(30 days)
UA-Cellular® Complete is an assayed chemistry and cellular urine control for evaluating the accuracy and precision of automated procedures that measure urinary sediment and chemistry parameters on the following instruments and testing methods: Sysmex® UF-1000i™ Automated Urine Particle Analyzer: Siemens® Clinitek Atlas Automated Urine Chemistry Analyzer utilizing the Clinitek Atlas 10 Reagent Pak; the Arkray AUTION HYBRID™ AU-4050 fully-automated integrated urine analyzer: utilizing the Aution sticks 10EA Reagent strips: Siemens Clinitek Status® line of automated chemistry strip reader analyzers; Manual Reading of Urine Refractive Index; Manual Reading of the Siemens Multistix® 10SG Reagent Strips, and the Siemens Clinitest® hCG Pregnancy test.
The list of assayed parameters includes:
Sysmex® UF-1000i™: RBC(/uL), WBC(/uL), Epithelial (/uL), Cast (/uL), Bacteria (/uL), Crystals
Arkray AU-4050: RBC(/uL), WBC(/uL), Epithelial (/uL), Cast (/uL), Bacteria (/uL), Crystals
Arkray AU-4050 with Aution sticks 10EA Reagent strips : Glucose (mg/dL), Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), pH (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured), Color (As Measured), Turbidity (As Measured)
Siemens ® Clinitek Atlas with Atlas 10 Reagent Pak: Glucose (mg/dL), Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured), Color (As Measured), Clarity (As Measured)
Siemens Clinitek Status System line with Multistix 10SG Reagent Strips: Glucose (mg/d); Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Mesured), pH (As Measured), Protein (me/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured)
Siemens Multistix 10SG Reagent Strips: Glucose (mg/dL), Bilirubin (As Measured), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As measured)
Siemens Clinitest hCG Pregnancy Test Cassette: Pregnancy hCG (As Measured)
Manual Confirmatory Testing: Refractive Index (nD)
UA-Cellular® Complete is a three-level, in-vitro diasis control that contains the following: stabilized mammalian red blood cells and white blood cells, stabilized bacteria, and simulative medium. Analyte levels are adjusted with appropriate chenicals. The product is packaged in a 4 oz. amber plastic bottle with a foil-lined flip-top cap. The product must be stored at 2-10°C.
The provided text describes the UA-Cellular® Complete device, a quality control material for urinalysis instruments, and studies performed to demonstrate its performance and stability.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format for each specific parameter (e.g., RBC count, glucose level). Instead, it describes acceptance as:
- Cellular study: "acceptable if the mean of each run was within the acceptable range of control."
- Chemistry study: "considered acceptable if it was in agreement with the assigned range/concentration."
The reported device performance is broadly stated as:
- "All data collected fell within the acceptance criteria established for each instrument."
- "Study results show UA-Cellular Complete to be consistently equivalent to the predicate products, and stable for the entire product dating."
- "UA-Cellular Complete is a safe and effective product, which fulfills its intended use when used as instructed in the Instructions for Use."
2. Sample Size Used for the Test Set and Data Provenance
The studies primarily focus on precision and stability testing of the quality control material itself, rather than a clinical trial with patient samples as a "test set" in the typical sense for a diagnostic device.
Multi-Site Precision Study (Test Set equivalent for evaluating the QC material's performance):
- Cellular Instrument Study (Arkray AU4050): Conducted across 3 instruments at three different sites. A single operator at each site ran each lot and level of control for 5 days, 2 runs per day, and 3 replicates per run.
- Chemistry Instrument Study: Not explicitly stated as a number of samples but implied by the different instruments/methods used. "Each site was instructed to run at minimum one 10-run."
- Data Provenance: Not explicitly stated as country of origin, but described as "Multi-Site," indicating data from multiple locations, likely within the US, given the FDA submission. The studies are prospective as they were conducted to substantiate the product performance.
Single-Site Precision Study:
- Cellular Instrument Study (UF-1000 and Arkray AU4050): Conducted with three separately manufactured lots of control. The "20x2x2 model" was followed: Two vials of control were used for each testing interval, and each vial of control was run in duplicate. This means 20 days x 2 vials x 2 replicates = 80 measurements per lot/level. Data was collected internally at Streck.
- Chemistry Instruments/Manual Methods Study: Conducted with three separately manufactured lots of control. The "20x2x2 model" was followed as above. Data was collected internally at Streck.
- Data Provenance: Internally collected at Streck. Prospective.
Open-Vial Stability Study:
- Cellular Instrument Study (UF-1000 and Arkray systems): Conducted with three separately manufactured lots of control. One vial of control per level from each lot was analyzed over 30 days plus one additional time point. Four replicates were taken during each testing event. Data was collected internally with one operator.
- Chemistry Instrument Study: Conducted with three separately manufactured lots of control for each representative instrument/method. One vial of control per level from each lot was analyzed over 30 days plus one additional time point. Four replicates were taken during each testing event.
- Data Provenance: Internally collected at Streck. Prospective.
Closed-Vial Stability Study:
- Cellular Instrument Study (UF-1000 and Arkray systems): Conducted with three separately manufactured lots of control. Two vials of control per level from each lot were analyzed in duplicate over 100 days plus one additional time point. Four data points were collected at each testing event. Data was collected internally with one operator.
- Chemistry Instrument Study: Conducted with three separately manufactured for each representative instrument/method. One vial of control per level from each lot was analyzed over 100 days plus an additional time point. Four replicates were taken during each testing event.
- Data Provenance: Internally collected at Streck. Prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This device is a quality control material, not a diagnostic device that interprets patient data. Therefore, the concept of "ground truth" established by experts (like radiologists for image interpretation) for a "test set" of patient cases is not directly applicable.
Instead, the "ground truth" for this product is the assigned range/concentration of the analytes within the control material, determined by the manufacturer through rigorous characterization and validation processes not explicitly detailed in this summary (though typically involves reference methods and multiple testing events). The studies described here verify that the device performs within those pre-defined ranges.
4. Adjudication Method for the Test Set
Not applicable in the context of this type of device and study. The studies assess the control material's performance against its own established ranges/concentrations, not an interpretation of patient data requiring adjudication.
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 diagnostic devices where human readers (e.g., radiologists) interpret cases, and the study aims to show how AI assistance affects their diagnostic performance compared to reading without AI. UA-Cellular® Complete is a quality control material used to assess the performance of laboratory instruments, not for direct human interpretation of patient data or for AI-assisted diagnostic tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies described are essentially "standalone" in the sense that they evaluate the performance of the UA-Cellular® Complete material on automated instruments without active human interpretive intervention for each "case." The human role is in performing the tests according to protocols and analyzing the resulting quantitative data.
7. The Type of Ground Truth Used
The ground truth for these studies is the assigned range/concentration for each analyte (e.g., RBC, glucose, pH) within the UA-Cellular® Complete material, established by the manufacturer. The studies then demonstrate that the device, when run on various instruments, consistently produces results that fall within these pre-defined acceptable ranges. This is an intrinsic property of the quality control material itself, rather than an external reference standard like pathology or outcomes data from patients.
8. The Sample Size for the Training Set
This document describes performance and stability studies for a quality control material. It does not mention a "training set" in the context of machine learning or AI models. The device itself (UA-Cellular® Complete) is a physical control material, not an algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
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.