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510(k) Data Aggregation
(130 days)
ABX PENTRA Glucose HK CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 for quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose hexokinase method by colorimetry. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
ABX PENTRA Uric Acid CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 for quantitative in vitro diagnostic determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric bench top clinical chemistry analyzer.
The ABX PENTRA Glucose HK CP is an in vitro diagnostic assay for the quantitative determination of glucose in human serum, plasma and urine based on an enzymatic method using hexokinase coupled with glucose-6-phosphate dehydrogenase. It is composed of a bi-reagent cassette, with 56 ml and 14 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Uric Acid CP is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). It is composed of a bi-reagent cassette, with 60 ml and 15 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annex, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.
Here's a breakdown of the acceptance criteria and study information for the ABX PENTRA Glucose HK CP and ABX PENTRA Uric Acid CP, focusing on the added urine sample performance. The ABX PENTRA Urine Control L/H is simply a control for these assays and its performance is described in terms of stability, not analytical performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (ABX PENTRA Glucose HK CP - Urine) | Reported Device Performance (ABX PENTRA Uric Acid CP - Urine) |
|---|---|---|---|
| Limit of Blank | Not explicitly stated | 1.95 mg/dl | 2.33 mg/dl |
| Limit of Detection | Not explicitly stated | 2.9 mg/dl | 3.49 mg/dl |
| Limit of Quantitation | Not explicitly stated | 3.3 mg/dl | 5.20 mg/dl |
| Accuracy and Precision | CV Total < 5% (Implied) | CV Total < 4.82% | CV Total < 4.36% |
| Linearity | Adequate range for clinical use (Implied) | 3.9 mg/dl - 900 mg/dl | 5.20 mg/dl - 252 mg/dl |
| Measuring range | Adequate for clinical use (Implied) | 3.9 mg/dl - 900 mg/dl (up to 2700 mg/dl with auto-dilution) | 5.20 mg/dl - 252.00 mg/dl (up to 756.00 mg/dl with auto-dilution) |
| Correlation (R²) vs. Reference | > 0.99 (Implied, from context of "correlation coefficient") | r² = 0.997 (Y = 0.96 x + 0.84 mg/dl) | r² = 0.9949 (Y = 1.01 x + 0.99 mg/dl) |
| Calibration stability | Not explicitly stated | 21 days | 15 days |
| Reagent stability (closed) | Not explicitly stated | 36 months at 2-8°C | 36 months at 2-8°C |
| Reagent stability (on-board) | Not explicitly stated | 55 days (refrigerated area) | 41 days (refrigerated area) |
Note: The document states that the performance testing data demonstrated that the devices "met all acceptance criteria." However, explicit numerical acceptance criteria are not provided for all metrics. The reported performance values themselves serve as the demonstration of meeting internal acceptance criteria. For correlation, an R² value of >0.99 is generally considered excellent in such studies, hence the implied criterion. For CV Total, often <5% is an industry standard for analytical precision.
2. Sample Size Used for the Test Set and Data Provenance
- Glucose HK CP:
- Sample Size: n=208 (for correlation study on urine samples).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This information is typically proprietary. The submission is from France, which might imply data from that region, but it's not confirmed. It's likely retrospective data collection from clinical samples.
- Uric Acid CP:
- Sample Size: n=226 (for correlation study on urine samples).
- Data Provenance: Not explicitly stated (same as above).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "devices" in question are in vitro diagnostic assays for quantitative determination of analytes (glucose and uric acid). The "ground truth" for these tests is established by a reference method or a comparative device, not by expert interpretation of images or clinical cases.
4. Adjudication Method for the Test Set
This is not applicable as the ground truth is established by a quantitative measurement method, not through expert scoring or review requiring adjudication.
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
This is not applicable. This submission concerns quantitative in-vitro diagnostic assays, not AI-assisted image interpretation or clinical decision support systems involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. These are reagent-based assays run on an automated analyzer (ABX PENTRA 400), not standalone algorithms. Their performance is inherently "standalone" in the sense that the analyzer provides a direct quantitative result.
7. The Type of Ground Truth Used
The ground truth used for these quantitative assays is a comparative method or reference method. The correlation studies (e.g., Y = 0.96 x + 0.84 mg/dl) indicate a comparison to a "reference" method, where 'x' typically represents the result from the reference method and 'Y' represents the result from the new device. The document does not specify what the exact reference method was, but for glucose and uric acid, these are well-established laboratory techniques.
8. The Sample Size for the Training Set
This information is not provided and is generally not applicable in the context of traditional quantitative IVD assays like these. These methods are developed based on chemical principles and validation studies, not "trained" on data sets in the way AI algorithms are.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the reasons outlined in point 8. The assays are based on established enzymatic reactions and photometric measurement, not on a "training set" with ground truth established through a separate process.
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