(224 days)
The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative determination of constituents in blood and other fluids.
The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative determination of carbon dioxide concentration in serum using the ACE Axcel Clinical Chemistry System. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Direct Bilirubin Reagent is intended for the quantitative determination of direct bilirubin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Total Bilirubin Reagent is intended for the quantitative determination of total bilirubin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Magnesium Reagent is intended for the quantitative determination of magnesium concentration in serum using the ACE Axcel Clinical Chemistry System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low serum levels of magnesium) and hypermagnesemia (abnormally high serum levels of magnesium). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Axcel Clinical Chemistry System consists of two major components, the chemistry instrument and an integrated Panel PC. The instrument accepts the physical patient samples, performs the appropriate optical or potentiometric measurements on those samples and communicates that data to an integral Panel PC. The Panel PC uses keyboard or touch screen input to manually enter a variety of data, control and accept data from the instrument, manage and maintain system information and generate reports relative to patient status and instrument performance. The Panel PC also allows remote download of patient requisitions and upload of patient results via a standard interface.
In the ACE Carbon Dioxide (CO2-LC) Reagent assay, serum carbon dioxide (in the form of bicarbonate) reacts with phosphoenolpyruvate in the presence of phosphoenolpyruvate carboxylase and magnesium to yield oxaloacetic acid and phosphate. In the presence of malate dehydrogenase, the reduced cofactor is oxidized by oxaloacetic acid. The reduced cofactor absorbs strongly at 408 nm whereas its oxidized form does not. The rate of decrease in absorbance, monitored bichromatically at 408 nm/692 nm, is proportional to the carbon dioxide content of the sample.
In the ACE Direct Bilirubin Reagent assay, sodium nitrite added to sulfanilic acid forms diazotized sulfanilic acid. Bilirubin glucuronide in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The increase in absorbance, measured bichromatically at 554 nm/692 nm, one minute after sample addition, is directly proportional to the direct bilirubin concentration.
In the ACE Total Bilirubin Reagent assay, sodium nitrite, when added to sulfanilic acid. forms diazotized sulfanilic acid. Bilirubin in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The inclusion of dimethyl sulfoxide (DMSO) in the reagent as an accelerator causes both direct and indirect bilirubin to react rapidly. The increase in absorbance, measured bichromatically at 554 nm/692 nm, is directly proportional to the total bilirubin concentration in the sample.
Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium to produce a red complex which is measured bichromatically at 525 nm/692 nm. The intensity of color produced is directly proportional to the magnesium concentration in the sample. EGTA prevents calcium interference by preferential chelation of calcium present in the sample.
This document describes the performance of the ACE Carbon Dioxide (CO2-LC) Reagent, ACE Direct Bilirubin Reagent, ACE Total Bilirubin Reagent, and ACE Magnesium Reagent when used with the ACE Axcel Clinical Chemistry System. The study aims to demonstrate substantial equivalence to the predicate device, the Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K931786).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided in the document are implicitly established by demonstrating comparability to the predicate device. The performance data presented are the results obtained for the current device and reagents.
| Reagent | Metric | Acceptance Criteria (Implicit) | Reported Device Performance (ACE Axcel System) |
|---|---|---|---|
| ACE Carbon Dioxide (CO2-LC) Reagent | |||
| Precision - Within-run CV (22 days, 4 levels) | 1.6 - 8.7% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 1.6 - 8.7% |
| Precision - Total CV (22 days, 4 levels) | 4.3 - 12.2% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 4.3 - 12.2% |
| Precision - Within-run CV (5 days, 3 POL sites) | 1.0 - 2.6% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 1.0 - 2.6% |
| Precision - Total CV (5 days, 3 POL sites) | 1.8 - 5.7% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 1.8 - 5.7% |
| Accuracy - Correlation Coefficient (main study, n=120) | Not explicitly stated, but high correlation with predicate expected | 0.9758 | |
| Accuracy - Correlation Coefficient (POL studies, 3 sites) | Not explicitly stated, but high correlation with predicate expected | 0.9819 to 0.9952 | |
| Detection Limit | Not explicitly stated but expected to be clinically acceptable | 1.2 mEq/L | |
| ACE Direct Bilirubin Reagent | |||
| Precision - Within-run CV (22 days, 4 levels) | 0.8 - 16.5% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 0.8 - 16.5% |
| Precision - Total CV (22 days, 4 levels) | 1.5 - 16.6% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 1.5 - 16.6% |
| Precision - Within-run CV (5 days, 3 POL sites) | 0.0 - 4.6% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 0.0 - 4.6% |
| Precision - Total CV (5 days, 3 POL sites) | 0.0 - 4.6% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 0.0 - 4.6% |
| Accuracy - Correlation Coefficient (main study, n=116) | Not explicitly stated, but high correlation with predicate expected | 0.9996 | |
| Accuracy - Correlation Coefficient (POL studies, 3 sites) | Not explicitly stated, but high correlation with predicate expected | 0.9996 to 0.9997 | |
| Detection Limit | Not explicitly stated but expected to be clinically acceptable | 0.1 mg/dL | |
| ACE Total Bilirubin Reagent | |||
| Precision - Within-run CV (22 days, 4 levels) | 0.6 - 10.6% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 0.6 - 10.6% |
| Precision - Total CV (22 days, 4 levels) | 1.1 - 10.6% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 1.1 - 10.6% |
| Precision - Within-run CV (5 days, 3 POL sites) | 0.9 - 22.1% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 0.9 - 22.1% |
| Precision - Total CV (5 days, 3 POL sites) | 0.0 - 3.3% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 0.0 - 3.3% |
| Accuracy - Correlation Coefficient (main study, n=117) | Not explicitly stated, but high correlation with predicate expected | 0.9997 | |
| Accuracy - Correlation Coefficient (POL studies, 3 sites) | Not explicitly stated, but high correlation with predicate expected | 0.9993 to 1.0000 | |
| Detection Limit | Not explicitly stated but expected to be clinically acceptable | 0.2 mg/dL | |
| ACE Magnesium Reagent | |||
| Precision - Within-run CV (22 days, 4 levels) | 2.7 - 5.9% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 2.7 - 5.9% |
| Precision - Total CV (22 days, 4 levels) | 4.1 - 7.6% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 4.1 - 7.6% |
| Precision - Within-run CV (5 days, 3 POL sites) | 1.2 - 4.1% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 1.2 - 4.1% |
| Precision - Total CV (5 days, 3 POL sites) | 2.0 - 6.9% | Not explicitly stated but expected to be comparable to predicate/clinically acceptable | 2.0 - 6.9% |
| Accuracy - Correlation Coefficient (main study, n=108) | Not explicitly stated, but high correlation with predicate expected | 0.9690 | |
| Accuracy - Correlation Coefficient (POL studies, 3 sites) | Not explicitly stated, but high correlation with predicate expected | 0.9858 to 0.9930 | |
| Detection Limit | Not explicitly stated but expected to be clinically acceptable | 0.2 mg/dL |
The study demonstrates that the ACE Axcel Clinical Chemistry System with the listed reagents achieves precision and accuracy comparable to the predicate device, supporting substantial equivalence.
2. Sample sizes used for the test set and the data provenance
The studies conducted are primarily accuracy (correlation) and precision studies.
- ACE Carbon Dioxide (CO2-LC) Reagent:
- Accuracy (correlation study): 120 samples.
- Accuracy (patient correlation studies): Conducted at three separate Physician Office Laboratory (POL) sites; the number of samples per POL site is not specified, but the total across all sites for CO2 values ranged from 3.2 to 47.6 mEq/L.
- Precision: Four CO2 levels tested for 22 days; three separate POL sites tested for 5 days.
- ACE Direct Bilirubin Reagent:
- Accuracy (correlation study): 116 samples.
- Accuracy (patient correlation studies): Conducted at three separate POL sites; the number of samples per POL site is not specified, but the total across all sites for Direct Bilirubin values ranged from 0.2 to 12.5 mg/dL.
- Precision: Four direct bilirubin levels tested for 22 days; three separate POL sites tested for 5 days.
- ACE Total Bilirubin Reagent:
- Accuracy (correlation study): 117 samples.
- Accuracy (patient correlation studies): Conducted at three separate POL sites; the number of samples per POL site is not specified, but the total across all sites for Total Bilirubin values ranged from 0.2 to 34.8 mg/dL.
- Precision: Four total bilirubin levels tested for 22 days; three separate POL sites tested for 5 days.
- ACE Magnesium Reagent:
- Accuracy (correlation study): 108 samples.
- Accuracy (patient correlation studies): Conducted at three separate POL sites; the number of samples per POL site is not specified, but the total across all sites for Magnesium values ranged from 0.6 to 5.5 mg/dL.
- Precision: Four magnesium levels tested for 22 days; three separate POL sites tested for 5 days.
Data Provenance: The document does not explicitly state the country of origin for the data. The "POL sites" (Physician Office Laboratory sites) suggest these are real-world clinical samples, likely from within the United States given the 510(k) submission. The data appears to be prospective in nature, as indicated by the description of testing conducted over 22 days and 5 days at different sites for precision and the collection of samples for correlation studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is a clinical chemistry device for quantitative determination. The ground truth is established by comparing the device's measurements against a predicate device (Alfa Wassermann ACE Clinical Chemistry System). Therefore, no human experts are explicitly mentioned as establishing a "ground truth" in the diagnostic interpretation sense. The predicate device itself serves as the reference standard.
4. Adjudication method for the test set
Not applicable. This study involves quantitative measurements by a device and comparison to a predicate device, not qualitative interpretations requiring human 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
Not applicable. This is a clinical chemistry analyzer and reagent system, not an AI-assisted diagnostic imaging or interpretation system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance data presented are for the standalone algorithm/device (ACE Axcel Clinical Chemistry System with the specified reagents) measuring analytes in samples, compared directly against a predicate device. There is no human-in-the-loop component mentioned in the context of the reported performance data.
7. The type of ground truth used
The type of ground truth used is comparison to a legally marketed predicate device. The ACE Axcel Clinical Chemistry System and its reagents were compared to the Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K931786). The predicate device's measurements serve as the reference for established accuracy.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that typically involves a distinct "training set." The device's performance is based on established chemical reactions and detection methods. The studies described are for validation/testing of the device's performance against a predicate, not for training an algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set in the context of this device.
§ 862.1160 Bicarbonate/carbon dioxide test system.
(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.