(69 days)
Liquichek Microalbumin Control is intended for use as an assayed quality control urine to monitor the precision of laboratory procedures listed in the package insert.
Liquichek Microalbumin Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Liquichek Microalbumin Control is prepared from human urine with added constituents of human, pure chemicals, preservatives and stabilizers. The contral is provided in Iliginal form for convenience.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Liquichek Microalbumin Control":
This document is a 510(k) Premarket Notification for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against predefined acceptance criteria in the same way a novel device might. The "acceptance criteria" here are implicitly tied to the performance of the predicate device and the stability of the new control material itself.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this submission (a control material seeking substantial equivalence), the "acceptance criteria" are primarily related to the stability claims, which are demonstrated to be within acceptable limits for a quality control material.
| Acceptance Criteria (Implied from Submission) | Reported Device Performance |
|---|---|
| Open Vial Stability: Able to monitor precision for at least 30 days when stored tightly capped at 2-8 °C. | Open Vial Stability: All analytes stable for 30 days when stored tightly capped at 2-8 °C. |
| Shelf Life (Unopened): Stable for an extended period when stored at 2-8 °C. | Shelf Life: Two years when stored at 2-8 °C (with ongoing real-time studies). |
| Matrix: Human urine based. | Matrix: Human urine based. |
| Form: Liquid. | Form: Liquid. |
| Intended Use: As an assayed quality control urine to monitor precision of laboratory procedures for listed analytes. | Intended Use: As an assayed quality control urine to monitor the precision of laboratory procedures for microalbumin and creatinine. |
Note: The document emphasizes that the new device (Liquichek Microalbumin Control) is substantially equivalent to the predicate device (Liquichek Urine Chemistry Control) in many key characteristics (intended use, form, matrix, storage claims) and simply has a more focused analyte panel. The core "performance data" presented directly relates to the stability of the control material, ensuring it reliably functions as intended during its shelf life and open-vial period.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the traditional sense of a clinical study with patient samples. The performance data presented refers to stability studies conducted on the control material itself.
- Sample Size: Not explicitly stated as a number of samples in the context of a clinical study, but rather implied through the successful completion of stability experiments on the control material.
- Data Provenance: The stability studies were conducted by Bio-Rad Laboratories. The country of origin for the data is implicitly the United States, where Bio-Rad Laboratories is located. The studies are prospective as they track the performance of the control material over time for open-vial and shelf-life stability.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable to this type of submission. This device is a quality control material, not a diagnostic device that interprets clinical data or images requiring expert judgment for ground truth. The "ground truth" for a control material is its chemical composition and stability characteristics, measured through analytical methods.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication" for stability testing of a quality control material. The assessment is based on objective chemical analysis and predefined statistical criteria for stability.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic imaging systems or clinical decision support tools where multiple human readers interpret cases. This document is for a laboratory quality control material.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a laboratory reagent (quality control material), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Chemical Analysis and Reference Measurements: The actual concentrations of microalbumin and creatinine within the control material are determined using validated analytical methods.
- Stability Studies: These studies involve periodically measuring the analyte concentrations in the control material under specified storage conditions (e.g., 2-8 °C) over time to ensure they remain within predefined acceptable limits of variation. This demonstrates the material's consistency and reliability as a control.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device does not have a training set.
§ 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.