(37 days)
Liquid Assayed Multiqual Premium is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
This product is prepared from human serum to which purified biochemical (tissue extracts of human and animal origin), chemicals, drugs, preservatives and stabilizers have been added. The control is provided in liquid form for convenience.
This document is a 510(k) summary for the Bio-Rad Laboratories Liquid Assayed Multiqual Premium. It describes a quality control material intended to monitor the precision of laboratory testing procedures.
The study presented focuses solely on the stability of the device itself, as its intended use is to serve as a quality control material. Therefore, typical acceptance criteria and study designs for diagnostic or AI-powered devices (e.g., sensitivity, specificity, MRMC studies, ground truth established by experts/pathology) are not applicable to this type of device.
Here's the information gleaned from the submission regarding its acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Stability Type | Acceptance Criteria (Stated Claim) | Reported Device Performance (Confirmed by Study) |
|---|---|---|
| Shelf Life Stability | "3 Years at -20 to -70 ℃" | "Acceptance criteria were met to support product as claimed." (Based on Accelerated Stability studies) |
| Thawed & Unopened Vial Stability | "All analytes will be stable for 30 days when the control material is thawed and stored unopened at 2 to 8°C, with the following exceptions: Direct Bilirubin will be stable for 11 days, Triglycerides, HDL, Cholinesterase, and Phosphorus will be stable for 7 days." (From Table 1, Predicate) | |
| Note: The new device claims "All analytes will be stable for 14 days...exceptions: Direct Bilirubin, Triglycerides, HDL, Cholinesterase, and Phosphorus will be stable for 7 days." and the text in Section 8 repeats the 14-day claim. | "All analytes will be stable for 14 days when stored tightly capped at 2 to 8°C, with the following exceptions: Direct Bilirubin, Triglycerides, HDL, Cholinesterase, and Phosphorus will be stable for 7 days." (Based on Real Time Stability studies; there is a discrepancy between the text in Section 8 and the table for the general stability period claim) | |
| Thawed & Opened Vial Stability | "Once the product stopper is punctured, all analytes will be stable for 5 days when stored at 2 to 8°C." (From Table 1, Predicate) | |
| Note: The new device claims "all analytes will be stable for 14 days...exceptions: Direct Bilirubin, Triglycerides, HDL, Cholinesterase, and Phosphorus will be stable for 7 days." | "All analytes will be stable for 14 days when stored tightly capped at 2 to 8℃, with the following exceptions: Direct Bilirubin, Triglycerides, HDL, Cholinesterase, and Phosphorus will be stable for 7 days." (Based on Real Time Stability studies) | |
| Frozen Aliquot Stability | "No claims made." (From Table 1, Predicate) | "AST/SGOT, Direct Bilirubin, HDL, Phosphorus, LDL, and Triglycerides will be stable for 14 days when stored in tightly capped aliquot amber vials at -20 to -70°C." (Based on Real Time Stability studies) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "replicate analyses" and "a representative sampling of this lot of product" for value assignment, and "Real Time Stability studies" and "Accelerated Stability studies" for stability claims. However, specific numbers of samples or batches tested are not provided.
- Data Provenance: The studies were conducted by Bio-Rad Laboratories or "independent laboratories." The data appears to be prospective as it's generated specifically for the stability claims being made for this new device. The country of origin for the data is not specified, but Bio-Rad Laboratories is located in Irvine, California, USA, implying the studies were likely conducted there or overseen by their US operations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device is a quality control material, not a diagnostic or AI device that requires expert interpretation for its "ground truth" performance in a clinical setting. The "ground truth" in this context pertains to the stability of the analytes within the control material, which is determined by analytical measurements against established reference methods, not expert consensus.
- The "Value Assignment" section states that "The mean values and the corresponding ±3SD ranges printed in this Insert were derived from replicate analyses and are specific for this lot of product. Data from Unity™ Interlaboratory Program are included in the determination of some ranges." This indicates analytical testing and interlaboratory data were used to assign values, not expert opinions.
4. Adjudication Method for the Test Set
- Not Applicable. As this is a quality control material stability study, there is no "adjudication method" in the sense of resolving discrepancies in expert interpretations. The stability is determined by meeting pre-defined analytical criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. This is not applicable to a quality control material. MRMC studies are used for evaluating diagnostic performance (e.g., image interpretation) where human readers are involved.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not Applicable. This is a chemical control material, not an algorithm or AI device.
7. The Type of Ground Truth Used
- The "ground truth" for this device is the analytical stability of the constituents (analytes) over time and under various storage conditions. This is established through analytical testing using manufacturer-supported reagents and representative samples of the product. The acceptance criteria for stability (e.g., within certain limits or recovery percentages relative to initial measurements) likely guide the determination of whether the analytes are "stable."
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI or machine learning device that requires a "training set." The product's characteristics are determined through analytical chemistry and stability testing.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.