STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)

K970921 · Alko Diagnostic Corp. · JIX · Apr 8, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970921
• Device Name: STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)
• Applicant: Alko Diagnostic Corp.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Apr 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The A,B,C Standards are intended for use in calibrating Na⁺, K⁺, Cl⁻ and TCO₂ analytes on the Dade Dimension® Chemistry Systems.

Device Story

ALKO Standards A, B, and C are liquid calibration reagents for Dade Dimension® Chemistry Systems equipped with MultiPLY™ Integrated Multisensor (IMT) modules. These standards serve as direct replacements for OEM Dade Chemistry Systems reagents. The system uses Ion Selective Electrode (ISE) technology to measure Na⁺, K⁺, Cl⁻, and TCO₂ in patient serum samples. Laboratory technicians use these standards to calibrate the analyzer, ensuring accurate measurement of electrolytes and TCO₂. The output of the analyzer, calibrated by these standards, provides quantitative electrolyte and TCO₂ levels, which clinicians use to assess patient metabolic and electrolyte status. The device benefits patients by ensuring the accuracy of diagnostic tests performed on the Dade Dimension® platform.

Clinical Evidence

Bench testing only. Precision study: 45 runs per analyte level (Na⁺, K⁺, Cl⁻, TCO₂) on Dade Dimension® System with IMT. Total CV% ranged from 0.50% to 5.29%. Method comparison: 156-168 patient serum samples and 12 controls compared against Dade reagents. Linear regression analysis showed high correlation (R=0.966 to 0.991) for all analytes.

Technological Characteristics

Liquid calibration reagents for Ion Selective Electrode (ISE) analysis. Designed for use with Dade Dimension® Chemistry Systems with MultiPLY™ Integrated Multisensor modules. No specific materials of construction or connectivity standards provided; device is a chemical reagent set.

Indications for Use

Indicated for use in clinical laboratory settings to calibrate Na⁺, K⁺, Cl⁻, and TCO₂ analytes on Dade Dimension® Chemistry Systems with MultiPLY™ Integrated Multisensor modules for patient serum sample analysis.

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

• Dade Dimension® Chemistry System product S540 (MultiPLY™ Standard A)
• Dade Dimension® Chemistry System product S550 (MultiPLY™ Standard B)
• Dade Dimension® Chemistry System product S560 (MultiPLY™ Standard C)

Submission Summary (Full Text)

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K970921

# 510(k) Summary

ALKO Standards A,B, and C
for Dade Dimension® Chemistry Systems
with MultiPLY™ Integrated Multisensor module Installed

APR - 8 1997

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 A,B,C Standards are intended for use in calibrating Na⁺, K⁺, Cl⁻ and TCO₂ analytes on the Dade Dimension® Chemistry Systems. Dade Chemistry Systems Inc. is the original equipment manufacturer (OEM) of the system and of predicate Standard Reagents which are necessary for the continued operation and use of the system.

The ALKO products stated are currently cleared under docket K:926518. Information herein will support ALKO’s position to extend the intended use of these products to the Dade Dimension® Chemistry System with MultiPLY™ Integrated Multisensor module installed. The MultiPLY™ Integrated Multisensor module measures Na⁺, K⁺, Cl⁻ by using Integrated Multiple Technology means. The TCO₂ analyte is measured by the system’s Ion Selective Electrode. 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 Product A202-0 (Standard A) is equivalent to Dade Dimension® Chemistry System product S540 (MultiPLY™ Standard A). ALKO product A103-0 (Standard B) is equivalent to Dade Dimension® Chemistry System product S550 (MultiPLY™ Standard B). ALKO product A200-0 (Standard C) is equivalent to Dade Dimension® Chemistry System product S560 (MultiPLY™ Standard C). For marketing purposes ALKO will assign new product numbers for the extended use labeling.

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

- Through a method comparison where results obtained on a Dade Dimension® Chemistry System with IMT installed, calibrated with ALKO products and compared with results obtained on the same analyzer calibrated with Dade products; and
- Through a precision study where ALKO products were installed on a Dade Dimension® Chemistry System with IMT installed and samples were measured over 20 runs.

A summary of the results of these studies follows:

A Worldwide Supplier of Blood Gas and ISE

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ALKO Diagnostic Corporation • 333 Fiske Street • Holliston, MA 01746-2048 • USA • Phone: [phone] • Fax: [phone]

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## Precision Data

Precision data was collected from the analysis of two levels of serum controls measured three runs per day, three times per run for 5 days on a Dade Dimension® System with IMT installed for Na⁺, K⁺, Cl⁻, TCO₂ calibrated with ALKO reagents.

### Level 1

| Analyte | | N | Mean | STD | CV% | Min | Max |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Na⁺ | Total | 45 | 121.0 | 1.2285 | 1.0149 | 120 | 124 |
| | Run to Run | 15 | 121.0 | 0.7588 | 0.6269 | 120 | 122 |
| K⁺ | Total | 45 | 2.70 | 0.0494 | 1.8308 | 2.6 | 2.8 |
| | Run to Run | 15 | 2.70 | 0.0333 | 1.2328 | 2.6 | 2.7 |
| Cl⁻ | Total | 45 | 78.5 | 0.4999 | 0.6367 | 78 | 79 |
| | Run to Run | 15 | 78.5 | 0.3189 | 0.4062 | 78 | 79 |
| TCO₂ | Total | 45 | 16.59 | 0.7824 | 4.7153 | 14.6 | 18.0 |
| | Run to Run | 15 | 16.59 | 0.7373 | 4.4432 | 14.8 | 17.5 |

### Level 2

| Analyte | | N | Mean | STD | CV% | Min | Max |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Na⁺ | Total | 45 | 180.0 | 1.0217 | 0.5677 | 178 | 183 |
| | Run to Run | 15 | 180.0 | 0.7350 | 0.4084 | 179 | 181 |
| K⁺ | Total | 45 | 6.45 | 0.0542 | 0.8393 | 6.4 | 6.6 |
| | Run to Run | 15 | 6.45 | 0.0361 | 0.5595 | 6.4 | 6.5 |
| Cl⁻ | Total | 45 | 120.6 | 0.6070 | 0.5032 | 119 | 122 |
| | Run to Run | 15 | 120.6 | 0.5287 | 0.4383 | 120 | 122 |
| TCO₂ | Total | 45 | 34.24 | 1.8110 | 5.2894 | 29.7 | 39.3 |
| | Run to Run | 15 | 34.24 | 1.6119 | 4.7079 | 31.0 | 37.1 |

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ALKO Diagnostic Corporation • 333 Fiske Street • Holliston, MA 01746-2048 • USA • Phone: [phone] • Fax: [phone]

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## Accuracy by Correlation with Dade MultiPLY™ Standard Reagents

Correlation data was collected from 156 patient serum samples and 12 control samples for Na⁺, K⁺, Cl⁻ and from 76 patient serum samples for TCO₂, measured on a Dade Dimension® System with IMT installed, calibrated with ALKO reagents as compared with Dade reagents separately. A Linear Regression Analysis was performed using the Dade data as the Independent X Variable and ALKO Data as the Dependent Y Variable in the equation $$Y = a + bX$$.

| Analyte | N | Slope | Intercept | R* | Range |
| --- | --- | --- | --- | --- | --- |
| Na⁺ | 168 | 0.998 | 2.699 | 0.982 | 120 - 180 |
| K⁺ ** | 166 | 0.989 | 0.173 | 0.991 | 2.6 - 7.6 |
| Cl⁻ | 168 | 0.960 | 4.091 | 0.966 | 78 - 122 |
| TCO₂ | 76 | 0.909 | 2.037 | 0.975 | 4.8 - 34.4 |

*R = Correlation Coefficient
** Two outliers excluded

I hope that you find this information useful and informative.


Janet A. McGrath
Regulatory Affairs

3/11/97 (date prepared)

A Worldwide Supplier of Blood Gas and ISE

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ALKO Diagnostic Corporation • 333 Fiske Street • Holliston, MA 01746-2048 • USA • Phone: [phone] • Fax: [phone]