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.

Device Description

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. 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided text:

Device: ALKO Diagnostic Corporation ISE Reagents for BMD Hitachi Clinical Chemistry 700 Series and 911 Systems

Description of Device: ISE Reagents (Diluent, Internal Reference Solution, 1N KCI Solution, Low Standard, High Standard) intended for use on the ISE Module of BMD Hitachi Clinical Chemistry Systems for the quantitative determination of Na+, K+, and Cl- in Serum, Plasma, and Urine. They are designed as direct replacements for Boehringer Mannheim Diagnostic (BMD) products.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the sponsor's claim of "performance equivalence" to the predicate BMD reagents. The study aims to demonstrate that results obtained with ALKO reagents are comparable to those obtained with BMD reagents, and that ALKO reagents exhibit acceptable precision.

Performance Equivalence (Correlation Study):
The acceptance criteria are not explicitly stated as numerical thresholds (e.g., "slope must be between X and Y"). Instead, the document presents linear regression results (Slope, Intercept, R-squared) between ALKO and BMD reagents, implying that a slope close to 1, an intercept close to 0, and a high R-squared value (close to 1) indicate equivalence. For the purpose of this table, we will highlight the reported statistics.

Precision Study:
The acceptance criteria for precision are also not explicitly stated in numerical terms (e.g., "CV% must be < X%"). The reported data includes Total Standard Deviation (Ttl SD) and Total Coefficient of Variation (Ttl CV%), as well as Within-Run Standard Deviation (WR SD) and Within-Run Coefficient of Variation (WR CV%). The expectation is that these values should be within generally accepted limits for clinical chemistry assays, and the sponsor presents them as evidence of acceptable precision.

Test Type	Analyte	Sample Type	System	Acceptance Criteria (Implicit)	Reported Device Performance (ALKO Reagents)
Correlation				Slope ≈ 1, Intercept ≈ 0,
(ALKO vs. BMD)				R. Sq ≈ 1
	Na	Urine	736		Slope: 1.0076, Intercept: 1.5483, R. Sq: 0.9995
	K	Urine	736		Slope: 1.0028, Intercept: 0.4064, R. Sq: 0.9995
	Cl	Urine	736		Slope: 1.0419, Intercept: -2.5008, R. Sq: 0.9986
	Na	Urine	704		Slope: 1.0798, Intercept: -5.1321, R. Sq: 0.9985
	K	Urine	704		Slope: 1.0436, Intercept: -0.4654, R. Sq: 0.9904
	Cl	Urine	704		Slope: 1.0769, Intercept: -5.9423, R. Sq: 0.9988
	Na	Urine	737		Slope: 1.0239, Intercept: -2.0167, R. Sq: 0.9992
	K	Urine	737		Slope: 0.9828, Intercept: -0.0362, R. Sq: 0.9996
	Cl	Urine	737		Slope: 1.0243, Intercept: -2.0894, R. Sq: 0.9978
	Na	Urine	911		Slope: 1.0368, Intercept: -4.2943, R. Sq: 0.9997
	K	Urine	911		Slope: 0.9574, Intercept: 0.1334, R. Sq: 0.9992
	Cl	Urine	911		Slope: 1.0295, Intercept: -1.5562, R. Sq: 0.9993
	Na	Plasma	736		Slope: 1.0141, Intercept: -1.6476, R. Sq: 0.9955
	K	Plasma	736		Slope: 0.9747, Intercept: 0.1266, R. Sq: 0.9990
	Cl	Plasma	736		Slope: 0.9968, Intercept: -0.4270, R. Sq: 0.9955
	Na	Plasma	704		Slope: 0.9705, Intercept: 3.64833, R. Sq: 0.9913
	K	Plasma	704		Slope: 0.9704, Intercept: 0.1084, R. Sq: 0.9982
	Cl	Plasma	704		Slope: 1.0023, Intercept: -1.3518, R. Sq: 0.9946
	Na	Plasma	737		Slope: 1.0331, Intercept: -7.4335, R. Sq: 0.9949
	K	Plasma	737		Slope: 0.9843, Intercept: -0.04915, R. Sq: 0.9991
	Cl	Plasma	737		Slope: 1.0185, Intercept: -4.5429, R. Sq: 0.9976
	Na	Plasma	911		Slope: 1.0096, Intercept: -1.2435, R. Sq: 0.9930
	K	Plasma	911		Slope: 0.9553, Intercept: -0.2228, R. Sq: 0.9992
	Cl	Plasma	911		Slope: 0.9574, Intercept: 5.8746, R. Sq: 0.9917
Precision				Acceptable CV% for clinical
(ALKO Reagents only)				chemistry (context dependent)
	Na (L1)	Urine	704		Mean: 88.43, Ttl SD: 2.38, Ttl CV%: 2.69, WR SD: 0.42, WR CV%: 0.47
	K (L1)	Urine	704		Mean: 28.73, Ttl SD: 0.48, Ttl CV%: 1.67, WR SD: 0.34, WR CV%: 1.19
	Cl (L1)	Urine	704		Mean: 80.28, Ttl SD: 3.05, Ttl CV%: 3.80, WR SD: 0.32, WR CV%: 0.39
	Na (L2)	Urine	704		Mean: 188.39, Ttl SD: 2.32, Ttl CV%: 1.23, WR SD: 0.73, WR CV%: 0.39
	K (L2)	Urine	704		Mean: 73.29, Ttl SD: 4.01, Ttl CV%: 5.47, WR SD: 3.02, WR CV%: 4.12
	Cl (L2)	Urine	704		Mean: 190.09, Ttl SD: 5.58, Ttl CV%: 2.94, WR SD: 1.86, WR CV%: 0.98
	Na (L1)	Urine	717		Mean: 83.28, Ttl SD: 1.77, Ttl CV%: 2.13, WR SD: 0.57, WR CV%: 0.68
	K (L1)	Urine	717		Mean: 29.64, Ttl SD: 0.59, Ttl CV%: 1.98, WR SD: 0.55, WR CV%: 1.85
	Cl (L1)	Urine	717		Mean: 77.53, Ttl SD: 3.91, Ttl CV%: 5.04, WR SD: 1.13, WR CV%: 1.46
	Na (L2)	Urine	717		Mean: 180.05, Ttl SD: 2.26, Ttl CV%: 1.26, WR SD: 1.00, WR CV%: 0.56
	K (L2)	Urine	717		Mean: 77.73, Ttl SD: 3.91, Ttl CV%: 5.04, WR SD: 1.13, WR CV%: 1.46
	Cl (L2)	Urine	717		Mean: 182.78, Ttl SD: 6.71, Ttl CV%: 3.67, WR SD: 1.82, WR CV%: 1.00
	Na (L1)	Urine	736		Mean: 81.25, Ttl SD: 2.00, Ttl CV%: 2.47, WR SD: 0.87, WR CV%: 1.07
	K (L1)	Urine	736		Mean: 29.25, Ttl SD: 0.46, Ttl CV%: 1.46, WR SD: 0.35, WR CV%: 1.20
	Cl (L1)	Urine	736		Mean: 80.38, Ttl SD: 4.32, Ttl CV%: 5.38, WR SD: 2.37, WR CV%: 2.95
	Na (L2)	Urine	736		Mean: 179.05, Ttl SD: 2.63, Ttl CV%: 1.47, WR SD: 2.53, WR CV%: 1.41
	K (L2)	Urine	736		Mean: 94.90, Ttl SD: 1.99, Ttl CV%: 2.09, WR SD: 0.44, WR CV%: 0.46
	Cl (L2)	Urine	736		Mean: 159.48, Ttl SD: 6.44, Ttl CV%: 4.04, WR SD: 1.75, WR CV%: 1.10
	Na (L1)	Urine	737		Mean: 27.83, Ttl SD: 1.39, Ttl CV%: 4.99, WR SD: 0.69, WR CV%: 2.48
	K (L1)	Urine	737		Mean: 7.57, Ttl SD: 0.11, Ttl CV%: 1.45, WR SD: 0.09, WR CV%: 1.24
	Cl (L1)	Urine	737		Mean: 26.75, Ttl SD: 4.03, Ttl CV%: 15.08, WR SD: 1.83, WR CV%: 6.84
	Na (L2)	Urine	737		Mean: 57.33, Ttl SD: 1.59, Ttl CV%: 2.78, WR SD: 0.52, WR CV%: 0.91
	K (L2)	Urine	737		Mean: 15.85, Ttl SD: 0.17, Ttl CV%: 1.07, WR SD: 0.04, WR CV%: 0.28
	Cl (L2)	Urine	737		Mean: 56.55, Ttl SD: 2.29, Ttl CV%: 4.05, WR SD: 0.59, WR CV%: 1.05

Study to Prove Device Meets Acceptance Criteria

The studies conducted are described as:

Comparative Analysis (Correlation Study): Comparing results from BMD Hitachi Chemistry Systems calibrated with ALKO products versus BMD products.
Precision Study: Measuring samples over 20 runs on BMD Hitachi Clinical Chemistry Systems with ALKO products.

2. Sample Size Used for the Test Set and Data Provenance

Correlation Study (Urine Samples):
- Hitachi 736 System: N=40
- Hitachi 704 System: N=40
- Hitachi 737 System: N=42
- Hitachi 911 System: N=42
Correlation Study (Plasma Samples):
- Hitachi 736 System: N=59
- Hitachi 704 System: N=57 (Na, K); N=59 (Cl)
- Hitachi 737 System: N=59
- Hitachi 911 System: N=59
Precision Study (Urine Samples): For each analyte (Na, K, Cl) at two levels (Level 1, Level 2) on systems 704, 717, 736, and 737, the sample size (N) is 20.

Data Provenance: Not explicitly stated in the provided text. It is a retrospective analysis comparing against an existing predicate. The document refers to "samples measured on Hitachi..." suggesting patient samples were collected and analyzed. No mention of country of origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

N/A. This is a study comparing analytical reagent performance, not an AI or diagnostic imaging device requiring expert interpretation for ground truth. The "ground truth" for the correlation study is the measurement obtained using the predicate (BMD) reagents.

4. Adjudication Method for the Test Set

N/A. Not applicable for this type of analytical performance study. The adjudication is the agreement between the ALKO and BMD reagent measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

N/A. This is not an MRMC study. It is an analytical performance study of reagents.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

N/A. This is not an AI or algorithm-based device. It's a chemical reagent. The performance described is the standalone performance of the ALKO reagents in terms of their analytical output on the specified instruments.

7. The Type of Ground Truth Used

For the correlation study, the ground truth is the measurements obtained using the Boehringer Mannheim Diagnostic (BMD) predicate reagents on the same Hitachi Clinical Chemistry Systems. This is a comparative type of ground truth where the new device's performance is gauged against an established, accepted method.

For the precision study, the ground truth is implicitly the statistical expectation of minimal variability around the mean value of repeated measurements of the same sample. There isn't an external "ground truth" measurement, but rather an assessment of the consistency of the device's own measurements.

8. The Sample Size for the Training Set

N/A. This is not a machine learning or AI device that requires a training set. The reagents are chemical formulations.

9. How the Ground Truth for the Training Set Was Established

N/A. Not applicable.

Summary

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K963734

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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Correlation with BMD Reagents - Plasma Samples

1. 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

SHEET 55 OF 62

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Page 4/ ALKO 510 (k) Summary for ISE Hitachi Reagents

Precision of ALKO Reagents - Urine Samples

1. 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

SHEET 5 OF 1/2

Regulation Number and Section

§ 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.