(100 days)
Liquichek Immunoassay premium Control 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.
Liquichek immunoassay Premium Control is prepared from human serum with added constituents of human and animal origin, chemicals, therapeutic drugs, stabilizers and preservatives. The control is provided in liquid form for convenience.
The provided text is for a 510(k) premarket notification for a medical device called "Liquichek Immunoassay Premium Control." This device is a quality control material and as such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" refers to the stability testing of the control material itself, rather than diagnostic accuracy or clinical effectiveness for patient diagnosis.
Here's the breakdown of the information requested, based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Study Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Thawed Opened Stability | Recovery result on final day (TFinal) being ± 10% of the recovery result of time zero vial (Tzero) | 14 days at 2 to 8°C (for most analytes) |
| Thawed Unopened Stability | Recovery result on final day (TFinal) being ± 10% of the recovery result of time zero vial (Tzero) | 28 days at 2 to 8°C (for most analytes) |
| Frozen Aliquot Stability | Recovery result on final day (TFinal) being ± 10% of the recovery result of time zero vial (Tzero) | 28 days at -20°C to -70°C |
| Shelf Life Stability* | Recovery result on final day (TFinal) being ± 10% of the recovery result of time zero vial (Tzero) | 28 Months at -20°C to -70°C (for most analytes) |
*Note: Real-time stability studies are ongoing to support the shelf life, implying that the 28-month claim is based on accelerated stability studies or early real-time data which met the criteria.
2. Sample size used for the test set and the data provenance
The document states that the mean values and ±3SD ranges for the control were derived from "replicate analyses," and that "Data from Unity™ Interlaboratory Program are included in the determination of some ranges." The stability studies involved testing the control at different time points (TFinal vs. Tzero).
- Sample Size (Test Set): Not explicitly stated as a single number. The term "replicate analyses" suggests multiple measurements were taken, but the exact number of replicates, samples, or lots tested for stability is not provided.
- Data Provenance: The studies were conducted by Bio-Rad Laboratories ("the manufacturer") and/or "independent laboratories using manufacturer supported reagents." The data would be prospective for the stability studies, as specific protocols would have been followed to test the device over time. The country of origin for the data is not specified, but Bio-Rad Laboratories is based in Irvine, California, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device. The "ground truth" for a quality control material like the Liquichek Immunoassay Premium Control is its known concentration of analytes and its stability over time. Ground truth is established through rigorous internal testing and value assignment processes, not expert consensus in the diagnostic sense, pathology, or outcomes data.
4. Adjudication method for the test set
Not applicable. As described above, this is a quality control material where the "ground truth" is measured analytical values, not expert interpretation requiring 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 device is a quality control material and does not involve human readers, AI, or diagnostic interpretation of cases. Its purpose is to monitor the precision of laboratory testing procedures performed by instruments.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical control material, not an algorithm or software. It is used in conjunction with laboratory instruments to ensure their accurate performance.
7. The type of ground truth used
The ground truth for this device is the assigned analyte concentrations (mean values) and expected stability performance over time. This is established through internal testing (replicate analyses by the manufacturer and/or independent laboratories) and comparison against specified acceptable ranges (e.g., ±10% recovery from Tzero).
8. The sample size for the training set
Not applicable. As a quality control material, there is no "training set" in the context of machine learning. The "value assignment" process involves establishing the target values and ranges for each analyte in a given lot of the control, which is an analytical characterization process.
9. How the ground truth for the training set was established
Not applicable, as there is no training set. The "value assignment" for the control material is done through "replicate analyses" by the manufacturer and/or independent laboratories, with "Data from Unity™ Interlaboratory Program" also included in some determinations. Each laboratory is then recommended to establish its own acceptable ranges, using the provided values as guides.
§ 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.