(308 days)
Liquichek Cardiac Markers Plus Control LT is intended for use as a quality control serum to monitor the precision of laboratory testing procedures listed in the package insert.
The following analytes are listed in the package insert: B-type Natriuretic Peptide (BNP) CK-MB Isoenzyme C-Reactive Protein (CRP) Creatine Kinase (CK) D-dimer Digitoxin Homocysteine Myeloperoxidase (MPO) Myoglobin N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) Troponin I Troponin T
Liquichek Cardiac Markers Plus Control LT is prepared from human serum with added constituents of human and animal origin, stabilizers and preservatives. This product 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 document is a 510(k) premarket notification summary for a quality control material, not an AI/ML medical device. Therefore, many of the requested categories for AI/ML device studies are not applicable.
However, I can extract information relevant to the 'acceptance criteria' and 'study' framework as much as possible for this type of device, focusing on stability studies which are analogous to performance studies for these materials.
1. Table of Acceptance Criteria and Reported Device Performance
For a quality control material, "acceptance criteria" often refer to the established stability periods under various conditions, which are then met by "reported device performance" through stability studies.
| Acceptance Criteria (Stability Goal) | Reported Device Performance (Stability Achieved) |
|---|---|
| Thawed and Opened Stability: | |
| NT-proBNP: 15 days at 2 to 8°C | 15 days at 2 to 8°C |
| Troponin I: 10 days at 2 to 8°C | 10 days at 2 to 8°C |
| BNP: 8 days at 2 to 8°C | 8 days at 2 to 8°C |
| Troponin T: 4 days at 2 to 8°C | 4 days at 2 to 8°C |
| All other analytes: 20 days at 2 to 8°C | 20 days at 2 to 8°C |
| Frozen Aliquot Stability: | |
| 30 days at -20 to -70°C | 30 days at -20 to -70°C |
| Shelf Life Stability: | |
| Until expiration (goal) | 36 months at -20 to -70°C |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify exact sample sizes for the stability studies (e.g., number of lots, replicates per time point). It mentions "replicate analyses" were used to derive mean values and ranges for value assignment and that "a representative sampling of this lot of control" was used for testing.
- Data Provenance: The studies were performed by the manufacturer, Bio-Rad Laboratories, and/or independent laboratories. The document does not specify the country of origin of the data, but the manufacturer is based in Irvine, California, USA. The studies are prospective in nature, as they are real-time and accelerated stability studies conducted on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- This question is not applicable. For a quality control material, analytical values (the "ground truth" equivalent for performance testing) are established through "value assignment" processes using validated laboratory methods and instruments, not by expert consensus from individuals like radiologists. The document states: "The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents."
4. Adjudication Method for the Test Set
- This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical image interpretation or clinical decision-making studies, not for the analytical performance of laboratory quality control materials.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools that involve human interpretation of medical images or data. The device here is a quality control material intended to monitor the precision of laboratory testing procedures.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable. This device is a quality control material, not an algorithm or AI system. Its "performance" is its stability and its ability to provide target values for laboratory instruments.
7. The Type of Ground Truth Used
- For the value assignment (which serves as the "ground truth" for expected analytic values), laboratory results from specific analytical methods and instruments are used. The document states, "The mean values and the corresponding ±3SD ranges printed in this insert 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 this lot of control." This is essentially analytical reference values established by validated laboratory testing.
8. The Sample Size for the Training Set
- This question is not applicable. This device is a quality control material and does not involve AI/ML algorithms that require training sets.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable, as there is no training set for this device.
§ 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.