Search Results

Date Cleared

2004-12-27

(257 days)

Product Code

CDS

Regulation Number

862.1770

Type

Panel

Reference & Predicate Devices

K761061

Intended Use

The BUN Reagent is to be used for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman SYNCHRON CX3® System to aid in the diagnosis of renal function and pre renal disease states, such as cardiac decompensation and others.

Device Description

The Device is a reagent containing sufficient Urease, surfactants and other ingredients necessary for optimum system operation on the Beckman Synchron CX3® Analyzer.

AI/ML Overview

Acceptance Criteria and Device Performance Study for GenChem, Inc. BUN Reagent

This document outlines the acceptance criteria and the results of a study demonstrating the performance of the GenChem, Inc. Electrode, Ion Specific, Urea Nitrogen (BUN) Reagent (K040973).

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Precision/Reproducibility	Based on NCCLS EP3-T guidelines; generally low %CV for various BUN levels.	Serum 1 (7.1 mg/dL): Within Run %CV = 9.1%, Total %CV = 9.4%
Serum 2 (35.4 mg/dL): Within Run %CV = 1.8%, Total %CV = 1.9%
Serum 3 (63.8 mg/dL): Within Run %CV = 0.8%, Total %CV = 1.3%
Urine 1 (21.7 mg/dL): Within Run %CV = 4.1%, Total %CV = 3.8%
Urine 2 (112.2 mg/dL): Within Run %CV = 0.7%, Total %CV = 1.1%
Linearity/Reportable Range	Demonstrates linearity across the stated analytical range with a high correlation coefficient and low intercept/slope deviation from ideal.	Slope = 0.995, Intercept = -0.12, Standard Error of Estimate = 0.49, r² = 1.00
Analytical Range: 2 - 150 mgN/dL (Normal); 150 - 300 mgN/dL (ORDAC*)
Sensitivity	Observed sensitivity limit to be ≤ claimed limit.	Claimed Limit = 2 mg/dL
Observed Sensitivity Limit (3 SD) = 1.43 mg/dL
Analytical Specificity	No adverse effect from common interferents at specified concentrations.	Hemoglobin (up to 500 mg/dL), Bilirubin (up to 20 mg/dL), Lipemia (up to 1800 mg/dL) showed no adverse effect on 15 mg/dL BUN sample.
Method Comparison (Correlates with Predicate Device)	Strong correlation with the predicate device across the analytical range, indicated by high R² value, slope close to 1, and intercept close to 0.	Serum (N=80): Intercept = -0.3, Slope = 0.995, R² = 0.999
Plasma (N=80): Intercept = -0.2, Slope = 0.989, R² = 0.998
Urine (N=79): Intercept = 0.9, Slope = 0.979, R² = 1.000

*ORDAC: Off-Range Dilution and Concentration

2. Sample Size and Data Provenance (Test Set)

Precision/Reproducibility:
- Sample Size: 60 replicates for each of 5 samples (3 serum, 2 urine) (N=60 for each sample type). Assayed twice per day in triplicate on 10 different days over a 30-day period.
- Data Provenance: Not explicitly stated, but likely from laboratory controlled samples (control sera, diluted urine pools). This is typically a retrospective analysis of controlled lab materials.
Linearity/Assay Reportable Range:
- Sample Size: Analyzed 7 commercially available linearity standards ranging from 0 to 158 mg/dL in triplicate.
- Data Provenance: Commercially available linearity standards, typically retrospective analysis in a controlled lab setting.
Sensitivity:
- Sample Size: 21 replicates of a diluted serum control.
- Data Provenance: Diluted serum control, typically retrospective analysis in a controlled lab setting.
Analytical Specificity:
- Sample Size: Not explicitly stated as a numerical sample size but involved testing stock samples with varying concentrations of interferents (Hemoglobin, Bilirubin, Lipemia) against a base pool.
- Data Provenance: Laboratory-prepared stock solutions and base pool, typically retrospective analysis in a controlled lab setting.
Patient Comparison (Method Comparison):
- Sample Size: 80 serum specimens, 80 plasma specimens, and 79 urine specimens.
- Data Provenance: "Collected from adult patients." This indicates prospective or retrospective patient sample collection, but the context generally implies real patient samples that were de-identified and used for the study. The country of origin is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The studies described in the provided text are for an in vitro diagnostic reagent and system. For such devices, "ground truth" is typically established by comparative analysis with a well-characterized reference method or a legally marketed predicate device, rather than expert interpretation of images or clinical data.

For Precision, Linearity, Sensitivity, and Analytical Specificity: Ground truth is established by the inherent properties of the reference materials used (e.g., certified control sera, linearity standards with known concentrations) or by accepted laboratory analytical methods. No external "experts" (like radiologists) are involved in establishing this type of ground truth.
For Patient Comparison: The "ground truth" for the test set (GenChem BUN reagent) is the measurement obtained from the predicate device (Beckman BUN reagent for the CX3). The "experts" in this context would be the skilled laboratory technicians operating the instruments, but their role is to accurately perform the assays, not to interpret an uncertain "ground truth."

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in studies where subjective interpretation (e.g., imaging reads) is involved and discrepancies between readers need to be resolved. For an IVD reagent, data is quantitative and is compared statistically. Therefore, no adjudication method as typically understood in image-based studies was used. The comparison was a direct statistical correlation between the test device and the predicate device's quantitative results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices that involve human interpretation of results (e.g., radiologists reading images and improved performance with AI assistance). The GenChem BUN Reagent is an automated in vitro diagnostic assay where the output is a quantitative value, not subject to human interpretation in the same way. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Yes, all performance studies described are essentially standalone performance studies for the reagent on the Beckman CX3® Synchron Analyzer. The analytical performance characteristics (Precision, Linearity, Sensitivity, Analytical Specificity, and Method Comparison) measure the reagent's performance as an "algorithm only" (in the sense of an automated test system yielding a quantitative result without direct human interpretation influencing the result itself). The human "in the loop" would be operating the instrument and performing quality control, but not providing an interpretation that the algorithm augments or replaces.

7. Type of Ground Truth Used

The primary ground truth used for the method comparison study (patient comparison) was the predicate device's measurement (Beckman BUN reagent for the CX3). For other performance characteristics like precision, linearity, and sensitivity, the ground truth was established by reference materials, certified standards, or accepted laboratory methods (e.g., known concentrations of linearity standards, the mean value for precision calculations). This is synonymous with a form of expert consensus if the reference methods are considered the established gold standard.

8. Sample Size for the Training Set

The provided documentation describes performance studies for regulatory submission (510(k)). These are analytical validation studies, not machine learning model development. Therefore, there is no explicit "training set" in the context of an AI/ML algorithm. The "training" in this context refers to the development and optimization of the reagent and its methods, which would typically be done by the manufacturer through various iterations using proprietary internal samples and methodologies, but these are not disclosed as a "training set" in a regulatory submission for an IVD reagent.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the context of an AI/ML algorithm, this question is not applicable. The development of chemical reagents and analytical methods for IVD devices involves extensive R&D and optimization, where "ground truth" is established against known chemical properties, reference methods, and clinical needs during the development phase.

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K Number

K040974

Device Name

GLUCOSE OXIDASE, GLUCOSE

Manufacturer

Date Cleared

2004-12-27

(257 days)

Product Code

CGA

Regulation Number

862.1345

Type

Panel

Reference & Predicate Devices

K761060

Intended Use

The GenChem Glucose Oxidase Reagent is for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid on the Beckman SYNCHRON CX3® System to aid in the diagnosis of diabetes, liver disease and certain endocrine disorders.

Device Description

The Device is a solution containing sufficient Glucose Oxidase, surfactants and other ingredients necessary for optimum system operation on the Beckman CX3® Analyzer.

AI/ML Overview

This submission pertains to the GenChem Glucose Oxidase Reagent for the quantitative determination of glucose. The study evaluates the device's performance against predefined criteria across various metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Precision/Reproducibility
Serum Glucose (60mg/dL)	Low %CV for within-run and total imprecision	Within Run: 1.4%CV; Total: 2.1%CV
Serum Glucose (220mg/dL)	Low %CV for within-run and total imprecision	Within Run: 0.6%CV; Total: 1.1%CV
Serum Glucose (387mg/dL)	Low %CV for within-run and total imprecision	Within Run: 0.6%CV; Total: 1.3%CV
CSF Glucose (57mg/dL)	Low %CV for within-run and total imprecision	Within Run: 1.2%CV; Total: 2.4%CV
CSF Glucose (33mg/dL)	Low %CV for within-run and total imprecision	Within Run: 1.9%CV; Total: 4.1%CV
Urine Glucose (24mg/dL)	Low %CV for within-run and total imprecision	Within Run: 2.9%CV; Total: 5.8%CV
Urine Glucose (315mg/dL)	Low %CV for within-run and total imprecision	Within Run: 1.0%CV; Total: 1.6%CV
ORDAC Serum Glucose (557mg/dL)	Low %CV for within-run and total imprecision	Within Run: 1.5%CV; Total: 1.8%CV
ORDAC Serum Glucose (770mg/dL)	Low %CV for within-run and total imprecision	Within Run: 0.9%CV; Total: 1.5%CV
Linearity/Assay Reportable Range	Slope close to 1, Intercept close to 0, high R-squared	Slope: 1.012, Intercept: 0.1.97, R²: 1.000
Normal Range (All Specimens)	Accurate detection within 5 to 450 mg/dL	5 to 450 mg/dL (0.3 to 25 mmol/L)
ORDAC Range (All Specimens)	Accurate detection within 450 to 900 mg/dL	450 to 900 mg/dL (25 to 50 mmol/L)
Sensitivity	Value

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K Number

K040975

Device Name

GENCHEM CO2 ACID REAGENT

Manufacturer

Date Cleared

2004-12-27

(257 days)

Product Code

JFL

Regulation Number

862.1160

Type

Panel

Reference & Predicate Devices

K014034

Intended Use

The GenChem CO2 Acid Reagent when used in conjunction with the GenChem ISE Electrolyte Reference, GenChem Electrolyte Buffer, GenChem CO2 Alkaline Buffer, GenChem Wash Concentrate, and appropriate Calibrators or Calibration Standards is intended for the quantitative determination of Carbon Dioxide in serum and plasma on the Beckman CX3®. Carbon Dioxide results are used in the diagnosis and treatment of numerous and potentially serious disorders associated with changes in the body's acidbase balance.

Device Description

The Device is a solution containing 0.6 mol/L sulfuric acid, nonreactive surfactants and other ingredients necessary for optimum system operation.

AI/ML Overview

The provided text describes performance characteristics for the GenChem CO2 Acid Reagent, primarily focusing on its analytical performance rather than diagnostic accuracy against a ground truth dataset. Therefore, some of the requested information, particularly regarding expert consensus, MRMC studies, and ground truth establishment for a diagnostic algorithm, is not applicable or cannot be extracted from this document, as it describes a laboratory reagent for quantitative measurement of CO2.

Here's the information that can be extracted and presented according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied/Standard)	Reported Device Performance (GenChem CO2 Acid Reagent)
Precision/Reproducibility	Low %CV for various analyte levels	Serum 1: 3.2% CV (within run), 3.0% CV (total)
		Serum 2: 1.4% CV (within run), 1.6% CV (total)
		Serum 3: 1.7% CV (within run), 2.1% CV (total)
Linearity/Reportable Range	Excellent linearity (slope ~1, R² ~1)	Slope: 1.000, Intercept: 0.15, R²: 1.000
	Wide linear range	0.0 to 40.0 mmol/L
Sensitivity	Low detection limit	0.255 mg/dL (calculated as 3 SD), below claimed limit of 5.0 mg/dL
Analytical Specificity	Minimal interference from common substances	No adverse effect from Hemoglobin (up to 500 mg/dL), Bilirubin (up to 20 mg/dL), Lipemia (up to 1800 mg/dL)

2. Sample size used for the test set and the data provenance

Precision Study:
- Sample Size: 60 measurements for each of 3 control sera (2 measurements/day in triplicate over 10 days).
- Data Provenance: Not explicitly stated, but results are from tests performed on control sera.
Patient Comparison Study:
- Sample Size: 80 serum samples and 80 plasma samples.
- Data Provenance: "Collected from adult patients." No specific country of origin is mentioned. These appear to be retrospective samples used for comparison.

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 reagent for quantitative CO2 measurement, not a diagnostic algorithm that requires expert ground truth establishment in the traditional sense (e.g., for image interpretation). The "ground truth" for the patient comparison study would be the measurements obtained by the predicate device (Beckman CO2 Reagent on the CX3®). No human experts are mentioned for establishing ground truth for the test set.

4. Adjudication method for the test set

Not applicable. The study involves quantitative measurements of CO2, not subjective interpretations 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 is a submission for a chemical reagent, not an AI-powered diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a submission for a chemical reagent. Its performance is inherently "standalone" in generating a quantitative value, as it's not an algorithm that assists a human.

7. The type of ground truth used

Precision, Linearity, Sensitivity, Analytical Specificity: These studies use controlled materials with known or expected values as their reference. The "ground truth" is the established chemical and analytical properties of the reference materials.
Patient Comparison: The "ground truth" for comparison was the measurements obtained by the predicate device (Beckman CO2 Reagent on the CX3®).

8. The sample size for the training set

Not applicable. This is a submission for a chemical reagent, not an AI-powered device that requires a training set. The "development" would involve chemical formulation and validation rather than algorithm training.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned for this type of device.

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K Number

K040972

Device Name

CALCIUM, AZO DYE REAGENT

Manufacturer

Date Cleared

2004-12-27

(257 days)

Product Code

CJY

Regulation Number

862.1145

Type

Panel

GENCHEM CREATININE REAGENT

Reference & Predicate Devices

K941764

Intended Use

GenChem Calcium Reagent is intended for the quantitative determination of total calcium in serum, plasma and urine on the Beckman SYNCHRON CX3® System to aid in the diagnosis of diseases associated with hypercalcemia and hypocalcemia.

Device Description

GenChem's Calcium reagent is a liquid composed of Arsenazo III and buffer for the quantitative determination of Calcium in serum, plasma and urine on the Beckman Synchron CX3® System.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the GenChem Calcium, Azo Dye Reagent, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Criteria (Implied/Standard)	Reported Device Performance
Precision	Low %CV (Coefficient of Variation) for both within-run and total imprecision, indicating consistent and reproducible results across various calcium levels. Specific targets are not explicitly stated but are implicit in good laboratory practice and NCCLS standards.	Serum 1 (7.2 mg/dL): Within-run SD 0.06, %CV 0.7; Total SD 0.10, %CV 1.4
Serum 2 (10.6 mg/dL): Within-run SD 0.05, %CV 0.5; Total SD 0.09, %CV 0.9
Serum 3 (14.0 mg/dL): Within-run SD 0.05, %CV 0.3; Total SD 0.09, %CV 0.6
Urine 1 (4.0 mg/dL): Within-run SD 0.03, %CV 0.7; Total SD 0.16, %CV 4.1
Urine 2 (12.7 mg/dL): Within-run SD 0.06, %CV 0.5; Total SD 0.13, %CV 1.0
Linearity	Strong linear relationship (R-squared close to 1.0) across the claimed analytical range, with a slope close to 1 and intercept close to 0 when compared to reference or known values.	Slope: 0.911
Intercept: 0.34
Standard error of estimate: 0.35
R-squared (r²): 1.000 (indicating excellent linearity)
Reportable Range	Defined usable range for accurate measurements.	Conventional Units: 0.1 to 15 mg/dL
SI Units: 0.5 – 3.75 mmol/L
Sensitivity	Ability to detect the lowest concentration of calcium accurately. The observed sensitivity should be at or below the claimed limit.	Claimed sensitivity: 0.1 mg/dL
Observed sensitivity (3 SD of 21 replicate within-run precision study): 0.05 mg/dL (which is below the claimed limit)
Analytical Specificity	No significant interference from common endogenous substances (hemoglobin, bilirubin, lipemia) or acceptable anticoagulants.	Hemoglobin: Up to 500 mg/dL showed no adverse effect.
Bilirubin: Up to 20 mg/dL showed no adverse effect.
Lipemia: Up to 1800 mg/dL showed no adverse effect.
Acceptable Anticoagulants: Heparin, Lithium Heparin, Ammonium Heparin, EDTA.
Method Comparison	Good correlation with a legally marketed predicate device (Predicate Device Name: HICHEM Calcium Reagent for the CX3). Indicators include R-squared close to 1.0, slope close to 1, and intercept close to 0.	Serum: Intercept -0.1, Slope 0.994, R² 0.971
Plasma: Intercept -0.1, Slope 0.973, R² 0.980
Urine: Intercept 0.1, Slope 0.999, R² 0.999
Expected Values	Provision of reference ranges for serum/plasma and urine.	Serum/Plasma: 8.4 - 10.2 mg/dL (2.10 - 2.55 mmol/L)
Urine: 100 - 300 mg/day (2.5 - 7.5 mmol/day)
(Note: Stated that "Each laboratory should establish its own normal ranges.")

Study Details:

Sample sizes used for the test set and the data provenance:
- Precision:
  - 60 data points for each of 5 samples (3 serum controls, 2 urine pools). Total 300 measurements.
  - Data provenance: Not explicitly stated, but implies laboratory-prepared control sera and diluted urine pools, likely internal to GenChem or the testing facility.
- Linearity:
  - Commercially available linearity standards (0 to 15 mg/dL) analyzed in triplicate. Specific number of standards not given, but at least 2 points are needed to determine a slope.
  - Data provenance: Commercially available standards.
- Sensitivity:
  - 21 replicates of a diluted serum control.
  - Data provenance: Diluted serum control.
- Analytical Specificity:
  - Hemoglobin, Bilirubin, Lipemia (stock solutions tested with a base pool containing 9.4 mg/dL calcium). Number of samples not specified, but typically involves a few replicates for each interferent.
  - Data provenance: Prepared stock solutions and a base pool.
- Patient Comparison (Method Comparison):
  - Serum: N = 82 patient specimens
  - Plasma: N = 84 patient specimens
  - Urine: N = 76 patient specimens
  - Data provenance: "collected from adult patients." Country of origin is not specified, but the context implies it was likely from a clinical site in the US. The data is retrospective, as the samples were "collected" and then assayed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For Precision, Linearity, Sensitivity, Analytical Specificity: Not applicable. The "ground truth" for these tests comes from known concentrations in control materials or the inherent chemical properties of analytes and interferents.
- For Method Comparison: The ground truth is established by the results obtained from the predicate device (HICHEM Calcium Reagent for the CX3) on the Beckman CX3 Synchron Analyzer. There is no mention of human experts establishing ground truth for these quantitative measurements.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is a quantitative diagnostic device, not one requiring subjective interpretation that would necessitate adjudication among human readers. The performance is assessed by comparing numerical results to expected values or a predicate device.
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:
- No. This is a chemical reagent for an automated analyzer, not an AI-assisted diagnostic imaging or interpretative device. Therefore, MRMC studies and human reader improvement with AI are not relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The entire performance evaluation describes the standalone performance of the GenChem Calcium Reagent on the Beckman CX3® System. The test results are generated by the algorithm (reagent and instrument's measurement process) without human interpretive input affecting the quantitative result itself (though human interaction is needed for sample loading, running the test, and interpreting the final numerical value in a clinical context).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Precision, Linearity, Sensitivity, Analytical Specificity: Known concentrations of control materials, linearity standards, or stock solutions.
- Method Comparison: Results from a legally marketed predicate device (HICHEM Calcium Reagent for the CX3), assuming the predicate device provides accurate measurements, served as the reference for comparison.
The sample size for the training set:
- Not applicable. This device is a chemical reagent and not an AI/machine learning algorithm that requires a training set in the conventional sense. The development of such reagents relies on chemical formulation, optimization, and validation studies rather than data-driven "training."
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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K Number

K040976

Device Name

Manufacturer

Date Cleared

2004-12-27

(257 days)

Product Code

CGX

Regulation Number

862.1225

Type

Panel

GENCHEM ELECTROLYTE BUFFER

Reference & Predicate Devices

K915077

Intended Use

The GenChem Creatinine Test Reagent System is intended for the quantitative determination of creatinine in serum, plasma and urine on the Beckman SYNCHRON CX3® System and as an aid in the diagnosis of renal impairment and diseases such as chronic glomerulonephritis, diabetic nephropathy, chronic interstitial nephritis and as an indicator of glomerular filtration rate.

Device Description

The Device is a Reagent containing alkaline picrate for the determination of creatinine for optimum system operation on the Beckman Synchron CX3® System.

AI/ML Overview

Here's an analysis of the provided text regarding the GenChem Creatinine Test Reagent, structured to address your specific questions.

It's important to note that this document is a 510(k) Summary for an in vitro diagnostic (IVD) reagent, not an AI/ML device. Therefore, many of your questions related to AI-specific aspects (such as ground truth establishment by experts, adjudication methods, MRMC studies, training set, etc.) are not applicable to this type of submission. The performance criteria for IVDs typically revolve around analytical performance characteristics.

Acceptance Criteria and Device Performance for GenChem Creatinine Test Reagent

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Characteristic	Acceptance Criteria (Implicit from Predicate)**	Reported Device Performance
Precision/Reproducibility	Comparable to predicate device (Beckman Creatinine Reagent for the CX3) and acceptable for clinical use.	Serum 1: Mean 0.5 mg/dL, Within Run SD 0.05, %CV 9.8, Total SD 0.05, %CV 9.8
Serum 2: Mean 4.0 mg/dL, Within Run SD 0.02, %CV 0.5, Total SD 0.02, %CV 0.5
Serum 3: Mean 7.4 mg/dL, Within Run SD 0.03, %CV 0.5, Total SD 0.05, %CV 0.7
Urine 1: Mean 40.3 mg/dL, Within Run SD 0.41, %CV 1.0, Total SD 0.56, %CV 1.4
Urine 2: Mean 222.9 mg/dL, Within Run SD 2.29, %CV 1.0, Total SD 2.79, %CV 1.3
Linearity/Reportable Range	Demonstrates linearity across the clinical range and comparable to predicate.	Slope 0.994, Intercept -0.05, Standard Error of Estimate 0.11, r = 1.00
Serum/Plasma: 0.2 to 25 mg/dL
Urine: 10 to 400 mg/dL
Sensitivity	Detects creatinine at clinically relevant low levels.	0.2 mg/dL (claimed limit), observed sensitivity 0.01 mg/dL (lower is better)
Analytical Specificity (Interference)	No significant interference from common exogenous or endogenous substances at tested concentrations.	No adverse effect on 1.1 mg/dL creatinine sample from:
Hemoglobin up to 500 mg/dL
Bilirubin up to 20 mg/dL
Lipemia up to 1800 mg/dL
Method Comparison (Patient Samples)	Results compare favorably with the predicate device on patient samples, demonstrating substantial equivalence.	Serum: Intercept 0.0, Slope 0.991, R2 0.997 (N=80, Range 0.4 - 30.4 mg/dL)
Plasma: Intercept 0.05, Slope 0.998, R2 0.998 (N=80, Range 0.4 - 30.4 mg/dL)
Urine: Intercept -0.3, Slope 1.000, R2 1.000 (N=79, Range 12.1 - 400 mg/dL)

Notes on Acceptance Criteria:

For IVD devices seeking 510(k) clearance, the primary acceptance criterion is substantial equivalence to a legally marketed predicate device. This means the new device must perform as well as or better than the predicate, or perform similarly without raising new questions of safety or effectiveness.
The document implies that the "acceptance criteria" for each performance characteristic were that the results should be consistent with the expected performance for a creatinine assay and demonstrate equivalence to the predicate device (Beckman Creatinine Reagent for the CX3). Specific numeric acceptance thresholds are not explicitly stated as they might be for a novel device, but rather implied by the successful comparison to the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

Precision/Reproducibility:
- Serum samples: 60 data points each for Serum 1, Serum 2, Serum 3 (assayed twice per day in triplicate over 10 days).
- Urine samples: 59 data points for Urine 1, 60 data points for Urine 2 (assayed twice per day in triplicate over 10 days).
- Data Provenance: Not explicitly stated, but likely from laboratory-prepared control sera/urine pools. This would be considered retrospective in the sense that the controls were pre-defined, but the testing was prospective.
Linearity: Commercially available linearity standards (0 to 25.7 mg/dl) analyzed in triplicate. Not specified how many distinct standards were used beyond the range.
Sensitivity: A diluted serum control was used, with 21 replicates for the within-run precision study.
Analytical Specificity: Stock samples with 1.1 mg/dL creatinine were tested. Not specified how many replicates or distinct samples.
Patient Comparison:
- Serum: 80 patient samples (ranging from 0.4 to 30.4 mg/dl).
- Plasma: 80 patient samples (ranging from 0.4 to 30.4 mg/dl).
- Urine: 79 patient samples (ranging from 12.1 to 400 mg/dL).
- Data Provenance: "collected from adult patients." This would be considered prospective data collection for the method comparison study. Country of origin is not specified but presumed to be the USA, given the FDA submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not Applicable. This is an in vitro diagnostic (IVD) reagent for chemical analysis, not an AI/ML device that requires expert human interpretation of images or other subjective data to establish ground truth. The "ground truth" for an IVD device's performance is established by the analytical method (e.g., using known concentrations in linearity standards, measuring against a reference standard in patient comparison studies using a legally marketed predicate device).

4. Adjudication Method for the Test Set:

Not Applicable. See explanation in point 3. Adjudication is typically used to resolve discrepancies in human expert interpretations, which is not relevant for this type of device.

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 an AI-assisted diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not Applicable. This is an IVD reagent, not an algorithm. The device is the reagent; its performance is in its chemical reaction and subsequent detection, which is inherently "standalone" in its analytical function (meaning it provides a result without human interpretation of the underlying chemistry).

7. The Type of Ground Truth Used:

Analytical Reference/Comparative Method:
- Precision: Statistical calculations (SD, %CV) from repeated measurements of control materials with known or expected values.
- Linearity/Sensitivity: Measurements against commercially available linearity standards or diluted controls with known concentrations.
- Analytical Specificity: Measurements of samples spiked with known interferents against an unspiked control sample.
- Patient Comparison: The "ground truth" in this context is the result obtained from the predicate device (Beckman Creatinine Reagent on the SYNCHRON CX3® System). The study aimed to show that the GenChem reagent produced results that were statistically equivalent to those produced by the predicate device when testing the same patient samples.

8. The Sample Size for the Training Set:

Not Applicable. This is not an AI/ML device that requires a training set. The "development" of the reagent would involve chemical formulation and optimization, not machine learning training.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. See explanation in point 8.

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K Number

K040977

Device Name

Manufacturer

Date Cleared

2004-12-27

(257 days)

Product Code

JGS,CEM,CGZ,JFL,JFP

Regulation Number

862.1665

Type

Panel

GENCHEM ISE ELECTROLYTE REFERENCE

Reference & Predicate Devices

K801896

Intended Use

GenChem ISE Electrolyte Buffer, when used in conjunction with the GenChem ISE Electrolyte Reference, GenChem CO2 Acid Reagent, GenChem CO2 Alkaline Buffer, GenChem Wash Concentrate, and appropriate Calibrators or Calibration Standards, is intended for the quantitative determination of sodium, potassium, chloride, and total CO2 in serum and plasma, and sodium, potassium and chloride in urine, and 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 insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by the destruction of the adrenal glands), dehvdration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. 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 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 serious 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 spasm).

Device Description

Sodium, Potassium, Chloride, CO2 and Calcium are determined by the use of Ion Specific Electrodes, the conductivity of which is proportional to the concentration of electrolyte in the sample which is mixed with high ionic strength buffer using the ISE Solution as the reference.

AI/ML Overview

This document describes the performance characteristics and acceptance criteria for the GenChem ISE Electrolyte Buffer, a device used for the quantitative determination of various electrolytes.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are demonstrated through its performance in precision, linearity, sensitivity, and patient comparison studies. The performance is compared to established methods using a predicate device (Beckman CX3 Synchron Analyzer). Given that this is a 510(k) summary for a reagent/buffer, the "acceptance criteria" are implied by the demonstration of performance that is substantially equivalent to a legally marketed predicate device. The values provided represent the device's reported performance which met the implicit acceptance for commercialization.

Performance Metric	Analyte	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance
Precision	All Electrolytes	(Within-Day & Day-to-Day) – CV values and standard deviations should be comparable to the predicate device and within clinically acceptable limits for the respective analytes. (Specific numerical criteria are not explicitly stated as "acceptance criteria" but rather as results of testing for substantial equivalence).	Within-Day (N=60): Details are presented in a highly fragmented table. The text next to the tables appears to be OCR errors and garbled. However, the tables themselves, while presented poorly, likely contain the standard deviation (SD) and Coefficient of Variation (CV) for S-1, S-2, S-3 (presumably control levels), U-1, U-2. Day-to-Day (N=60): Similarly, data for S-1, S-2, U-1, U-2, S-3 are presented, presumably showing SD/CV. The data is unreadable in the provided text, but the study was conducted.
Linearity/Reportable Range	Calcium	Linear range should encompass clinically relevant values. The R2 value should be close to 1, indicating good linearity.	Range: 0.8 – 14.3 mg/dL. Intercept: 0.34, Slope: 0.911, R2: 1.000, Sey: 0.35.
	Sodium	Linear range should encompass clinically relevant values. The R2 value should be close to 1, indicating good linearity.	Range: 0 – 200 mmol/L. Intercept: 2.37, Slope: 0.968, R2: 1.000, Sey: 2.61.
	Potassium	Linear range should encompass clinically relevant values. The R2 value should be close to 1, indicating good linearity.	Range: 0.9 – 15.2 mmol/L. Intercept: -0.09, Slope: 1.017, R2: 1.000, Sey: 0.03.
	Chloride	Linear range should encompass clinically relevant values. The R2 value should be close to 1, indicating good linearity.	Range: 0 – 197 mmol/L. Intercept: -0.71, Slope: 0.999, R2: 1.000, Sey: 0.99.
	CO2	Linear range should encompass clinically relevant values. The R2 value should be close to 1, indicating good linearity.	Range: 0 – 40 mmol/L. Intercept: 0.15, Slope: 1.000, R2: 1.000, Sey: 0.41.
Sensitivity	Calcium	Limit of detection should be clinically acceptable.	Limit of Detection: 1.5 mg/dL.
	Sodium	Limit of detection should be clinically acceptable.	Limit of Detection: 10 mmol/L.
	Potassium	Limit of detection should be clinically acceptable.	Limit of Detection: 1.0 mmol/L.
	Chloride	Limit of detection should be clinically acceptable.	Limit of Detection: 15 mmol/L.
	Total CO2	Limit of detection should be clinically acceptable.	Limit of Detection: 5.0 mmol/L.
Patient Comparison	All Electrolytes	Comparison results (slope (m), intercept (b), correlation coefficient (r)) should demonstrate substantial equivalence to the predicate device. An 'r' value close to 1 indicates good correlation.	Calcium (Serum): n=80, m=0.989, b=0.0, r=0.985, Range=7.1-10.6.Calcium (Plasma): n=80, m=0.990, b=0.0, r=0.995, Range=7.1-10.7.Calcium (Urine): n=74, m=1.007, b=-0.2, r=0.998, Range=2.4-15.2.
Chloride (Serum): n=80, m=0.988, b=1.0, r=0.935, Range=98-127.
Chloride (Plasma): n=80, m=0.998, b=0.8, r=0.985, Range=98-127.
Chloride (Urine): n=78, m=1.049, b=-5.1, r=0.999, Range=22-289.
Chloride (CSF): n=44, m=1.024, b=-3.4, r=0.985, Range=113-152.
Potassium (Serum): n=80, m=0.969, b=0.13, r=1.000, Range=3.2-10.8.
Potassium (Plasma): n=80, m=0.987, b=0.15, r=1.000, Range=3.2-10.8.
Potassium (Urine): n=80, m=0.993, b=0.01, r=1.000, Range=3.5-136.
Sodium (Serum): n=80, m=0.930, b=9.1, r=0.938, Range=132-159.
Sodium (Urine): n=78, m=1.000, b=-0.3, r=1.000, Range=17-288.
Total CO2 (Serum): n=80, m=0.949, b=1.2, r=0.953, Range=9.5-29.
Total CO2 (Plasma): n=80, m=0.965, b=0.9, r=0.960, Range=9.5-29.

2. Sample Size Used for the Test Set and Data Provenance

Precision (Test Set):
- Within-Day: N=60 for each analyte, across different control levels (S-1, S-2, S-3, U-1, U-2).
- Day-to-Day: N=60 measurements over 30 days for each analyte, across different control levels (S-1, S-2, U-1, U-2, S-3).
- Data Provenance: Not explicitly stated, but typically these types of studies use manufactured controls and spiked samples, likely performed within the manufacturer's laboratory or a designated testing facility. The document mentions "commercially available linearity standards" and "serum control."
Linearity (Test Set): Commercially available linearity standards were analyzed in triplicate. The exact number of distinct linearity standards (concentration points) is not specified, but typically involves at least 5-7 levels.
Sensitivity (Test Set): A serum control was repetitively assayed, and then diluted, with replicates of 10 runs to establish the limit of detection. The sample size for establishing the limit of detection for each analyte was 10 replicates.
Patient Comparison (Test Set):
- Serum, plasma, cerebrospinal fluid (CSF), and urine specimens were used.
- Calcium (Serum, Plasma): n=80 each.
- Calcium (Urine): n=74.
- Chloride (Serum, Plasma): n=80 each.
- Chloride (Urine): n=78.
- Chloride (CSF): n=44.
- Potassium (Serum, Plasma, Urine): n=80 each.
- Sodium (Serum): n=80.
- Sodium (Urine): n=78.
- Total CO2 (Serum, Plasma): n=80 each.
- Data Provenance: Collected from adult patients. No specific country of origin is mentioned, but typically this refers to a clinical site within the USA for FDA submissions. The study is prospective in the sense that these samples were collected and analyzed specifically for this comparison study, in parallel on both the predicate and test devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of device (electrolyte buffer for a clinical chemistry analyzer) does not typically involve human expert interpretation for "ground truth" establishment in the way that image analysis or diagnostic AI systems do. The "ground truth" for the test set is established by:

Reference Methods/Predicate Device: For the patient comparison study, the "ground truth" is the result obtained from the legally marketed predicate device (Beckman CX3 Synchron Analyzer), which is an established and accepted methodology for measuring these electrolytes.
Known Reference Materials: For precision, linearity, and sensitivity studies, the "ground truth" is derived from the known concentrations of commercially available control materials and linearity standards.

Therefore, there were no human "experts" with specific qualifications (like radiologists) involved in establishing ground truth in the context of interpretation, but rather the performance of an already-approved, established diagnostic device.

4. Adjudication Method for the Test Set

No adjudication method as typically understood in studies involving human interpretation (e.g., 2+1, 3+1) was used or is applicable for this type of in-vitro diagnostic device. The comparison is objective, based on quantitative measurements. For patient comparison, the results from the GenChem device were compared statistically (least squares linear regression) against the results from the Beckman CX3 Synchron Analyzer.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic imaging or interpretation tasks where human readers make subjective assessments (e.g., radiologists interpreting images). The GenChem ISE Electrolyte Buffer is an in-vitro diagnostic reagent/buffer for an automated analyzer, thus human interpretation is not the primary output being evaluated. The device's performance is objective (numeric measurements of analytes).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, the performance presented for precision, linearity, sensitivity, and patient comparison is standalone performance of the GenChem ISE Electrolyte Buffer when used with the specified analyzer (Beckman CX3 Synchron Analyzer and associated reagents). There is no "human-in-the-loop" component for the measurement process itself, other than the standard operation of the analyzer by trained lab personnel. The device itself (the buffer) is a reagent, not an algorithm, so the concept of an "algorithm only" performance applies to the entire analytical system with the new buffer.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used for this device's validation is primarily:

Reference Measurement (Predicate Device): For patient comparison, the measurements obtained from the predicate Beckman CX3 Synchron Analyzer served as the reference standard.
Known Concentrations: For precision, linearity, and sensitivity, the known, assayed values of commercially available control materials and linearity standards were used.

There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for the analytical performance of this IVD device.

8. The Sample Size for the Training Set

This document describes a pre-market notification (510(k)) for a medical device (reagent/buffer), not a machine learning or AI algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable. The device's formulation and manufacturing processes are developed and optimized through R&D, but there is no "training phase" with a distinct dataset as there would be for an AI model.

9. How the Ground Truth for the Training Set Was Established

As explained above, there is no "training set" in the AI sense for this device. The chemical and performance characteristics are established through standard chemical and analytical development processes, not through machine learning.

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K Number

K040971

Device Name

Manufacturer

Date Cleared

2004-12-22

(252 days)

Product Code

JGS,CEM,CGZ,JFL,JFP

Regulation Number

862.1665

Type

Panel