(66 days)
This product is intended for in vitro diagnostic use as a control product to assess the analytical performance of immunochemistry systems and clinical chemistry systems using methods for the quantitative measurement of the listed analytes. It is intended to provide the necessary control material required by inspection agencies for the evaluation of system performance. In addition, it will provide assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies.
DOCUMENT® TDM ULTRA Assayed Controls consist of three levels of a human serum matrix containing 25 commonly monitored analytes. The formulation design provides a liquid matrix intended for use on automated and semi-automated immunochemistry systems and clinical chemistry systems for the determination of blood acetaminophen (ACET), amikacin (AMI), carbamazepine (CARB), digoxin (DIG), disopyramide (DISO), ethanol (ETOH), ethosuximide (ETHO), gentamicin (GENT) e lidocaine (LIDO), methotrexate (METH), N-acetylprocainamide (NAPA), phenobarbital (PHENO), phenytoin (PHENY), primidone (PRIM), procainamide (PROC), quinidine (QUIN), salicylate (SAL), theophylline (THEO), thyroid-stimulating hormone (hTSH), thyroxine (T4), tobramycin (TOB), triiodothyronine (T3), T-Uptake (TU), valproic acid (VAL), and vancomycin (VANCO).
The provided text describes a 510(k) summary for the "DOCUMENT® TDM ULTRA Assayed Control" device, which is an in vitro diagnostic control product. This summary focuses on demonstrating substantial equivalence to predicate devices, rather than a study about a device's performance in diagnosing or screening for a condition in human subjects.
Therefore, many of the requested sections (e.g., sample size for the test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, ground truth for the training set) are not applicable to this type of device and study. The information provided is primarily about chemical controls and their properties.
However, I can extract the relevant information regarding acceptance criteria and reported "performance" in the context of a control device.
Here's the breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
For a control device, "acceptance criteria" and "performance" are primarily related to its characteristics and how it compares to predicate devices in its intended use as a control material. The document highlights the intended use and compares various characteristics. The ultimate "acceptance criterion" here is demonstrating comparable inter-assay precision to the predicate devices. The reported "performance" is that it "behaves in a similar manner" to the predicate devices in this regard.
| Characteristic | Acceptance Criteria (Implied by Comparison) | Reported Device Performance (DOCUMENT® TDM ULTRA Assayed Control) |
|---|---|---|
| Intended Use | To assess the analytical performance of analytical systems in the quantitative measurement of therapeutic drugs, thyroid function, and ethanol. (Similar to predicate devices' intended use for monitoring accuracy and precision in clinical assays, quantitating therapeutic drugs/thyroid hormones, and validating calibration.) | To assess the analytical performance of analytical systems in the quantitative measurement of therapeutic drugs, thyroid function, and ethanol. (Directly stated and aligns with the general functions of the predicate devices.) |
| Number of Levels | Three levels for comprehensive control. (Matches one predicate, similar to another with three, and incorporates the concept from a two-level predicate). | Three (3): Level I, Level II, Level III |
| Type | Assayed (Matches all predicate devices) | Assayed |
| Analytes | To cover a relevant panel of commonly monitored analytes. (The device covers 25 analytes, fewer than one predicate but more than another, and is specific in its selection). | 25 (Specific list provided: ACET, AMI, CARB, DIG, DISO, ETHO, GENT, LIDO, METH, NAPA, PHENO, PHENY, PRIM, PROC, QUIN, SAL, THEO, hTSH, T4, TOB, T3, TU, VAL, VANCO). This covers the range of analytes from the predicate devices collectively, although no single predicate has all of them. |
| Volume | Sufficient volume for intended use (Generally 5 mL for most predicates). | 5 mL |
| Matrix | Suitable matrix for immunochemistry and clinical chemistry systems. (Human serum, liquid, as compared to varied predicate matrices like human source lyophilized, bovine serum lyophilized, human blood components liquid). | Human serum, Liquid (This is a key differentiator from some predicates but is claimed to be suitable for purpose). |
| Dilution | None required. (Matches all predicate devices). | None required |
| Unopened Stability | Stable until expiration date. (Matches all predicate devices). | Until Expiration Date |
| Open Stability | Reasonable open stability for laboratory use. (30 days for the device, compared to ranges from "varies" to "Up to four weeks" to "Until Expiration Date" for predicates). | 30 Days |
| Equivalence | The inter-assay precision of the DOCUMENT TDM ULTRA Assayed Control should be comparable to that of the predicate devices for the listed analytes, demonstrating suitability for use as a control. | The results show that the DOCUMENT® TDM ULTRA Assayed Control behaves in a similar manner compared to the predicate devices and is suitable for use as a control for the listed analytes. (This is the primary demonstrated performance claim related to a study.) |
2. 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: "The equivalence for this product was carried out by comparing the inter-assay precision of the listed analytes of the DOCUMENT TDM ULTRA Assayed Control to that of Dade Immunoassay Controls Comprehensive Tri-Level, Instrumentation Laboratory TheraChem TDC Therapeutic Drug Controls and Abbott REA Ethanol Serum Control."
- Sample Size: Not specified for the "test set" (which in this context would likely refer to the number of measurements or replicates performed for the inter-assay precision study).
- Data Provenance: Not specified.
- Retrospective/Prospective: Not specified, but generally, studies for control device validation are prospective experiments conducted by the manufacturer.
3. 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)
This is not applicable. For a control device, "ground truth" is established by the known concentrations (target values) of the analytes within the control material, measured using reference methods. It's not about expert interpretation of clinical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as it's not a diagnostic study requiring human adjudication.
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
Not applicable. This is a control device, not an AI diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a control device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this control device, the "ground truth" for each analyte would be its reference value or target concentration, established by highly accurate and precise analytical methods. The document doesn't explicitly state how these target values were established, but it is standard practice for assayed controls.
8. The sample size for the training set
Not applicable. This is a control device, not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable.
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general 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.