The GenChem CO2 Acid Reagent when used in conjunction with the GenChem ISE Electrolyte Reference, GenChem Electrolyte Buffer, GenChem CO2 Alkaline Buffer, GenChem Wash Concentrate, and appropriate Calibrators or Calibration Standards is intended for the quantitative determination of Carbon Dioxide in serum and plasma on the Beckman CX3®. Carbon Dioxide results are used in the diagnosis and treatment of numerous and potentially serious disorders associated with changes in the body's acidbase balance.

Device Description

The Device is a solution containing 0.6 mol/L sulfuric acid, nonreactive surfactants and other ingredients necessary for optimum system operation.

AI/ML Overview

The provided text describes performance characteristics for the GenChem CO2 Acid Reagent, primarily focusing on its analytical performance rather than diagnostic accuracy against a ground truth dataset. Therefore, some of the requested information, particularly regarding expert consensus, MRMC studies, and ground truth establishment for a diagnostic algorithm, is not applicable or cannot be extracted from this document, as it describes a laboratory reagent for quantitative measurement of CO2.

Here's the information that can be extracted and presented according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied/Standard)	Reported Device Performance (GenChem CO2 Acid Reagent)
Precision/Reproducibility	Low %CV for various analyte levels	Serum 1: 3.2% CV (within run), 3.0% CV (total)
		Serum 2: 1.4% CV (within run), 1.6% CV (total)
		Serum 3: 1.7% CV (within run), 2.1% CV (total)
Linearity/Reportable Range	Excellent linearity (slope ~1, R² ~1)	Slope: 1.000, Intercept: 0.15, R²: 1.000
	Wide linear range	0.0 to 40.0 mmol/L
Sensitivity	Low detection limit	0.255 mg/dL (calculated as 3 SD), below claimed limit of 5.0 mg/dL
Analytical Specificity	Minimal interference from common substances	No adverse effect from Hemoglobin (up to 500 mg/dL), Bilirubin (up to 20 mg/dL), Lipemia (up to 1800 mg/dL)

2. Sample size used for the test set and the data provenance

Precision Study:
- Sample Size: 60 measurements for each of 3 control sera (2 measurements/day in triplicate over 10 days).
- Data Provenance: Not explicitly stated, but results are from tests performed on control sera.
Patient Comparison Study:
- Sample Size: 80 serum samples and 80 plasma samples.
- Data Provenance: "Collected from adult patients." No specific country of origin is mentioned. These appear to be retrospective samples used for comparison.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This document describes the performance of a reagent for quantitative CO2 measurement, not a diagnostic algorithm that requires expert ground truth establishment in the traditional sense (e.g., for image interpretation). The "ground truth" for the patient comparison study would be the measurements obtained by the predicate device (Beckman CO2 Reagent on the CX3®). No human experts are mentioned for establishing ground truth for the test set.

4. Adjudication method for the test set

Not applicable. The study involves quantitative measurements of CO2, not subjective interpretations requiring adjudication.

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 a submission for a chemical reagent, not an AI-powered diagnostic device.

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

Not applicable. This is a submission for a chemical reagent. Its performance is inherently "standalone" in generating a quantitative value, as it's not an algorithm that assists a human.

7. The type of ground truth used

Precision, Linearity, Sensitivity, Analytical Specificity: These studies use controlled materials with known or expected values as their reference. The "ground truth" is the established chemical and analytical properties of the reference materials.
Patient Comparison: The "ground truth" for comparison was the measurements obtained by the predicate device (Beckman CO2 Reagent on the CX3®).

8. The sample size for the training set

Not applicable. This is a submission for a chemical reagent, not an AI-powered device that requires a training set. The "development" would involve chemical formulation and validation rather than algorithm training.

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

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

Summary

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DEC 27 2004

510(k) SUMMARY K040975

1.0 Submitted By:

C.C. Allain, Ph.D. Chief Scientific Officer GenChem, Inc. 471 W. Lambert Road, Ste 107 Brea, CA 92821 Telephone: (714) 529-7125 FAX: (714) 529-3339

2.0 Date of Preparation: June 1, 2004

3.0 Regulatory Information:

3.1 Regulation section:
3.2 21 CFR § 862.1160, pH Rate Measurement, Carbon Dioxide
3.3 Clasification : Class II
3.4 Product Code: JFL
3.5 Panel: Clinical Chemistry (75)

4.0 Device Description:

The Device is a solution containing 0.6 mol/L sulfuric acid, nonreactive surfactants and other ingredients necessary for optimum system operation.

5.0 Substantial Equivalence Information:

a. Predicate Device Name: Beckman CO2 Reagent for the CX3.
b. Predicate K Number: K014034
c. Comparison with Predicate: Both Reagents are similar in design, function and chemical principle as well as ingredient composition and concentration.

Performance Characteristics: All studies were performed on the Beckman CX3 6.0 Synchron Analyzer

6.1 Precision/Reproducibility:
Three control sera were each assayed for total CO2 twice per day in triplicate using flow cell reagents, wash solutions and calibrators on a SYNCHRON CX3® System. Data were collected on ten different days over a thirty day period.

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Estimates of within run and total imprecision were calculated as described in NCCLS publication EP3-T.10

Precision of Total CO2 Recoveries (mmol/L)

Sample	n	mean	SD	%CV	SD	%CV
Serum 1	60	12.6	0.40	3.2	0.38	3.0
Serum 2	60	22.2	0.32	1.4	0.36	1.6
Serum 3	60	30.9	0.53	1.7	0.66	2.1

6.2 Linearity/assay reportable range:

Linearity was performed according to NCCLS Guideline EP6-A. Commercially available linearity standards ranging from 0 to 40 mmol/L were analyzed in triplicate on the Beckman CX3® and the results analyzed by the Least Squares method. The results gave a slope of 1.000 with an intercept of 0.15, a standard error of estimate of 0.41 and r2 = 1.000. Samples exceeding these limits should be diluted with normal saline and reanalyzed. Multiply the result by the appropriate dilution factor.

Usable Ranges
Instrument	Conventional Units	SI Units
CX3®	0.0 to 40.0 mmol/L	same

6.3 SENSITIVITY:

The sensitivity of this method is 5.0 mmol/L and was documented through the repetitive assay of a diluted serum control. The observed sensitivity limit, calculated as three standard deviations of a 21 replicate within run precision study, is 0.255 mg/dL and is below the claimed limit of 5.0 mg/dL.

6.4 Analytical Specificity:

Determined according to NCCLS EP7-A. Hemoglobin levels up to 500 mg/dL, Bilirubin levels up to 20 mg/dL, and Lipemia levels up to 1800 mg/dL were tested and did not show any adverse effect on a stock sample with a glucose level of 19 mmol/L. Stock solutions of the substance to be tested were prepared at 20x

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concentrations and 0.5 ml of this stock was placed in a 10 ml volumetric flask and made up to volume with the base pool. The control stock was prepared similarly but with water as the diluent. Sodium Heparin, Lithium Heparin, Ammonium Heparin, sodium fluoride and potassium oxalate are acceptable anticoagulants.

Patient Comparison

Serum and plasma specimens, collected from adult patients, were assayed for total CO2 on a SYNCHRON CX3® System using GenChem (Y) and Beckman®(X) flow cell reagents, wash solutions and calibrators. Results were compared by least squares linear regression and the following statistics were obtained.

VALUE	SERUM	PLASMA
Intercept	1.2	1.0
Slope	0.949	0.979
R² Value	0.953	0.987
N	80	80
Range (mmol/L)	9.5 – 29.1	9.6 – 30.0

Expected Values/ Reference Range: 7.0

The expected values for total CO2 are listed below. Use these ranges only as guides. Each laboratory should establish its own normal ranges.

	Normal Ranges
Specimens	Conventional Units	SI Units
Serum/Plasma	22-29 mmol/L	same

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 27 2004

C.C. Allain, Ph.D. Chief Scientific Officer GenChem, Inc. 471 W. Lambert Road, Suite 107 Brea. CA 92821

K040975 Trade/Device Name: GenChem CO2 Acid Reagent Regulation Number: 21 CFR 862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class II Product Code: JFL Dated: October 15, 2004 Received: October 15, 2004

Dear Dr. Allain:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,

Cornelia B. Parks

Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number: K040975

Device Name: GenChem CO2 Acid Reagent

Indications For Use:

Alberto

Office of In Vitro Diagno Device Evaluation and S

510(k) K040975

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Regulation Number and Section

§ 862.1160 Bicarbonate/carbon dioxide test system.

(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.