(94 days)
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.
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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.
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in 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 antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.