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
Indications for 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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