(56 days)
AlbuTrol is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Urine Albumin and HemoCue® Albumin 201 systems.
AlbuTrol is an assayed urine albumin control material. AlbuTrol control material is filled of in dropper bottles. Each dropper bottle contains 1.0 mL human urine with a specific amount of human albumin. AlbuTrol provides two physiologically relevant levels covering the clincally interesting ranges of urine albumin: ~25 mg/L albumin and ~75 mg/L aboumin. The assigned values of each batch are printed on both the carton box and the dropper bottles.
AlbuTrol is packed in carton boxes. Each carton box contains 2 dropper bottles of the same level on a carton tray. An insert with Intended Use is packed in each box of album of the
The provided text describes the 510(k) summary for AlbuTrol, a quality control material. It focuses on the product's description, intended use, technological characteristics, and a brief statement about performance assessment.
However, the document does not contain the detailed study information required to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:
- Explicit acceptance criteria: The document states that AlbuTrol is for "verification of the precision and accuracy" of HemoCue systems, but it does not specify quantitative targets or thresholds for this precision and accuracy (e.g., a specific coefficient of variation, bias limits, etc.).
- Detailed study methodology: It mentions "Studies were conducted in-house to demonstrate the performance," but provides no details about these studies, such as sample sizes, ground truth establishment, expert qualifications, or adjudication methods.
- Reported device performance: While it assures performance, it doesn't present actual results against any criteria.
- Information on training sets, MRMC studies, or standalone performance.
Therefore, I cannot populate most of your requested tables and sections based solely on the provided text.
Here's an attempt to answer based on the limited information available, with significant gaps noted:
Acceptance Criteria and Reported Device Performance
Note: The provided document does not explicitly state quantitative acceptance criteria or detailed reported performance values. It only generically states the material's purpose is for "verification of the precision and accuracy."
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document) |
|---|---|---|
| Precision | (e.g., %CV |
§ 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.