(235 days)
The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is assayed quality control material consisting of two sets of five levels of aqueous buffer. Each level of Set 1 contains the following analytes: Phosphorous, Urea Nitrogen, Uric Acid. Each level of Set 2 contains the following analytes: Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin, These five levels of each set demonstrate a linear relationship to each other for their respective analytes, reagents and instruments.
The product is intended for use with quantitative assays on the indicated analyzer specified in the labeling. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is "For In Vitro Diagnostic Use Only".
The Audit® MicroCV™ Urine/Fluids Chemistry Linearity is a aqueous buffer based, lyophilized, two five level sets of QC material, with each level of the first set containing Phosphorous, Urea Nitrogen, Uric Acid.and the second set containing Amylase, Calcium, Chloride, Creatinine, Glucose, Magnesium, Microalbumin, Microprotein, Potassium, Sodium. It is used to confirm the proper calibration, linear operating range, and reportable range of Phosphorous, Urea Nitrogen, Uric Acid, Amylase, Calcium, Chloride, Creatinine, Glucose, Magnesium, Microalbumin, Microprotein, Potassium, Sodium Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B - D are related by linear dilution of Level A and Level E.
The provided text describes a 510(k) premarket notification for a medical device called "Audit® MicroCV™ Urine/Fluids Chemistry Linearity". This device is a quality control material used to confirm the proper calibration, linear operating range, and reportable range of various analytes in urine and fluid chemistry.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission claims substantial equivalence to a predicate device (Audit® MicroCV™ General Chemistry Linearity Set (K042318)). The performance criteria are primarily focused on stability and linearity, demonstrating that the new device performs similarly to the predicate.
| Characteristic | Acceptance Criteria (Implied by Substantial Equivalence to Predicate K042318) | Reported Device Performance (Audit® MicroCV™ Urine/Fluids Chemistry Linearity K111964) |
|---|---|---|
| Intended Use | Assayed QC material demonstrating linear relationship for analytes, reagents, and instruments. For in vitro diagnostic use. | The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is assayed quality control material consisting of two sets of five levels of aqueous buffer. These five levels of each set demonstrate a linear relationship to each other for their respective analytes, reagents and instruments. "For In Vitro Diagnostic Use Only". |
| Number of Analytes | Set 1: 30 analytes (for predicate General Chemistry) | Set 1: 3 analytes (Phosphorous, Urea Nitrogen, Uric Acid) |
| Set 2: 11 analytes (Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin) | ||
| Number of Levels per Set | 5 | 5 |
| Contents | 5 x 5 mL | 10 x 2 mL |
| Matrix | Human Based Serum | Aqueous Based Buffer |
| Type of Analytes | Albumin, ALP, ALT, Amylase, AST, Bilirubin (Total and Direct), BUN, Calcium, Chloride, Cholesterol, CO2, Creatine Kinase, Creatinine, Gamma-GT, Glucose, Iron, HDL Cholesterol, Lactate, LDH, LDL Cholesterol, Lipase, Magnesium, Phosphorus, Potassium, Sodium, Total Protein, Triglycerides and Uric Acid. | Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin, Phosphorous, Urea Nitrogen, Uric Acid. |
| Form | Lyophilized | Lyophilized |
| Storage | 2 to 8° C Until expiration date | 2 to 8° C Until expiration date |
| Reconstituted Stability | 1 day at 2 to 8° C | Set 1: 72 hours at 2 to 8° C |
| Set 2: 10 days at 2 to 8° C | ||
| Shelf Life | Demonstrated by predicate. | One year, when stored unopened at 2 - 8º C. (Real-time studies ongoing). |
Note: The acceptance criteria for the new device are implicitly met by demonstrating substantial equivalence to the predicate device. The performance data provided are the reported characteristics of the new device itself, which are compared to those of the predicate. The key "proof" is that these characteristics are considered acceptable, given the similarity to the predicate, even if the new device has different analytes or matrix type (which is discussed in the context of substantial equivalence).
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Stability studies have been performed to determine the reconstituted stability and shelf life for the Audit® MicroCV™ Urine/Fluids Chemistry Linearity Set. All supporting data is retained on file at Aalto Scientific, Ltd."
- Sample Size: Not explicitly stated in the provided text.
- Data Provenance: The studies were conducted by Aalto Scientific, Ltd. (the manufacturer). The text does not specify the country of origin for the data or whether it was retrospective or prospective, though "real time studies are ongoing" for shelf life, indicating a prospective component for that aspect.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to the validation of a chemistry linearity quality control material. The "ground truth" for linearity sets is established through analytical methods and statistical analysis, not expert interpretation of images or patient data. The manufacturer would establish the expected linear relationship of the analyte concentrations within the different levels of the control material through precise preparation and analytical testing.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert review of ambiguous data (e.g., medical images) to establish a consensus ground truth. For a chemistry linearity control, the "ground truth" is determined by the meticulously prepared concentrations and subsequent analytical measurements.
5. 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 device is a quality control material for chemistry analyzers, not an AI-powered diagnostic tool requiring human interpretation. Therefore, MRMC studies and the concept of AI assistance for human readers are irrelevant in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or an AI product. It is a physical chemical solution used to calibrate and verify the linearity of laboratory instruments.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is the analytically determined concentrations and the designed linear relationship among the different levels of the control material. The manufacturer would have precisely formulated each level to have specific, known concentrations of the analytes, creating an expected linear progression. The performance study verifies that both the stability and the linearity of these known concentrations are maintained over time and storage conditions with analytical testing.
8. The Sample Size for the Training Set
Not applicable. As a quality control material, there is no "training set" in the context of machine learning or AI. The product is manufactured to a specific formulation and then tested to demonstrate its characteristics.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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.