(57 days)
The Multiple Analyte (Benzoylecgonine, Methamphetamine, Methadone, Morphine. Oxazepam, Secobarbital, Phencyclidine, and Propoxyphene) Urine Drugs of Abuse Calibrators intended for in vitro diagnostic use for the calibration of their respective enzyme immunoassays to detect d-methamphetamine, benzoylecgonine, opiate, benzodiazepines. barbiturates, methadone, phencyclidine or propoxyphene in human urine.
The Multiple Analyte (Benzoylecgonine, Methamphetamine, Methadone, Morphine, Oxazepam, Secobarbital, Phencyclidine, and Propoxyphene) Urine Drugs of Abuse Controls are intended for in vitro diagnostic use for the validation of their respective enzyme immunoassays to detect d-methamphetamine, benzoylecgonine, opiate, benzodiazepines, barbiturates, methadone, phencyclidine or propoxyphene in human urine.
All of the DAU Calibrators and Controls are liquid, and ready to use. These Calibrators and Controls do not have any especially unique technical characteristics. Each contains a known concentration of a specific drug analyte as a mixture.
The Negative DAU Calibrator is a processed, drug-free human urine matrix. The Low, Cutoff. Intermediate, and High Calibrators, as well as the 2 levels of Controls are prepared by spiking known concentrations of drug analyte into the Negative DAU Calibrator matrix. The various concentrations of each drug analyte in their corresponding calibrators and controls are summarized as follows:
| | Low
Calibrator | Cutoff
Calibrator | Intermediate
Calibrator | High
Calibrator | Control
Level 1 | Control
Level 2 |
|-----------------|-------------------|----------------------|----------------------------|--------------------|--------------------|--------------------|
| Material | ng/mL | ng/mL | ng/mL | ng/mL | ng/mL | ng/mL |
| Methamphetamine | 250 | 500 | 750 | 1000 | 375 | 625 |
| Secobarbital | 100 | 200 | 500 | 1000 | 100 | 300 |
| Oxazepam | 100 | 200 | 500 | 1000 | 100 | 300 |
| Benzoylecgonine | 75 | 150 | 300 | 1000 | 110 | 190 |
| Methadone | 150 | 300 | 600 | 1000 | 225 | 375 |
| Morphine | 1000 | 2000 | 4000 | 6000 | 1500 | 2500 |
| Phencyclidine | 12.5 | 25 | 50 | 100 | 18 | 35 |
| Propoxyphene | 150 | 300 | 600 | 1000 | 225 | 375 |
The provided 510(k) summary (K051088) describes Lin-Zhi International, Inc.'s Multiple Analyte Urine Drugs of Abuse Calibrators and Controls. This device is a set of liquid calibrators and controls used for in vitro diagnostic testing to detect various drugs of abuse in human urine via enzyme immunoassays.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria, but it implies that the performance characteristics were deemed "acceptable" based on established guidelines. The device's performance is tied to its manufacturing process and confirmation against GC/MS.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | Not explicitly stated, but "acceptable" for intended use. | "acceptable" |
| Accuracy | Confirmed with GC/MS. | "acceptable" |
| Stability | Not explicitly stated, but "acceptable" for intended use. | "acceptable" |
| Matrix | Processed, drug-free human urine matrix similar to predicate. | Processed, drug-free human urine matrix. |
| Intended Use | Calibration/Validation of enzyme immunoassays for drugs of abuse in human urine. | Matches intended use. |
| Preparation | According to SAMHSA's guidelines. | According to SAMHSA's guidelines. |
| Concentrations | Spiked known concentrations confirmed by GC/MS. | Confirmed by GC/MS. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of an AI/algorithm-based device. Instead, the testing pertains to the quality control and validation of the calibrator and control materials themselves.
- Sample Size:
- The sample size for confirming the concentrations of the calibrators and controls is not explicitly stated. It refers to the "spiked values of calibrators and controls" being confirmed. This would likely involve multiple aliquots or batches of each calibrator and control level.
- Data Provenance:
- The calibrators and controls are prepared by spiking known concentrations of drug analyte into a "processed, drug-free human urine matrix."
- The document does not specify the country of origin for this human urine matrix.
- The data is inherently prospective in the sense that the device itself is manufactured, and its characteristics (concentration, accuracy) are assessed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The concept of "experts" establishing ground truth in the traditional sense of image interpretation or clinical diagnosis is not directly applicable here.
- Ground Truth Establishment: The "ground truth" for the concentrations of drug analytes in the calibrators and controls is established by:
- "Spiking known concentrations of drug analyte" into the urine matrix. This implies precise laboratory measurements and preparation.
- Confirmation with GC/MS (Gas Chromatography/Mass Spectrometry): GC/MS is a highly accurate analytical method often considered a gold standard for confirming the presence and concentration of substances in toxicology. This is an objective chemical measurement, not an expert opinion.
- Qualifications of Experts: Not applicable in the context of expert human review. The expertise lies in analytical chemistry and laboratory practice for GC/MS analysis and solution preparation.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are typically used for disagreements in human expert interpretations in clinical studies. This is not relevant for the type of device and testing described. The "adjudication" for the concentrations is performed by a comparison against GC/MS results, which is a definitive analytical method used for confirmation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or is applicable here. This device is a laboratory reagent (calibrator/control) and not an AI or imaging device that would assist human readers in interpretation. Therefore, there is no "effect size of how much human readers improve with AI vs without AI assistance."
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical chemical product (calibrator/control), not an algorithm or software. It does not have an "algorithm-only" performance in the sense of AI. Its performance is evaluated by its ability to accurately reflect known concentrations when measured by standard analytical methods.
7. Type of Ground Truth Used
The ground truth used for the device's performance is analytical (objective chemical measurement). Specifically:
- Spiked Concentrations: The concentrations of the drug analytes are known because they are accurately spiked into the matrix during manufacturing.
- GC/MS Confirmation: These known, spiked concentrations are then confirmed using Gas Chromatography/Mass Spectrometry, which acts as the definitive analytical ground truth.
8. Sample Size for the Training Set
Not applicable. This device is not an AI or machine learning model, so there is no "training set" in that context. The "training" for the device would be the quality control and manufacturing processes ensuring consistency.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an AI model. For the manufacturing of the calibrators and controls, the "ground truth" for the raw materials and spiking concentrations is established through:
- Certified Reference Materials: Use of accurately weighed and certified pure drug analytes.
- Precision Laboratory Techniques: Accurate volumetric and gravimetric measurements during spiking.
- Quality Control Processes: In-process checks and final product testing to ensure batch-to-batch consistency and accuracy against the intended formulations.
§ 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.