The products encompassed by this request are intended for in vitro diagnostic use and the quantitative determination of Na", K", and Cl ", on the Olympus Chemistry Systems. Olympus America Incorporated is the original equipment manufacturer (OEM) of the chemistry systems and of the predicate Reagents. The Olympus Chemistry Systems performs a broad array of clinical chemistry tests. The Olympus Chemistry Systems with the ISE module measures sodium (Na), potassium (K), and chloride (Cl ) by Ion Selective Electrodes. These Reagents are intended to be used with the equivalent Olympus Chemistry Systems. As such, ALKO products are intended to serve as direct replacements to like named products manufactured by Olympus .

The Buffer dilutes all measured samples for the quantitative determinations in Na ", K , and Cl in serum and urine by ISE. The Mid-Standard Solution is intended as a means of compensating for calibration drift in the quantitative determination of Na , K , and Cl in samples on the Olympus Chemistry Systems. The Reference Solution is intended to provide a stable reference potential for Na ", K", and Cl " electrodes on the Olympus Chemistry System. The Serum High/Low Standard and Urine High/Low Standard are used to calibrate the Na *, K , and Cl clectrodes of the system's ISE module. The ISE Na "/K " Selectivity Na 7, KT, electrode verification. The products Check Solutions are intended for encompassed are to be handled using normal laboratory precautions.

Device Description

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 ISE Reagents are intended for use on the ISE module of the Olympus Chemistry Systems. Olympus America Incorporated is the original equipment manufacturer (OEM) of the system and of predicate ISE Reagents which are necessary for the continued operation and use of the ISE module on these systems.

Information herein will support ALKO's position for the intended use of these products to the Olympus Chemistry System with the ISE module. The ISE module measures Na , K , Cl by using the system's Ion Selective Electrodes. The ALKO Reagents are intended to serve as direct replacements to like named products manufactured by Olympus America Incorporated. The Buffer dilutes all measured samples for the quantitative determinations of Na , K , and Cl concentrations in serum and urine by ISE. The Mid-Standard Solution is intended as a means of compensating for calibration drift. in the quantitative determination of Na K , and Cl in samples on the Olympus Chemistry Systems. The Reference Solution is intended to provide a stable reference potential for Na , K , and Cl electrodes on the Olympus Chemistry Systems. The ISE Serum/Urine and High/Low Standards are used to calibrate the electrodes of Na , K , and Cl on the system's ISE module. The ISE Na /K Selectivity Check Solutions are intended for Na and K electrode verification.

ALKO product A101-100 (ISE Buffer) is equivalent to Olympus Chemistry System product AUH1011 (ISE Buffer). ALKO Product A101-200 (ISE Mid - Standard Solution) is equivalent to Olympus Chemistry System product AUH1012 (ISE Mid-Standard). ALKO product A101-300 (ISE Reference Solution) is equivalent to Olympus Chemistry System product AUH1013 (ISE Reference Solution). ALKO product A101-400 (ISE Low Serum Standard) is equivalent to Olympus Chemistry System product AUH1014 (ISE Low Serum Standard). ALKO product A101-500 (ISE High Serum Standard) is equivalent to Olympus Chemistry System product AUH1015 (ISE High Serum Standard). ALKO product A101-600 (ISE High/Low Urine Standard) is equivalent to Olympus Chemistry System product AUH1016 (ISE High/Low Urine Standard), ALKO product A101-800 (Na7 K Selectivity Check Solution) is equivalent to Olympus Chemisty System product AUH1018 ((Na / K+ Selectivity Check Solution).

ALKO uses a similar composition, description and packaging design as that used by Olympus America in its products.

AI/ML Overview

The ALKO Reagents for the Olympus AU 800™/AU 5200™ Chemistry Systems are intended as direct replacements for Olympus reagents for the quantitative determination of Na+, K+, and Cl- concentrations in serum and urine by Ion Selective Electrodes (ISE).

1. Acceptance Criteria and Reported Device Performance:

The document describes two main types of studies to demonstrate equivalence: Precision Data and Correlation with Olympus Reagents.

Precision Data Acceptance Criteria (Implied):
While explicit acceptance criteria (e.g., maximum allowable CV%) are not stated, the reported precision data for ALKO reagents is expected to be within acceptable limits for clinical laboratory use and comparable to predicate device performance (Olympus reagents). The data shows Coefficient of Variation (CV%) values generally below 1.5% for all analytes across various serum and urine levels, indicating good precision.

Correlation with Olympus Reagents Acceptance Criteria (Implied):
For correlation studies, the acceptance criteria are generally based on:

Slope: Close to 1.0 (indicating proportional agreement)
Intercept: Close to 0.0 (indicating no systematic bias)
R-squared (Correlation Coefficient Squared): Close to 1.0 (indicating strong linear correlation)

Table of Acceptance Criteria (Implied) and Reported Device Performance:

Performance Metric	Analyte	Acceptance Criteria (Implied)	Reported ALKO Reagent Performance	Meets Criteria?
Precision (CV%)	Na+	< ~1.5% (Typical for clinical chemistry)	0.47% - 1.35%	Yes
	K+	< ~1.5% (Typical for clinical chemistry)	0.45% - 1.33%	Yes
	Cl-	< ~1.5% (Typical for clinical chemistry)	0.58% - 0.93%	Yes
Correlation (Slope)	Na+	Close to 1.0	Serum: 1.0242, Urine: 1.0191	Yes
	K+	Close to 1.0	Serum: 0.9900, Urine: 1.0325	Yes
	Cl-	Close to 1.0	Serum: 0.9892, Urine: 1.0016	Yes
Correlation (Intercept)	Na+	Close to 0.0	Serum: -3.4021, Urine: -1.0199	Yes (within clinical relevance)
	K+	Close to 0.0	Serum: 0.0242, Urine: -1.0404	Yes (within clinical relevance)
	Cl-	Close to 0.0	Serum: -0.6464, Urine: 0.4077	Yes (within clinical relevance)
Correlation (R-Sq)	Na+	Close to 1.0	Serum: 0.9995, Urine: 0.9991	Yes
	K+	Close to 1.0	Serum: 0.9998, Urine: 0.9997	Yes
	Cl-	Close to 1.0	Serum: 0.9997, Urine: 0.9993	Yes

Note: The "acceptance criteria" are implied based on common expectations for clinical chemistry assays and the reported values supporting substantial equivalence.

2. Sample Sizes Used for the Test Set and Data Provenance:

Precision Test Set:
- Serum: 3 levels of serum controls. Each level involved 48 measurements (duplicate per run, 4 runs per day for 5 days).
- Urine: 2 levels of urine controls. Each level involved 48 measurements (duplicate per run, 4 runs per day for 5 days).
- Data Provenance: Not explicitly stated, but assumed to be from a controlled laboratory setting. It is a prospective study as data was collected specifically for this filing.
Correlation Test Set:
- Serum: 40 serum samples and 9 serum controls (Total N=49).
- Urine: 70 urine samples and 6 urine controls for Na+ and Cl- (Total N=76). 66 urine samples and 6 urine controls for K+ (Total N=72).
- Data Provenance: Not explicitly stated, but assumed to be from a controlled laboratory setting. It is a prospective study as data was collected specifically for this filing.

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

Not Applicable. This submission is for in vitro diagnostic reagents on an automated chemistry analyzer, not for image-based diagnostic devices requiring expert interpretation. The "ground truth" for the test samples would be the values obtained by the established reference method (Olympus reagents) or highly controlled, traceable values for the controls.

4. Adjudication Method for the Test Set:

Not Applicable. As this is not an expert-based diagnostic assessment, no adjudication method like 2+1 or 3+1 is relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

Not Applicable. This is an in vitro diagnostic device for quantitative chemical analysis, not an AI-assisted diagnostic tool involving human readers.

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

Yes, in spirit. The performance studies (precision and correlation) represent the standalone performance of the ALKO reagents when used on the Olympus system. The results reported are direct measurements from the analyzer using ALKO reagents, with comparison to results obtained using Olympus reagents. There is no human interpretation or intervention in the measurement process itself that would constitute a "human-in-the-loop."

7. The Type of Ground Truth Used:

Comparative Reference Method: For the correlation study, the "ground truth" for the test samples was the analytical results obtained using the Olympus reagents on the same Olympus AU800 analyzer. This establishes equivalence by comparing ALKO reagents to the predicate device's performance.
Known Control Values: For the precision study, commercially available serum and urine controls with established target ranges were used. The mean values obtained are compared against potentially expected values for these controls.

8. The Sample Size for the Training Set:

Not Applicable. This device is a set of chemical reagents for an existing automated analyzer, not a machine learning or AI algorithm that requires a training set. The "training" of the system would involve calibration with the provided standards according to the manufacturer's instructions.

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

Not Applicable. As there is no training set in the AI sense, this question is not relevant. The "ground truth" for the calibrators (standards) used to set up the assay would be based on their certified values, often traceable to reference materials or methods. The document mentions "The ISE Serum/Urine and High/Low Standards are used to calibrate the electrodes of Na , K , and Cl on the system's ISE module," implying these calibrators have established values.

Summary

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K972004

510(k) Summary for ALKO Reagents on the ISE Module of the Olympus AU 800™ /AU 5200TM JUN 1 6 1997 Chemistry Systems

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

O Through a method comparison where results obtained on an equivalent Olympus Chemistry System, calibrated with ALKO products and compared with results obtained on the same analyzer calibrated with Olympus products; and
O Through a precision study where ALKO products were installed on an equivalent Olympus Chemistry System and samples were measured over 20 runs. A summary of the results of these studies follows:

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Page 2 / ALKO 510(k) Summary for ISE Olympus Reagents.

PERFORMANCE CHARACTERISTICS

Precision Data

Precision data was collected from the analysis of three levels of serum controls and two levels of urine controls, measured in duplicate per run, four runs per day for at least five days on the ISE Module of the Olympus AU800 analyzer for Na /K+/Cl , calibrated with all ALKO reagents.

Serum Level 1

	N	Mean	STD	CV%
Na+	Total 48	127	0.7535	0.5939
	W-Run 24	127	0.8165	0.6435
K+	Total 48	3.2	0.0143	0.4466
	W-Run 24	3.2	0.0204	0.6383
Cl-	Total 48	83	0.6641	0.7993
	W-Run 24	83	0.5774	0.6977

Serum Level 2

			. Mean	I STD STD I STD STORE I STORE I STORES STATE STORES STATE STATE STATE STATE STATE STATE STATE STATE STATE STATE STATE ASSESS FOR STATE ASSESS FOR STATE ASSESS FOR AND STATES	CV% -
	Total	48	139	0.8777	0.6314
	W-Run	24	139	0.9789	0.7042
	Total	48	4.5	0.0534	1.1749
	W-Run	24	4.5	0.0408	0.8989
Crisi	Total	48	83	0.6641	0.7993
	W-Run	24	83	0.5774	ﺔ 0.6977

Serum Level 3

		N	Mean	STD	CV%
Na+	Total	48	156	0.8268	0.5302
	W-Run	24	156	0.7360	0.4720
K+	Total	48	5.9	0.0729	1.2266
	W-Run	24	5.9	0.0791	1.3310
Cl-	Total	48	114	0.9270	0.8159
	W-Run	24	114	0.7638	0.6722

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Urine Level 1

		N	Mean	STD	CV%
Na+	Total	48	58	0.5770	0.9866
	W-Run	24	58	0.7906	1.3519
K+	Total	48	23.4	0.1887	0.8065
	W-Run	24	23.4	0.1568	0.6700
Cl-	Total	48	58	0.4560	0.7881
	W-Run	24	58	0.5401	0.9335

Urine Level 2

		N	Mean	STD	CV%
Na $+$	Total	48	184	1.2741	0.6942
	W-Run	24	184	1.0801	0.5885
K $+$	Total	48	130.6	0.9643	0.7383
	W-Run	24	130.6	0.7277	0.5572
Cl $-$	Total	48	288	2.3629	0.8219
	W-Run	24	288	1.6583	0.5768

Note: W-Run = Within Run

Correlation with Olympus Reagents

Linear Regression Analyses were performed using the Olympus data as the Independent X Variable and ALKO Data as the Dependent Y Variable in the equation Y = a + bX.

Serum Samples :

Correlation data were collected from 40 serum samples and 9 serum controls for Na 7K / C/C / measured on the ISE Module of the Olympus AU800 analyzer, calibrated with ALKO as compared with Olympus reagents separately.

	Na	K	Cl
N	49	49	49
Slope	1.0242	0.9900	0.9892
Intercept	-3.4021	0.0242	-0.6464
R Sq.*	0.9995	0.9998	0.9997
Range	65 - 183	1.4 - 10.9	37 - 165

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. . Urine Samples:

Urine Samples:
Correlation data were collected from 70 urine samples and 6 urine controls for Na 7 CT, and 66 urine samples and 6 urine controls for K+, measured on the ISE Module of the Olympus AU800 analyzer, calibrated with ALKO as compared with Olympus reagents separately.

	Na	K	Cl
N	76	72	76
Slope	1.0191	1.0325	1.0016
Intercept	-1.0199	-1.0404	0.4077
R Sq.*	0.9991	0.9997	0.9993
Range	13 - 361	5.7 - 306.0	13 - 452

*R Sq = Correlation Coefficient Squared

I hope that you find this information useful and informative.

Janet McCurdy

Janet A.McGrath Regulatory Affairs

ರಿಗ ర న్నారు. విశ

(date prepared)

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wing shapes, creating a sense of movement and flight.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 6 1997

Janet A. McGrath Regulatory Affairs Specialist ALKO Diagnostics …………………………………… 333 Fiske Street Holliston, Massachusetts 01746

Re : K972004 ISE Reagents for Olympus AU 800™/AU 5200™ Chemistry Systems Requlatory Class: II Product Code: CGZ, JGS, CEM May 29, 1997 Dated: Received: May 30, 1997

Dear Ms. McGrath:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Paqe 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as ... described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

在 If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

sincerely yours,
Steven Sitman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K972004

Device Name: ISB Reagents on Equivalent Olymous Chemistry Systems

Indication For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.