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510(k) Data Aggregation
(50 days)
ELAN HOLDINGS, INC.
The ATAC PAK Direct HDL Reagent Kit, the ATAC Direct HDL Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of HDL-cholesterol in serum and plasma. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the risk of developing cardiovascular disease. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
The ATAC PAK Direct HDL Reagent determines HDL-cholesterol through the enzymatic action of cholesterol esterase and cholesterol oxidase on HDL-cholesterol while rendering other sources of cholesterol inactive. The resulting increase in absorbance at approximately 600 nm is proportional to the HDL-cholesterol concentration in the sample.
Here's a breakdown of the acceptance criteria and the study details for the ATAC PAK Direct HDL Reagent Kit, ATAC Direct HDL Calibrator, and ATAC 8000 Random Access Chemistry System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (ATAC PAK Direct HDL Reagent) |
|---|---|
| Linearity Range | 10 to 140 mg/dL |
| Linearity Regression | (ATAC Recoveries) = 0 mg/dL + 0.9570 x (Standard Factors), sv.x = 4.5 mg/dL, r = 0.995 (for n = 40) |
| Precision (Within Run) - Serum 1 (~26 mg/dL) | 1SD = 1.0 mg/dL, %CV = 3.8% |
| Precision (Within Run) - Serum 2 (~55 mg/dL) | 1SD = 1.5 mg/dL, %CV = 2.8% |
| Precision (Within Run) - Serum 3 (~68 mg/dL) | 1SD = 2.0 mg/dL, %CV = 2.9% |
| Precision (Total) - Serum 1 (~26 mg/dL) | 1SD = 1.9 mg/dL, %CV = 7.4% |
| Precision (Total) - Serum 2 (~55 mg/dL) | 1SD = 2.8 mg/dL, %CV = 5.1% |
| Precision (Total) - Serum 3 (~68 mg/dL) | 1SD = 2.7 mg/dL, %CV = 3.9% |
| Comparison to Competitive Reagent (Regression) | ATAC 8000 = 2.8 mg/dL + 0.912 x Competitive Reagent |
| Comparison to Competitive Reagent (Correlation) | r = 0.978 |
| Comparison to Competitive Reagent (Range) | 4.7 - 123 mg/dL |
| Detection Limit Claim | 10 mg/dL |
| Observed Detection Limit | 1.5 mg/dL (calculated as two standard deviations of a 30 replicate within-run precision study of a diluted serum pool) |
| On-board Reagent Stability | 30 days |
| Calibration Stability | 14 days |
| Stability Performance (Total Imprecision during stated stability periods) | Less than 3 mg/dL or 6% |
2. Sample Sizes Used for the Test Set and Data Provenance
- Linearity Study: n = 40 (for regression comparison of standard recoveries to standard factors, indicating the number of data points used to establish linearity). The provenance of these "standard factors" is not explicitly stated, but it implies a controlled laboratory setting.
- Precision (Replicate Assay): n = 66 (replicates for each of Serum 1, Serum 2, and Serum 3). The samples are described as "commercially available control serum and a serum pool," suggesting a controlled lab setting, likely in the US, but the country of origin is not explicitly stated. This was a retrospective analysis of method performance.
- Serum/Plasma Comparison: n = 156 ("mixed serum and plasma specimens, collected from adult patients"). The specific country of origin is not mentioned, but the overall context of the submission to the FDA in the US suggests a US-based study or data relevant to the US market. The phrasing "collected from adult patients" suggests a prospective or retrospectively collected clinical sample set.
- Detection Limit: 30 replicates of a diluted serum pool. Provenance is not specified, but likely a controlled lab setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a clinical chemistry device for quantitative determination, not an imaging or diagnostic interpretation device that typically relies on expert consensus for ground truth. Therefore, the concept of "experts" to establish ground truth in the traditional sense (e.g., radiologists interpreting images) does not apply here.
The "ground truth" for comparison is often established by a reference method or a competitive reagent. In this case, the Roche HDL-Cholesterol plus Reagent Kit is identified as the substantially equivalent predicate device, and the "Competitive Reagent" is used for comparison in the serum/plasma study. The qualifications of those who developed or validated the competitive reagent are not stated in this document.
4. Adjudication Method for the Test Set
Not applicable. This is a quantitative measurement device, not one requiring diagnostic interpretation and adjudication of results by multiple experts. The "ground truth" for comparison is either a known value (for linearity standards), a reference method, or a competitive reagent.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic devices where human readers interpret cases (e.g., radiology images). This documentation describes the performance of a quantitative laboratory diagnostic system, not one involving human interpretation of cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this entire study describes the standalone performance of the ATAC PAK Direct HDL Reagent Kit and the ATAC Direct HDL Calibrator used on the ATAC 8000 Random Access Chemistry System. It reports the analytical performance characteristics of the device itself (linearity, precision, detection limit, correlation with a competitive method, and stability). There is no "human-in-the-loop" component in the direct measurement of HDL-cholesterol by this automated chemistry system.
7. The Type of Ground Truth Used
- Known Values/Standards: For the linearity study, "standard recoveries to standard factors" were compared, implying a ground truth established by known concentrations of HDL-cholesterol.
- Reference Method/Competitive Reagent: For the serum/plasma comparison, the "Competitive Reagent" (implicitly the Roche HDL-Cholesterol plus Reagent Kit or a similar validated method) served as the comparative standard.
- Analytical Determination: For precision and detection limit, the ground truth is based on statistical analysis of repeated measurements, effectively using the device's own measurements against each other to assess consistency.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning. This is a traditional chemical assay, not an AI/ML-based device that typically requires distinct training and test sets. The studies described here are analytical validation studies for the device's performance.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a "training set" in the context of an AI/ML model. The ground truth for the analytical validation studies was established as described in section 7.
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(62 days)
ELAN HOLDINGS, INC.
The ATAC PAK CPK Reagent Kit and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of creatine kinase in serum and plasma. Creatine Kinase measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
The ATAC PAK CPK Reagent Kit and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of creatine kinase in serum and plasma. Creatine kinase results are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. The ATAC PAK CPK Reagent determines creatine kinase activity in the sample by measuring the rate of increase in absorbance at approximately 340 nm, which is proportional to the rate of progression of NAD to NADH.
Here's an analysis of the provided text to extract the acceptance criteria and study details for the ATAC PAK CPK Reagent Kit:
Device: ATAC PAK CPK Reagent Kit
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Linearity/Recovery | Linear from 4 to 1,600 U/L | Range: 0 - 1,635 U/L, sy.x = 13.8 U/L, r² = 0.999 | Meets (exceeds) criteria |
| Hyperactive Range: 1,400 to 5,200 U/L | Range: 1,317 - 3,212 U/L, sy.x = 28.3 U/L | Meets the general criteria of a hyperactive range, though the reported range is narrower than what the criteria implies for the "standard dilution factors." | |
| Lower Limit of Detection | The lower limit of the linear range (4 U/L) | 1.2 U/L (documented through repetitive assay of a diluted serum control, within run precision study) | Meets (exceeds) criteria: 1.2 U/L is below the claimed 4 U/L limit. |
| Precision (Normal Range) | Not explicitly stated with numerical targets, but implied by "Precision statistics, calculated analogous to the method described in NCCLS Guideline EP3-T" | Serum 1 (mean 46 U/L): Within Run 1SD = 0.7 (1.5%CV), Total 1SD = 1.4 (3.0%CV) | Performance demonstrated. |
| Serum 2 (mean 556 U/L): Within Run 1SD = 5.8 (1.0%CV), Total 1SD = 16.2 (2.9%CV) | Performance demonstrated. | ||
| Serum 3 (mean 1177 U/L): Within Run 1SD = 11.9 (1.0%CV), Total 1SD = 33.3 (2.8%CV) | Performance demonstrated. | ||
| Precision (Hyperactive Dilutions) | Not explicitly stated with numerical targets, but implied by "Precision statistics, calculated analogous to the method described in NCCLS Guideline EP3-T" | Serum 1 (mean 2202 U/L): Within Run 1SD = 19 (0.9%CV), Total 1SD = 45 (2.1%CV) | Performance demonstrated. |
| Serum 2 (mean 2636 U/L): Within Run 1SD = 29 (1.1%CV), Total 1SD = 57 (2.2%CV) | Performance demonstrated. | ||
| Method Comparison | Not explicitly stated with numerical targets, but implied by comparison to a "commercially available method." | Bias = -6 U/L, Slope = 1.012, n = 232, range = 4 - 1176 U/L, r = 0.999 | Performance demonstrated. |
| Reagent Stability | Deviations in results over 30 days are less than the greater of 3 U/L or 3% for both primary and hyperactive ranges. | "deviations... over the test period are less than the greater of 3 U/L or 3% for both the primary usable range and the extended hyperactive dilution range." | Meets criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Linearity/Recovery:
- Primary Usable Range: df = 69 (likely corresponds to 70 data points).
- Hyperactive Usable Range: df = 39 (likely corresponds to 40 data points).
- Lower Limit of Detection: Not explicitly stated, but involved "repetitive assay of a diluted serum control."
- Precision:
- Normal Range: n = 60 for each of the three serum samples.
- Hyperactive Dilutions: n = 70 for Serum 1, n = 72 for Serum 2.
- Method Comparison: n = 232 specimens.
- Data Provenance: "Mixed serum and plasma specimens, collected from adult patients." (Country of origin not specified, prospective or retrospective not explicitly stated but implies prospective collection for the comparison study).
- Reagent Stability: Not explicitly stated, but involved "assay of serum controls over the claimed period."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The device being a reagent kit for quantitative determination of creatine kinase, the "ground truth" is typically established by reference methods or validated laboratory measurements, not by expert interpretation in the way it might apply to imaging or diagnostic algorithms. There is no mention of human experts establishing ground truth for the test set in the context of interpretation. Instead, other reference methods and statistical validation methods are used to establish performance.
4. Adjudication Method for the Test Set
Not applicable. For quantitative chemical assays, ground truth is established by a reference method or known concentrations, not through a human adjudication process.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices where human readers (e.g., radiologists) are involved in assessing cases. This submission is for a quantitative chemical assay.
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies reported are for the standalone performance of the ATAC PAK CPK Reagent Kit combined with the ATAC 8000 Random Access Chemistry System. It measures creatine kinase levels directly and objectively.
7. The Type of Ground Truth Used
- For Linearity/Recovery: Known standard dilutions with defined concentrations of creatine kinase.
- For Lower Limit of Detection: Known low-concentration serum control.
- For Precision: Commercially available serum controls with target mean values.
- For Method Comparison: A "commercially available method" (presumably a predicate or established laboratory method) was used to assay the same patient specimens, and its results served as the reference for comparison.
- For Reagent Stability: Values from serum controls measured over time are compared against initial values or acceptable analytical variations.
8. The Sample Size for the Training Set
Not explicitly stated. For a reagent kit, "training set" doesn't apply in the same way as for an AI algorithm. Method validation studies typically establish performance characteristics rather than "train" the assay. The manufacturing process and quality control would ensure consistency.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the AI/algorithm sense. The performance characteristics (linearity, precision, stability, method comparison) are established through detailed analytical studies using known standards, controls, and patient samples compared to predicate devices/methods. The "ground truth" for these analytical methods is based on established chemical principles and metrological traceability.
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(48 days)
ELAN HOLDINGS, INC.
Ask a specific question about this device
(61 days)
ELAN HOLDINGS, INC.
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(42 days)
ELAN HOLDINGS, INC.
Ask a specific question about this device
(94 days)
ELAN HOLDINGS, INC.
HiChem® ISE Electrolyte Buffer, when used in conjunction with the HiChem® ISE Electrolyte Reference, HiChem® CO2 Acid Reagent, HiChem® CO2 Alkaline Buffer, HiChem® Wash Concentrate, and HiChem® Calibration Standards, is intended for the quantitative determination of sodium, chloride, and total CO2 in serum and plasma, and sodium, potassium and chloride in urine, and chloride in cerebrospinal fluid on the Beckman® CX® and CX® DELTA Systems. On appropriately configured SYNCHRON® CX® DELTA Systems, HiChem® ISE Electrolyte Buffer will also determine calcium in serum, plasma and urine.
Sodium results are for the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiurelic hormone secretion, or other diseases involving electrolyte balance. Potassium results are used to monitor electrolyte imbalance in the diagnosis and treatment of diseases and conditions characterized by low or high blood potassium levels. Chloride results are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Carbon dioxide results are used in the diagnosis and treatment of numerous and potentially senous disorders associated with changes in the body's acid-base balance. Calcium results are used in the diagnosis and treatment of parathyroid diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
This reagent is intended for professional use only.
HiChem® ISE Electrolyte Buffer is intended for the quantitative determination of sodium, potassium, chloride, and total CC2 in serum and plasma, and sodium, potassium and chloride in urine, and chloride in cerebrospinal fluid on the Beckman® SYNCHRON® CX® and CX® DELTA Systems. On appropriately configured SYNCHRON® CX® DELTA Systems. HiChem® ISE Electrolyte Buffer will also determine calcium in serum, plasma and urine.
The provided document describes the safety and effectiveness information for the HiChem® ISE Electrolyte Buffer, which is intended for the quantitative determination of various electrolytes in biological fluids. The study aims to demonstrate substantial equivalence to a predicate device, the SYNCHRON® CX® Systems ISE Electrolyte Buffer Kit.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for "substantial equivalence" are implicitly demonstrated through performance comparable to a legally marketed predicate device. This is evaluated through precision studies (imprecision, expressed as %CV) and patient comparison studies (linear regression analysis, including slope 'b', intercept 'a', and correlation coefficient 'r'). The device is considered to meet acceptance criteria if its performance is comparable to or better than the predicate device across various analytes and sample types.
Precision Study Acceptance Criteria (Implicit for Substantial Equivalence):
The HiChem® Reagents should show similar or better precision (lower %CV) compared to the Beckman® Reagents for all analytes and sample types.
| Analyte | Sample | HiChem® Reagents - Total %CV (Reported) | Beckman® Reagents - Total %CV (Predicate) | Acceptance Met? (HiChem ≤ Beckman) |
|---|---|---|---|---|
| Calcium in mg/dL | Serum 1 | 1.9% | 2.0% | Yes |
| Serum 2 | 1.0% | 1.1% | Yes | |
| Serum 3 | 1.1% | 1.1% | Yes | |
| Urine 1 | 3.9% | 4.2% | Yes | |
| Urine 2 | 2.8% | 2.8% | Yes | |
| Chloride in mmol/L | Serum 1 | 1.4% | 1.5% | Yes |
| Serum 2 | 1.0% | 1.0% | Yes | |
| Serum 3 | 1.1% | 0.8% | No (HiChem higher) | |
| Urine 1 | 1.9% | 1.9% | Yes | |
| Urine 2 | 2.4% | 2.2% | No (HiChem higher) | |
| CSF 1 | 1.4% | 1.5% | Yes | |
| CSF 2 | 1.5% | 1.5% | Yes | |
| Potassium in meq/L | Serum 1 | 1.3% | 1.4% | Yes |
| Serum 2 | 0.8% | 0.8% | Yes | |
| Serum 3 | 1.1% | 0.8% | No (HiChem higher) | |
| Urine 1 | 1.0% | 1.2% | Yes | |
| Urine 2 | 1.4% | 1.7% | Yes | |
| Sodium in meq/L | Serum 1 | 1.3% | 1.5% | Yes |
| Serum 2 | 0.7% | 0.8% | Yes | |
| Serum 3 | 0.9% | 0.8% | No (HiChem higher) | |
| Urine 1 | 3.9% | 4.7% | Yes | |
| Urine 2 | 1.2% | 1.5% | Yes | |
| Total CO2 in mmol/L | Serum 1 | 3.0% | 2.9% | No (HiChem higher) |
| Serum 2 | 1.6% | 1.7% | Yes | |
| Serum 3 | 2.1% | 1.5% | No (HiChem higher) |
Patient Comparison Study Acceptance Criteria (Implicit for Substantial Equivalence):
The linear regression parameters (slope 'b', intercept 'a', and correlation coefficient 'r') for HiChem® vs. Beckman® results should ideally be close to b=1, a=0, and r=1, indicating close agreement between the two reagent systems. There are no explicit numerical thresholds stated, but typical acceptance ranges for such studies would be, for example, a slope between 0.95 and 1.05 and a correlation coefficient (r) above 0.975 (or 0.98), though these are not formally defined in the document.
| Analyte | Specimen | Unit | n | Slope 'b' (Reported) | Intercept 'a' (Reported) | Correlation 'r' (Reported) | Acceptance Met? (Implicit: b near 1, a near 0, r near 1) |
|---|---|---|---|---|---|---|---|
| Calcium | Serum/Plasma | mg/dL | 160 | 0.989 | 0.0 | 0.985 | Yes (appears good) |
| Urine | mg/dL | 74 | 1.007 | -0.2 | 0.998 | Yes (appears very good) | |
| Chloride | Serum/Plasma | mmol/L | 160 | 0.988 | 1.0 | 0.935 | Moderately good correlation, intercept slightly high. |
| Urine | mmol/L | 78 | 1.049 | -5.1 | 0.999 | Very good correlation, but intercept is somewhat large. | |
| CSF | mmol/L | 44 | 1.024 | -3.4 | 0.985 | Good correlation, but intercept is somewhat large. | |
| Potassium | Serum/Plasma | meq/L | 160 | 0.969 | 0.13 | 1.000 | Very good (perfect correlation reported). |
| Urine | meq/L | 80 | 0.993 | 0.01 | 1.000 | Very good (perfect correlation reported). | |
| Sodium | Serum/Plasma | meq/L | 160 | 0.930 | 9.1 | 0.938 | Lower correlation and larger intercept. |
| Urine | meq/L | 78 | 1.000 | -0.3 | 1.000 | Very good (perfect correlation reported). | |
| Total CO2 | Serum/Plasma | mmol/L | 160 | 0.949 | 1.2 | 0.953 | Good, but slightly lower correlation and higher intercept. |
Summary of Acceptance: While there are a few instances where the HiChem® Reagents show slightly higher %CV in the precision study, these differences are generally small. The patient comparison study generally shows good agreement (high 'r' values and 'b' values close to 1), although some intercepts ('a') are noticeable, and the correlation for Chloride and Sodium in Serum/Plasma is somewhat lower than other analytes. Overall, the provided data aims to demonstrate "substantial equivalence", and the FDA's clearance (K992844) indicates that these results were considered acceptable.
2. Sample Size Used for the Test Set and the Data Provenance
-
Precision Study Test Set:
- For calcium, chloride, potassium, sodium, and total CO2, 60 replicates (n=60) were performed for most serum and urine samples with HiChem reagents, and 59 or 58 for some CSF and urine samples. The same applies to Beckman reagents.
- Data collection occurred twice per day in triplicate over ten different days (totaling 30 days time frame).
- Data Provenance: Not explicitly stated, but the study was conducted using the Beckman® SYNCHRON® CX® DELTA System. It is likely that the controls and pools used were standard laboratory materials, not patient samples specifically.
-
Patient Comparison Study Test Set:
- Calcium: Serum/Plasma (n=160), Urine (n=74)
- Chloride: Serum/Plasma (n=160), Urine (n=78), CSF (n=44)
- Potassium: Serum/Plasma (n=160), Urine (n=80)
- Sodium: Serum/Plasma (n=160), Urine (n=78)
- Total CO2: Serum/Plasma (n=160)
- Data Provenance: "Serum, plasma, cerebrospinal fluid and urine specimens, collected from adult patients" were used. The country of origin for these patients is not specified, but it's implied to be retrospective as they are "collected specimens."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document describes the performance of a diagnostic reagent kit, not a device requiring human interpretation of results. The "ground truth" for the precision study would be the true concentration of the analytes in the controlled samples (controls, urine pools). For the patient comparison study, the "ground truth" for evaluating the HiChem® device's performance is the results obtained from the predicate Beckman® reagent system. No human experts are used for establishing ground truth in this type of in vitro diagnostic device study; the "ground truth" is established by the reference method (the predicate device) or by the known concentrations of quality control materials.
4. Adjudication Method for the Test Set
Not applicable. This is an in vitro diagnostic (IVD) device measuring quantitative analytes. Results are numerical and compared directly to a predicate device's numerical results or to known concentrations for quality control. There is no human interpretation or adjudication involved in determining the "truth."
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC study was not done. This type of study is relevant for imaging devices or other diagnostics where human readers interpret results, often with and without AI assistance, to assess the impact of the AI on diagnostic accuracy or efficiency. This document concerns an in vitro diagnostic reagent kit, which does not involve human readers in the interpretation of raw data.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, implicitly. The performance data presented for the HiChem® ISE Electrolyte Buffer is its "standalone" performance when run on the specified Beckman® SYNCHRON® CX® and CX® DELTA Systems. The device itself is a reagent and operates automatically once specimens are introduced to the analyzer. The results are generated directly by the analytical system using the reagent, without human intervention in the result calculation or interpretation beyond operating the instrument and ensuring quality control.
7. The type of ground truth used
- Precision Study: The ground truth for evaluating imprecision is the mean concentration of the analyte within the control material or urine pools, and then the variability (SD, %CV) around that mean is calculated. The "true" concentration of these controls/pools serves as a reference.
- Patient Comparison Study: The ground truth for evaluating agreement is the results obtained from the predicate device (Beckman® reagents). The HiChem® results are compared against these predicate results via linear regression to demonstrate substantial equivalence, not against an external, independent "gold standard" truth like pathology or patient outcomes.
8. The Sample Size for the Training Set
The document describes a 510(k) submission for a new reagent kit, demonstrating its performance. It does not utilize machine learning or AI that would require a distinct "training set" in the computational sense. The "training" for such a system would typically refer to the internal development and calibration of the reagent and the analytical device itself, which is not detailed here. The studies described (precision, patient comparison) are validation studies.
9. How the ground truth for the training set was established
As there is no "training set" in the conventional AI/ML sense for this type of IVD device, this question is not applicable. The device's calibration and performance characteristics would have been established by the manufacturer through rigorous internal development and testing, likely using certified reference materials and established analytical methods.
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(94 days)
ELAN HOLDINGS, INC.
HiChem® ISE Electrolyte Reference, when used in conjunction with the HiChem® ISE Electrolyte Buffer, HiChem® CO2 Acid Reagent, HiChem® CO2 Alkaline Buffer, HiChem® Wash Concentrate, and HiChem® Calibration Standards, is intended for the quantitative determination of sodium, chloride, and total CO2 in serum and plasma, and sodium, potassium and chloride in urine, and chloride in cerebrospinal fluid on the Beckman® CX® and CX® DELTA Systems. On appropriately configured SYNCHRON® CX® DELTA Systems, HiChem® ISE Electrolyte Reference will also determine calcium in serum, plasma and urine.
Sodium results are for the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insigidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiurelic hormone secretion, or other diseases involving electrolyte balance. Potassium results are used to monitor electrolyte imbalance in the diagnosis and treatment of diseases and conditions characterized by low or high blood potassium levels. Chloride results are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Carbon dioxide results are used in the diagnosis and treatment of numerous and potentially senous disorders associated with changes in the body's acid-base balance. Calcium results are used in the diagnosis and treatment of parathyroid diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
This reagent is intended for professional use only.
Not Found
The provided document describes the safety and effectiveness information for the HiChem® ISE Electrolyte Reference kit. The study compares the performance of the HiChem® kit to a predicate device, the SYNCHRON® CX® Systems ISE Electrolyte Reference Kit, manufactured by Beckman Coulter, Inc.
Here's an analysis of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a numerical or categorical format with pass/fail thresholds. Instead, it demonstrates performance by showing the precision and patient comparison results of the HiChem® reagents alongside the predicate Beckman® reagents. The implicit acceptance criterion is that the HiChem® reagents perform comparably to the legally marketed predicate device.
Precision Statistics (HiChem® Reagents vs. Beckman® Reagents)
| Analyte | Sample | HiChem® Within Run %CV (Max) | HiChem® Total %CV (Max) | Beckman® Within Run %CV (Max) | Beckman® Total %CV (Max) |
|---|---|---|---|---|---|
| Calcium in mg/dL | Serum 1 | 2.1% | 1.9% | 2.0% | 2.0% |
| Serum 2 | 0.8% | 1.0% | 0.8% | 1.1% | |
| Serum 3 | 0.9% | 1.1% | 0.7% | 1.1% | |
| Urine 1 | 3.5% | 3.9% | 3.5% | 4.2% | |
| Urine 2 | 3.1% | 2.8% | 2.9% | 2.8% | |
| Chloride in mmol/L | Serum 1 | 1.4% | 1.4% | 1.0% | 1.5% |
| Serum 2 | 0.6% | 1.0% | 0.7% | 1.0% | |
| Serum 3 | 0.8% | 1.1% | 0.6% | 0.8% | |
| Urine 1 | 1.8% | 1.9% | 2.0% | 1.9% | |
| Urine 2 | 1.0% | 2.4% | 1.1% | 2.2% | |
| CSF 1 | 1.2% | 1.4% | 1.3% | 1.5% | |
| CSF 2 | 1.0% | 1.5% | 1.4% | 1.5% | |
| Potassium in meq/L | Serum 1 | 0.8% | 1.3% | 0.8% | 1.4% |
| Serum 2 | 0.6% | 0.8% | 0.7% | 0.8% | |
| Serum 3 | 0.9% | 1.1% | 0.7% | 0.8% | |
| Urine 1 | 0.9% | 1.0% | 1.1% | 1.2% | |
| Urine 2 | 1.4% | 1.4% | 1.8% | 1.7% | |
| Sodium in meq/L | Serum 1 | 1.5% | 1.3% | 1.5% | 1.5% |
| Serum 2 | 0.6% | 0.7% | 0.7% | 0.8% | |
| Serum 3 | 0.9% | 0.9% | 0.6% | 0.8% | |
| Urine 1 | 4.4% | 3.9% | 5.5% | 4.7% | |
| Urine 2 | 1.4% | 1.2% | 1.7% | 1.5% | |
| Total CO2 in mmol/L | Serum 1 | 3.2% | 3.0% | 3.0% | 2.9% |
| Serum 2 | 1.4% | 1.6% | 1.5% | 1.7% | |
| Serum 3 | 1.7% | 2.1% | 1.2% | 1.5% |
Patient Comparison (Linear Regression of HiChem® vs. Beckman® Results)
| Analyte | Specimen | Unit | n | a (Intercept) | b (Slope) | r (Correlation) |
|---|---|---|---|---|---|---|
| Calcium | Serum/Plasma | mg/dL | 160 | 0.0 | 0.989 | 0.985 |
| Urine | mg/dL | 74 | -0.2 | 1.007 | 0.998 | |
| Chloride | Serum/Plasma | mmol/L | 160 | 1.0 | 0.988 | 0.935 |
| Urine | mmol/L | 78 | -5.1 | 1.049 | 0.999 | |
| CSF | mmol/L | 44 | -3.4 | 1.024 | 0.985 | |
| Potassium | Serum/Plasma | meq/L | 160 | 0.13 | 0.969 | 1.000 |
| Urine | meq/L | 80 | 0.01 | 0.993 | 1.000 | |
| Sodium | Serum/Plasma | meq/L | 160 | 9.1 | 0.930 | 0.938 |
| Urine | meq/L | 78 | -0.3 | 1.000 | 1.000 | |
| Total CO2 | Serum/Plasma | mmol/L | 160 | 1.2 | 0.949 | 0.953 |
The implicit acceptance criteria for this type of submission (510(k)) is substantial equivalence. This means the device must perform as safely and effectively as a legally marketed predicate device. The tables above demonstrate this by showing very similar precision and correlation values between the HiChem® device and the Beckman® predicate device across all analytes and sample types.
2. Sample sizes used for the test set and the data provenance
- Precision Test Set Sample Sizes:
- For calcium, chloride, potassium, sodium, and total CO2 across serum, CSF controls, and urine pools:
nvalues varied slightly, mostly aroundn=60for each sample type and analyte combination. The exactnvalues are listed in the precision tables (e.g., Serum 1 for Calcium hasn=60for both HiChem® and Beckman®).
- For calcium, chloride, potassium, sodium, and total CO2 across serum, CSF controls, and urine pools:
- Patient Comparison Test Set Sample Sizes:
- Calcium (Serum/Plasma): 160; Calcium (Urine): 74
- Chloride (Serum/Plasma): 160; Chloride (Urine): 78; Chloride (CSF): 44
- Potassium (Serum/Plasma): 160; Potassium (Urine): 80
- Sodium (Serum/Plasma): 160; Sodium (Urine): 78
- Total CO2 (Serum/Plasma): 160
- Data Provenance: The document states "Serum and CSF controls, and urine pools were each assayed..." for precision. For patient comparison, "Serum, plasma, cerebrospinal fluid and urine specimens, collected from adult patients, were assayed..."
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: Not explicitly stated as retrospective or prospective. However, tests of method comparison for 510(k) are typically prospective or newly acquired samples. The "collected from adult patients" suggests freshly collected samples for the patient comparison study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This study is for an In Vitro Diagnostic (IVD) device that measures analyte concentrations. The "ground truth" for such devices is typically established through a reference method or by comparing the test device's results with a well-established, legally marketed predicate device (as is the case here).
- Number of Experts: Not applicable in the context of human expert review for image interpretation or diagnosis. The "ground truth" is the measurement obtained from the predicate device (Beckman® SYNCHRON® CX® DELTA Systems).
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
Not applicable. This is not an imaging or diagnostic device that requires human adjudication of interpretations. The comparison is between quantitative measurements from two different reagent sets on the same analyzer system.
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 not a study involving human readers or AI assistance. It is a comparison of in vitro diagnostic reagents.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable in the sense of an algorithm. This is a standalone performance study of the HiChem® reagent kit (without "human-in-the-loop" in the algorithm sense, but human operation of the analyzer is inherent). The study evaluates the performance of the HiChem® reagents directly against the predicate Beckman® reagents.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the results obtained from the predicate device (SYNCHRON® CX® Systems ISE Electrolyte Reference Kit manufactured by Beckman Coulter, Inc.) running on the specified Beckman® SYNCHRON® CX® and CX® DELTA Systems. The goal is to show the HiChem® kit yields results substantially equivalent to the established predicate.
8. The sample size for the training set
Not applicable. This represents a traditional IVD device submission, not a machine learning/AI device that typically involves distinct training and test sets. The data presented are for performance validation (equivalent to a test set in ML terms, but focused on demonstrating equivalence).
9. How the ground truth for the training set was established
Not applicable, as there is no training set in this context.
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(55 days)
ELAN HOLDINGS, INC.
HiChem® Calibrators 1, 2 and 3 are intended to calibrate the Beckman® SYNCHRON CX® DELTA and CX® CE® Systems for the quantitative determination of sodium, potassium, chloride, urea, giucose, creatinine, calcium and total CO2.
HiChem® Calibrators 1, 2 and 3 for the SYNCHRON CX® DELTA and CX® CE® Systems are intended to establish points of reference that are used in the determination of values in the measurement of substances in specimens.
Not Found
Here's a breakdown of the acceptance criteria and study information for the HiChem® Calibrators 1, 2 and 3, based on the provided document:
Acceptance Criteria and Device Performance
The document doesn't explicitly state "acceptance criteria" in a separate section with numerical targets. Instead, it presents method comparison study results as evidence of effectiveness and substantial equivalence to the predicate device. The implicit acceptance criteria appear to be the demonstration of strong linear correlation (high 'r' value) and minimal bias (slope 'b' close to 1.0 and intercept 'a' close to 0.0) between the HiChem® calibrators and the Beckman® calibrators across various analytes and specimen types.
Table of Performance (derived from the method comparison study):
| Analyte | Specimen | Unit | Regression Statistics (n) | 'a' | 'b' | 'r' | Range | Mean X (Predicate) | Mean Y (Device) |
|---|---|---|---|---|---|---|---|---|---|
| Calcium | Serum/Plasma | mg/dL | 160 | 0.0 | 0.989 | 0.985 | 7.1 - 10.6 | 9.26 | 9.13 |
| Urine | mg/dL | 74 | -0.2 | 1.007 | 0.998 | 2.4 - 15.2 | 8.45 | 8.3 | |
| Chloride | Serum/Plasma | mmol/L | 160 | 1.0 | 0.988 | 0.935 | 98.2 - 127.5 | 107.3 | 107.0 |
| Urine | mmol/L | 78 | -5.1 | 1.049 | 0.999 | 22.4 - 289 | 126.8 | 127.9 | |
| CSF | mmol/L | 44 | -3.4 | 1.024 | 0.985 | 113.8 - 152.4 | 126.5 | 126.1 | |
| Potassium | Serum/Plasma | meq/L | 160 | 0.13 | 0.969 | 1.000 | 3.20 - 10.82 | 5.02 | 5.00 |
| Urine | meq/L | 80 | 0.01 | 0.993 | 1.000 | 3.48 - 136.0 | 50.5 | 50.2 | |
| Sodium | Serum/Plasma | meq/L | 160 | 9.1 | 0.930 | 0.938 | 131.8 - 159.1 | 141.0 | 140.3 |
| Urine | meq/L | 78 | -0.3 | 1.000 | 1.000 | 16.9 - 288.1 | 118.2 | 117.8 | |
| Total CO2 | Serum/Plasma | mmol/L | 160 | 1.2 | 0.949 | 0.953 | 9.5 - 29.1 | 23.3 | 23.2 |
| BUN | Serum/Plasma | mgN/dL | 160 | -0.3 | 0.987 | 0.999 | 4 - 126 | 19.0 | 18.4 |
| Urine | mgN/dL | 79 | 0.9 | 0.979 | 1.000 | 6 - 142 | 76.2 | 75.4 | |
| Glucose | Serum/Plasma | mg/dL | 159 | -1.2 | 1.011 | 0.999 | 29 - 341 | 100.7 | 100.6 |
| Urine | mg/dL | 81 | -2.1 | 1.012 | 0.999 | 1 - 359 | 197.3 | 197.4 | |
| CSF | mg/dL | 45 | 1.0 | 0.973 | 0.999 | 3 - 186 | 81.9 | 80.7 | |
| Creatinine | Serum/Plasma | mg/dL | 160 | 0.0 | 0.991 | 0.997 | 0.4 - 5.4 | 1.09 | 1.08 |
| Urine | mg/dL | 79 | -0.3 | 1.000 | 1.000 | 12.1 - 309.2 | 112.5 | 112.3 |
Summary of Device Performance against Implicit Acceptance Criteria:
The device consistently demonstrates strong linear correlation (r-values generally close to 1.0, with most >0.98 and only a few >0.93) and good agreement with the predicate device (slope 'b' generally close to 1.0 and intercept 'a' close to 0.0) across all tested analytes and specimen types. This performance suggests the device meets the implicit acceptance criteria for substantial equivalence to the predicate.
Study Details:
-
Sample sizes used for the test set and the data provenance:
- Sample Sizes (n):
- Serum/Plasma: 159 or 160 for most analytes
- Urine: 74-81 for most analytes
- CSF: 44 or 45 for some analytes (Chloride, Glucose)
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not explicitly stated, however, the phrase "were collected from adult patients and assayed" suggests a prospective collection for the purpose of this study.
- Sample Sizes (n):
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device (calibrators for laboratory instruments). The "ground truth" in this context is the analytical result obtained using the predicate device's calibrators on a controlled laboratory system. There are no human "experts" establishing a diagnostic ground truth. -
Adjudication method for the test set:
Not applicable. This is a quantitative measurement comparison study, not one requiring adjudication of subjective interpretations. -
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 comparing analytical calibrators, not an AI-assisted diagnostic device that involves human readers. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, in a sense, this is a standalone performance study of the calibrators. The performance shown directly reflects the analytical capability of the HiChem® calibrators in conjunction with the SYNCHRON CX® DELTA System, without human intervention in the measurement process itself, beyond operating the instrument. The results are compared against the predicate calibrators in the same system configuration. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this study is the analytical results obtained using the predicate calibrators (SYNCHRON® CX® Calibrators 1, 2 & 3) on the specified Beckman® SYNCHRON CX® DELTA System. This is a comparative study against an established, legally marketed calibrator. -
The sample size for the training set:
Not applicable. This device is a calibrator, and its evaluation involves method comparison studies, not machine learning or AI models that require a separate training set. -
How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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(55 days)
ELAN HOLDINGS, INC.
HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and plasma on the SYNCHRON CX® Systems and serum, plasma and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems. Total protein results are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. This reagent is intended for professional use only.
HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and plasma on the SYNCHRON CX® Systems and serum, plasma and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems.
The HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and plasma on the SYNCHRON CX® Systems, and serum, plasma, and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems. The study aimed to demonstrate its substantial equivalence to the SYNCHRON® CX® Systems Total Protein Reagent Kit (product no. 450224) manufactured by Beckman Coulter, Inc.
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines acceptance criteria through the comparison to a predicate device and established NCCLS guidelines for precision. While explicit numerical acceptance criteria are not stated as "acceptance criteria," the reported performance demonstrates equivalence, which is the underlying goal for 510(k) submission.
| Metric (Implied Acceptance Criterion: Comparable to Beckman® Reagent) | HiChem® Total Protein Reagent Performance | Beckman® Total Protein Reagent Performance (Predicate) | Discussion |
|---|---|---|---|
| Precision (Within Run %CV): | |||
| Serum 1 (3.8 g/dL) | 1.1% | 1.2% | Comparable |
| Serum 2 (5.9 g/dL) | 0.7% | 0.8% | Comparable |
| Serum 3 (8.0 g/dL) | 0.7% | 0.6% | Comparable |
| CSF 1 (21 mg/dL) | 15.2% | 5.2% | Higher for HiChem® |
| CSF 2 (53 mg/dL) | 3.1% | 2.8% | Comparable |
| Precision (Total %CV): | |||
| Serum 1 (3.8 g/dL) | 1.7% | 1.3% | Comparable |
| Serum 2 (5.9 g/dL) | 1.3% | 1.0% | Comparable |
| Serum 3 (8.0 g/dL) | 1.4% | 1.1% | Comparable |
| CSF 1 (21 mg/dL) | 19.7% | 12.2% | Higher for HiChem® |
| CSF 2 (53 mg/dL) | 4.4% | 5.2% | Comparable |
| Patient Comparison (Linear Regression for Serum/Plasma): | y = 0.2 + 0.970x | N/A (predicate comparison) | Strong correlation (r = 0.988) with the predicate. |
| Patient Comparison (Linear Regression for CSF): | y = -2.8 + 1.010x | N/A (predicate comparison) | Strong correlation (r = 0.995) with the predicate. |
Note: For the CSF 1 precision, the HiChem® reagent shows higher %CVs compared to the Beckman® reagent. However, the strong correlation in the patient comparison for CSF (r = 0.995) suggests that despite higher variability at lower concentrations, the overall agreement with the predicate is very high.
2. Sample Sizes and Data Provenance:
- Precision Test Set:
- Serum and Cerebrospinal Fluid Controls: Each control was assayed 3 times per day for 10 days, resulting in n=60 measurements for each sample (3 assays/day * 10 days * 2 reagents = 60 for HiChem®, 60 for Beckman®, for a total of 120 measurements per sample type).
- Data Provenance: Not explicitly stated, but assumed to be prospective, collected during the study. Country of origin is not specified.
- Patient Comparison Test Set:
- Serum/Plasma Specimens: n=160 adult patients.
- CSF Specimens: n=40 adult patients.
- Data Provenance: Retrospective, collected from adult patients. Country of origin is not specified.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This device is an in vitro diagnostic reagent, and its performance is assessed against a predicate device and NCCLS guidelines, not against human expert interpretation or a "ground truth" established by experts in the typical sense of image analysis or diagnostic interpretation.
4. Adjudication Method for the Test Set:
Not applicable, as the "ground truth" is based on quantitative measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not a device intended for human interpretation or a scenario where human readers would collaborate with AI.
6. Standalone (Algorithm Only) Performance:
Yes, the study presents the standalone performance of the HiChem® Total Protein Reagent. The precision and patient comparison studies demonstrate the reagent's performance in isolation, with measurements obtained directly from the SYNCHRON CX® DELTA System. There is no human-in-the-loop component in the evaluation of this reagent's analytical performance.
7. Type of Ground Truth Used:
The "ground truth" for this study is established by:
- Comparison to a legally marketed predicate device: The SYNCHRON® CX® Systems Total Protein Reagent Kit (product no. 450224) manufactured by Beckman Coulter, Inc. This implicitly serves as the standard for expected performance.
- Quantitative measurements: The accuracy of the reagent is assessed by its correlation with the predicate device using least squares linear regression.
- Internal precision: Assessed against NCCLS publication EP3-T guidelines, indicating repeatability and reproducibility.
8. Sample Size for the Training Set:
Not applicable. This is a chemical reagent, not an AI/ML algorithm that requires a training set. The performance is evaluated based on its chemical and analytical properties when run on a specified instrument.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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(51 days)
ELAN HOLDINGS, INC.
HiChem® BUN Reagent is intended for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman® SYNCHRON CX® and CX® DELTA Systems.
Urea nitrogen results are used in the treatment of numerous renal and metabolic diseases.
This reagent is intended for professional use only.
HiChem® BUN Reagent is intended for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman® SYNCHRON CX® and CX® DELTA Systems.
Here's a breakdown of the acceptance criteria and study details for the HiChem® BUN Reagent, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are implied by the comparison to the predicate device (Beckman® SYNCHRON® CX® Systems BUN Reagent Kit). The study's goal was to demonstrate similar performance. The quantitative acceptance criteria are not explicitly stated as numerical thresholds (e.g., "within X% difference"), but rather through statistical comparisons like correlation coefficients (r) and differences in regression equations.
| Performance Metric | Acceptance Criteria (Implied - Similar to Predicate) | HiChem® Reagent Performance | Beckman® Reagent Performance (Predicate) | Device Meets Criteria? |
|---|---|---|---|---|
| Precision | Similar %CV and 1SD values to predicate | See detailed tables below | See detailed tables below | Yes |
| Serum 1 (7.1 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 9.1%, 9.4%, 0.65, 0.66 | 9.1%, 8.4%, 0.65, 0.60 | Yes (very similar) |
| Serum 2 (35.4 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 1.8%, 1.9%, 0.62, 0.66 | 1.5%, 1.6%, 0.53, 0.57 | Yes (very similar) |
| Serum 3 (63.8 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 0.8%, 1.3%, 0.50, 0.80 | 1.1%, 1.2%, 0.72, 0.76 | Yes (very similar) |
| Urine 1 (21.7 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 4.1%, 3.8%, 0.89, 0.82 | 2.9%, 2.9%, 0.62, 0.63 | Yes (similar) |
| Urine 2 (112.2 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 0.7%, 1.1%, 0.75, 1.25 | 0.7%, 1.2%, 0.82, 1.31 | Yes (very similar) |
| ORDAC Precision | Similar %CV and 1SD values to predicate | See detailed tables below | See detailed tables below | Yes |
| Serum 1 (179-180 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 0.7%, 1.4%, 1.18, 2.58 | 0.7%, 1.2%, 1.18, 2.17 | Yes (very similar) |
| Serum 2 (258-262.4 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 0.7%, 1.4%, 1.91, 3.55 | 0.7%, 1.1%, 1.75, 2.78 | Yes (very similar) |
| Method Comparison (Serum/Plasma) | High correlation (r ≥ 0.99) and small intercept/slope deviation from 0/1 | r = 0.999, HiChem® = -0.3 + 0.987 * Beckman® | Not applicable (comparison) | Yes (very strong correlation, small bias) |
| Method Comparison (Urine) | High correlation (r ≥ 0.99) and small intercept/slope deviation from 0/1 | r = 1.000, HiChem® = 0.9 + 0.979 * Beckman® | Not applicable (comparison) | Yes (perfect correlation, small bias) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision Study:
- Serum/Urine Samples (non-ORDAC): For each of the 5 samples (3 serum, 2 urine), n = 60 (This represents 60 individual measurements for each sample type, collected over 10 days, assayed twice per day in triplicate).
- ORDAC Samples: For each of the 2 spiked serum samples, n = 60 (This represents 60 individual measurements for each sample type).
- Data Provenance: Not explicitly stated, but clinical laboratory studies often use control materials and patient samples from the country where the manufacturer is based (USA in this case, based on FDA submission). The study design (assaying twice per day over 30 days) suggests prospective data collection for the precision aspect.
- Patient Comparison (Method Comparison) Study:
- Serum/Plasma: n = 160
- Urine: n = 79
- Data Provenance: "collected from adult patients" - implies prospective collection of patient samples. Likely from the US, given the FDA submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This type of submission for a diagnostic reagent does not typically involve experts establishing a "ground truth" in the way an imaging or diagnostic AI model would. In in-vitro diagnostics, the "ground truth" is typically the quantitative result obtained from a reference method or the predicate device itself, which is assumed to be accurate.
Therefore, this section is not applicable for this device. The "ground truth" for comparison is the performance of the established, legally marketed predicate device (Beckman® SYNCHRON® CX® Systems BUN Reagent Kit).
4. Adjudication Method for the Test Set
Not applicable. There's no subjective interpretation requiring adjudication in a quantitative diagnostic assay comparison.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is a study comparing the performance of two quantitative diagnostic reagents, not a study involving human readers interpreting cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, in the sense that the device (reagent) performance itself is being evaluated and compared to a predicate, independent of human interpretation of the results. The "algorithm" here is the chemical reaction and analytical measurement process on the SYNCHRON CX® and CX® DELTA Systems. The reported performance metrics are purely analytical measurements of the reagent's characteristics.
7. The Type of Ground Truth Used
The ground truth or reference standard for comparison is the Beckman® SYNCHRON® CX® Systems BUN Reagent Kit. This is a well-established, legally marketed predicate device, and its performance is assumed to be the "gold standard" against which the new HiChem® BUN Reagent is evaluated for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is a diagnostic reagent, not an AI/ML model that requires a "training set." The development of the reagent itself would involve R&D and formulation, but not a "training set" in the computational sense.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of device.
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