(56 days)
The TDM Control Set is intended for use as an assayed quality control product on Roche/Hitachi and COBAS INTEGRA analyzers. Two assayed levels of serum barbiturates and three assayed levels of acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acety/procainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid and vancomycin are provided.
The TDM Control Set contains liquid controls based on human serum with added therapeutic drugs, preservative, and stabilizer. The adjusted concentrations and activities of the control components are usually in the normal range or at the normal/pathological threshold. Some of the methods as specified in the enclosed value sheet may not be available in all countries. The TDM Control Set contains a mixture of 17 different drugs. Drugs included are acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acetylprocainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid and vancomycin. The concentrations and activities of the components are lot-specific. The exact values are given in the enclosed value sheet. The control set contains three levels for each drug. In addition, the TDM Control Set is value assigned for two levels (level I & II) of serum barbiturates, utilizing phenobarbital already present in the controls.
The provided text describes a 510(k) summary for a medical device called the "TDM Control Set." This device is a quality control material intended for use with specific analyzers. The filing is for a modified version of an existing device (K060429), where the primary change is the addition of value assignments for serum barbiturates.
Acceptance Criteria and Study Information:
This 510(k) summary does not contain the typical structure for reporting acceptance criteria and a study demonstrating performance in the way one might expect for a diagnostic or therapeutic device that directly impacts patient diagnosis or treatment. This is because the device is a quality control material, not a diagnostic test itself. Its "performance" is judged by its ability to reliably provide known concentrations of therapeutic drugs for calibrating and verifying the accuracy and precision of analytical instruments.
Therefore, the study described here focuses on demonstrating the substantial equivalence of the modified device to its predicate, particularly regarding the newly added value assignment for serum barbiturates, rather than a clinical performance study with sensitivity, specificity, etc.
Here's an attempt to extract and interpret the requested information based on the provided text, while acknowledging the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance:
Given the nature of a quality control material, the "acceptance criteria" revolve around the accuracy and reliability of the assigned values for the control components. The "reported device performance" is the successful assignment of these values, particularly for the new component.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Reliability and accuracy of value assignments for all 17 therapeutic drugs, consistent with the predicate device. | The device contains the same 17 drugs and has not changed in stability or composition compared to the predicate, implying continued reliable value assignment for these drugs. "No new analytes were added, and no drug levels have changed. Therefore, stability and composition have not changed." |
| Successful and accurate value assignment for two levels of serum barbiturates (Level I & II) based on the phenobarbital content. | The controls were tested using the Serum Barbiturates assay. The assay is calibrated with secobarbital, with cross-reactivity to phenobarbital of approximately 26%. "Essentially, we are using the cross-reactivity of the phenobarbital in the controls to allow us to assign targets for the Serum Barbiturates assay." This indicates successful establishment of target values for serum barbiturates through a defined methodology using existing components. |
| Performance of the TDM Control Set on Roche/Hitachi and COBAS INTEGRA analyzers for quality control, maintaining accuracy and precision for quantitative methods. | The device is intended for "quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheet" on "Roche/Hitachi and COBAS INTEGRA analyzers." The claim of substantial equivalence with a device that is already marketed and used on these platforms, implies continued expected performance in this role. |
| Equivalence to the predicate device (K060429) in all aspects except the explicit value assignment for serum barbiturates. | "The predicate device, TDM Control Set (K060429) is identical with the current TDM Control set except that it is not value assigned for two levels of serum barbiturates." This statement, along with the detailed comparison, serves as the primary "performance" metric for a 510(k) of this nature. The device is claimed to be substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a "sample size" in the context of a typical clinical trial. For a quality control material, the "test set" would refer to the lots of the control material produced and tested to establish their assigned values. The description mentions "three levels for each drug" and "two levels (level I & II) of serum barbiturates." It doesn't quantify the number of units or replicates tested to establish these values.
- Data Provenance: Not explicitly stated. Given that Roche Diagnostics Corporation is the submitter and the product is a control material, the data would likely originate from their internal R&D and manufacturing facilities. It would be considered prospective for the purpose of establishing the new value assignments for serum barbiturates, as these values were specifically determined for this modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- This information is not provided in the summary. For a quality control material, the "ground truth" (i.e., the assigned values) is typically established through a rigorous internal validation process involving analytical chemists, biochemists, and metrology experts, rather than clinical experts.
4. Adjudication Method for the Test Set:
- This information is not provided. Adjudication methods like "2+1, 3+1" are relevant for expert consensus in image interpretation or clinical diagnosis. For a quality control material, the "adjudication" would be through statistical analysis and adherence to established analytical validation protocols to determine the most accurate and precise assigned values for the components.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret results, often in comparison to an AI algorithm. The TDM Control Set is not a diagnostic device; it's a calibrator/quality control material for automated analyzers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This concept is not directly applicable. The "device" itself is a chemical reagent. Its "performance" is in providing accurate and precise concentrations when measured by an analytical instrument. The "algorithm" here would be the analytical method on the Roche/Hitachi and COBAS INTEGRA analyzers. The control set is used with these existing algorithms to ensure their accuracy, it doesn't have an "algorithm" of its own in the AI sense.
7. The Type of Ground Truth Used:
- For the TDM Control Set, the "ground truth" for each drug concentration is established through analytical reference methods and calibrated internal standards. This involves highly accurate and precise quantitative chemical analyses to determine the exact concentration of each therapeutic drug within the control material. For the serum barbiturates, the ground truth is established by correlating the known phenobarbital concentration with the existing Serum Barbiturates assay's cross-reactivity.
8. The Sample Size for the Training Set:
- This information is not provided. The concept of a "training set" as understood in machine learning (where an algorithm learns from data) is not directly applicable here. For a quality control product, the "training" analogous to this would be the historical data and validation studies used to develop the manufacturing process and analytical methods that ensure the consistent production of the control material with accurate assigned values.
9. How the Ground Truth for the Training Set was Established:
- As mentioned above, the concept of a "training set" for a quality control material is different from AI/machine learning. The "ground truth" for establishing the consistency and assigned values of the control material (analogous to what might be learned from a training set) would be established through:
- Validated analytical methods: Using reference assays with known traceability and accuracy.
- Statistical processes: To determine confidence intervals and assigned values for each lot of the control material.
- Manufacturing controls: Ensuring consistent formulation and production of the control material.
- For the specific addition of serum barbiturates, the ground truth was established by experimentally determining the cross-reactivity of the existing phenobarbital in the control set with the Serum Barbiturates assay, which is calibrated with secobarbital.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.