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510(k) Data Aggregation
(132 days)
The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative determination of carbon dioxide concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. 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 and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. 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 and lithium heparin plasma using the ACE, ACE Alera and 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 in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
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. A surfactant system is included to remove protein interference.
The provided text describes several in vitro diagnostic reagents (ACE Carbon Dioxide (CO2-LC) Reagent, ACE Direct Bilirubin Reagent, ACE Total Bilirubin Reagent, and ACE Magnesium Reagent) and their associated performance data. There isn't information about an AI-powered device or software. Therefore, questions related to AI aspects like multi-reader multi-case studies, effect size of AI assistance, or standalone algorithm performance are not applicable.
The acceptance criteria are not explicitly stated as clear thresholds in the provided document; rather, the document presents detailed performance data (precision, linearity, interference, and method comparison) that demonstrates the device's capability to perform as intended and to be substantially equivalent to its predicate devices. The "reported device performance" is presented directly through tables and statistical analyses for each reagent.
Here's an attempt to structure the available information based on the request, interpreting "acceptance criteria" as the performance demonstrated to support substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit "acceptance criteria" (i.e., predefined thresholds for performance metrics) are not provided in the document, the "Reported Device Performance" below represents the data presented that presumably met the internal criteria for demonstrating substantial equivalence. The document primarily focuses on precision, linearity, interference, and method comparison with predicate devices and between different systems (ACE, ACE Alera, ACE Axcel).
ACE Carbon Dioxide (CO2-LC) Reagent
| Metric | Acceptance Criteria (Inferred from study design and historical data, not explicitly stated values) | Reported Device Performance (Summary of results across systems/sites) |
|---|---|---|
| Precision (In-House) | (Implied to be comparable to or better than predicate and acceptable for clinical use) | Serum: |
| Low: ~1.1-2.5% CV (Within-Run), ~5.6-7.5% CV (Total) | ||
| Mid: ~1.2-1.5% CV (Within-Run), ~3.3-3.7% CV (Total) | ||
| High: ~0.6-2.8% CV (Within-Run), ~2.6-3.2% CV (Total) | ||
| Plasma: | ||
| Low: ~1.3-3.0% CV (Within-Run), ~3.8-6.1% CV (Total) | ||
| Mid: ~0.7-1.2% CV (Within-Run), ~5.0-5.5% CV (Total) | ||
| High: ~1.0% CV (Within-Run), ~2.3-2.5% CV (Total) | ||
| Precision (POL sites) | (Implied to be comparable to in-house and acceptable for clinical use) | ACE: |
| Low (Sample 1): ~1.6-3.3% CV (Within-Run), ~3.0-4.3% CV (Total) | ||
| Mid (Sample 2): ~1.7-3.1% CV (Within-Run), ~2.7-7.4% CV (Total) | ||
| High (Sample 3): ~1.8-2.4% CV (Within-Run), ~2.4-6.4% CV (Total) | ||
| ACE Alera: | ||
| Low (Sample 1): ~1.3-2.0% CV (Within-Run), ~3.0-6.7% CV (Total) | ||
| Mid (Sample 2): ~0.9-1.7% CV (Within-Run), ~2.4-3.9% CV (Total) | ||
| High (Sample 3): ~1.0-1.6% CV (Within-Run), ~3.1-5.8% CV (Total) | ||
| Method Comparison (Serum vs. Plasma) | (Slope near 1, intercept near 0, high correlation) | ACE: Slope: 1.031, Intercept: -1.03, Correlation: 0.9922 |
| ACE Alera: Slope: 1.000, Intercept: -0.09, Correlation: 0.9955 | ||
| ACE Axcel: Slope: 0.988, Intercept: -0.35, Correlation: 0.9889 | ||
| Method Comparison (POL vs. In-House) | (Slope near 1, intercept near 0, high correlation) | ACE (POL 1-3 vs. In-House ACE): Slopes: 0.963-0.984, Intercepts: -0.71-1.29, Correlations: 0.9530-0.9908 |
| ACE Alera (POL 1-3 vs. In-House ACE): Slopes: 0.972-0.987, Intercepts: 0.10-0.57, Correlations: 0.9767-0.9903 | ||
| Detection Limits (ACE Alera) | (Appropriate for clinical use) | LoB: 1.27 mEq/L, LoD: 1.97 mEq/L, LoQ: 3.03 mEq/L |
| Linearity (ACE Alera) | (Linearity up to/beyond desired measuring range) | Linear to: 50 mEq/L (Equation: y=1.006x + 0.01) |
| Interferences (ACE Alera) | (No significant interference from common interferents) | No significant interference at or below Icterus 58.8 mg/dL, Hemolysis 250 mg/dL, Lipemia 2388 mg/dL, Ascorbic Acid 6 mg/dL |
ACE Direct Bilirubin Reagent
| Metric | Acceptance Criteria (Inferred from study design and historical data, not explicitly stated values) | Reported Device Performance (Summary of results across systems/sites) |
|---|---|---|
| Precision (In-House) | (Implied to be comparable to or better than predicate and acceptable for clinical use) | Serum: |
| Low: ~12.5-24.5% CV (Within-Run), ~14.0-30.0% CV (Total) | ||
| Mid: ~0.9-1.6% CV (Within-Run), ~1.2-2.2% CV (Total) | ||
| High: ~0.6-1.5% CV (Within-Run), ~1.1-1.7% CV (Total) | ||
| Plasma: | ||
| Low: ~16.6-26.6% CV (Within-Run), ~19.7-35.4% CV (Total) | ||
| Mid: ~0.8-2.4% CV (Within-Run), ~1.1-2.8% CV (Total) | ||
| High: ~0.7-1.9% CV (Within-Run), ~1.1-2.3% CV (Total) | ||
| Precision (POL sites) | (Implied to be comparable to in-house and acceptable for clinical use) | ACE: |
| Low (Sample 1): ~2.9-4.2% CV (Within-Run), ~2.9-4.9% CV (Total) | ||
| Mid (Sample 2): ~1.0-1.8% CV (Within-Run), ~1.3-2.1% CV (Total) | ||
| High (Sample 3): ~1.3-2.3% CV (Within-Run), ~2.0-2.3% CV (Total) | ||
| ACE Alera: | ||
| Low (Sample 1): ~2.5-5.1% CV (Within-Run), ~2.5-5.4% CV (Total) | ||
| Mid (Sample 2): ~1.0-1.5% CV (Within-Run), ~1.0-1.9% CV (Total) | ||
| High (Sample 3): ~0.6-2.6% CV (Within-Run), ~1.3-2.6% CV (Total) | ||
| Method Comparison (Serum vs. Plasma) | (Slope near 1, intercept near 0, high correlation) | ACE: Slope: 1.021, Intercept: 0.00, Correlation: 0.9982 |
| ACE Alera: Slope: 1.005, Intercept: 0.01, Correlation: 0.9978 | ||
| ACE Axcel: Slope: 1.004, Intercept: 0.00, Correlation: 0.9983 | ||
| Method Comparison (POL vs. In-House) | (Slope near 1, intercept near 0, high correlation) | ACE (POL 1-3 vs. In-House ACE): Slopes: 1.003-1.022, Intercepts: 0.04-0.11, Correlations: 0.9984-0.9986 |
| ACE Alera (POL 1-3 vs. In-House ACE): Slopes: 0.969-0.995, Intercepts: 0.09-0.11, Correlations: 0.9984-0.9991 | ||
| Detection Limits (ACE Alera) | (Appropriate for clinical use) | LoB: 0.06 mg/dL, LoD: 0.08 mg/dL, LoQ: 0.12 mg/dL |
| Linearity (ACE Alera) | (Linearity up to/beyond desired measuring range) | Linear to: 14.0 mg/dL (Equation: y=1.015x + 0.16) |
| Interferences (ACE Alera) | (No significant interference from common interferents) | Not Applicable (Icterus), No significant interference at or below Hemolysis 62.5 mg/dL, Lipemia 782 mg/dL, Ascorbic Acid 6 mg/dL |
ACE Total Bilirubin Reagent
| Metric | Acceptance Criteria (Inferred from study design and historical data, not explicitly stated values) | Reported Device Performance (Summary of results across systems/sites) |
|---|---|---|
| Precision (In-House) | (Implied to be comparable to or better than predicate and acceptable for clinical use) | Serum: |
| Low: ~11.0-21.3% CV (Within-Run), ~13.9-21.3% CV (Total) | ||
| Mid: ~1.0-1.1% CV (Within-Run), ~1.0-1.1% CV (Total) | ||
| High: ~0.4-0.7% CV (Within-Run), ~0.5-0.8% CV (Total) | ||
| Plasma: | ||
| Low: ~20.3-23.7% CV (Within-Run), ~21.3-29.4% CV (Total) | ||
| Mid: ~0.5-1.0% CV (Within-Run), ~0.5-1.1% CV (Total) | ||
| High: ~0.5-0.6% CV (Within-Run), ~0.5-0.7% CV (Total) | ||
| Precision (POL sites) | (Implied to be comparable to in-house and acceptable for clinical use) | ACE: |
| Low (Sample 1): ~3.4-5.5% CV (Within-Run), ~3.7-5.8% CV (Total) | ||
| Mid (Sample 2): ~0.5-1.7% CV (Within-Run), ~1.3-3.7% CV (Total) | ||
| High (Sample 3): ~1.0-1.2% CV (Within-Run), ~1.2-2.1% CV (Total) | ||
| ACE Alera: | ||
| Low (Sample 1): ~4.2-4.9% CV (Within-Run), ~4.5-5.2% CV (Total) | ||
| Mid (Sample 2): ~0.7-2.0% CV (Within-Run), ~0.8-2.1% CV (Total) | ||
| High (Sample 3): ~0.5-1.4% CV (Within-Run), ~0.6-1.7% CV (Total) | ||
| Method Comparison (Serum vs. Plasma) | (Slope near 1, intercept near 0, high correlation) | ACE: Slope: 1.017, Intercept: 0.01, Correlation: 0.9996 |
| ACE Alera: Slope: 1.020, Intercept: 0.00, Correlation: 0.9993 | ||
| ACE Axcel: Slope: 1.008, Intercept: 0.00, Correlation: 0.9995 | ||
| Method Comparison (POL vs. In-House) | (Slope near 1, intercept near 0, high correlation) | ACE (POL 1-3 vs. In-House ACE): Slopes: 0.979-1.000, Intercepts: 0.00-0.04, Correlations: 0.9995-0.9998 |
| ACE Alera (POL 1-3 vs. In-House ACE): Slopes: 0.957-1.020, Intercepts: 0.01-0.07, Correlations: 0.9991-0.9998 | ||
| Detection Limits (ACE Alera) | (Appropriate for clinical use) | LoB: 0.11 mg/dL, LoD: 0.14 mg/dL, LoQ: 0.14 mg/dL |
| Linearity (ACE Alera) | (Linearity up to/beyond desired measuring range) | Linear to: 40.0 mg/dL (Equation: y=1.004x + 0.03) |
| Interferences (ACE Alera) | (No significant interference from common interferents) | Not Applicable (Icterus), No significant interference at or below Hemolysis 62.5 mg/dL, Lipemia 951 mg/dL, Ascorbic Acid 6 mg/dL |
ACE Magnesium Reagent
| Metric | Acceptance Criteria (Inferred from study design and historical data, not explicitly stated values) | Reported Device Performance (Summary of results across systems/sites) |
|---|---|---|
| Precision (In-House) | (Implied to be comparable to or better than predicate and acceptable for clinical use) | Serum: |
| Low: ~3.1-5.1% CV (Within-Run), ~4.3-5.9% CV (Total) | ||
| Mid: ~1.7-2.6% CV (Within-Run), ~1.8-3.0% CV (Total) | ||
| High: ~1.0-1.4% CV (Within-Run), ~1.6-1.7% CV (Total) | ||
| Plasma: | ||
| Low: ~2.4-4.7% CV (Within-Run), ~4.1-6.8% CV (Total) | ||
| Mid: ~2.4-2.8% CV (Within-Run), ~2.6-3.7% CV (Total) | ||
| High: ~0.9-1.6% CV (Within-Run), ~1.8-1.9% CV (Total) | ||
| Precision (POL sites) | (Implied to be comparable to in-house and acceptable for clinical use) | ACE: |
| Low (Sample 1): ~3.3-4.6% CV (Within-Run), ~5.0-6.3% CV (Total) | ||
| Mid (Sample 2): ~1.3-2.5% CV (Within-Run), ~2.8-3.5% CV (Total) | ||
| High (Sample 3): ~1.1-1.8% CV (Within-Run), ~1.4-3.1% CV (Total) | ||
| ACE Alera: | ||
| Low (Sample 1): ~3.0-6.0% CV (Within-Run), ~4.5-8.4% CV (Total) | ||
| Mid (Sample 2): ~2.0-2.9% CV (Within-Run), ~2.5-5.2% CV (Total) | ||
| High (Sample 3): ~0.9-1.9% CV (Within-Run), ~1.6-4.8% CV (Total) | ||
| Method Comparison (Serum vs. Plasma) | (Slope near 1, intercept near 0, high correlation) | ACE: Slope: 0.957, Intercept: 0.04, Correlation: 0.9765 |
| ACE Alera: Slope: 0.986, Intercept: 0.05, Correlation: 0.9817 | ||
| ACE Axcel: Slope: 0.986, Intercept: 0.025, Correlation: 0.9892 | ||
| Method Comparison (POL vs. In-House) | (Slope near 1, intercept near 0, high correlation) | ACE (POL 1-3 vs. In-House ACE): Slopes: 0.970-1.026, Intercepts: -0.04-0.16, Correlations: 0.9902-0.9927 |
| ACE Alera (POL 1-3 vs. In-House ACE): Slopes: 0.990-1.010, Intercepts: -0.11-0.00, Correlations: 0.9870-0.9930 | ||
| Detection Limits (ACE Alera) | (Appropriate for clinical use) | LoB: 0.26 mg/dL, LoD: 0.37 mg/dL, LoQ: 0.37 mg/dL |
| Linearity (ACE Alera) | (Linearity up to/beyond desired measuring range) | Linear to: 6.1 mg/dL (Equation: y=0.959x + 0.27) |
| Interferences (ACE Alera) | (No significant interference from common interferents) | No significant interference at or below Icterus 50 mg/dL, Hemolysis 500 mg/dL, Lipemia 620 mg/dL, Ascorbic Acid 6 mg/dL |
2. Sample Size Used for the Test Set and the Data Provenance
The document describes several types of studies:
-
In-House Precision:
- CO2-LC: Low, Mid, High serum and plasma samples were tested (number of replicates per sample and runs is implicitly part of SD/CV calculation, but not explicitly stated).
- Direct Bilirubin: Low, Mid, High serum and plasma samples.
- Total Bilirubin: Low, Mid, High serum and plasma samples.
- Magnesium: Low, Mid, High serum and plasma samples.
- Data Provenance: In-house (Alfa Wassermann Diagnostic Technologies, LLC, West Caldwell, NJ), prospective testing.
-
POL (Physician Office Laboratory) Precision: Studies conducted at 3 POL sites.
- CO2-LC: 3 samples at each of 3 POL sites and in-house.
- Direct Bilirubin: 3 samples at each of 3 POL sites and in-house.
- Total Bilirubin: 3 samples at each of 3 POL sites and in-house.
- Magnesium: 3 samples at each of 3 POL sites and in-house.
- Data Provenance: Not explicitly stated but inferred to be from POLs in the USA (prospective testing under typical POL conditions).
-
In-House Matrix Comparison (Serum vs. Plasma):
- CO2-LC: 53-54 pairs (serum/plasma) on ACE and ACE Alera; 51 pairs on ACE Axcel.
- Direct Bilirubin: 102 pairs on ACE; 101 pairs on ACE Alera; 56 pairs on ACE Axcel.
- Total Bilirubin: 102 pairs on ACE and ACE Alera; 56 pairs on ACE Axcel.
- Magnesium: 101 pairs on ACE and ACE Alera; 55 pairs on ACE Axcel.
- Data Provenance: In-house, retrospective (presumably collected for a range of values).
-
POL Method Comparison (In-House ACE vs. POL ACE/Alera):
- CO2-LC: 45-46 samples per POL site comparison.
- Direct Bilirubin: 49-51 samples per POL site comparison.
- Total Bilirubin: 48-50 samples per POL site comparison.
- Magnesium: 50-52 samples per POL site comparison.
- Data Provenance: Not explicitly stated but inferred to be from POLs in the USA (prospective testing under typical POL conditions) compared against in-house data.
-
Detection Limits (LoB, LoD, LoQ), Linearity, Interferences (ACE Alera):
- Sample sizes for detection limits and linearity: Not explicitly stated, typically involves multiple replicates at various concentrations.
- Sample sizes for interferences: Not explicitly stated, typically involves samples spiked with various concentrations of interferents.
- Data Provenance: In-house.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. For in vitro diagnostic assays, the "ground truth" is typically the reference method or established clinical laboratory results obtained from a highly accurate and calibrated instrument or laboratory using validated methods, rather than human expert consensus for image or clinical interpretation. The document compares performance against other (presumably established) methods and predicate devices.
4. Adjudication Method for the Test Set
This concept (e.g., 2+1, 3+1 for resolving discrepancies) is not applicable to these types of in vitro diagnostic device studies. Performance is measured numerically and objectively.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is an in vitro diagnostic assay, not an AI-powered diagnostic imaging device.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The performance data presented are for the reagent and instrument system.
7. The Type of Ground Truth Used
For precision studies, the "ground truth" is the true concentration of the analyte in the control material or patient sample, which is established by reference methods or manufacturing specifications of the control materials. For method comparison studies, the predicate device's results or an established in-house method are used as the comparative reference. The document states the intended use is for "quantitative determination" of analytes, implying comparison to a quantitative gold standard.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning device and therefore does not have a "training set" in that context. The development of reagents and the establishment of their performance characteristics do not involve machine learning training sets.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for these reagents in the context of AI/ML.
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(259 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.
ACE Hemoglobin A1c (HbA1c) Reagent is intended for the quantitative determination of hemoglobin A1c (µmol/L) and total hemoglobin (g/dL) in human EDTA whole blood for the calculation of percent hemoglobin A1c using the ACE Axcel Clinical Chemistry System. The test is intended for use in clinical laboratories or physician office laboratories to monitor long term blood glucose control in individuals with diabetes mellitus. For in vitro diagnostic use only.
The ACE CEDIA T Uptake homogenous enzyme immunoassay is intended for the quantitative determination of unoccupied binding sites of thyroxine-binding proteins in serum using the ACE Axcel Clinical Chemistry System. Measurements of triiodothyronine uptake are used in the diagnosis and treatment of thyroid disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE T4 Reagent is intended for the quantitative determination of total thyroxine (T4) concentration in serum using the ACE Axcel Clinical Chemistry System. Total thyroxine measurements are used in the diagnosis and treatment of thyroid diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Ferritin Reagent is intended for the quantitative determination of ferritin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia. 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.
Prior to the ACE Hemoglobin A1c (HbA1c) Reagent assay, whole blood samples require a pretreatment step, which is done on-board the analyzer. The red blood cells in the sample are lysed by the Hemoglobin Denaturant and the hemoglobin chains are hydrolyzed. For determination of HbA1c, a latex agglutination inhibition assay is used. In the absence of HbA1c in the sample, the agglutinator (synthetic polymer containing the immunoreactive portion of HbA1c) in the HbA1c Agglutinator Reagent and the antibody-coated microparticles in the HbA1c Antibody Reagent will agglutinate. The presence of HbA1c in the sample competes for the antibody binding sites and inhibits agglutination. The increase in absorbance, monitored monochromatically at 592 nm, is inversely proportional to the HbA1c present in the sample. For the determination of total hemoglobin, all hemoglobin derivatives in the sample are converted to alkaline hematin. The reaction produces a green colored solution, which is measured bichromatically at 573 nm/692 nm. The intensity of color produced is directly proportional to the total hemoglobin concentration in the sample. The concentrations of both HbA1c and total hemoglobin are measured, the ratio is calculated and the result reported as percent HbA1c.
The CEDIA T Uptake assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based the bacterial enzyme β-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously re-associate to form fully active enzyme which, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically. In the assay, enzyme donor thyroxine conjugate binds directly to the unoccupied thyroxine-binding sites in the sample, preventing the spontaneous re-association of the enzyme fragments to form the active enzyme. Thus, thyroxine-binding proteins regulate the amount of β-galactosidase formed from the reassembly of the remaining donor and enzyme acceptor as monitored by the hydrolysis of the substrate o-nitrophenyl-β-galactopyranoside.
The ACE T4 Assay is a homogeneous enzyme immunoassay using ready-to-use liquid ACE T4 Reagent. The assay uses 8-anilino-1-naphthalene sulfonic acid (ANS) to dissociate thyroxine from the plasma binding proteins. Using specific antibodies to thyroxine, this assay is based on the competition of glucose-6-phosphate dehydrogenase (G6PD) labeled thyroxine and the dissociated thyroxine in the sample for a fixed amount of specific antibody binding sites. In the absence of thyroxine from the sample, the thyroxine labeled G6PD in the second reagent is bound by the specific antibody in the first reagent, inhibiting the enzyme's activity. The enzyme G6PD catalyzes the oxidation of glucose-6-phosphate (G6P) with nicotinamide adenine dinucleotide (NAD+) to form 6-phosphogluconate and reduced nicotinamide adenine dinucleotide (NADH). NADH strongly absorbs at 340 nm whereas NAD+ does not. The rate of conversion, determined by measuring the increase in absorbance bichromatically at 340 nm/505 nm during a fixed time interval, is directly proportional to the amount of thyroxine in the sample. The concentration of thyroxine is determined automatically by the ACE Clinical Chemistry System using a logarithmic calibration curve established with calibrators, which are provided separately.
In the Ferritin Assay, serum ferritin, in the presence of anti-ferritin conjugated latex micorparticles, and a buffer promoting aggregation, initiates an antigen-antibody reaction, resulting in the agglutination of the latex microparticles. The agglutination is detected turbidometrically by an absorbance change measured at a wavelength of 592 nm. The magnitude of the absorbance change is proportional to the ferritin concentration in the sample.
The provided text is a 510(k) summary for the Alfa Wassermann Diagnostic Technologies ACE Axcel Clinical Chemistry System and several associated reagents. It describes the devices, their intended uses, and technological characteristics. However, the document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The content of the document focuses on:
- Identification of the device and reagents: Trade names, classifications, common names, and product codes.
- Predicate devices: Listing the previously approved systems and reagents used for comparison in the 510(k) submission.
- Device descriptions: Detailed explanations of the ACE Axcel Clinical Chemistry System's functionality and the biochemical principles of each reagent (HbA1c, CEDIA T Uptake, T4, Ferritin).
- Intended Use/Indications for Use: What each device/reagent is designed to measure and for what clinical purpose.
- Technological Characteristics: Specifications of the analyzer (throughput, reagent capacity, cooling, sample handling, optical system).
- Regulatory approval notice: A letter from the FDA indicating substantial equivalence.
Therefore, I cannot provide a table of acceptance criteria or details of a study proving the device meets those criteria from the provided text. The requested information about sample sizes, data provenance, expert qualifications, ground truth, MRMC studies, or standalone performance studies is not present in this document.
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(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.
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(197 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 measurement of general chemistry assays for clinical use in physician office laboratories or clinical laboratories.
The ACE Axcel Clinical System includes an Ion Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
- Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance
- Potassium measurements are used to monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
- Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The ACE Glucose Reagent is intended for the quantitative determination of glucose concentration in serum using the ACE Axcel Clinical Chemistry System. 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. 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 Glucose Reagent assay, glucose in serum reacts with adenosine triphosphate in the presence of hexokinase and magnesium with the formation of glucose-6-phosphate and adenosine diphosphate. Glucose-6-phosphate dehydrogenase catalyzes the oxidation of glucose-6-phosphate with NAD+ to form 6-phosphogluconate and NADH. NADH absorbs strongly at 340 nm, whereas NAD+ does not. The total amount of NADH formed is proportional to the concentration of glucose in the sample. The increase in absorbance is measured bichromatically at 340 nm/378 nm.
The ACE Ion Selective Electrode (ISE) Module is used with ACE CAL A and CAL B Calibration Solutions in the performance of a two-point calibration in order to measure concentrations of sodium, potassium and chloride in undiluted serum. The ISE module uses a potentiometric method to simultaneously measure sodium, potassium and chloride in undiluted serum. Each electrode uses an ion-specific membrane to measure the difference in ionic concentration between an inner electrolyte solution and the sample. This difference causes an electro-chemical potential to form on the membrane of the active electrode. The connection of the amplifier and ground (reference electrode) to the ion selective electrode forms the measuring system. The two-point calibration with CAL A and CAL B with precisely known ion concentrations (two-point calibration) and the measured voltage difference of the sample and CAL A are used to determine the ion concentration in the sample.
Here's a summary of the acceptance criteria and study information for the Alfa Wassermann ACE Axcel Clinical Chemistry System, ACE Ion Selective Electrode (ISE) Module, and ACE Glucose Reagent, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Accuracy" data, where the device (y) is compared to a predicate device (x). The close correlation, with slopes near 1 and intercepts near 0, along with high correlation coefficients, indicates acceptable accuracy. Precision is evaluated by the Coefficient of Variation (CV%).
| Measurement (Reagent/Module) | Performance Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (ACE Axcel Clinical Chemistry System) |
|---|---|---|---|
| ACE Glucose Reagent | Precision (Within-run CV) | (Not explicitly stated, but low CV is desirable) | 1.0 to 1.4% (lab setting, 4 levels, 22 days); 0.3 to 2.2% (POL sites, 3 locations, 5 days) |
| Precision (Total CV) | (Not explicitly stated, but low CV is desirable) | 1.0 to 1.9% (lab setting); 0.5 to 2.2% (POL sites) | |
| Accuracy (Correlation Coefficient) | Close to 1.0 | 0.9998 (lab setting, 122 samples); 0.9992 to 0.9998 (POL sites, 3 locations) | |
| Accuracy (Slope) | Close to 1.0 | 1.001 to 1.009 (lab setting); 0.972 to 1.021 (POL sites) | |
| Accuracy (Intercept) | Close to 0 | -1.5 to 0.1 (lab setting); -3.0 to 4.1 (POL sites) | |
| Detection Limit | (Not explicitly stated, but low is desirable) | 3.1 mg/dL | |
| ACE Axcel Sodium ISE | Precision (Within-run CV) | (Not explicitly stated, but low CV is desirable) | 0.4 to 1.0% (lab setting, 4 levels, 21 days); 0.6 to 1.0% (POL sites, 3 locations, 5 days) |
| Precision (Total CV) | (Not explicitly stated, but low CV is desirable) | 0.8 to 1.4% (lab setting); 0.8 to 1.4% (POL sites) | |
| Accuracy (Correlation Coefficient) | Close to 1.0 | 0.9963 (lab setting, 113 samples); 0.9917 to 0.9995 (POL sites, 3 locations) | |
| Accuracy (Slope) | Close to 1.0 | 0.992 to 1.024 (lab setting); 0.989 to 1.067 (POL sites) | |
| Accuracy (Intercept) | Close to 0 | -3.60 to 0.92 (lab setting); -8.85 to 2.30 (POL sites) | |
| ACE Axcel Potassium ISE | Precision (Within-run CV) | (Not explicitly stated, but low CV is desirable) | 0.6 to 3.5% (lab setting, 4 levels, 21 days); 1.0 to 1.6% (POL sites, 3 locations, 5 days) |
| Precision (Total CV) | (Not explicitly stated, but low CV is desirable) | 1.3 to 3.5% (lab setting); 1.1 to 1.6% (POL sites) | |
| Accuracy (Correlation Coefficient) | Close to 1.0 | 0.9974 (lab setting, 115 samples); 0.9973 to 0.9996 (POL sites, 3 locations) | |
| Accuracy (Slope) | Close to 1.0 | 0.989 to 1.015 (lab setting); 0.960 to 1.035 (POL sites) | |
| Accuracy (Intercept) | Close to 0 | -0.050 to 0.095 (lab setting); -0.194 to 0.216 (POL sites) | |
| ACE Axcel Chloride ISE | Precision (Within-run CV) | (Not explicitly stated, but low CV is desirable) | 0.5 to 1.0% (lab setting, 4 levels, 21 days); 0.9 to 1.5% (POL sites, 3 locations, 5 days) |
| Precision (Total CV) | (Not explicitly stated, but low CV is desirable) | 1.1 to 1.5% (lab setting); 1.1 to 2.6% (POL sites) | |
| Accuracy (Correlation Coefficient) | Close to 1.0 | 0.9855 (lab setting, 111 samples); 0.9885 to 0.9996 (POL sites, 3 locations) | |
| Accuracy (Slope) | Close to 1.0 | 0.939 to 1.002 (lab setting); 0.976 to 1.088 (POL sites) | |
| Accuracy (Intercept) | Close to 0 | -1.07 to 5.63 (lab setting); -8.16 to 2.22 (POL sites) |
2. Sample Size Used for the Test Set and Data Provenance
-
ACE Glucose Reagent:
- Accuracy (Correlation Study): 122 samples (ranging from 6 to 729 mg/dL).
- Accuracy (Patient Correlation Studies): Data from three separate Physician Office Laboratory (POL) sites. Specific sample numbers per POL site are not provided, but the combined sites yielded multiple correlation coefficients, standard error estimates, and confidence intervals for slope and intercept.
- Provenance: Not explicitly stated, but likely from a laboratory setting and Physician Office Laboratories, presumably within the US given the submission to the FDA. The nature of the samples (e.g., patient samples, control materials) is not specified as prospective or retrospective.
-
ACE Axcel Sodium ISE:
- Accuracy (Correlation Study): 113 samples (ranging from 45.1 to 194.0 mmol/L).
- Accuracy (Patient Correlation Studies): Data from three separate Physician Office Laboratory (POL) sites.
- Provenance: Same as Glucose – likely US lab/POL, nature of samples not specified.
-
ACE Axcel Potassium ISE:
- Accuracy (Correlation Study): 115 samples (ranging from 1.57 to 14.20 mmol/L).
- Accuracy (Patient Correlation Studies): Data from three separate Physician Office Laboratory (POL) sites.
- Provenance: Same as Glucose – likely US lab/POL, nature of samples not specified.
-
ACE Axcel Chloride ISE:
- Accuracy (Correlation Study): 111 samples (ranging from 63.4 to 176.0 mmol/L).
- Accuracy (Patient Correlation Studies): Data from three separate Physician Office Laboratory (POL) sites.
- Provenance: Same as Glucose – likely US lab/POL, nature of samples not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. For this type of in vitro diagnostic device, "ground truth" is established by comparing the performance of the new device to a legally marketed predicate device (Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents) using quantitative measurements, not by expert interpretation. The predicate device itself acts as the reference method in these correlation studies.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is a quantitative comparison against a predicate device, not an interpretation-based ground truth 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
Not applicable. This device is a clinical chemistry analyzer, an automated system for measuring analytes in samples. It does not involve human readers interpreting images or data where AI assistance would be relevant in the context of MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance studies described are inherently "standalone" in the sense that they evaluate the performance of the ACE Axcel Clinical Chemistry System (including its reagents and ISE module) in producing quantitative results independently. The accuracy studies compare its output directly against a predicate device's output. There isn't a "human-in-the-loop" aspect to the core measurement performance itself.
7. The Type of Ground Truth Used
The "ground truth" for the accuracy studies is the quantitative result obtained from the predicate device (Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents). The studies are correlation studies comparing the new device's measurements (y) to the predicate device's measurements (x).
8. The Sample Size for the Training Set
Not applicable. This document describes a traditional medical device (clinical chemistry analyzer), not a machine learning or AI-based device that typically has a "training set." The device is intended to perform measurements based on established chemical and electrochemical principles.
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's development as described in the provided text.
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(210 days)
ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
ACE HDL-C Reagent is intended for the homogeneous, quantitative determination of HDL cholesterol (HDL-C) in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
ACE LDL-C Reagent is intended for the quantitative determination of low density lipoprotein cholesterol (LDL-C) in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
ACE Triglycerides Reagent is intended for the quantitative determination of triglycerides in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
In the ACE Cholesterol Reagent assay, cholesterol esters in serum or heparin plasma are completely hydrolyzed by cholesterol esterase to free cholesterol and free fatty acids. The cholesterol liberated by the esterase, plus any endogenous free cholesterol, are both oxidized by cholesterol oxidase to yield hydrogen peroxide. The hydrogen peroxide then acts to oxidatively couple p-hydroxybenzoic acid and 4-aminoantipyrine in a reaction catalyzed by peroxidase, producing a red colored quinoneimine complex which absorbs strongly at 505 nm. The amount of chromogen formed, determined by measuring the increase in absorbance, bichromatically at 505 nm/647 nm, is directly proportional to the cholesterol concentration in the sample.
The HDL-C Assay utilizes two reagents, the second containing a unique detergent. This detergent solubilizes only the HDL lipoprotein particles, thus releasing HDL cholesterol to react with the cholesterol esterase and cholesterol oxidase, in the presence of a chromogen to produce color. The detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL and chylomicron lipoproteins by adsorbing to their surfaces. The amount of chromogen formed, determined by measuring the increase in absorbance bichromatically at 592/692 nm, is directly proportional to the HDL cholesterol concentration in the sample.
In the ACE LDL-C Reagent assay, detergent 1 solubilizes non-LDL lipoprotein particles (HDL, VLDL and chylomicrons) and releases cholesterol. The cholesterol is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. In a second reaction, detergent 2 solublizes the remaining LDL particles and forms peroxide, via the enzymes cholesterol esterase and cholesterol oxidase. The peroxide, in the presence of peroxidase and two peroxidase substrates, 4-aminoantipyrine and DSBmT, results in a purple-red color. The amount of color formed, determined by measuring the increase in absorbance bichromatically at 544/692 nm, is directly proportional to the LDL cholesterol concentration in the sample.
In the ACE Triglycerides Reagent assay, triglycerides in serum or heparin plasma are hydrolyzed by lipase to form glycerol and free fatty acids. In the presence of adenosine triphosphate (ATP) and glycerol kinase, the glycerol is converted to glycerol-1-phosphate and the ATP to adenosine diphosphate. Glycerol-1-phosphate is oxidized by glycerol phosphate oxidase to yield hydrogen peroxide. The hydrogen peroxide then acts to oxidatively couple p-chlorophenol and 4-aminoantipyrine in a reaction catalyzed by peroxidase, producing a red colored quinoneimine complex which absorbs strongly at 505 nm. The amount of chromogen formed, determined by measuring the increase in absorbance bichromatically at 505 nm/692 nm, is directly proportional to the triglycerides concentration in the sample.
Here's a breakdown of the acceptance criteria and study details for the Alfa Wassermann ACE Cholesterol Reagent, ACE HDL-C Reagent, ACE LDL-C Reagent, and ACE Triglycerides Reagent, based on the provided 510(k) summary:
The studies presented are "matrix comparison data" studies, aiming to demonstrate substantial equivalence between using serum and lithium heparin plasma samples with the new ACE reagents on the ACE and ACE Alera Clinical Chemistry Systems. The performance is assessed by comparing quantitative measurements from paired serum/plasma samples.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly based on demonstrating strong correlation and agreement between serum and plasma measurements, specifically looking for regression equations close to y=x (slope near 1, intercept near 0) and high correlation coefficients. The provided confidence intervals for slope and intercept also serve as an implicit measure of acceptance.
| Reagent / System | Metric | Acceptance Criteria (Implicit) | Reported Device Performance (ACE Clinical Chemistry System) | Reported Device Performance (ACE Alera Clinical Chemistry System) |
|---|---|---|---|---|
| ACE Cholesterol Reagent | Regression Equation (y = plasma, x = serum) | Slope near 1, Intercept near 0 | y = 0.985x - 1.7 | y = 0.994x - 2.5 |
| Correlation Coefficient | High (e.g., > 0.95 or 0.98) | 0.9947 | 0.9934 | |
| Std. Error Est. | Low | 9.6 | 11.5 | |
| Confidence Interval Slope | Should enclose 1 (e.g., 0.9-1.1) | 0.965 to 1.005 | 0.971 to 1.016 | |
| Confidence Interval Intercept | Should enclose 0 (e.g., -10 to 10) | -5.7 to 2.3 | -7.0 to 2.1 | |
| ACE HDL-C Reagent | Regression Equation | Slope near 1, Intercept near 0 | y = 1.015x - 0.6 | y = 0.989x + 0.4 |
| Correlation Coefficient | High (e.g., > 0.95 or 0.98) | 0.9884 | 0.9874 | |
| Std. Error Est. | Low | 3.4 | 3.5 | |
| Confidence Interval Slope | Should enclose 1 | 0.984 to 1.045 | 0.957 to 1.020 | |
| Confidence Interval Intercept | Should enclose 0 | -2.1 to 0.8 | -1.2 to 1.9 | |
| ACE LDL-C Reagent | Regression Equation | Slope near 1, Intercept near 0 | y = 1.008x - 2.6 | y = 0.995x - 1.3 |
| Correlation Coefficient | High (e.g., > 0.95 or 0.98) | 0.9954 | 0.9954 | |
| Std. Error Est. | Low | 7.3 | 7.2 | |
| Confidence Interval Slope | Should enclose 1 | 0.989 to 1.028 | 0.976 to 1.014 | |
| Confidence Interval Intercept | Should enclose 0 | -5.0 to -0.2 | -3.7 to 1.0 | |
| ACE Triglycerides Reagent | Regression Equation | Slope near 1, Intercept near 0 | y = 1.005x - 7.9 | y = 1.007x - 7.4 |
| Correlation Coefficient | High (e.g., > 0.95 or 0.98) | 0.9977 | 0.9973 | |
| Std. Error Est. | Low | 11.1 | 11.8 | |
| Confidence Interval Slope | Should enclose 1 | 0.991 to 1.019 | 0.992 to 1.021 | |
| Confidence Interval Intercept | Should enclose 0 | -11.1 to -4.7 | -10.8 to -4.0 |
2. Sample Size Used for the Test Set and Data Provenance
- ACE Cholesterol Reagent (ACE Clinical Chemistry System): 102 paired samples (serum and lithium heparin plasma). 5 samples spiked.
- ACE Cholesterol Reagent (ACE Alera Clinical Chemistry System): 100 paired samples (serum and lithium heparin plasma). 6 samples spiked.
- ACE HDL-C Reagent (ACE Clinical Chemistry System): 101 paired samples (serum and lithium heparin plasma).
- ACE HDL-C Reagent (ACE Alera Clinical Chemistry System): 100 paired samples (serum and lithium heparin plasma).
- ACE LDL-C Reagent (ACE Clinical Chemistry System): 99 paired samples (serum and lithium heparin plasma). 4 samples spiked.
- ACE LDL-C Reagent (ACE Alera Clinical Chemistry System): 99 paired samples (serum and lithium heparin plasma). 4 samples spiked.
- ACE Triglycerides Reagent (ACE Clinical Chemistry System): 101 paired samples (serum and lithium heparin plasma). 5 samples spiked.
- ACE Triglycerides Reagent (ACE Alera Clinical Chemistry System): 101 paired samples (serum and lithium heparin plasma). 5 samples spiked.
Data Provenance: The data provenance is described as "paired samples drawn from the same patients." There is no explicit mention of the country of origin of the data, but the context of an FDA 510(k) submission for commercialization in the USA suggests it would likely be from a US-based or internationally recognized clinical setting. The studies are prospective in nature, as they involve drawing paired samples for direct comparison. Spiking of some samples was done to extend the measurement range.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study does not involve "experts" establishing a ground truth in the traditional sense of medical image interpretation or clinical diagnosis. Instead, the ground truth for each measurement type (Cholesterol, HDL-C, LDL-C, Triglycerides) is the quantitative value obtained from the serum sample, which serves as the established reference matrix. The performance of the devices is then compared against this reference when using plasma samples. Therefore, no external experts were used for this purpose; the "ground truth" is the instrumental measurement itself.
4. Adjudication Method for the Test Set
Not applicable. This is a quantitative laboratory test performance study, not an expert-driven adjudication of medical findings. The comparison is statistical (Deming regression) between instrument measurements from two different sample matrices (serum vs. plasma).
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 study evaluating the performance of in-vitro diagnostic reagents and systems, not an AI-assisted diagnostic device involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This study evaluates the standalone performance of the reagent and instrument system when used with different biological matrices (serum vs. plasma). There is no "human-in-the-loop" component in the interpretation of the numerical results beyond standard laboratory quality control and reporting procedures. The results provided are direct numerical outputs from the analytical instruments.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used in these studies is the quantitative measurement of the analytes (Cholesterol, HDL-C, LDL-C, Triglycerides) obtained from serum samples using the same ACE and ACE Alera Clinical Chemistry Systems. Serum is generally considered the standard matrix for these assays. The purpose of the study is to demonstrate that lithium heparin plasma samples yield comparable results to serum samples.
8. The sample size for the training set
Not applicable. This is a performance validation study for a medical device (reagents and instrument system), not a machine learning model that requires a distinct training set. The "training" in this context would refer to the development and optimization of the reagents and assay protocols, which typically occurs during the R&D phase and doesn't involve a formal "training set" as understood in AI/ML.
9. How the ground truth for the training set was established
Not applicable, as there is no training set in the context of machine learning. The reagents are developed to specifically measure the target analytes based on well-established biochemical principles (enzymatic reactions). The "ground truth" for the development of such assays would involve chemical standards, certified reference materials, and comparison to established reference methods, but this is part of the assay development, not a "training set" for the reported performance studies.
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