ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS by ALKO DIAGNOSTIC CORP.

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.

Device Description

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.

AI/ML Overview

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.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (ALKO Calibrators/Reagent)
Accuracy (Correlation with Baxter Reagents)	Slope close to 1, Intercept close to 0, High R-squared (indicating strong correlation with predicate)	Na+: Slope = 1.002, Intercept = -0.174, R Sq = 0.993
		K+: Slope = 1.002, Intercept = 0.007, R Sq = 0.998
		Cl-: Slope = 0.969, Intercept = 2.798, R Sq = 0.996
		Li+: Slope = 0.999, Intercept = 0.022, R Sq = 0.998
Precision (CV%)	Acceptable intra-run and run-to-run variability	Na+: Level 1 Total CV% = 0.74, Run-to-Run CV% = 0.65; Level 2 Total CV% = 0.89, Run-to-Run CV% = 0.57
		K+: Level 1 Total CV% = 1.46, Run-to-Run CV% = 1.22; Level 2 Total CV% = 2.28, Run-to-Run CV% = 1.63
		Cl-: Level 1 Total CV% = 1.01, Run-to-Run CV% = 0.85; Level 2 Total CV% = 1.73, Run-to-Run CV% = 1.54
		Li+: Level 1 Total CV% = 4.66, Run-to-Run CV% = 3.63; Level 2 Total CV% = 2.06, Run-to-Run CV% = 1.41

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).

Summary

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MAR 1 1 1996

Kracots

510(k) Summarv ALKO Calibrators and ISE Liquid Reagent for Baxter Diagnostics Paramax® CLiNaK™ Analyzers

ALKO uses a similar composition, description and packaging design as that used by Baxter Diagnostics in its products. ALKO has shown performance equivalence of its products to Baxter products in the following manner:

O Through a method comparison where results obtained on a Paramax® CLiNaK™ Analyzer calibrated with ALKO products were compared with results obtained on the same analyzer calibrated with Baxter products: and
Through a precision study where ALKO products were installed on a Paramax® CLiNaK™ 0 Analyzer and samples were measured over 20 runs.

A summary of the results of these studies follows:

SHEET 3 OF 76

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Accuracy by Correlation with Baxter (Dade) ISE Reagents

Correlation data was collected from 60 pooled serum samples with Na+, K+, Cl- and Li+ values adjusted using NaCl, KCL and LiCl salts. The correlation study was performed on a Baxter CLiNaK™ ISE module, calibrated with ALKO and Baxter reagents separately. A Linear Regression Analysis was performed using OEM data as the Independent X Variable and ALKO Data as the Dependent Y Variable in the equation Y = a + bX. One outlier for K+ and one outlier for Cl- data were expluded from the comparison. Outliers were excluded using a formula where if the individual value of the difference between the two methods is greater than four times the average absolute difference of all measurements then the individual is excluded.

Analyte	N	Slope	Intercept	R Sq	Range
Na+	60	1.002	-0.174	0.993	63 - 203
K+	58	1.002	0.007	0.998	0.9 - 14.3
Cl-	59	0.969	2.798	0.996	41 - 170
Li+	57	0.999	0.022	0.998	0.0 - 5.93

R Sq = Correlation Coefficient Squared

Precision Data

Na+, K+, Cl- and Li+ electrolyte precision data was collected from the analysis of controls measured on a Baxter CLiNaK™ ISE module (calibrated with all ALKO reagents) 3 times per run for a total of 20 runs. A separate calibration was performed prior to each run.

Level		N	Mean	STD	CV%	Min	Max
1	Total	60	146.2	1.077	0.74	144	149
	Run to Run	20	146.2	0.957	0.65	144.7	148.0
2	Total	60	126.3	1.118	0.89	124	129
	Run to Run	20	126.3	0.719	0.57	125.3	127.7

Na+

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Page 3 / ALKO 510(k) Summary for Paramax® CLiNaK™ Analyzer

Level		N	Mean	STD	CV%	Min	Max
1	Total	60	6.98	0.102	1.46	6.8	7.3
	Run to Run	20	6.98	0.085	1.22	6.83	7.17
2	Total	60	3.95	0.090	2.28	3.7	4.2
	Run to Run	20	3.95	0.065	1.63	3.83	4.10

CI-

Level		N	Mean	STD	CV%	Min	Max
1	Total	60	107.0	1.080	1.01	105	109
	Run to Run	20	107.0	0.906	0.85	105.3	108.7
2	Total	60	86.8	1.501	1.73	83	90
	Run to Run	20	86.8	1.337	1.54	84.3	89.3

Lit

Level		N	Mean	STD	CV%	Min	Max
1	Total	60	0.446	0.021	4.66	0.40	0.50
	Run to Run	20	0.446	0.016	3.63	0.423	0.487
2	Total	60	1.726	0.0355	2.06	1.65	1.81
	Run to Run	20	1.726	0.0244	1.41	1.680	1.790

I hope that you find this information useful and informative.

Brian L. Yacktman

Brian J. Young Director, Design and Regulatory Affairs

1/4/96
(date prepared)

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Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.