(183 days)
Liquid Assayed Multiqual is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Liquid Assayed Multiqual is prepared from human serum to which purified biochemical material (tissue extracts of human and animal origin), chemicals, drugs, preservatives, and stabilizers have been added.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Liquid Assayed Multiqual" device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" in the format of pass/fail thresholds for a device, as one might find for a diagnostic test's sensitivity or specificity. Instead, it describes product claims related to stability, which serve as performance characteristics that the device is intended to meet. The study's purpose is to demonstrate that the new device meets these claims, and establishes substantial equivalence to a predicate device.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Open Vial Stability | 5 days at 2 to 8°C (This is the claim the device intends to meet and thus serves as the implicit acceptance criterion for this characteristic.) | "Open vial 5 days at 2 to 8°C" (The study performed stability studies to determine this claim, implying it was met.) |
| Thawed and Unopened | 30 days at 2 to 8°C, with exceptions: Direct Bilirubin 11 days, Triglycerides, HDL, Cholinesterase, Phosphorus 7 days. Total Bilirubin and Direct Bilirubin values may decrease, Alkaline Phosphatase activity may rise. (This is the claim the device intends to meet and thus serves as the implicit acceptance criterion for this characteristic.) | "Thawed and Unopened: 30 days at 2 to 8°C, with the following exceptions: Direct Bilirubin 11 days, Triglycerides, HDL, Cholinesterase, Phosphorus 7 days. Total Bilirubin and Direct Bilirubin values may decrease, Alkaline Phosphatase activity may rise." (The study performed stability studies to determine this claim, implying it was met.) |
| Shelf Life Stability | 3 Years at -20°C to -50°C (This is the claim the device intends to meet and thus serves as the implicit acceptance criterion for this characteristic.) | "Shelf Life Stability 3 Years at -20°C to -50°C" (The study performed stability studies to determine this claim, implying it was met.) |
| Substantial Equivalence | The new device performs "similarly" to the predicate device (K043208) as outlined by their identical intended use, physical form, matrix, and comparable stability claims, with noted differences in specific analyte stability and fill volume. | The report concludes: "Liquid Assayed Multiqual (new device) is intended to be used for the same purposes as the predicate device, it has the same human serum matrix and performs similarly as the predicate device." (This confirms the finding of substantial equivalence based on the comparison provided.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states, "The assigned values were derived from replicate analyses and are specific for each lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of the product lot."
- This indicates that a "representative sampling of the product lot" was used for testing, but the exact number of samples or the sample size (n) for the stability studies is not specified in this summary.
- Data Provenance: The studies were performed by the manufacturer (Bio-Rad Laboratories) and/or independent laboratories. The country of origin for the data is not explicitly stated, but Bio-Rad Laboratories is based in Irvine, California, suggesting the studies were likely conducted in the USA or by labs commissioned from the USA. The studies appear to be prospective in nature, as they were conducted to determine the stability claims for a new product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a quality control material used to monitor the precision of laboratory testing procedures. The concept of "ground truth" established by experts, as required for diagnostic devices (e.g., radiologists interpreting images), is not applicable here.
Instead, the "ground truth" for this type of device (Assayed Quality Control Material) is the assigned values for the analytes within the control. These are established through:
- Method: "replicate analyses"
- Personnel: Tests were "performed by the manufacturer and/or independent laboratories"
- Qualifications: While not explicitly detailed, these laboratories would employ trained personnel (e.g., clinical chemists, laboratory scientists) proficient in the analytical methods for each analyte.
4. Adjudication Method for the Test Set
Again, the concept of "adjudication" in the sense of resolving discrepancies among expert readers (e.g., 2+1, 3+1) is not applicable to this type of device. The "ground truth" (assigned values) is established through rigorous laboratory testing using replicate analyses, not through human interpretation of complex data that might require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI
No, an MRMC comparative effectiveness study was not done. This device is a quality control material, not a diagnostic imaging or screening tool that would involve AI assistance for human readers. Therefore, the effect size of AI improvement is not relevant or reported.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is a biochemical control material, not an algorithm or AI system. Its performance is evaluated based on its stability and the accuracy of its assigned values when measured by laboratory instruments, not as a standalone algorithmic output.
7. The Type of Ground Truth Used
The ground truth used for this type of quality control device is the assigned values for the various analytes it contains. These values are established through:
- Expert Consensus / Reference Methods: While not explicitly stated as "expert consensus," the "replicate analyses" performed by the manufacturer and independent laboratories using "manufacturer supported reagents" are indicative of adherence to established, scientifically sound analytical methodologies that are considered the reference or "true" values for the analytes. The ±3SD ranges reported are statistical measures around this empirically determined true value.
8. The Sample Size for the Training Set
This document describes a quality control material, not a machine learning model. Therefore, the concept of a "training set" for an algorithm is not applicable. The device itself is the "product," and its stability and assigned values are characterized through direct experimentation.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no "training set" or "ground truth for a training set" in the context of this device. The "assigned values" for the control material are established through "replicate analyses" by the manufacturer and/or independent laboratories.
§ 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.