ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS

K960085 · Alko Diagnostic Corp. · JIX · Mar 11, 1996 · Clinical Chemistry

Device Facts

• Record ID: K960085
• Device Name: ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS
• Applicant: Alko Diagnostic Corp.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Mar 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

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 Story

ALKO calibrators and ISE liquid reagents serve as direct replacements for OEM Baxter Diagnostics products used with Paramax® CLiNaK™ Analyzers. These chemical solutions facilitate the calibration of ion-selective electrodes (ISE) and the dilution of serum samples for electrolyte analysis (Na+, K+, Cl-, Li+). Used in clinical laboratory environments by trained technicians; the reagents ensure the analyzer maintains measurement accuracy. By providing equivalent performance to the OEM reagents, these products allow for continued operation of the analyzer, supporting clinical decision-making based on electrolyte concentration results.

Clinical Evidence

Bench testing only. Method comparison study using 60 pooled serum samples compared ALKO reagents against Baxter OEM reagents on a CLiNaK™ ISE module. Linear regression showed high correlation (R Sq 0.993–0.998) for Na+, K+, Cl-, and Li+. Precision study conducted over 20 runs (3 measurements/run) demonstrated low CV% (0.74%–4.66% across analytes).

Technological Characteristics

Chemical reagents (calibrants and diluents) for ion-selective electrode (ISE) analysis. Composition and packaging designed to match OEM specifications for compatibility with Paramax® CLiNaK™ Analyzers. No electronic, software, or energy-emitting components.

Indications for Use

Indicated for use in clinical laboratory settings for the calibration and sample dilution of electrolytes (Na+, K+, Cl-, and Li+) measured on Baxter Diagnostics Paramax® CLiNaK™ Analyzers.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• Baxter Diagnostics ISE Calibrant A (B6110-151)
• Baxter Diagnostics ISE Calibrant B (B6110-152)
• Baxter Diagnostics ISE Liquid Reagent (B6110-153)

Submission Summary (Full Text)

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MAR 11 1996

# 510(k) Summary

K9ccos

ALKO Calibrators and ISE Liquid Reagent for Baxter Diagnostics 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. ALKO has shown performance equivalence of its products to Baxter products in the following manner:

- 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™ Analyzer and samples were measured over 20 runs.

A summary of the results of these studies follows:

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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 excluded 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 value 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 two levels 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.

Na⁺

| 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 |

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K+

| 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 |

Cl-

| 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 |

Li+

| 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 J. Young
Director, Design and
Regulatory Affairs

1/4/96 (date prepared)

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