both a test line and control line, and a positive urine sample will generate only a control line. The presence of control line serves as a built-in control, which demonstrates that the test is performed properly.
Here's an analysis of the acceptance criteria and the study information for the Ameditech ImmuTest Multi-Drug Screen, based on the provided text:
Acceptance Criteria and Device Performance
The provided document describes a Special 510(k) submission, meaning the device is substantially equivalent to a previously cleared predicate device. Therefore, the "acceptance criteria" are implicitly met by demonstrating equivalent performance to the predicate. The "reported device performance" is essentially the established performance of the predicate devices.
Table 1: Acceptance Criteria (Referencing Predicate Performance) and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (from Predicate Device) | Reported Device Performance (Modified Device) |
|---|---|---|
| Precision (Reproducibility) | Established and validated in predicate submissions | Equivalent to predicate (confirmed by analytical performance verification testing) |
| Analytical Specificity | Established and validated in predicate submissions | Equivalent to predicate (confirmed by analytical performance verification testing) |
| Interfering Substances | Established and validated in predicate submissions | Equivalent to predicate (confirmed by analytical performance verification testing) |
| Qualitative Detection (Cut-off Concentrations) | Specific cut-off concentrations for various drugs as defined for predicate | Identical cut-off concentrations for various drugs as per predicate |
| Visual Result Readability | Established in predicate submissions | Assumed equivalent due to identical test strips |
| Built-in Control Functionality | Established in predicate submissions | Assumed equivalent due to identical test strips |
Study Details
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Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document states that no clinical studies were conducted for this special 510(k) submission because the modified and predicate devices use identical test strips. Therefore, there is no new test set with specific sample sizes for this submission. The performance characteristics validated in the predicate submissions are considered applicable. The original provenance of data for predicate devices is not specified in this document.
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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 as no new clinical or performance studies were conducted for this submission. The ground truth (drug presence/absence and concentration) for the predicate device studies would have been established through methods like GC/MS or LC/MS, but the specific number and qualifications of experts involved in those prior studies are not detailed here.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no new clinical or performance studies were conducted for this submission.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a manual, visually-read immunoassay for drug detection and does not involve AI or human-in-the-loop performance in the context of diagnostic imaging or similar applications where MRMC studies are common.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a visually-read immunoassay and does not have a "standalone algorithm" in the typical sense of AI/image analysis. Its performance is inherent to the chemical reaction on the test strip and the visual interpretation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the predicate devices (and hence assumed for this modified device), the ground truth for drug presence and concentration in urine samples would have been established through more specific alternate chemical methods, primarily Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS). These are stated as the preferred confirmation methods for preliminary positive results.
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The sample size for the training set
- Not applicable. This device is a chemical immunoassay, not a machine learning model that requires a training set.
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How the ground truth for the training set was established
- Not applicable for the reason stated above.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).