The products encompassed by this request are intended for in vitro diagnostic use and are intended for use in calibrating the electrodes and cleaning / flushing the sample flow path of the equivalent ABL™ pH/Blood Gas Systems. Radiometer Medical/Copenhagen is the Original Equipment Manufacturer of the analyzers and of the predicate Reagents. The ABL™ pH/Blood Gas Analyzers perform a broad array of blood gas and co-oximetery tests. ALKO manufactures the calibration reagents for the analyzer's analyte pH, (concentration of hydrogen ions) which is measured by glass membrane electrodes. ALKO also manufactures the Cleaning, Rinse, Hypochlorite and Salt Bridge Solution. These Reagents are intended to be used with equivalent ABL™ pH/Blood Gas Analyzers. As such, ALKO products are intended to serve as direct replacements to like named products manufactured by Radiometer Medical/Copenhagen.

The Calibration Solution, pH 7.4/ 3 and Calibration Solution, pH 6.8/ 4 are intended to provide calibration points for the pH electrode on the analyzer. The Salt Bridge Solution /2 provides a liquid junction through the reference electrode during calibration and measurement. The Cleaning Solution /1, Rinse Solution /5 and Hypochlorite Solution are intended for maintenance of the analyzers electrodes and sample flow path. The products 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 Reagents are intended for use on equivalent ABL™ pH/ Blood Gas Analyzers. Radiometer Medical/Copenhagen is the original equipment manufacturer (OEM) of the analyzers and of predicate reagents which are necessary for the continued operation and use of the analyzers.

ALKO manufactures the calibration reagents for the analyzer's analyte pH (concentration of hydrogen ions) which is measured by the glass membrane electrode. ALKO also manufactures the Cleaning, Rinse, Hypochlorite and Salt Bridge Solution. The ALKO Reagents are intended to serve as direct replacements to like named products manufactured by Radiometer Medical /Copenhagen. The Calibration Solutions, pH 7.4/3 and Calibration Solution, pH 6.8/4 are buffered solutions for calibration of the pH electrode. The Salt Bridge Solution /2 provides a liquid junction through the reference electrode and the sample during calibration and measurement. The Cleaning Solution /S and Hypochlorite olution are all used to clean and rinse the analyzers electrodes, and sample flow path.

AI/ML Overview

The provided text describes the acceptance criteria and study proving equivalence for ALKO Reagents as direct replacements for Radiometer Medical/Copenhagen reagents on ABL™ pH/Blood Gas Analyzers.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied to be performance equivalence to the predicate Radiometer Medical/Copenhagen reagents. This is demonstrated through two types of studies: a method comparison (accuracy) and a precision study.

Precision Data (Measured one run per day for twenty days)

Analyte	Metric	N	Mean	STD	CV%	Min	Max
Level 1
pH	Total	60	7.155	0.0025	0.0344	7.149	7.159
	Run to Run	20	7.155	0.0023	0.0325	7.149	7.157
pCO2	Total	60	73.5	0.8096	1.1022	72.2	75.8
	Run to Run	20	73.5	0.7140	0.9720	72.5	75.6
pO2	Total	60	76.4	1.2870	1.6848	73.9	79.2
	Run to Run	20	76.4	0.9898	1.2951	74.8	78.7
Level 2
pH	Total	60	7.370	0.0022	0.0301	7.365	7.381
	Run to Run	20	7.370	0.0015	0.0209	7.367	7.374
pCO2	Total	60	44.2	0.5873	1.3296	43.4	47.5
	Run to Run	20	44.2	0.3177	0.7193	43.8	45.1
pO2	Total	60	102.2	1.8308	1.7906	98.7	109.9
	Run to Run	20	102.2	1.5290	1.4955	99.5	105.3
Level 3
pH	Total	60	7.576	0.0026	0.0345	7.571	7.586
	Run to Run	20	7.576	0.0020	0.0267	7.572	7.579
pCO2	Total	60	20.3	0.4511	2.2171	17.4	20.8
	Run to Run	20	20.3	0.3096	1.5214	19.2	20.8
pO2	Total	60	157.4	3.6420	2.3146	149.0	165.3
	Run to Run	20	157.4	3.1385	1.9946	151.0	163.3

Accuracy (Correlation with Radiometer ABL™ Reagents)

Analyte	N	Slope	Intercept	R Squared *	Range
pH	51	1.0068	-0.04888	0.9998	6.816 - 7.987
pCO2	51	1.0106	-0.14954	0.9995	5.1- 152.7
pO2	51	0.9961	0.46989	0.9995	12.6 - 285.0

R Squared = Correlation Coefficient Squared. The acceptance criteria for these correlation values are not explicitly stated but are implicitly for high correlation (close to 1 for R-squared, slope close to 1, intercept close to 0) to demonstrate equivalence.

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

Test Set Sample Size:
- Precision study: 20 days of measurements for each of 3 control levels (resulting in N=60 for "Total" and N=20 for "Run to Run" for each analyte at each level).
- Accuracy (Method Comparison) study: 51 blood samples.
Data Provenance: Not explicitly stated but inferred to be from laboratory testing involving ALKO and Radiometer reagents on ABL™ 500 analyzers. There is no information about country of origin beyond "Holliston, MA" for ALKO and "Radiometer Medical/Copenhagen," or whether the data is retrospective or prospective. It is implied to be prospective testing conducted for the 510(k) submission.

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

Not applicable. This device involves chemical reagents and instrument performance, not interpretation by human experts. The "ground truth" for the accuracy study is derived from measurements performed using the predicate Radiometer Medical/Copenhagen reagents.

4. Adjudication Method for the Test Set

Not applicable, as this is a performance study for chemical reagents and not an assessment requiring expert adjudication of results.

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 not an AI-assisted diagnostic device or an imaging product requiring human reader interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is essentially a "standalone" performance study for the reagents, as it evaluates their intrinsic performance when used on the specified analyzers without human interpretive element. The results are quantitative measurements.

7. The type of ground truth used

Precision Study: The ground truth is the inherent concentration or value of the control materials. The study aims to demonstrate reproducibility around this ground truth.
Accuracy (Method Comparison) Study: The "ground truth" is established by the measurements obtained using the predicate Radiometer Medical/Copenhagen reagents on an equivalent ABL™ 500 analyzer. The ALKO reagents are compared against these established values to demonstrate "equivalence."

8. The sample size for the training set

Not applicable. This is not a machine learning model or an AI device that requires a training set in the conventional sense. The development of the ALKO reagents would involve internal R&D and formulation work, but this document describes the validation of the final product for regulatory submission.

9. How the ground truth for the training set was established

Not applicable, as there is no training set in the context of this device.

Summary

{0}------------------------------------------------

JUN 1 2 1998

K9811795

510(k) Summary for ALKO Reagents on ABL™ 50, 500, 510, 520, 600. 610 and 620 pH/ Blood Gas Analyzers

Information herein will support ALKO's position for the intended use of these products to the equivalent ABL™ pH/ Blood Gas Analyzers. The ABL™ pH/Blood Gas Analyzers perform a broad array of blood gas and co-oximetery tests. ALKO manufactures the calibration reagents for the analyzer's analyte pH (concentration of hydrogen ions) which is measured by the glass membrane electrode. ALKO also manufactures the Cleaning, Rinse, Hypochlorite and Salt Bridge Solution. The ALKO Reagents are intended to serve as direct replacements to like named products manufactured by Radiometer Medical /Copenhagen. The Calibration Solutions, pH 7.4/3 and Calibration Solution, pH 6.8/4 are buffered solutions for calibration of the pH electrode. The Salt Bridge Solution /2 provides a liquid junction through the reference electrode and the sample during calibration and measurement. The Cleaning Solution /S and Hypochlorite olution are all used to clean and rinse the analyzers electrodes, and sample flow path.

. ALKO product A943-791 (Calibration Solution, pH 7.4/ 3) is equivalent to Radiometer Medical/Copenhagen product S1565 / 943-791 (Calibration Solution, pH 7.4/ 3).
ALKO Product A943-792 (Calibration Solution, pH 6.8/ 4), is equivalent to Radiometer . Medical/Copenhagen S1575 / 943-792 (Calibration Solution, pH 6.8/ 4).
ALKO product A943-794 (Salt Bridge Solution /2) is equivalent to Radiometer Medical/Copenhagen product S4915 / 943 -794 (Salt Bridge Solution /2).
. ALKO product A943-795 (Cleaning Solution /1) is equivalent to Radiometer Medical/Copenhagen product S5345 / 943 -795 (Cleaning Solution /1).
. ALKO product A943-793 (Rinse Solution /5) is equivalent to Radiometer Medical/Copenhagen product S4901 / 943 -793 (Rinse Solution /5).
. ALKO product A943-906 (Hypochlorite Solution) is equivalent to Radiometer Medical/Copenhagen product S5362 / 943 -906 (Hypochlorite Solution).

{1}------------------------------------------------

Page 2 / ALKO 510(k) Summary for ABL™ Equivalent Reagents.

ALKO uses a similar composition, description and packaging design as that used by Radiometer fedical/Copenhagen in its products. Equivalence is explained in the packaging section of this submission. (C.C.) L. Shown performance equivalence of its products to Radiometer Medical/Copenhagen products in the following manner:

Through a method comparison where results obtained on an equivalent ABL™ p/H Blood Gas O Analyzer, calibrated with ALKO products and compared with results obtained on the same analyzer calibrated with Radiometer Medical/Copenhagen products; and
Through a precision study where ALKO products were installed on an equivalent ABL™ p/H O Blood Gas Analyzer and samples were measured one run per day for twenty days. A summary of the results of these studies follows:

PERFORMANCE CHARACTERISTICS

Precision Data

Precision data were collected from the analyses of three levels of control materials measured one run per day for twenty days on an ABL™ 500 pH/pCO2/pO2 analyzer calibrated with all ALKO reagents.

Analyte		N	Mean	STD	CV%	Min	Max
pH	Total	60	7.155	0.0025	0.0344	7.149	7.159
	Run to Run	20	7.155	0.0023	0.0325	7.149	7.157
pCO2	Total	60	73.5	0.8096	1.1022	72.2	75.8
	Run to Run	20	73.5	0.7140	0.9720	72.5	75.6
pO2	Total	60	76.4	1.2870	1.6848	73.9	79.2
	Run to Run	20	76.4	0.9898	1.2951	74.8	78.7

Level 1

Level 2

Analyte		N	Mean	STD	CV%	Min	Max
pH	Total	60	7.370	0.0022	0.0301	7.365	7.381
	Run to Run	20	7.370	0.0015	0.0209	7.367	7.374
pCO2	Total	60	44.2	0.5873	1.3296	43.4	47.5
	Run to Run	20	44.2	0.3177	0.7193	43.8	45.1
pO2	Total	60	102.2	1.8308	1.7906	98.7	109.9
	Run to Run	20	102.2	1.5290	1.4955	99.5	105.3

{2}------------------------------------------------

Level 3

Analyte		N	Mean	STD	CV%	Min	Max
pH	Total	60	7.576	0.0026	0.0345	7.571	7.586
	Run to Run	20	7.576	0.0020	0.0267	7.572	7.579
pCO2	Total	60	20.3	0.4511	2.2171	17.4	20.8
	Run to Run	20	20.3	0.3096	1.5214	19.2	20.8
pO2	Total	60	157.4	3.6420	2.3146	149.0	165.3
	Run to Run	20	157.4	3.1385	1.9946	151.0	163.3

Accuracy by Correlation with Radiometer ABL™ Reagents

Correlation data were obtained from 51 blood samples for pH/pCO2/pO2, measured on two ABL™ 500 analyzers, one calibrated with all ALKO reagents as compared with the other one calibrated with all Radiometer reagents. A Linear Regression Analysis was performed using the Radiometer 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 Squared *	Range
pH	51	1.0068	-0.04888	0.9998	6.816 - 7.987
CO2	51	1.0106	-0.14954	0.9995	5.1- 152.7
pO2	51	0.9961	0.46989	0.9995	12.6 - 285.0

*R Squared= Correlation Coefficient Squared

I hope you find this information useful and informative.

Jack C. Smith

Janet A, McGrath Regulatory Affairs

5|19|98

(date prepared)

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 2 1998

Janet A. McGrath · Requlatory Affairs Specialist Thermo BioAnalysis 333 Fiske Street Holliston, Massachusetts 01746

Re : K981795 Calibration Solutions pH 7.4, pH 6.8 and Cleaning, Salt Bridge, Rinse and Hypochlorite Solutions Regulatory Class: II Product Code: JIX, CHL May 19, 1998 Dated: Received: May 21, 1998

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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.

{4}------------------------------------------------

Page 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.

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 Litman

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

{5}------------------------------------------------

Page 1 of 1

510(k) Number (if known):

Device Name: Reagents on Equivalent ABL™ pH/Blood Gas Analyzers

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 diag
510(k) Number. 282775

Prescription Use ✓
(Per 21 CFR 801.109)
OR

Over-The-Counter Use __

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
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.)(b)
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.