(29 days)
Liquichek Cardiac Markers Plus Control LT is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Liquichek Cardiac Markers Plus Control LT is prepared from human serum with added constituents of human and animal origin, chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.
The provided text describes a quality control material (Liquichek Cardiac Markers Plus Control LT) and its substantial equivalence to a predicate device. It is not a medical device that diagnoses, treats, or monitors a disease, so the concept of an "algorithm" and many of the requested criteria (like ground truth, expert readers, MRMC studies, effect size, etc.) are not applicable here.
However, I can extract the relevant information regarding its acceptance criteria (primarily stability) and the studies conducted to demonstrate that it meets these criteria.
Acceptance Criteria and Device Performance
This device is a quality control material, and its performance is primarily assessed by its stability under various conditions. The "acceptance criteria" here relate to the claimed stability parameters.
| Acceptance Criteria (Stability Claim) | Reported Device Performance (Study Result) |
|---|---|
| Thawed and Opened: | 10 days at 2 to 8°C |
| Thawed and Unopened: | 10 days at 2 to 8°C |
| Shelf Life Stability: | 32.5 months at -20 to -50°C |
Note: The text explicitly states, "Based on the available data, product claims are as follows:", indicating these are the accepted specifications derived from the studies.
Study Information
-
Sample size used for the test set and the data provenance:
- The document does not explicitly state a numerical sample size for the test set. It 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. This implies multiple samples were tested over time.
- Data Provenance: The studies were conducted by the manufacturer, Bio-Rad Laboratories, and/or independent laboratories. The country of origin of the data is not specified but is presumably the USA, where Bio-Rad Laboratories is based. The studies appear to be prospective as they are "real-time stability studies" and "accelerated stability studies" specifically designed to establish the claims.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a quality control material, not a diagnostic device that requires expert interpretation for "ground truth." Its "truth" is its inherent stability and the concentrations of analytes within it, determined through analytical methods, not expert consensus.
-
Adjudication method for the test set:
- Not applicable. There is no adjudication method described as this is a quality control material and not a device whose performance is determined by human interpretation.
-
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 is a quality control material, not an AI-powered diagnostic device. No human reader studies (MRMC or otherwise) were conducted or are relevant.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device does not involve an algorithm. Its performance is chemical and physical stability.
-
The type of ground truth used:
- Analytical Measurement/Internal Standards: The "ground truth" for this device's performance (i.e., its stability and assigned values) is established through rigorous analytical testing using established laboratory methods and possibly reference materials or calibrated instruments. The document mentions "mean values and the corresponding ±3SD ranges printed in this insert were derived from replicate analyses."
-
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device, so there is no training set.
-
How the ground truth for the training set was established:
- Not applicable. As above, no training set is involved.
§ 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.