(77 days)
Chemtrue® Multi-Panel DOA Dip Card Tests:
The Chemtrue® Multi-Panel DOA Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Morphine, Methamphetamine, Phencyclidine, Benzodiazepines, Ecstasy, Methadone and Oxycodone drugs in human urine. The test cut-off concentrations and the tests are calibrated to are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) |
|---|---|---|---|
| Amphetamine | AMP | d-Amphetamine | 1000 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Methamphetamine | MAMP / MET | d-Methamphetamine | 1000 |
| Morphine | MOR | Morphine | 300 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Marijuana | THC | 11-nor-Δ9-THC9-COOH | 50 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxymethamphetamine | 500 |
| Methadone | MTD | Methadone | 300 |
| Oxycodone | OXY | Oxycodone | 100 |
The Chemtrue® Multi-Panel DOA Dip Card Tests panel can consist of any combination of the above listed drug analytes. The tests are intended for prescription and Over-The-Counter (OTC) use.
The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the prefered confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates and Oxycodone. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
Chemtrue® Multi-Panel DOA Dip Card with OPI 2000 Tests:
The Chemtrue® Multi-Panel DOA Dip Card with OPI 2000 Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Cocaine, Marijuana, Opiates 2000, Methamphetamine, Phencyclidine, Benzodiazepines. Barbiturates, Ecstasy, Methadone and Oxycodone drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) |
|---|---|---|---|
| Amphetamine | AMP | d-Amphetamine | 1000 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Methamphetamine | MAMP /MET | d-Methamphetamine | 1000 |
| Opiates | OPI | Morphine | 2000 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Marijuana | THC | 11-nor-Δ9-THC9-COOH | 50 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxymethamphetamine | 500 |
| Methadone | MTD | Methadone | 300 |
| Oxycodone | OXY | Oxycodone | 100 |
The Chemrue® Multi-Panel DOA Dip Card with OP1 2000 Tests can consist of any combination of the above listed drug analytes. The tests are intended for prescription and Over-The-Counter (OTC) use.
The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GCMS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates and Oxycodone. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
The Chemtrue® DOA Tests are colloidal gold based lateral flow immunoassays for the rapid, qualitative detection of drugs of abuse in human urine. The tests are single-use, in vitro diagnostic devices, which come in the formats of dip card, cup, or cassette, as indicated by the test name.
The provided document, K142580, describes the substantial equivalence determination for the Chemtrue® Multi-Panel DOA Dip Card Tests. It references previous 510(k) clearances (K102203, K111322, K121339, and K123080) for the individual drug analytes, stating that the test strips, sample matrix, test format, and cut-off concentrations for these analytes are identical to those previously cleared. Therefore, the performance characteristics and studies for the individual analyte tests are found in those referenced 510(k) submissions.
This document focuses on the new combination of these previously cleared test strips into multi-panel kits and confirms that verification and validation activities were conducted for this combination.
Here's an analysis of the acceptance criteria and study information provided (or inferred from the context of a 510(k) summary for a diagnostic device):
1. Table of Acceptance Criteria and Reported Device Performance
Since this 510(k) references prior clearances for the individual analytes, the general acceptance criteria for such qualitative tests involve achieving a certain level of agreement (e.g., sensitivity and specificity) with a validated reference method (like GC/MS or LC/MS) at and around the cut-off concentration. The document states that the performance characteristics (precision, specificity, interference, method comparison, stability, and lay-user study information) for each individual drug analyte were established in the predicate 510(k)s.
The "reported device performance" specifically mentioned in this document relates to the intended use and cut-off concentrations, which are considered to be "Same" as the predicate devices.
| Acceptance Criteria (General for Qualitative DOA Tests) | Reported Device Performance (as stated in K142580) |
|---|---|
| Qualitative detection of drugs of abuse in human urine | Qualitative detection of Amphetamine, Cocaine, Marijuana, Morphine, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone, and Oxycodone drugs in human urine. |
| Specific cut-off concentrations for each analyte | Chemtrue® Multi-Panel DOA Dip Card Tests: |
- Amphetamine: 1000 ng/mL
- Cocaine: 300 ng/mL
- Methamphetamine: 1000 ng/mL
- Morphine: 300 ng/mL
- Phencyclidine: 25 ng/mL
- Marijuana: 50 ng/mL
- Benzodiazepines: 300 ng/mL
- Barbiturates: 300 ng/mL
- Ecstasy: 500 ng/mL
- Methadone: 300 ng/mL
- Oxycodone: 100 ng/mL
Chemtrue® Multi-Panel DOA Dip Card with OPI 2000 Tests: - Amphetamine: 1000 ng/mL
- Cocaine: 300 ng/mL
- Methamphetamine: 1000 ng/mL
- Opiates: 2000 ng/mL
- Phencyclidine: 25 ng/mL
- Marijuana: 50 ng/mL
- Benzodiazepines: 300 ng/mL
- Barbiturates: 300 ng/mL
- Ecstasy: 500 ng/mL
- Methadone: 300 ng/mL
- Oxycodone: 100 ng/mL
All cut-offs are "Same" as predicate devices. |
| Maintain performance characteristics (precision, specificity, interference, stability, method comparison, lay-user accuracy) as previously cleared devices. | Stated that "Test strips, sample matrix, test format, and cut-off concentrations for these drugs of abuse analytes are identical to those cleared under K102203, K111322, K121339, and K123080. See K102203, K111322, K121339, and K123080 for additional precision, specificity, interference, method comparison, stability and lay-user study information." |
| Verification and validation of the multi-panel combination. | "Verification and validation activities were conducted to support combining the test strips to create the multi-panel candidate devices, including interference studies and usability testing." Specific results not detailed in this document. |
| Intended Use (Prescription and OTC) | "Same" as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in this document for the overall multi-panel device. The document defers to prior 510(k)s (K102203, K111322, K121339, and K123080) for the individual analyte performance. For a typical qualitative DOA test submission, sample sizes would often involve testing a range of concentrations around the cut-off (e.g., -25%, -50%, +25%, +50% of cut-off) with multiple replicates (e.g., 20 or more) for each analyte, across multiple lots.
- Data Provenance: Not explicitly stated in this document. Given it's a submission to the FDA, it's generally expected that studies would be conducted in a way that is acceptable to the FDA, likely involving studies in the US or under internationally recognized standards. The document does not specify if the data was retrospective or prospective.
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 K142580 document. For diagnostic tests of this nature, the "ground truth" for individual samples (e.g., whether a urine sample actually contains a drug above a certain concentration) is typically established by definitive analytical methods, not human expert consensus.
4. Adjudication Method for the Test Set
- Not applicable in the typical sense for a qualitative diagnostic device where chemical analysis provides the "ground truth." The reference method itself (e.g., GC/MS, LC/MS) is considered the gold standard.
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 study was not done, and this is not an AI/Reader-based device. The Chemtrue® Multi-Panel DOA Dip Card Tests are rapid lateral flow immunoassays designed for direct visual interpretation. There is no AI component or human reader assistance mechanism to evaluate in an MRMC study. However, the document mentions "lay-user study information" in the predicate devices, which would assess how well a typical non-professional user can interpret the results, which is a form of human performance assessment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- N/A. This is a physical, in vitro diagnostic test, not an algorithm, so the concept of "algorithm only" performance (standalone) does not apply. The device's performance is its direct ability to detect analytes in a given sample.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- The implicit ground truth that would have been used for the predicate devices (and thus for these tests, by extension) is definitive analytical methods, specifically Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS). The Indications for Use section explicitly states these are "the preferred confirmatory methods" to obtain a "confirmed assay result" after a preliminary result from the dip card.
8. The Sample Size for the Training Set
- Not explicitly stated for the individual analytes in this document, as it refers to previous 510(k)s. For this type of qualitative immunoassay, there isn't a "training set" in the machine learning sense. Instead, the "training" (or development and optimization) of the assay's chemical components (antibodies, conjugates) would involve numerous experiments with various concentrations of analytes and interferents to establish optimal performance around the cut-off.
9. How the Ground Truth for the Training Set Was Established
- As mentioned above, there isn't a "training set" in the AI/ML context here. The development and validation of the chemical components and detection mechanisms for an immunoassay rely on precisely prepared samples with known concentrations of the target analytes, often verified by highly accurate analytical chemistry methods like GC/MS or LC/MS.
§ 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).