ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS
Device Facts
| Record ID | K963734 |
|---|---|
| Device Name | ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS |
| Applicant | Alko Diagnostic Corp. |
| Product Code | CGZ · Clinical Chemistry |
| Decision Date | Oct 24, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1170 |
| Device Class | Class 2 |
Intended Use
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 1N KCl 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.
Device Story
ALKO ISE Reagents serve as direct replacements for Boehringer Mannheim Diagnostics (BMD) consumables used on Hitachi Clinical Chemistry Systems (704, 717, 736, 737, 747, 911). The system utilizes Ion Selective Electrode (ISE) technology to measure Na+, K+, and Cl- concentrations. Reagents include diluents, internal reference solutions, 1N KCl solutions, and high/low calibrators. The device is used in clinical laboratory settings by trained technicians. The analyzer processes patient samples, and the ISE module measures potential differences to determine electrolyte concentrations. Output is provided as quantitative values for clinical decision-making regarding patient electrolyte balance. ALKO products are designed to match the composition and performance of the OEM reagents, ensuring compatibility with existing analyzer workflows and calibration procedures.
Clinical Evidence
Bench testing only. Comparative analysis performed on Hitachi 736, 704, 737, and 911 systems using urine and plasma samples. Linear regression analysis (Y=a+bX) showed high correlation (R-squared values ranging from 0.9904 to 0.9997). Precision studies conducted over 4-6 days (N=20) across multiple systems demonstrated total CV% ranging from 0.47% to 15.08% depending on analyte and system.
Technological Characteristics
Ion Selective Electrode (ISE) reagents including diluents, reference solutions, and calibrators. Designed for compatibility with BMD Hitachi Clinical Chemistry Systems. Materials and composition are formulated to be functionally equivalent to OEM specifications. No specific ASTM standards or software algorithm classes are cited.
Indications for Use
Indicated for the quantitative determination of sodium (Na+), potassium (K+), and chloride (Cl-) in serum, plasma, and urine samples using BMD Hitachi Clinical Chemistry Systems.
Regulatory Classification
Identification
A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Predicate Devices
- Boehringer Mannheim Diagnostics ISE Reagents (OEM equivalents)
Related Devices
- K972004 — ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS · Alko Diagnostic Corp. · Jun 16, 1997
- K013451 — PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES · Phoenix Diagnostics, Inc. · Dec 18, 2001
- K960085 — ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS · Alko Diagnostic Corp. · Mar 11, 1996
- K982501 — ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 · Alko Diagnostic Corp. · Sep 1, 1998
Submission Summary (Full Text)
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ALKO
ALKO Diagnostic Corporation
A Life Sciences International Company
OCT 24 1996
K963734
# 510(k) Summary
ISE Reagents
for BMD Hitachi Clinical Chemistry 700 Series and 911 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, 333 Fiske Street, Holliston, MA 01746. 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 1N KCl 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. Boehringer Mannheim Diagnostics is the original equipment manufacturer (OEM) of the analyzer(s) and of predicate ISE Reagents which are necessary for the continued operation and use of ISE Subsystem on the analyzer.
The ISE Hitachi Reagents are intended to serve as direct replacement to like named product manufactured by Boehringer Mannheim Diagnostic. Listed below are ALKO products and their OEM equivalents.
| ALKO # | OEM | Description | Models | Class |
| --- | --- | --- | --- | --- |
| A858-044 | 820637 | ISE Diluent | 704 | 1 |
| A820-636 | 820638 | ISE Diluent | 717,736,737,747 | 1 |
| A450-043 | 450043 | ISE Diluent | 911 | 1 |
| A820-644 | 836246 | ISE Internal Reference Solution | 704,717,737,747 | 1 |
| A836-244 | 836245 | ISE Internal Reference Solution | 736 | 1 |
| A450-042 | 450042 | ISE Internal Reference Solution | 911 | 1 |
| A820-652 | 820639 | ISE 1N KCl Solution | 704,717,736,737,747 | 1 |
| A450-041 | 450041 | ISE 1N KCl Solution | 911 | 1 |
| A620-428 | 620428 | ISE Low Standard | 704,717,736,737,747,911 | 2 |
| A620-427 | 620427 | ISE High Standard | 704,717,736,737,747,911 | 2 |
ALKO uses a similar composition, description and packaging design as that used by Boehringer Mannheim in its products. ALKO has shown performance equivalence of its products to Boehringer Mannheim Company's products in the following manner:
- Through a comparative analysis where results obtained on BMD Hitachi Clinical Chemistry Systems calibrated with ALKO products were compared with results obtained on the same system calibrated with BMD Hitachi products; and
- Through a precision study where ALKO products were installed on BMD Hitachi Clinical Chemistry Systems and samples were measured over 20 runs.
A summary of the results of these studies follows:
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# PERFORMANCE CHARACTERISTICS
## Correlation with BMD Reagents - Urine Samples
1. Correlation data collected from urine samples measured on Hitachi 736, 704, 737 and 911 System, calibrated with ALKO and BMD products separately. The study compares values obtained using ALKO products as compared BMD products wherein Linear Regression Analyses were performed using ALKO Data as the Dependent Y Variable and BMD Data as the Independent X Variable in the equation $Y = a + bX$.
### Hitachi 736 System
| Analyte | (N) | Slope | Intercept | R Sq. | Range |
| --- | --- | --- | --- | --- | --- |
| Na | 40 | 1.0076 | 1.5483 | 0.9995 | 9-253 |
| K | 40 | 1.0028 | 0.4064 | 0.9995 | 5.7-81.1 |
| Cl | 40 | 1.0419 | -2.5008 | 0.9986 | 13-214 |
### Hitachi 704 System
| Analyte | (N) | Slope | Intercept | R Sq | Range |
| --- | --- | --- | --- | --- | --- |
| Na | 40 | 1.0798 | -5.1321 | 0.9985 | 10.0-258.8 |
| K | 40 | 1.0436 | -0.4654 | 0.9904 | 5.1- 83.2 |
| Cl | 40 | 1.0769 | -5.9423 | 0.9988 | 10.8-237.7 |
### Hitachi 737 System
| Analyte | (N) | Slope | Intercept | R Sq | Range |
| --- | --- | --- | --- | --- | --- |
| Na | 42 | 1.0239 | -2.0167 | 0.9992 | 6-190 |
| K | 42 | 0.9828 | -0.0362 | 0.9996 | 3.3-102.5 |
| Cl | 42 | 1.0243 | -2.0894 | 0.9978 | 7-235 |
### Hitachi 911 System
| Analyte | (N) | Slope | Intercept | R Sq | Range |
| --- | --- | --- | --- | --- | --- |
| Na | 42 | 1.0368 | -4.2943 | 0.9997 | 2-187 |
| K | 42 | 0.9574 | 0.1334 | 0.9992 | 3.2-101.5 |
| Cl | 42 | 1.0295 | -1.5562 | 0.9993 | 14-231 |
R Sq = Correlation Coefficient Squared
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# Correlation with BMD Reagents - Plasma Samples
2. Correlation data collected from plasma samples measured on Hitachi 736, 704, 737 and 911 Clinical Chemistry Systems, calibrated with ALKO and BMD products separately. The study compares values obtained using ALKO products as compared BMD products wherein Linear Regression Analyses were performed using ALKO Data as the Dependent Y Variable and BMD Data as the Independent X Variable in the equation $Y = a + bX$.
## Hitachi 736 System
| Analyte | (N) | Slope | Intercept | R Sq | Range |
| --- | --- | --- | --- | --- | --- |
| Na | 59 | 1.0141 | -1.6476 | 0.9955 | 86-178 |
| K | 59 | 0.9747 | 0.1266 | 0.9990 | 3.0-11.9 |
| Cl | 59 | 0.9968 | -0.4270 | 0.9955 | 64-154 |
## Hitachi 704 System
| Analyte | (N) | Slope | Intercept | R Sq | Range |
| --- | --- | --- | --- | --- | --- |
| Na | 57 | 0.9705 | 3.64833 | 0.9913 | 84.6-180.9 |
| K | 57 | 0.9704 | 0.1084 | 0.9982 | 2.9-12.2 |
| Cl | 59 | 1.0023 | -1.3518 | 0.9946 | 63.6-150.0 |
## Hitachi 737 System
| Analyte | (N) | Slope | Intercept | R Sq | Range |
| --- | --- | --- | --- | --- | --- |
| Na | 59 | 1.0331 | -7.4335 | 0.9949 | 85-180 |
| K | 59 | 0.9843 | -0.04915 | 0.9991 | 3.0-12.2 |
| Cl | 59 | 1.0185 | -4.5429 | 0.9976 | 62-156 |
## Hitachi 911 System
| Analyte | (N) | Slope | Intercept | R Sq | Range |
| --- | --- | --- | --- | --- | --- |
| Na | 59 | 1.0096 | -1.2435 | 0.9930 | 86-179 |
| K | 59 | 0.9553 | -0.2228 | 0.9992 | 3.0-12.2 |
| Cl | 59 | 0.9574 | 5.8746 | 0.9917 | 67-154 |
R Sq = Correlation Coefficient Squared
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## Precision of ALKO Reagents - Urine Samples
3. Precision data collected from urine samples measured on Hitachi 704, 717, 736 and 737 Clinical Chemistry Systems, over a period of four to six days using all ALKO reagents.
### Hitachi 704 System
| Level | Analyte | (N) | Mean | Ttl SD | Ttl CV% | WR SD | WR CV% |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Level 1 | Na | 20 | 88.43 | 2.38 | 2.69 | 0.42 | 0.47 |
| | K | 20 | 28.73 | 0.48 | 1.67 | 0.34 | 1.19 |
| | Cl | 20 | 80.28 | 3.05 | 3.80 | 0.32 | 0.39 |
| Level 2 | Na | 20 | 188.39 | 2.32 | 1.23 | 0.73 | 0.39 |
| | K | 20 | 73.29 | 4.01 | 5.47 | 3.02 | 4.12 |
| | Cl | 20 | 190.09 | 5.58 | 2.94 | 1.86 | 0.98 |
### Hitachi 717 System
| Level | Analyte | (N) | Mean | Ttl SD | Ttl CV% | WR SD | WR CV% |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Level 1 | Na | 20 | 83.28 | 1.77 | 2.13 | 0.57 | 0.68 |
| | K | 20 | 29.64 | 0.59 | 1.98 | 0.55 | 1.85 |
| | Cl | 20 | 77.53 | 3.91 | 5.04 | 1.13 | 1.46 |
| Level 2 | Na | 20 | 180.05 | 2.26 | 1.26 | 1.00 | 0.56 |
| | K | 20 | 77.73 | 3.91 | 5.04 | 1.13 | 1.46 |
| | Cl | 20 | 182.78 | 6.71 | 3.67 | 1.82 | 1.00 |
### Hitachi 736 System
| Level | Analyte | (N) | Mean | Ttl SD | Ttl CV% | WR SD | WR CV% |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Level 1 | Na | 20 | 81.25 | 2.00 | 2.47 | 0.87 | 1.07 |
| | K | 20 | 29.25 | 0.46 | 1.46 | 0.35 | 1.20 |
| | Cl | 20 | 80.38 | 4.32 | 5.38 | 2.37 | 2.95 |
| Level 2 | Na | 20 | 179.05 | 2.63 | 1.47 | 2.53 | 1.41 |
| | K | 20 | 94.90 | 1.99 | 2.09 | 0.44 | 0.46 |
| | Cl | 20 | 159.48 | 6.44 | 4.04 | 1.75 | 1.10 |
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Hitachi 737 System
| Level | Analyte | (N) | Mean | Ttl SD | Ttl CV% | WR SD | WR CV% |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Level 1 | Na | 20 | 27.83 | 1.39 | 4.99 | 0.69 | 2.48 |
| | K | 20 | 7.57 | 0.11 | 1.45 | 0.09 | 1.24 |
| | Cl | 20 | 26.75 | 4.03 | 15.08 | 1.83 | 6.84 |
| Level 2 | Na | 20 | 57.33 | 1.59 | 2.78 | 0.52 | 0.91 |
| | K | 20 | 15.85 | 0.17 | 1.07 | 0.04 | 0.28 |
| | Cl | 20 | 56.55 | 2.29 | 4.05 | 0.59 | 1.05 |
## Conclusion
ALKO manufactures products that serve as functional equivalents to consumable distributed by Original Equipment Manufacturer. All such products are manufactured with the intent of complying with the Good Manufacturing Practice Regulations.
As previously stated the product encompassed by this request serves as a functional equivalent to the product currently manufactured and marketed by Boehringer Mannheim Diagnostics. We believe that BMD has received 510 (k) market approval given that they are currently distributing the instruments and related consumable domestically. The previously described labeling and performance verification should provide adequate documentation as to the equivalence of the ALKO Product.
I hope you find the documentation provided informative and helpful.
Janet A. McGrath
Regulatory Affairs
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