(25 days)
The Hematronix qUAntify™ Control System is a liquid, ready-to-use, urine dipstick control. No reconstitution or dilution is required. The control is prepared from human source material and predetermined chemicals. Controls evaluate the quality of day-to-day test performance. The qUAntify Control System is used to determine accuracy and precision in the measurement of the physical and chemical tests commonly employed in semiquantitative urine dipstick testing. Alternative tests such as the Glucose (Clinites), Bilirubin (Ictotest) and Ketone (Acetest) are also assayed. This control can be used to quality control the specified urine hCG tests. Two distinct levels are included to verify the recovery of normal and elevated patient values.
The Hematronix qUAntify™ Control System is a liquid, ready-to-use, urine dipstick control. No reconstitution or dilution is required. The control is prepared from human source material and predetermined chemicals.
This document describes the qUAntify™ Control System, a liquid, ready-to-use urine dipstick control. It is intended to determine accuracy and precision in the measurement of physical and chemical tests commonly employed in semiquantitative urine dipstick testing.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the qUAntify™ device are established by demonstrating substantial equivalence to the predicate device, Kenlor Liquid Urine Control. The performance is deemed acceptable if the observed ranges for various analytes fall within the published ranges of the predicate device.
| Analyte | qUAntify (Level I - Normal) Reported Performance | Kenlor (Level I - Normal) Predicate Range (Acceptance Criteria) | qUAntify (Level II - Abnormal) Reported Performance | Kenlor (Level II - Abnormal) Predicate Range (Acceptance Criteria) |
|---|---|---|---|---|
| Specific Gravity | 1.020 ±.005 | 1.010 ±.005 | 1.010-1.015 | 1.005-1.015 |
| pH | 6 ±.5 | 5.5 ±.5 | 8 | 7-8 |
| Leukocytes | Not reported for Level I | Not reported for Level I | ++ | + |
| Nitrite | Not reported for Level I | Not reported for Level I | + | + |
| Protein | Not reported for Level I | Not reported for Level I | 100 | 100 |
| Glucose | Not reported for Level I | Not reported for Level I | 250-500 | 250-350 |
| Ketones | Not reported for Level I | Not reported for Level I | ++ | ++ |
| Urobilinogen | Not reported for Level I | Not reported for Level I | 1-8 | 1-4 |
| Bilirubin | Not reported for Level I | Not reported for Level I | ++ | +++ |
| Hemoglobin | Not reported for Level I | Not reported for Level I | 250 | 250 |
| HCG | Not reported for Level I | Not reported for Level I | + | + |
Note: The table shows that while most qUAntify ranges align well with or encompass the Kenlor ranges, there are some differences. For instance, qUAntify's Specific Gravity for Level I is higher, pH for Level I is higher, Glucose for Level II has a wider upper range, Leukocytes is "++" for qUAntify vs. "+" for Kenlor, Urobilinogen has a wider range for qUAntify, and Bilirubin is "++" for qUAntify vs. "+++" for Kenlor. The document states that the ranges were "substantially equivalent," implying these differences were considered acceptable for equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "qUAntify was evaluated on several instruments for all 11 analytes." However, it does not specify an exact sample size (e.g., number of batches, number of individual tests performed).
- Data Provenance: The document does not explicitly state the country of origin for the data. Given the address provided for Hematronix, Inc. is in California, USA, it is highly probable the testing was conducted in the USA. The study appears to be retrospective in the sense that the qUAntify data was collected and then compared against the published package insert data of the predicate device, which would also be retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The ground truth for this device (urine control) is based on pre-established acceptable ranges of analyte concentrations, which are then used to verify the performance of a new control material.
- The document does not mention the direct involvement of experts in establishing the ground truth for this specific study. Instead, it relied on the published ranges from the predicate device's package inserts.
- Therefore, there is no information provided on the number or qualifications of experts directly involved in establishing the ground truth for this test set; rather, it leveraged existing, published standards from a comparator product.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method in the traditional sense (e.g., 2+1 physician review). The evaluation was a direct comparison of the instrument's readings of the qUAntify control against the pre-defined accepted ranges of the predicate device. If readings fell within the expected range, they were considered acceptable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. This type of study typically evaluates human performance with and without AI assistance, which is not applicable to a quality control material like qUAntify.
6. Standalone Performance Study
Yes, a standalone performance study was done for the qUAntify device. The document explicitly states: "qUAntify was evaluated on several instruments for all 11 analytes. The ranges observed were compared to published analytes. analy of the same analytes in package inserts provided with Kenlor's Liquid Urine Control." This describes the device (control material) being tested independently to determine its performance characteristics.
7. Type of Ground Truth Used
The type of ground truth used was predicate device performance data. Specifically, the published ranges for the 11 analytes in the package inserts of Kenlor's Liquid Urine Control served as the ground truth or "acceptance criteria" against which qUAntify's observed performance was compared.
8. Sample Size for the Training Set
The document is for a urine dipstick control material, not a machine learning or AI algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable. The control material itself is the "device," and its composition is predetermined, not "trained."
9. How the Ground Truth for the Training Set Was Established
As stated in point 8, the concept of a training set is not applicable to this device. For the control material itself, its "ground truth" (i.e., its expected analyte concentrations and ranges) would have been established during its manufacturing and characterization process, likely through analytical chemistry methods and repeated testing to ensure consistency and assign values. However, the document does not detail this internal process for qUAntify.
§ 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.