The CO2 Calibrator/Diluent is intended for in vitro diagnostic use to calibrate the enzymatic determination of CO2 on various Bayer diagnostic instruments. To calibrate Technicon RA, opeRA, and ADVIA IMS systems, this product is used in conjunction with Bayer Chemistry Calibrator (Prod. No. T03-1291-62). To calibrate ADVIA Chemistry systems, this product is used as a stand-alone product.

Device Description

The CO2 Calibrator/Diluent is an aqueous liquid solution containing bicarbonate at a defined concentration.

AI/ML Overview

The provided text is a 510(k) Summary for the Bayer Healthcare CO2 Calibrator/Diluent, which is a diagnostic device used to calibrate CO2 measurements. The nature of this device means that the "acceptance criteria" and "study" described are focused on its performance as a calibrator, primarily its stability and similarity to a predicate device, rather than a clinical study evaluating diagnostic accuracy in patients.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" or a direct study comparing the device against such criteria in the way one might expect for a diagnostic or imaging algorithm. Instead, it focuses on demonstrating that the device's performance is "similar to other products in commercial distribution intended for similar use" and that its stability meets Bayer's internal procedures.

Acceptance Criterion (Implied)	Reported Device Performance
Stability of CO2 Calibrator/Diluent value	Validated according to Bayer procedures based on results of three separate lots. Stable at 2-8°C until expiration date. Stable for 2 days when opened, reconstituted, stoppered, protected from light, and stored at 2-8°C (similar to predicate's 30-day post-reconstitution stability, but for a different format).
Performance vs. Predicate Device	"The performance of the calibrator is similar to other products in commercial distribution intended for similar use." (Comparison to Roche Diagnostics Corp. Calibrator for automated systems, K990460).
Intended Use	Meets the specified intended use: "to calibrate the enzymatic determination of CO2 on various Bayer diagnostic instruments."
Format	Aqueous liquid solution containing bicarbonate at a defined concentration (differs from predicate's lyophilized pooled human serum).
Level	Single level (matches predicate).

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

Sample Size (Test Set): The stability validation was based on "three separate lots of calibrator material." This refers to manufacturing lots, not patient samples or a traditional 'test set' for diagnostic accuracy.
Data Provenance: The data comes from internal validation procedures conducted by Bayer Healthcare Diagnostics Division. No mention of geographical origin (country) or retrospective/prospective nature other than it being an internal validation of product lots.

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

N/A. This type of device (a calibrator) does not involve expert interpretation or ground truth establishment in the manner of diagnostic image analysis or clinical data. Its "truth" is its certified concentration and stability, which would be determined through analytical chemistry methods and quality control, not expert consensus.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 are used for reconciling differences in expert opinions, which is not applicable to a calibrator device's performance evaluation.

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

No. An MRMC study is relevant for evaluating human reader performance with medical images or clinical data, often with and without AI assistance. This calibrator device does not involve human readers interpreting clinical cases, nor does it involve AI.

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

N/A. This device is a chemical calibrator, not an algorithm. Its performance is inherent to its chemical composition and manufacturing quality.

7. The Type of Ground Truth Used

The "ground truth" for this device would be the analytically verified concentration of bicarbonate and its stability over time and under specified conditions. This is established through accredited laboratory methods and quality control, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

N/A. This device is a calibrator, not an AI algorithm that requires a "training set."

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

N/A. As there is no training set, this question is not applicable.

Summary

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JAN - 8 2004

Assigned 510(k) number: Ko3 3643

Bayer Healthcare CO2 Calibrator/Diluent Summary of Safety and Effectiveness

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

1. Submitter Information

Contact person:

Kenneth T. Edds Ph.D.

Address: Bayer Healthcare Diagnostics Division 511 Benedict Ave. Tarrytown, NY 10591

Phone:	(914) 524-2446
FAX:	(914) 524-2500
e-mail:	ken.edds.b.@bayer.com

Date Summary Prepared:

November 17, 2003

2. Device Information

Proprietary Name: Common Name:

Classification Name: Class: CFR: Product Code:

CO2 Calibrator/Diluent Calibrator

Calibrator Class II 862.1150 75 JITT

Predicate Device Information 3.

Name:

Manufacturer:

Calibrator for automated systems

Roche Diagnostics Corp. 9115 Hague Rd. Indianapolis, IN 46250

510(k) Number:

K990460

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Device Description 4.

The CO2 Calibrator/Diluent is an aqueous liquid solution containing bicarbonate at a defined concentration.

క. Statement of Intended Use

Product Performance 6.

The stability of the CO2 Calibrator/Diluent value has been validated according to Bayer procedures and is based on the results of three separate lots of calibrator material. The performance of the calibrator is similar to other products in commercial distribution intended for similar use.

Roche Calibrator for Automatic CO2 Calibrator/Diluent Characteristic System The CO2 Calibrator/Diluent is intended for For use as a calibrator of clinical Intended use chemistry assays for automated in vitro diagnostic use to calibrate the analytical procedures. enzymatic determination of CO2 on various Bayer diagnostic instruments. To calibrate Technicon RA, opeRA, and ADVIA IMS systems, this product is used in conjunction with Bayer Chemistry Calibrator (Prod. No. T03-1291-62). To calibrate ADVIA Chemistry systems, this product is used as a stand-alone product. Lyophilized pooled human Liquid - aqueous solution Format serum with constituents added as required to obtain desired component levels. Stable at 2-8ºC until Stable at 2-8 ℃ until last day of the . Stability . month (expiration date) printed on label. expiration date. Stable for thirty (30) days when properly Stable 2 days when . . capped once the diluent vial is opened reconstituted, stoppered, protected from light and and stored at 2-8°C. stored at 2-8ºC, with exception noted in labeling. Single level Single level Level

7. Product Characteristics

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Bayer SETpoint CO2 calibrator/Diluent	Roche Calibrator for Automated Systems
Bicarbonate	Bicarbonate
	ALBUMIN
	BILIRUBIN, DIRECT
	BILIRUBIN, TOTAL
	CALCIUM
	CHOLESTEROL
	CREATININE
	GLUCOSE
	IRON
	MAGNESIUM
	PHOSPHORUS. INORGANIC
	TOTAL PROTEIN
	TRIGLYCERIDES
	UREA NITROGEN
	URIC ACID
	SODIUM
	POTASSIUM
	CHLORIDE
	LACTATE
	PHOSPHOLIPIDS
	SALICYLATE
	UNSATURATED IRON-BINDING CAPACITY
	ACID PHOSPHATASE
	ALKALINE PHOSPHATASE
	ALANINE AMINOTRANSFERASE
	CHOLINESTERASE
	CREATINE KINASE
	GAMMA-G:UTAMYLTRANSFERase
	GLUTAMATE DEHYDROGENASE
	ALPHA-HYDROXYBUTRATE DEHYDROGENASE
	LACTATE DEHYDROGENASE
	LIPASE
	UIBC
	LDI

Constituent Analytes

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN - 8 2004

Kenneth T. Edds, Ph.D. Regulatory Affairs Bayer HealthCare LLC Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591-5097

K033643 Re:

Trade/Device Name: Calibrator/diluent for CO2 Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: November 19, 2003 Received: November 20, 2003

Dear Dr. Edds:

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 for use sunce in the encreases 776 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 r ou may, dicrorore, mains of the Act include requirements for annual registration, listing of general of the profice, 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 it may or bund in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in Tear announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that + DT Has Intactions and regulations administered by other Federal agencies. You must or un+ x 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). Other general information on your responsibilities under the Act may be obtained 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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

KO33643 510(k) Number (if known):

Device Name: Calibrator/diluent for CO2

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Optional Format 1-2-

(Per 21 CFR 801.109) 96)

Nleets L

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033643

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.