(28 days)
Liquichek Pediatric Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Liquichek Pediatric Control is prepared from bovine serum with added chemicals. therapeutic drugs, preservatives and stabilizers. The control is provided in liquid form for convenience.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Liquichek Pediatric Control device:
The provided K130963 document is a 510(k) Premarket Notification for a quality control material, not a diagnostic device that performs clinical measurements or generates diagnoses. Therefore, the typical acceptance criteria and study designs (like standalone performance, MRMC studies, expert ground truth for clinical decision-making, large training sets, etc.) for AI/ML-driven diagnostic devices are not applicable.
This document describes a substantial equivalence claim for a laboratory control. The "performance" being evaluated is its stability and its ability to serve as a reliable control material over time.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly related to the stability claims, ensuring the control material remains consistent and effective for its stated duration. The "performance" is the successful demonstration of these stability periods.
| Acceptance Criteria (Implicit) | Reported Device Performance (Claims) |
|---|---|
| Maintained stability when thawed and opened in use. | Thawed and Opened Stability: 14 days at 2 to 8°C |
| Maintained stability when thawed and unopened. | Thawed and Unopened Stability: 45 days at 2 to 8°C or on-board Dimension Vista at 2 to 8°C |
| Maintained stability/shelf life in long-term storage. | Shelf Life Stability: 3 years at -20 to -50°C |
| Equivalent characteristics to the predicate device. | Demonstrated similarity in intended use, form, matrix, and thawed & opened stability to K872227. Differences in fill volume, thawed & unopened stability duration, storage temperature, and specific analytes were noted but deemed acceptable for substantial equivalence due to the stability studies. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "replicate analyses" and "representative sampling of this lot of product" for value assignment and stability studies. However, specific sample sizes (number of vials, number of runs, etc.) for the stability studies are NOT provided in this public summary.
- Data Provenance: Not explicitly stated regarding country of origin, but the testing was performed by "the manufacturer and/or independent laboratories." The studies are prospective in nature, as they are "real-time stability studies" and "accelerated stability studies" specifically conducted to establish the claims.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable in the typical sense for a diagnostic device. For this quality control material, the "ground truth" for analytes is established through value assignment and stability testing using validated analytical methods. This involves laboratory instruments and established chemical/biological testing procedures, not interpretation by human clinical experts. The "experts" would be analytical chemists or clinical laboratory scientists operating the testing equipment.
4. Adjudication Method for the Test Set
- Not applicable. This isn't a scenario requiring adjudication between human readers or algorithms in a diagnostic context. The "adjudication" would be based on the established analytical methods meeting predefined laboratory performance criteria for stability, precision, and accuracy compared to the predicate and internal specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No such study was done. MRMC studies are used for diagnostic devices where human interpretation is involved, often to assess the impact of AI assistance. This device is a quality control material and does not involve human readers making clinical interpretations.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable in the typical sense. This device is a material used within laboratory testing procedures, not a standalone algorithm. The "performance" is its physical and chemical stability over time, as assessed by analytical instruments, not an AI algorithm's output.
7. Type of Ground Truth Used
- The "ground truth" for this device relates to the assigned values for the analytes and the stability of these values over time under various storage conditions. This is established through:
- Validated analytical methods: The analytes' concentrations are determined using standard laboratory instruments and assays.
- Reference materials/calibrators: Primary calibrators or reference materials would be used to ensure the accuracy of the assigned values.
- Stability protocols: Real-time and accelerated stability studies are conducted according to predefined protocols to determine how long the analyte values remain within acceptable limits.
8. Sample Size for the Training Set
- Not applicable. This device is a quality control material, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI/ML algorithm and no training set, this question is not relevant to the provided submission.
§ 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.