(56 days)
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No
The summary describes reagents and calibrators for a clinical chemistry system, focusing on standard analytical methods (ISE) and performance metrics like linear regression and precision. There is no mention of AI or ML.
No
This device is an in vitro diagnostic solution used for the quantitative determination of certain ions in patient samples, not for directly treating or diagnosing physiological conditions.
Yes
The text explicitly states that the "The ISE Diluent dilutes all measured patient samples for the quantitative determination of Na +, K+, and Cl- in Serum, Plasma and Urine by ISE," and that all products "are Class I (75JJG) and Class II (75JIX) In Vitro Diagnostic Solutions." This indicates its use in determining clinical parameters from patient samples, which is a diagnostic function.
No
The device description explicitly states that the products are "In Vitro Diagnostic Solutions" and are intended for use on the "ISE Module of the BMD Hitachi Clinical Chemistry Systems." This indicates the device is a combination of reagents (solutions) and hardware components (ISE Module, electrodes, etc.), not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Device Description" section explicitly states: "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."
- Intended Use: The "Intended Use / Indications for Use" section describes the use of the reagents, calibrators, and solutions for the "quantitative determination of Na +, K+, and Cl- in Serum, Plasma and Urine by ISE." This is a classic example of an in vitro diagnostic test, as it involves analyzing biological samples (serum, plasma, urine) outside of the body to provide information about a patient's health status.
- Device Description: The description of the components (reagents, calibrators, solutions) and their function within the ISE Module of the clinical chemistry system further supports its role in performing in vitro diagnostic tests.
The information provided clearly indicates that this device is designed to be used in vitro (outside the living body) for diagnostic purposes.
N/A
Intended Use / Indications for 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 IN KCI 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.
Product codes (comma separated list FDA assigned to the subject device)
75JJG, 75JIX
Device Description
All product(s) encompassed by this 510(k) submission are Class I (75JJG) and Class II (75JIX) In Vitto Diagnostic Solutions manufactured by ALKO Diagnostic Corporation, 333 Fiske Street, Holliston, MA 01746. The ISE Hitachi Reagents are intended to serve as direct replacement to like named product manufactured by Boehringer Mannheim Diagnostic. ALKO uses a similar composition, description and packaging design as that used by Boehringer Mannheim in its products.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison Studies:
- Correlation with BMD Reagents - Urine Samples: Correlation data collected from urine samples measured on Hitachi 736, 704, 737 and 911 System, calibrated with ALKO and BMD products separately. 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: N=40 for Na, K, Cl. Slopes ranged from 1.0028 to 1.0419. R. Sq. ranged from 0.9986 to 0.9995.
- Hitachi 704 System: N=40 for Na, K, Cl. Slopes ranged from 1.0436 to 1.0798. R Sq ranged from 0.9904 to 0.9988.
- Hitachi 737 System: N=42 for Na, K, Cl. Slopes ranged from 0.9828 to 1.0243. R Sq ranged from 0.9978 to 0.9996.
- Hitachi 911 System: N=42 for Na, K, Cl. Slopes ranged from 0.9574 to 1.0368. R Sq ranged from 0.9992 to 0.9997.
- Correlation with BMD Reagents - Plasma Samples: Correlation data collected from plasma samples measured on Hitachi 736, 704, 737 and 911 Clinical Chemistry Systems, calibrated with ALKO and BMD products separately. 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: N=59 for Na, K, Cl. Slopes ranged from 0.9747 to 1.0141. R Sq ranged from 0.9955 to 0.9990.
- Hitachi 704 System: N=57 for Na, K, N=59 for Cl. Slopes ranged from 0.9704 to 1.0023. R Sq ranged from 0.9913 to 0.9982.
- Hitachi 737 System: N=59 for Na, K, Cl. Slopes ranged from 0.9843 to 1.0331. R Sq ranged from 0.9949 to 0.9991.
- Hitachi 911 System: N=59 for Na, K, Cl. Slopes ranged from 0.9553 to 1.0096. R Sq ranged from 0.9917 to 0.9992.
Precision Study:
- Precision of ALKO Reagents - Urine Samples: 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: N=20 for each analyte at each level.
- Hitachi 717 System: N=20 for each analyte at each level.
- Hitachi 736 System: N=20 for each analyte at each level.
- Hitachi 737 System: N=20 for each analyte at each level.
Key Results: Precision studies showed generally low Ttl CV% and WR CV% values across different analytes, levels, and Hitachi systems. Correlation studies consistently demonstrated high R. Sq values (close to 1), indicating a strong linear relationship and performance equivalence between ALKO products and BMD products. The slopes of the linear regression analyses were also close to 1, and intercepts close to 0, further supporting performance equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient Squared (R. Sq), Slope, Intercept, Total Standard Deviation (Ttl SD), Total Coefficient of Variation (Ttl CV%), Within-Run Standard Deviation (WR SD), Within-Run Coefficient of Variation (WR CV%).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1170 Chloride test system.
(a)
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.(b)
Classification. Class II.
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ALKO Diagnostic Corporation
Image /page/0/Picture/2 description: The image shows a logo with a thick, black triangle at the top. Inside the triangle is a white space that also forms a triangle. Below the triangle is the word "ALKO" in bold, black capital letters. To the right of the top triangle is a small circle with an R inside, indicating a registered trademark.
A Life Sciences International Company
510(k) Summary
OCT 2 4 1996
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 Vitto 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 IN KCI 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 KCI Solution | 704,717,736,737,747 | 1 |
| A450-041 | 450041 | ISE 1N KCI 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:
- O Through a comparative analysis where results obtained on BMD Hitachi Chemistry Systems calibrated with ALKO products were compared with results obtained on the same system calibrated with BMD Hitachi products; and
- O 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 these studies follows: Worldwide Supplier of Blood Gas and ISE
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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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Page 3/ ÀLKO 510 (k) Summary for ISE Hitachi Reagents
Correlation with BMD Reagents - Plasma Samples
-
- 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.
| 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 736 System
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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Page 4/ ALKO 510 (k) Summary for ISE Hitachi Reagents
Precision of ALKO Reagents - Urine Samples
-
- 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.
| 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 704 System
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 |
| Level 1 | K | 20 | 29.64 | 0.59 | 1.98 | 0.55 | 1.85 |
| Level 1 | 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 |
| Level 2 | K | 20 | 77.73 | 3.91 | 5.04 | 1.13 | 1.46 |
| Level 2 | 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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Page 5/ ALKO 510 (k) Summary for ISE Hitachi Reagents
| 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 |
Hitachi 737 System
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 nd related consumable domestically. The previously described labeling and performance verification "chould 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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