(81 days)
The Preciset DAT Plus I calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.
The Preciset DAT Plus II calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.
The Cfas DAT Qualitative Plus calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.
Roche Preciset DAT Plus I calibrators contain a mixture of 10 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine and propoxyphene. The calibrator set contains up to six levels for each drug contained in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of each drug in a multi-analyte mixture.
Roche Preciset DAT Plus II calibrators contain a mixture of 4 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, benzodiazepines. cannabinoids, and opiates. The calibrator set contains up to six levels for each drug contained in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of each drug in a multianalyte mixture.
Roche Cfas DAT Qualitative Plus calibrator contains a mixture of 10 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine, and propoxyphene. The calibrator set contains a single level for each drug in a drug mixture.
This 510(k) premarket notification is for calibrators used with drug abuse assays, not a diagnostic device with performance metrics like sensitivity and specificity. Therefore, many of the requested categories (e.g., expert consensus, MRMC studies, standalone performance) are not applicable in the traditional sense for this type of device.
This submission focuses on demonstrating substantial equivalence to already marketed calibrators by Roche. The "acceptance criteria" here are implicitly meeting the performance characteristics and intended use of the legally marketed predicate devices.
Here's an attempt to structure the available information according to your request, with significant caveats for the non-applicability of certain criteria:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Preciset DAT Plus I Calibrators: | |
| - Intended for calibration of Roche assays for drugs of abuse in human urine. | - Preciset DAT Plus I calibrators contain a mixture of 10 drugs (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine, propoxyphene) at up to six specified levels (e.g., Amphetamines: 0, 250, 500, 1000, 3000, 5000 ng/mL). |
| - Composition (drugs included and their levels) similar to predicate device (K031775). | - Quantitative addition of drug or drug metabolite to drug-free human urine. |
| Preciset DAT Plus II Calibrators: | |
| - Intended for calibration of Roche assays for drugs of abuse in human urine. | - Preciset DAT Plus II calibrators contain a mixture of 4 drugs (amphetamines, benzodiazepines, cannabinoids, opiates) at up to six specified levels (e.g., Amphetamines: 0, 150, 300, 600, 1000, 2000 ng/mL). |
| - Composition (drugs included and their levels) similar to predicate device (K033306). | - Quantitative addition of drug or drug metabolite to drug-free human urine. |
| Cfas DAT Qualitative Plus Calibrator: | |
| - Intended for qualitative calibration of Roche assays for drugs of abuse in human urine. | - Cfas DAT Qualitative Plus calibrator contains a mixture of 10 drugs (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine, propoxyphene) at a single specified level for each (e.g., Amphetamines: 500 ng/ml, Barbiturates: 200 ng/ml). |
| - Composition (drugs included and their levels) similar to predicate device (K033306). | - Quantitative addition of drug or drug metabolite to drug-free human urine. |
| Overall: Functionally equivalent to predicates, enabling calibration of assays. | - The submission states the devices "are substantially equivalent to other products cleared for commercial distribution intended for similar use. Most notably, they are substantially equivalent to the currently marketed Roche Preciset DAT Plus I calibrators, cleared in 510(k) K031775 and Preciset DAT Plus II and Cfas DAT Qualitative Plus cleared in 510(k) K033306." The description highlights the specific drug mixtures and concentrations in the new and predicate devices, demonstrating the scope of the substantial equivalence claim. The primary "proof" is the detailed comparison of the new devices' components and concentrations to those of the predicate devices, showing they serve the same function (calibration) with comparable drug panels and levels, facilitating a determination of substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- N/A (for traditional diagnostic device testing): This submission is for calibrators, not a diagnostic test that processes patient samples to generate a "test set" in the conventional sense. The "test" here involves comparing the composition and intended use of the new calibrators to existing, cleared predicate calibrators.
- Data Provenance: The calibrators themselves are "prepared by the quantitative addition of drug or drug metabolite to drug-free human urine." This suggests an in-house manufacturing process rather than external data provenance like country of origin or clinical data collection. The submission doesn't specify any external "testing" data from a large population.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable: For calibrators, "ground truth" isn't established by expert consensus on clinical images or patient data. The "ground truth" concerning the calibrators' composition is established by the manufacturing process – the quantitative addition of specified drug concentrations to drug-free human urine. Analytical techniques would verify these concentrations during manufacturing and quality control.
4. Adjudication Method for the Test Set
- Not Applicable: There is no clinical "test set" and thus no need for an adjudication method for disagreements among experts, as would be common in diagnostic imaging or clinical assessment studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No: MRMC studies are used to assess the impact of a diagnostic device (often AI-based) on human reader performance. This submission is for calibrators, which are reagents used to set the measurement scale for an assay, not a diagnostic tool read by humans.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable: Calibrators do not have an "algorithm" or standalone "performance" in the way an AI diagnostic device would. Their function is to provide known reference points for an assay. Their performance is related to their stability, accuracy of stated concentrations, and ability to correctly calibrate the associated assays, which would be validated during manufacturing and quality control, not as a standalone "algorithm."
7. The Type of Ground Truth Used
- Manufacturing Specifications / Quantitative Addition: The "ground truth" for these calibrators is their precisely defined chemical composition. They are "prepared by the quantitative addition of drug or drug metabolite to drug-free human urine." This means the concentration of each drug in each level of the calibrator is precisely known and controlled during the manufacturing process.
8. The Sample Size for the Training Set
- Not Applicable: Calibrators are physical reference materials, not algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As above, there is no training set for this type of device.
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). 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.