(109 days)
Multichem U is intended for use as an assayed urine quality control to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. Two levels of Controls (Level 1 and Level 2) are supplied in liquid form.
Technopath has developed two levels of a urine control prepared from human urine to which purified biochemical material (extracts of human and animal origin), chemicals, drugs/preservatives and stabilizers have been added. The control is used in liquid form for convenience. The two levels of control are available to allow performance monitoring within the analytical range.
The following kit configurations are available:
Model UC 201A.10 with Level 1 control; 15 vials with 10 mL contents
Model UC 202A.10 with Level 2 control; 15 vials with 10 mL contents
Model 05P80-10, with Bi-Level controls; 6 Level 1 vials and 6 Level 2 vials; vials have 5mL contents
The provided 510(k) summary for Multichem U describes a quality control material and focuses on its substantial equivalence to a predicate device rather than presenting formal acceptance criteria and a study proving the device meets those criteria in the typical sense of a diagnostic or therapeutic device. Quality control materials are evaluated differently.
However, I can extract the relevant performance characteristics and the "studies" (which are more accurately "testing protocols" for QC materials) that demonstrate the device performs as intended for its stated use.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For a quality control material, "acceptance criteria" revolve around its stability, value assignment, and consistent performance across different reagent lots and calibrator lots. The "reported device performance" demonstrates that these characteristics were met.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Value Assignment Ranges: Establish appropriate ranges for each analyte to monitor precision of laboratory testing procedures. | Value assignment ranges were established at 20% around the grand mean for most analytes. |
| A 10% range was applied to Potassium, Sodium, and Chloride. This demonstrates that target values and acceptable ranges for variation were successfully determined for all listed analytes. | |
| Open Vial Stability: Maintain performance for a defined period after opening. | 30 days at 2°C - 8°C was confirmed. |
| "point of failure was determined by the maximum allowable drift (degradation), which was determined to be analyte specific." | |
| Shelf-Life Stability (Closed Vial): Maintain performance for a defined period when stored unopened. | Accelerated testing utilizing CLSI EP25A supported a shelf-life storage claim of 24 months at 2°C - 8°C. |
| The Drift Limit was determined to be 10%. "These results concluded that the Multichem U Controls product is predicted to be stable for in excess of 24 months." Real-time testing is ongoing. | |
| Compatibility with Reagent/Calibrator Variation: Performance should be consistent across different lots of reagents and calibrators. | For value assignment, 2 reagent lots and 2 calibrator lots were used to incorporate reagent and calibrator variation. This demonstrates the control's ability to provide stable results despite expected variations in other laboratory consumables. |
| Robustness to Operational/Environmental Variation: Performance should be consistent across different runs and calibration events. | For value assignment, 16 runs with 2 replicates each (total of 32 data points), with minimum gaps of 2 hours, were performed. |
| A minimum of 8 calibration events were performed to incorporate variation from calibration and environmental sources. This indicates the control's consistent performance under typical laboratory operating conditions. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Value Assignment: For each analyte, 2 replicates from 16 runs were performed, yielding a total of 32 data points.
- Sample Size for Stability Testing:
- Open Vial: Replicates of 3 were tested at each time point.
- Shelf-Life (Accelerated): Three lots of controls were used.
- Data Provenance: Not explicitly detailed regarding "country of origin for the data" for the internal studies. However, the manufacturer is Technopath from Ireland, and the contact is in the US (Global Compliance Plus). The serum used as a base material was tested using "United States Food and Drug Administration (FDA) approved methods." The studies were conducted internally by Technopath. All testing was performed on Abbott ARCHITECT c8000 clinical chemistry systems. The studies are prospective in the sense that they were designed and executed to determine the specific performance characteristics of the Multichem U product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable in the traditional sense for a quality control material.
- Ground truth for QC materials is not established by human experts interpreting clinical cases. Instead, the "truth" (or target value) for an analyte in a QC material is determined through value assignment protocols using reference methods or well-calibrated laboratory instruments.
- The "experts" involved would be trained laboratory personnel and chemists following established protocols for analytical testing and possibly statisticians for data analysis, but not "radiologists with 10 years of experience" as one might see for an AI diagnostic device.
4. Adjudication Method for the Test Set
This section is not applicable.
- Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert interpretations of clinical data (e.g., medical images, pathology slides) to establish a gold standard.
- For quality control materials, the "truth" is determined by precise analytical measurement, not subjective interpretation requiring adjudication.
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 relevant for diagnostic devices where human readers (e.g., radiologists) interpret cases (e.g., medical images) with and without the assistance of an AI algorithm.
- Multichem U is a quality control material used to assess the precision of laboratory instruments; it does not involve human interpretation of clinical "cases" in a way that would be assisted by an AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done.
- This concept is also relevant for AI/ML-driven diagnostic devices.
- Multichem U is a physical reagent used in conjunction with laboratory instrumentation; it is not an algorithm, and therefore, an "algorithm only" performance study is not applicable.
7. The Type of Ground Truth Used
For Multichem U, the "ground truth" for the analyte concentrations is established through value assignment testing protocols using calibrated laboratory instruments (Abbott ARCHITECT c8000 clinical chemistry systems) and associated reagent test systems.
- It is not expert consensus, pathology, or outcomes data. It's direct analytical measurement following validated procedures.
- The document states: "Value assignment testing was performed utilizing internal procedures and protocols to determine typical values that would be seen for the product..."
8. The Sample Size for the Training Set
This section is not applicable in the context of Multichem U.
- "Training set" refers to data used to train machine learning models.
- Multichem U is a physical quality control material, not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the reasons stated above. As there is no training set, there is no ground truth for a training set.
§ 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.