(30 days)
Liquichek Immunoassay Plus 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 Plus 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. Each human donor unit used to manufacture this control was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2. This product may also contain other human source material for which there are no approved tests.
This submission describes the Liquichek Immunoassay Plus Control, a quality control serum for laboratory testing. The primary focus of the provided text is on demonstrating substantial equivalence to a predicate device and outlining stability studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Study Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Thawed Opened Stability | Recovery result on final day (T_final) is ± 10% of the recovery result of freshly opened vial (T_zero) | 4 days at 2 to 8°C (meets criteria as this is the claimed stability) |
| Thawed Unopened Stability | Recovery result on final day (T_final) is ± 10% of the recovery result of freshly opened vial (T_zero) | 4 days at 2 to 8°C (meets criteria as this is the claimed stability) |
| Shelf Life Stability (unopened) | Recovery result on final day (T_final) is ± 10% of the recovery result of freshly opened vial (T_zero) | 28 Months at -20°C to -50°C (meets criteria as this is the claimed stability) |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state the sample size (number of vials or runs) for the stability studies. It mentions "a representative sampling of this lot of product" was used for value assignment and, by implication, for the stability studies.
Data provenance is from Bio-Rad Laboratories, the manufacturer based in Irvine, California, USA. The studies appear to be prospective as they were conducted to establish claims for the new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The "ground truth" for the stability studies on a quality control material would typically involve laboratory measurements and statistical analysis, rather than expert interpretation in the way a diagnostic image might. The document states that "The tests listed were performed by the manufacturer and/or independent laboratories."
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of stability studies for a control material, a traditional adjudication method (like 2+1, 3+1 for clinical images) is not applicable. The acceptance criteria are based on quantitative recovery results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not performed. This type of study is typically relevant for diagnostic imaging systems where human readers interpret results, and the AI's impact on their performance is being evaluated. This device is a quality control material, not a diagnostic AI system for interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study in the context of an AI algorithm was not performed. The "performance" studies described are stability studies for a laboratory control material, which inherently describe the material's performance over time. The device itself is not an algorithm that produces interpretations or diagnoses.
7. Type of Ground Truth Used
For the stability studies, the "ground truth" is defined by the initial recovery results of freshly opened vials (T_zero) for each analyte, which are then compared to subsequent measurements (T_final). These are objective quantitative measurements obtained through laboratory testing using manufacturer-supported reagents and methods.
8. Sample Size for the Training Set
This information is not applicable/not provided. The device is a quality control material, not an AI algorithm that requires a "training set" in the conventional machine learning sense. The "value assignment" for the control material is derived from "replicate analyses," but this is not a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided as there is no "training set" for an AI algorithm. The "mean values and the corresponding ±3SD ranges printed in this insert were derived from replicate analyses" performed 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.