The products encompassed by this request are intended for in vitro diagnostic use and are intended for use in calibrating the electrodes and flushing the sample flow path of the equivalent Chiron (Ciba-Corning) pH/Blood Gas Analyzer. Chiron Diagnostics is the Original Equipment Manufacturer of the analyzers and of the predicate Reagents. The Chiron (Ciba-Corning) pH/Blood Gas Analyzer performs a broad array of blood gas 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 Wash Solution. These Reagents are intended to be used with equivalent Chiron (Ciba-Corning) pH/Blood Gas Analyzers. As such. ALKO products are intended to serve as direct replacements to like named products manufactured by Chiron Diagnostics.

The Buffer Solution 7.3, and Buffer Solution 6.8, are intended to provide calibration points for the pH electrode on the analyzer. The Wash Solution is intended for rinse of the analyzers 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 I he products chooligable of assis Corporation, 333 Fiske Street, Holliston, MA 01746. The Reagents are intended for use on equivalent Chiron (Ciba-Corning) pH/ Blood Gas Analyzers. Chiron Diagnostics (formally Ciba-Corning) 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 buffer reagents for the analyzer's analyte pH (concentration of hydrogen ions) which is measured by the glass membrane electrode. ALKO also pri (6.nouther the Wash Solution. The ALKO Reagents are intended to serve as direct replacements to like named oroducts manufactured by Chiron Diagnostics. The Buffer Pack which consists of one bottle each of 6.8 and 7.3 Buffer, are Buffered Solutions for calibration of the pH electrode. The Wash Solution is used to rinse the analyzers sample flow path.

ALKO product A473-496 (6.8 / 7.3 Buffer Pack) is equivalent to Chiron Diagnostics product 473496 . (6.8 / 7.3 Buffer Pack).
ALKO Product A473-497 (Wash Solution), is equivalent to Chiron Diagnostics product 473497 . (Wash Solution).

ALKO uses a similar composition and packaging design as that used by Chiron Diagnostics in its products.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ALKO Reagents on CHIRON pH/ Blood Gas Analyzer, based on the provided text:

Acceptance Criteria and Device Performance Study for ALKO Reagents

The ALKO Reagents (6.8 / 7.3 Buffer Pack and Wash Solution) are intended as direct replacements for Chiron Diagnostics' equivalent products used on Chiron (Ciba-Corning) pH/Blood Gas Analyzers. The primary goal of the study was to demonstrate performance equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on demonstrating equivalence rather than setting explicit acceptance criteria as pass/fail thresholds. Instead, it presents performance data for ALKO reagents and compares it to the expected performance characteristics of a blood gas analyzer to show that the ALKO reagents perform comparably to the predicate Chiron reagents. The "acceptance criteria" thus are implicit in the demonstration of adequate precision and strong correlation with the predicate reagents.

Precision Data (Measured with ALKO Reagents)

Parameter	Level	N	Mean	STD	CV%
pH	1	40	7.166	0.0025	0.0351
pH	2	40	7.431	0.0019	0.0262
pH	3	40	7.653	0.0030	0.0394
pCO2	1	40	79.3	1.2343	1.5574
pCO2	2	40	43.7	0.4989	1.1409
pCO2	3	40	18.9	0.1856	0.9811
pO2	1	40	57.6	1.5465	2.6843
pO2	2	40	96.2	1.1632	1.2089
pO2	3	40	149.3	2.8649	1.9183

Correlation Data (ALKO vs. Chiron Reagents)

Parameter	N	R² (Correlation Coefficient Squared)	Intercept	Slope	Range
pH	120	0.9949	0.0382	0.9939	6.946 - 7.962
pCO2	120	0.9968	0.1342	0.9931	9.3 - 101.8
pO2	120	0.9977	0.0608	0.9983	2.4 - 293.1

The high R² values (close to 1) and slopes close to 1 with small intercepts demonstrate excellent correlation and equivalence between the ALKO reagents and the predicate Chiron reagents across the tested ranges for pH, pCO2, and pO2. The precision data indicates that the ALKO reagents allow the analyzer to maintain acceptable levels of precision for each analyte.

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

Precision Study:
- Sample Size: For each of three control levels (Level 1, 2, 3), 40 measurements were taken for pH, pCO2, and pO2. These were collected from measuring "three levels of control materials, measured in duplicate per run, four runs per day for five days". This means (2 duplicates/run * 4 runs/day * 5 days = 40 measurements per level).
- Data Provenance: The study was conducted on a Chiron 248 pH/blood gas analyzer, calibrated with ALKO reagents. The control materials are not specified, but the study implies a laboratory setting. No country of origin is explicitly stated, nor is it explicitly stated if it's retrospective or prospective, but the description of the experimental setup suggests a prospective study.
Correlation Study:
- Sample Size: 120 human blood samples were used for pH, pCO2, and pO2 measurements.
- Data Provenance: The samples were "human blood samples" measured on "two Chiron 248 analyzers; one calibrated with all ALKO reagents as compared with all Chiron reagents." The data provenance is human blood samples, and it's a prospective method comparison study.

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

Not applicable. This type of submission (IVD reagents for a blood gas analyzer) typically relies on quantitative measurements against known standards (control materials) or comparison to a predicate device's measurements, rather than expert consensus on interpretive tasks. The ground truth for the precision study is the established values of the control materials, and for the correlation study, it's the results generated by the predicate Chiron reagents.

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, the studies involve quantitative measurements and direct comparison, not subjective evaluations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for interpretive tasks where human readers assess cases, often with and without AI assistance (e.g., radiology image interpretation). This submission is for in vitro diagnostic reagents where performance is assessed quantitatively and directly, not through human interpretation.

6. If a Standalone Study Was Done

Yes, a standalone study (algorithm-only, or in this case, reagent-only performance) was done for the precision data. The precision data demonstrates the performance of the analyzer when calibrated solely with ALKO reagents (i.e., ALKO reagents "standalone" from the predicate reagents). It shows the inherent variability of the test system using the new reagents.

The correlation study is a direct comparison study, not a standalone study, as it directly compares ALKO performance to Chiron performance.

7. The Type of Ground Truth Used

Precision Study: The ground truth for the precision study is the expected values of the control materials used. These materials have known, established concentrations for pH, pCO2, and pO2. The study aims to show that when using ALKO reagents, the analyzer can consistently measure these known values with acceptable variability.
Correlation Study: The ground truth for the correlation study is the measurements obtained from the same human blood samples analyzed on a Chiron 248 analyzer calibrated with the predicate Chiron Diagnostics reagents. The goal is to show that ALKO reagents yield results that are highly correlated and equivalent to those obtained with the already approved predicate reagents.

8. The Sample Size for the Training Set

Not applicable. The ALKO products are reagents for an in vitro diagnostic device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The studies described are validation and comparison studies for the chemical reagents.

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

Not applicable, as there is no training set for this type of medical device submission.

Summary

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K984384

510(k) Summary F. 23 10 1 for ALKO Reagents on CHIRON (Ciba-Corning) 248 pH/ Blood Gas Analyzer

Information herein will support ALKO's position for the intended use of these products to the equivalent Chiron (Ciba-Corning) pH/ Blood Gas Analyzers. The Chiron (Ciba-Corning) 248 pH/Blood Gas Analyzer performs a broad array of blood gas tests. ALKO manufactures the buffer reagents for the analyzer's analyte pH (concentration of hydrogen ions) which is measured by the glass membrane electrode. ALKO also pri (6.nouther the Wash Solution. The ALKO Reagents are intended to serve as direct replacements to like named oroducts manufactured by Chiron Diagnostics. The Buffer Pack which consists of one bottle each of 6.8 and 7.3 Buffer, are Buffered Solutions for calibration of the pH electrode. The Wash Solution is used to rinse the analyzers sample flow path.

ALKO product A473-496 (6.8 / 7.3 Buffer Pack) is equivalent to Chiron Diagnostics product 473496 . (6.8 / 7.3 Buffer Pack).
ALKO Product A473-497 (Wash Solution), is equivalent to Chiron Diagnostics product 473497 . (Wash Solution).

ALKO uses a similar composition and packaging design as that used by Chiron Diagnostics in its products. Equivalence is explained in the packaging section of this submission. ALKO has shown performance equivalence of its products to Chiron Diagnsotics products in the following manner:

Through a method comparison where results obtained on an equivalent Chiron (Ciba-Corning) O pH Blood Gas Analyzer, calibrated with ALKO products and compared with results obtained on the same analyzer calibrated with Chiron Diagnostics products; and
Through a precision study where ALKO products were installed on an equivalent Chiron (Ciba-O Corning) pH Blood Gas Analyzer and samples were measured four runs per day for five days. A summary of the results of these studies follows:

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PERFORMANCE CHARACTERISTICS

Precision Data

Precision data were collected from the analysis of three levels of control materials, measured in duplicate per run, four runs per day for five days on a Chiron 248 pH/blood gas analyzer calibrated with all ALKO reagents. .....

Level 1		N	Mean	STD	CV%
pH	Total	40	7.166	0.0025	0.0351
	W-Run	20	7.166	0.0017	0.0231
pCO2	Total	40	79.3	1.2343	1.5574
	W-Run	20	79.3	1.1177	1.4103
pO2	Total	40	57.6	1.5465	2.6843
	W-Run	20	57.6	1.3294	2.3064

Level 2
	N	Mean	STD	CV%
pH	Total	40	7.431	0.0019	0.0262
	W-Run	20	7.431	0.0013	0.0170
pCO2	Total	40	43.7	0.4989	1.1409
	W-Run	20	43.7	0.4461	1.0202
pO2	Total	40	96.2	1.1632	1.2089
	W-Run	20	96.2	0.7857	0.8165

Level	3
-------	---

		N	Mean	STD	CV%
pH	Total	40	7.653	0.0030	0.0394
	W-Run	20	7.653	0.0012	0.0159
pCO2	Total	40	18.9	0.1856	0.9811
	W-Run	20	18.9	0.1294	0.6841
pO2	Total	40	149.3	2.8649	1.9183
	W-Run	20	149.3	1.5502	1.0380

Note: \W-Run = Within Run

Page 12 of Page 53

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Page 3 / ALKO 510(k) Summary for Chiron (Ciba-Corning) Equivalent Reagents.

orrelation with Chiron reagents

Correlation data were obtained from 120 human blood samples for pH, pCO2 and pO2, measured on two Chiron 248 analyzers; one calibrated with all ALKO reagents as compared with all Chiron reagents. Linear andiyzels, the callirated with an ALKO reagently and ALKO data as the Dependent Y variable in the equation Y=a+ bX.

			Interce
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000pH = = = = = =	120	0.9949	0.0382	0.9939	6.946 - 7.962
pCO2 program	120	0.9968	0.1342	0.9931	9.3 - 101.8
PO2 - 13:14CHASTERNE	120	0.9977	0.0608	0.9983	2.4 - 293.1

Note: R Sq. = Correlation Coefficient squared

I hope you find this information useful and informative.

Janet A. Smith

|2|3|08|
(date prepared)

Hanet A, McGrath Regulatory Affairs

Page 13 of Page 53

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Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract eagle design, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling the eagle. The text is arranged in a circular pattern around the eagle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 22 1998

Janet A. McGrath Regulatory Affairs Specialist Thermo BioAnalysis 333 Fiske Street Holliston, MA 01746

Re: K984384 Trade Name: 6.8/7.8 Buffer Pack & Wash Solution Pack Requlatory Class: II Product Code: CHL Dated: December 4, 1998 December 8, 1998 Received:

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 legally marketed predicate 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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification Please note: 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 requlations.

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Page 2

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/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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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510(k) Number (if known):

Device Name: Reagents on Equivalent Chiron (Ciba-Corning) 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)	Veronica D. Caluin for AWM
Division of Clinical Laboratory Devices
510(k) Number	K984384

Prescription Use	✓ (Per 21 CFR 801.109)	OR	Over-The-Counter Use	(Optional Format 1-2-96)
------------------	------------------------------------------------------------------------------------------------------------------------------	----	----------------------	----------------------------------------------------------------------------

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

Regulation Number and Section

§ 862.1120 Blood gases (P

CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.