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The products encompassed by this request are intended for in vitro diagnostic use and are intended for use in the quantitative determinations of Nat K . Cl . and CO., Beckman Instrument is the Original Equipment Manufacturer of the Chemistry Analyzers and of the predicate Reagents. The Beckman Chemistry Analyzers perform a broad array of tests. ALKO manufactures the ISE Reagents, wherein samples are analyzed for quantitative determinations of Nat, K, Cl and CO2 by ISE method. These Reagents are intended to be used with equivalent Beckman Chemistry Analyzers. As such, ALKO products are intended to serve as direct replacements to like named products manufactured by Beckman Instrument Inc.

The Electrolyte Buffer is intended to provide constant ionic strength for measuring electrolytes in the samples. As such, it is diluted with Wash Solution and introduced into the sample and/or calibrator, for quantitative determination of Nat, K*, Cl and CO., The Electrolyte Reference Reagent is intended to provide reference points for Na , K , Cl and CO2. The CO2 Acid Reagent is intended to release CO2 from serum and plasma samples and/or calibrators. The CO, Alkaline Buffer is to provide a constant CO, concentration as reference for the CO, Electrode. The Wash Concentrate is intended to be diluted with deionized water. The prepared Wash Solution is used to wash the systems sample flow path and to dilute reagents on equivalent Beckman CX® Systems.

The products encompassed by this 510(k) submission are Class II (75JIX) In Vitro Diagnostic Solutions manufactured by ALKO Diagnostic Corporation, 333 Fiske Street, Holliston, MA 01746. The Reagents are intended for use on equivalent Beckman Analyzers. Beckman Instrument is the original equipment manufacturer (OEM) of the analyzers and of predicate reagents which are necessary for the continued operation and use of the analyzers.

Information herein will support ALKO's position for the intended use of these products to the equivalent Beckman Chemistry Analyzers. The Beckman Chemistry Añalyzers perform a broad array of tests. ALKO manufactures the ISE Reagents, wherein samples are analyzed for quantitative determinations of Nat, K', Cl ' and CO, by ISE method. These Reagents are intended to be used with equivalent Beckman Chemistry Analyzers. As such, ALK O products are intended to serve as direct replacements to like named products manufactured by Beckman Instrument Inc.

The Electrolyte Buffer is intended to provide constant ionic strength for measuring electrolytes in the samples. As such, it is diluted with Wash Solution and introduced into the sample and/or calibrator, for quantitative determination of Nat, K., Cl - and CO2. The Electrolyte Reference Reagent is to provide reference points for Nat, K*, Cl and CO, The CO, Acid Reagent is to release CO, from serum and plasma samples and/or librators. The CO, Alkaline Buffer is to provide a constant CO2 concentration as reference for the CO2 * Electrode. The Wash Concentrate is intended to be diluted with de-ionized water. The prepared Wash Solution is used to wash the systems sample probe and to dilute reagents on equivalent Beckman CX® Systems.

• ALKO product A443-325 (Electrolyte Buffer) is equivalent to Beckman Instrument product 443325 . (Electrolyte Buffer).
• ALKO product A443-315 (Electrolyte Reference Reagent), is equivalent to Beckman Instrument product . 443315 (Electrolyte Reference Reagent).
• ALKO product A443-330 (CO2 Acid Reagent), is equivalent to Beckman Instrument product 443330 . (CO2 Acid Reagent).
• ALKO product A443-320 (CO2 Alkaline Buffer), is equivalent to Beckman Instrument product 443320 . (CO2 Alkaline Buffer).
• ALKO product A443-335 (Wash Concentrate), is equivalent to Beckman Instrument product 443335 . (Wash Concentrate).

ALKO uses a similar composition, description and packaging design as that used by Beckman Instrument Inc. in its products.

Acceptance Criteria and Study for ALKO Reagents on Beckman CX® Series Analyzers

This document describes the acceptance criteria and study proving equivalence for ALKO Reagents when used on Beckman CX® Series and equivalent analyzers. The goal is to demonstrate that ALKO products can serve as direct replacements for Beckman Instrument Inc. reagents for quantitative determination of Na+, K+, Cl-, and CO2 by ISE method.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the performance characteristics demonstrated to be equivalent to the predicate Beckman reagents. For the purposes of this summary, the key performance characteristics are precision and correlation with Beckman reagents.

Acceptance Criteria for Precision (implicitly defined by demonstrated performance)

The acceptance criteria for precision are implicitly based on the observed Coefficient of Variation (CV%) values, which are considered acceptable for quantitative electrolyte measurement in clinical diagnostics.

Acceptance Criteria for Correlation with Beckman Reagents (implicitly defined by demonstrated performance)

The acceptance criteria for correlation are implicitly based on high R-squared values (close to 1), slopes close to 1, and intercepts close to 0, indicating strong agreement and similar performance to the Beckman reagents.

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

Precision Study:

• Sample Size (Test Set): For each analyte (Na+, K+, Cl-, CO2), there were 60 measurements for each control level (serum normal, serum abnormal, urine level 1, urine level 2) for "Total" precision, derived from 20 runs performed in triplicate per run. For "Run to Run" precision, N=20 (representing 20 individual runs).
• Data Provenance: The document does not explicitly state the country of origin. Given the FDA 510(k) submission, it is likely that the study was conducted in the US or under US regulatory standards. The study appears to be prospective as it involved measurements over a defined period (20 runs over 30 days).

Correlation Study:

• Serum/Plasma Samples (Beckman CX®3): 68+ serum and plasma samples were used across the analytes, with specific N values: Na+ (72), K+ (74), Cl- (77), CO2 (68).
• Serum Samples (Beckman CX®5): 34+ serum samples were used across the analytes, with specific N values: Na+ (38), K+ (40), Cl- (34), CO2 (38).
• Urine Samples (Beckman CX®3): 54+ urine samples were used across the analytes, with specific N values: Na+ (54), K+ (54), Cl- (55).
• Data Provenance: The document does not explicitly state the country of origin. This study appears to be prospective as it involved measuring samples with ALKO reagents and comparing them to measurements with Beckman reagents on the same analyzers.

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

This type of study (comparative performance of IVD reagents) does not typically involve human experts establishing "ground truth" in the same way imaging or clinical decision support AI devices do. The "ground truth" or reference standard for this study is the performance of the predicate Beckman reagents on the same analyzer. There are no human experts involved in determining the analytical accuracy or precision of the measurements.

4. Adjudication Method for the Test Set

Not applicable. As described above, this study focuses on analytical performance characteristics (precision, correlation) of diagnostic reagents, not clinical interpretation that would require expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. This study pertains to in vitro diagnostic reagents, which measure analytes (Na+, K+, Cl-, CO2) directly. MRMC studies are typically performed for clinical decision support or imaging interpretation devices where human interpretation is a critical component influencing diagnostic accuracy.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, this study presents standalone performance of the ALKO reagents in conjunction with the Beckman analyzers. The measurements are performed by the automated ISE module of the analyzers, calibrated with either ALKO or Beckman reagents, without human interpretation of the raw analytical results being the primary endpoint of the study. The performance characteristics (precision, correlation) are inherent to the reagent-analyzer system.

7. The Type of Ground Truth Used

The "ground truth" for the correlation study is established by the measurements obtained using the predicate Beckman reagents on the same Beckman CX® Series analyzers. The study aims to show that the ALKO reagents produce results that are statistically equivalent and highly correlated with those from the established and legally marketed Beckman reagents. For the precision study, there is no external "ground truth"; rather, the assay's own reproducibility is assessed.

8. The Sample Size for the Training Set

This document describes a performance validation study for in vitro diagnostic reagents. In this context, there isn't a "training set" in the sense of machine learning algorithms. The reagents themselves are "trained" or optimized during their development and manufacturing process to meet certain specifications. The data presented here are validation data used to demonstrate that the final manufactured product performs as intended and equivalently to the predicate.

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

Not applicable, as there is no "training set" in the context of a machine learning algorithm. The "ground truth" for the development of ALKO reagents would involve internal R&D and quality control processes to ensure the chemical properties and performance characteristics meet design specifications and are comparable to market leaders like Beckman.

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The products encompassed by this request are intended for in vitro diagnostic use and the quantitative determination of Na", K", and Cl ", on the Olympus Chemistry Systems. Olympus America Incorporated is the original equipment manufacturer (OEM) of the chemistry systems and of the predicate Reagents. The Olympus Chemistry Systems performs a broad array of clinical chemistry tests. The Olympus Chemistry Systems with the ISE module measures sodium (Na), potassium (K), and chloride (Cl ) by Ion Selective Electrodes. These Reagents are intended to be used with the equivalent Olympus Chemistry Systems. As such, ALKO products are intended to serve as direct replacements to like named products manufactured by Olympus .

The Buffer dilutes all measured samples for the quantitative determinations in Na ", K , and Cl in serum and urine by ISE. The Mid-Standard Solution is intended as a means of compensating for calibration drift in the quantitative determination of Na , K , and Cl in samples on the Olympus Chemistry Systems. The Reference Solution is intended to provide a stable reference potential for Na ", K", and Cl " electrodes on the Olympus Chemistry System. The Serum High/Low Standard and Urine High/Low Standard are used to calibrate the Na *, K , and Cl clectrodes of the system's ISE module. The ISE Na "/K " Selectivity Na 7, KT, electrode verification. The products Check Solutions are intended for encompassed are to be handled using normal laboratory precautions.

The products encompassed by this 510(k) submission are Class II (75JIX) In Vitro Diagnostic Solutions manufactured by ALKO Diagnostic Corporation, 333 Fiske Street, Holliston, MA 01746. The ISE Reagents are intended for use on the ISE module of the Olympus Chemistry Systems. Olympus America Incorporated is the original equipment manufacturer (OEM) of the system and of predicate ISE Reagents which are necessary for the continued operation and use of the ISE module on these systems.

Information herein will support ALKO's position for the intended use of these products to the Olympus Chemistry System with the ISE module. The ISE module measures Na , K , Cl by using the system's Ion Selective Electrodes. The ALKO Reagents are intended to serve as direct replacements to like named products manufactured by Olympus America Incorporated. The Buffer dilutes all measured samples for the quantitative determinations of Na , K , and Cl concentrations in serum and urine by ISE. The Mid-Standard Solution is intended as a means of compensating for calibration drift. in the quantitative determination of Na K , and Cl in samples on the Olympus Chemistry Systems. The Reference Solution is intended to provide a stable reference potential for Na , K , and Cl electrodes on the Olympus Chemistry Systems. The ISE Serum/Urine and High/Low Standards are used to calibrate the electrodes of Na , K , and Cl on the system's ISE module. The ISE Na /K Selectivity Check Solutions are intended for Na and K electrode verification.

ALKO product A101-100 (ISE Buffer) is equivalent to Olympus Chemistry System product AUH1011 (ISE Buffer). ALKO Product A101-200 (ISE Mid - Standard Solution) is equivalent to Olympus Chemistry System product AUH1012 (ISE Mid-Standard). ALKO product A101-300 (ISE Reference Solution) is equivalent to Olympus Chemistry System product AUH1013 (ISE Reference Solution). ALKO product A101-400 (ISE Low Serum Standard) is equivalent to Olympus Chemistry System product AUH1014 (ISE Low Serum Standard). ALKO product A101-500 (ISE High Serum Standard) is equivalent to Olympus Chemistry System product AUH1015 (ISE High Serum Standard). ALKO product A101-600 (ISE High/Low Urine Standard) is equivalent to Olympus Chemistry System product AUH1016 (ISE High/Low Urine Standard), ALKO product A101-800 (Na7 K Selectivity Check Solution) is equivalent to Olympus Chemisty System product AUH1018 ((Na / K+ Selectivity Check Solution).

ALKO uses a similar composition, description and packaging design as that used by Olympus America in its products.

The ALKO Reagents for the Olympus AU 800™/AU 5200™ Chemistry Systems are intended as direct replacements for Olympus reagents for the quantitative determination of Na+, K+, and Cl- concentrations in serum and urine by Ion Selective Electrodes (ISE).

1. Acceptance Criteria and Reported Device Performance:

The document describes two main types of studies to demonstrate equivalence: Precision Data and Correlation with Olympus Reagents.

Precision Data Acceptance Criteria (Implied):
While explicit acceptance criteria (e.g., maximum allowable CV%) are not stated, the reported precision data for ALKO reagents is expected to be within acceptable limits for clinical laboratory use and comparable to predicate device performance (Olympus reagents). The data shows Coefficient of Variation (CV%) values generally below 1.5% for all analytes across various serum and urine levels, indicating good precision.

Correlation with Olympus Reagents Acceptance Criteria (Implied):
For correlation studies, the acceptance criteria are generally based on:

• Slope: Close to 1.0 (indicating proportional agreement)
• Intercept: Close to 0.0 (indicating no systematic bias)
• R-squared (Correlation Coefficient Squared): Close to 1.0 (indicating strong linear correlation)

Table of Acceptance Criteria (Implied) and Reported Device Performance:

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The A,B . C Standards are intended for use in calibrating Nat, K., Cl. and TCO, analytes on the Dade Dimension Chemistry Systems.

The products encompassed by this 510(k) submission are Class II (75JIX) In Vitro Diagnostic Solutions manufactured by ALKO Diagnostic Corporation. The ALKO Standard Reagents are intended to serve as direct replacements to like named products manufactured by Dade Chemistry Systems Inc.(formally Dupont International). ALKO uses a similar composition, description and packaging design as that used by Dade Chemistry Systems Inc. in its products.

Here's an analysis of the provided 510(k) summary, structured to address your specific questions about acceptance criteria and study details:

Acceptance Criteria and Device Performance for ALKO Standards A, B, and C

This 510(k) submission describes ALKO Standards A, B, and C, intended for calibrating Na+, K+, Cl-, and TCO2 analytes on Dade Dimension Chemistry Systems with the MultiPLY™ Integrated Multisensor module. The study aims to demonstrate performance equivalence of ALKO products to Dade Chemistry Systems products.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state pre-defined acceptance criteria for the precision or accuracy studies in a tabular format. However, based on the presented data and the nature of calibration standards, implicit acceptance criteria can be inferred, primarily alignment with the performance of the predicate device (Dade Standards) and generally acceptable precision for diagnostic assays.

Implicit Acceptance Criteria and Reported Performance:

Note: The implicit criteria are based on standard expectations for clinical chemistry assays and the goal of demonstrating equivalence to a predicate device. Specific numerical targets for acceptance are not provided in the document.

2. Sample Size and Data Provenance

• Precision Study (Test Set):

  • Sample Size: For each analyte (Na+, K+, Cl-, TCO2) at each of the two levels of serum controls, data from 45 total observations (N=45) were used. This was derived from 3 runs per day, 3 times per run for 5 days (3 x 3 x 5 = 45). For "Run to Run" precision, N=15 for each analyte at each level (presumably representing the 5 days of testing with 3 runs per day as a unit).
  • Data Provenance: Not explicitly stated, but given the US manufacturer (ALKO Diagnostic Corporation, Holliston, MA) and the use of the Dade Dimension system, it's highly likely the data was collected in the United States. The study appears to be prospective for the purposes of this 510(k) submission, as it describes data collection for the specific purpose of demonstrating performance equivalence.

• Accuracy (Correlation) Study (Test Set):

  • Sample Size:
    • Na+, K+, Cl-: 156 patient serum samples and 12 control samples (Total N=168).
    • TCO2: 76 patient serum samples.
  • Data Provenance: Not explicitly stated, but likely United States (similar reasoning as above). The mention of "patient serum samples" suggests the data was collected for this study, making it prospective in nature.

3. Number of Experts and Qualifications for Ground Truth

• This submission describes calibration standards for an in vitro diagnostic chemistry system. The ground truth for such devices is typically established through:
  • Reference Methods: Highly accurate and precise analytical methods used to assign true values to calibrator and control materials.
  • Predicate Device Performance: The primary "ground truth" or reference for this 510(k) is the performance of the Dade MultiPLY™ Standard Reagents already cleared for use.
• There is no mention of human experts (like radiologists) being used to establish ground truth for this type of IVD device. The "ground truth" is analytical and comparative to a predicate device.

4. Adjudication Method for the Test Set

• Not applicable. This type of IVD submission, involving calibration standards and analytical performance, does not typically involve adjudication by human experts in the way clinical diagnostic imaging studies might. The comparison is objective, based on analytical values generated by the instruments with different calibrators.

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

• No, an MRMC comparative effectiveness study was not done. This type of study focuses on human reader performance (e.g., radiologists interpreting images) with and without AI assistance. This 510(k) pertains to chemical calibration standards and analytical device performance, not human interpretation.

6. Standalone (Algorithm Only) Performance

• Essentially, yes, this is a standalone performance assessment in its context. The "device" in this case is the ALKO calibration standard. The studies assess the performance of the Dade Dimension instrument calibrated with ALKO standards (standalone performance of the calibrator-instrument system) against the same instrument calibrated with the predicate Dade standards. There is no human-in-the-loop component in the analytical measurements themselves.

7. Type of Ground Truth Used

• The ground truth in the context of this submission is effectively the performance of the predicate device (Dade MultiPLY™ Standard Reagents).
  • For the precision study, the ground truth is the inherent analytical variability of the system when calibrated with ALKO reagents (measured against itself).
  • For the accuracy (correlation) study, the ground truth for comparison is the values obtained when the Dade Dimension system is calibrated with Dade's own standards. The goal is to show that using ALKO standards yields comparable results.

8. Sample Size for the Training Set

• No separate training set is explicitly mentioned or relevant for this type of 510(k) submission. This device (calibration standard) is not an AI algorithm that "learns" from data. The studies performed are verification and validation studies (precision and accuracy) to demonstrate the product's performance against established benchmarks (the predicate device).

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

• Not applicable. As there is no "training set" in the AI sense, there is no ground truth established for a training set. The relevant ground truth (predicate device performance) is referenced directly for the test/comparison studies.

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The tHb Cal Standard is intended for use in calibrating the total hemoglobin channel of the IL CO-Oximeters and Oximeters.

The product encompassed by this 510(k) submission is a Class II (81KRZ) In Vitro Diagnostic Solution manufactured by ALKO Diagnostic Corporation. The tHb Cal Standard is intended to serve as direct replacement to like named product manufactured by Instrumentation Laboratory Company. ALKO Product A331-50 (tHb Cal Standard) is equivalent to Instrumentation Laboratory product 33150-50 (Cal Dye and Reference Standard). ALKO uses a similar composition, description and packaging design as that used by Instrumentation Laboratory Company in its products.

Here's a breakdown of the acceptance criteria and study findings for the ALKO Diagnostics Corporation's tHb Cal Standard, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ALKO tHb Cal Standard are implicitly defined by its equivalence to the predicate device, Instrumentation Laboratory's Cal Dye™ Reference Standard, and its ability to consistently calibrate CO-Oximeters and Oximeters within acceptable ranges. The performance metrics reported are precision (as Total and Run-to-Run CV%) and comparative agreement with assayed values and the predicate device.

• Level 1 (Mean 16.9): Total CV% 0.6993, Run to Run CV% 0.3826
• Level 2 (Mean 13.8): Total CV% 0.8340, Run to Run CV% 0.5857
• Level 3 (Mean 7.2): Total CV% 1.0758, Run to Run CV% 0.7435

These CV% values are very low, indicating high precision. |
| Comparative Data (tHb Cal Standard vs. Predicate) | The ALKO tHb Cal Standard should yield total hemoglobin (tHb) values that are effectively equivalent to those obtained with the IL Cal Dye™ Reference Standard when measured on the same IL CO-Oximeters/Oximeters. The mean tHb values, standard deviations, and CV% should be very similar, and the measured range (min-max) should encompass or align closely with the assayed values and the predicate's performance. Consistency across different instrument models (IL 282, IL 482) is also a criterion. | On IL 282:

• IL 33150 (Predicate): Mean 14.7, STD 0.0653, CV% 0.4450, tHb min.-max. 14.6-14.8, Assay Value 14.8
• ALKO A331-50: Mean 15.0, STD 0.0499, CV% 0.3316, tHb min.-max. 15.0-15.1, Assay Value 15.0

On IL 482:

• IL 33150 (Predicate): Mean 14.9, STD 0.0730, CV% 0.4901, tHb min.-max. 14.8-15.0, Assay Value 14.9
• ALKO A331-50: Mean 14.8, STD 0.0442, CV% 0.2993, tHb min.-max. 14.7-14.8, Assay Value 14.8

The mean tHb values, SDs, and CV% are very close between the ALKO and IL products on both instruments, demonstrating strong agreement and comparability. The measured ranges are also consistent with the respective assayed values. |
| Functional Equivalence (with predicate) | When used to calibrate IL CO-Oximeters/Oximeters, the ALKO tHb Cal Standard should enable the instrument to produce mean values for various blood gas parameters (tHb, %O2Hb, %COHb, %MetHb, O2 Ct, %RHb) from control samples that fall within the assayed control ranges and are comparable to results obtained when the instrument is calibrated with the predicate IL Cal Dye™ Reference Standard. | On IL 282 & IL 482: For all three control levels and across all measured parameters (tHb, %O2Hb, %COHb, %MetHb, O2 Ct, %RHb), the mean values obtained when calibrating with ALKO tHb Cal Standard are very similar to those obtained with the IL Cal Dye™ Reference Standard. Critically, these mean values consistently fall within the specified "Assayed Control Values" ranges, which broadens the acceptance window. The results demonstrate that the ALKO calibrator allows the instruments to perform functionally equivalently to calibration with the predicate. |

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

• Precision Test Set: The precision study used three levels of IL CO-OX controls. Each level was analyzed 3 times per run, for 5 runs, after a separate calibration for each run. This totals 15 data points (N=15) for each level for "Total" precision, and 5 data points (N=5) for "Run to Run" precision (representing the 5 runs).
• Comparative Data Test Set: For both the IL 282 and IL 482 analyzers, 15 measurements (N=15) were taken for both the IL predicate product and the ALKO product.
• Functional Tests Test Set: Three levels of IL CO-OX controls were measured in triplicate (meaning 3 measurements per level). This was done after calibrating separately with the ALKO standard and the IL predicate standard. (The exact total number of individual measurements for functional tests across all parameters is not explicitly stated as 'N' in a table, but it implies 3 measurements * 3 levels * 2 calibration methods * number of parameters).
• Data Provenance: The data was generated by ALKO Diagnostic Corporation, 333 Fiske Street, Holliston, MA 01746, USA. This indicates the testing was done in the USA. The study appears to be prospective as it involves direct testing and comparison of the ALKO product against the predicate and control materials with specific measurement protocols.

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

The document does not mention the use of experts to establish ground truth for the test set. Instead, the ground truth is established through:

• Assayed values: For the comparative data and functional tests, "Assay Value" or "Assayed Control Values" are provided, which represent the target or expected values for the control materials. These values are typically established by the control manufacturer using reference methods or multiple laboratory testing, not by ad-hoc experts for this specific study.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method in the context of expert review. The study relies on direct quantitative comparison of instrument readings against established assay values or predicate device performance.

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

This is not applicable as the device is an in-vitro diagnostic solution (calibrator) for an instrument, not an AI-powered diagnostic imaging or decision support tool that is interpreted by human readers.

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

This is standalone performance in the context of an IVD calibrator. The performance of the ALKO tHb Cal Standard is assessed by its direct functional impact on the IL CO-Oximeters/Oximeters, allowing them to accurately measure control samples. There is no "human-in-the-loop" interpretation beyond the operation of the instrument itself. The study objective is to show the calibrator functions on its own to enable accurate instrument readings.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used consists of:

• Assayed Values: These are reference values provided by the manufacturer of the IL CO-OX controls for specific parameters (tHb, %O2Hb, etc.). These are typically established through rigorous analytical testing using reference methods.
• Predicate Device Performance: The performance of the Instrumentation Laboratory Cal Dye™ Reference Standard is used as a direct benchmark, as the ALKO product is intended to be a direct replacement and functionally equivalent. The equivalence to an already marketed and presumably validated product serves as a form of "ground truth" for comparative studies.

8. The Sample Size for the Training Set

This is not applicable. The ALKO tHb Cal Standard is an in-vitro diagnostic reagent (calibrator), not an algorithm or AI model that requires a training set. The "composition, description and packaging design" mention indicates a manufacturing process, not a machine learning process.

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

This is not applicable as there is no training set mentioned for this product.

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The ISE Reagents are intended for use on the ISE Module of the BMD Hitachi Clinical Chemistry Systems. The ISE High and Low Calibrators are intended to provide calibration points for the Na +, K+, and Cl- Electrodes on the ISE Subsystem. The IN KCI Solutions are intended to provide stable reference potential for the Na +, K+, and Cl- Electrodes. The ISE Diluent dilutes all measured patient samples for the quantitative determination of Na +, K+, and Cl- in Serum, Plasma and Urine by ISE. The ISE Internal Reference Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na +, K+, and Cl- in Serum, Plasma and Urine samples on the BMD Hitachi Clinical Chemistry Systems.

All product(s) encompassed by this 510(k) submission are Class I (75JJG) and Class II (75JIX) In Vitro Diagnostic Solutions manufactured by ALKO Diagnostic Corporation. The ISE Reagents are intended for use on the ISE Module of the BMD Hitachi Clinical Chemistry Systems. The ISE High and Low Calibrators are intended to provide calibration points for the Na +, K+, and Cl- Electrodes on the ISE Subsystem. The IN KCI Solutions are intended to provide stable reference potential for the Na +, K+, and Cl- Electrodes. The ISE Diluent dilutes all measured patient samples for the quantitative determination of Na +, K+, and Cl- in Serum, Plasma and Urine by ISE. The ISE Internal Reference Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na +, K+, and Cl- in Serum, Plasma and Urine samples on the BMD Hitachi Clinical Chemistry Systems.

Here's an analysis of the acceptance criteria and study detailed in the provided text:

Device: ALKO Diagnostic Corporation ISE Reagents for BMD Hitachi Clinical Chemistry 700 Series and 911 Systems

Description of Device: ISE Reagents (Diluent, Internal Reference Solution, 1N KCI Solution, Low Standard, High Standard) intended for use on the ISE Module of BMD Hitachi Clinical Chemistry Systems for the quantitative determination of Na+, K+, and Cl- in Serum, Plasma, and Urine. They are designed as direct replacements for Boehringer Mannheim Diagnostic (BMD) products.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the sponsor's claim of "performance equivalence" to the predicate BMD reagents. The study aims to demonstrate that results obtained with ALKO reagents are comparable to those obtained with BMD reagents, and that ALKO reagents exhibit acceptable precision.

Performance Equivalence (Correlation Study):
The acceptance criteria are not explicitly stated as numerical thresholds (e.g., "slope must be between X and Y"). Instead, the document presents linear regression results (Slope, Intercept, R-squared) between ALKO and BMD reagents, implying that a slope close to 1, an intercept close to 0, and a high R-squared value (close to 1) indicate equivalence. For the purpose of this table, we will highlight the reported statistics.

Precision Study:
The acceptance criteria for precision are also not explicitly stated in numerical terms (e.g., "CV% must be

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The calibrators are intended for use in calibrating the electrodes of Paramax® CLiNaK™ Analyzers. The ISE Liquid Reagent is used to dilute samples measured on the Paramax® CLiNaK™ Analyzers.

The products encompassed by this 510(k) submission are Class II (75JIX) In Vitro Diagnostic Solutions manufactured by ALKO Diagnostic Corporation, 333 Fiske Street, Holliston, MA 01746. The calibrators are intended for use in calibrating the electrodes of Paramax® CLiNaK™ Analyzers. The ISE Liquid Reagent is used to dilute samples measured on the Paramax® CLiNaK™ Analyzers. Baxter Diagnostics, Inc. is the original equipment manufacturer (OEM) of the analyzer and of predicate Calibrators and ISE Liquid Reagent which are necessary for the continued operation and use of the analyzer.

The ALKO calibrators and ISE Liquid Reagent are intended to serve as direct replacements to like named products manufactured by Baxter Diagnostics. Inc. (currently Dade International). ALKO Product A611-151 (ALKO Calibrant A) is equivalent to Baxter Diagnostics Product B6110-151 (ISE Calibrant A). ALKO Product A611-152 (ALKO Calibrant B) is equivalent to Baxter Diagnostics Product B6110-152 (ISE Calibrant B). ALKO Product A611-153 (ALKO ISE Liquid Reagent) is equivalent to Baxter Diagnostics Product B6110-153 (ISE Liquid Reagent).

ALKO uses a similar composition, description and packaging design as that used by Baxter Diagnostics in its products.

Here's an analysis of the provided text regarding the ALKO Calibrators and ISE Liquid Reagent, structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as distinct numerical thresholds for the new device. Instead, it aims to demonstrate "performance equivalence" to the predicate device (Baxter products). The study results are presented as direct comparisons or precision measurements. Therefore, the "acceptance criteria" are implied to be comparable performance to the predicate device, or achieving acceptable precision levels.

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

• Accuracy (Correlation Study):

  • Test Set Sample Size: 60 pooled serum samples for Na+, K+, Cl- and Li+. (Note: 1 outlier for K+ and 1 for Cl- were excluded, resulting in N=58 for K+ and N=59 for Cl- in the final analysis).
  • Data Provenance: Not explicitly stated, but the study was performed on a "Baxter CLiNaK™ ISE module." The samples themselves are "pooled serum samples with Na+, K+, Cl- and Li+ values adjusted using NaCl, KCL and LiCl salts," indicating a controlled laboratory setting rather than direct patient samples. This suggests a retrospective or controlled laboratory study design. The country of origin is not mentioned.

• Precision Study:

  • Test Set Sample Size: "Controls" were analyzed 3 times per run for a total of 20 runs. For each analyte (Na+, K+, Cl-, Li+), there were 2 levels of controls. This means 2 levels * 3 analyses/run * 20 runs = 120 measurements per analyte for Total precision, and 20 runs for Run-to-Run precision.
  • Data Provenance: Not explicitly stated, but the analysis was performed on a "Baxter CLiNaK™ ISE module." It used "controls," which are standardized samples. This also suggests a retrospective or controlled laboratory study. The country of origin is not mentioned.

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

This type of information is not applicable to this submission. The "ground truth" in this context is the quantitative measurement of analytes (Na+, K+, Cl-, Li+) by precisely calibrated instruments. It does not involve expert interpretation of medical images or clinical cases.

4. Adjudication Method for the Test Set

This type of information is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are used for expert consensus in subjective assessments (e.g., radiology reads). In this case, the measurements are objective and quantitative. The only "adjudication-like" process mentioned is the exclusion of outliers based on a statistical formula.

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

This type of information is not applicable to this submission. This device is an in-vitro diagnostic reagent/calibrator, not an AI-assisted diagnostic tool that involves human readers interpreting cases.

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

This type of information is not applicable to this submission. This is not an algorithm or AI device. It's a chemical reagent/calibrator for an existing analyzer. The performance assessed is of the reagent/calibrator combination with the analyzer, not a standalone algorithm.

7. The Type of Ground Truth Used

• Accuracy Study: The ground truth for comparative purposes was established by using the Baxter (OEM) reagents and calibrators as the reference method on the same analyzer. The "adjusted pooled serum samples" served as the test material for this comparison.
• Precision Study: The ground truth for precision was the measured values of the standardized control samples on the Baxter CLiNaK™ ISE module calibrated with ALKO reagents.

8. The Sample Size for the Training Set

This type of information is not applicable to this submission. This is not an AI/machine learning device that requires a "training set." The product is a chemical reagent.

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

This type of information is not applicable to this submission for the same reason as above (not an AI/ML device).

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