Bayer SETpoint Calibrator is intended for in vitro diagnostic use to calibrate the following systems: Technicon RA and opeRA Chemistry Systems, Technicon RA-100, Technicon DAX, ADVIA 1650/ADVIA 2400 Chemistry systems, and ADVIA IMS Chemistry systems.

Device Description

The SETpoint Chemistry Calibrator is a bovine serum based solution containing various nonhuman constituents at defined concentrations.

AI/ML Overview

The provided text describes the Bayer Healthcare SETpoint Chemistry Calibrator. It is a calibrator for multiple analytes intended for in vitro diagnostic use to calibrate various Technicon and ADVIA Chemistry systems.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define "acceptance criteria" in a quantitative manner (e.g., specific thresholds for performance metrics). Instead, it states that the device's performance is "similar to other products in commercial distribution intended for similar use" and validates stability according to Bayer procedures. The primary performance characteristic discussed is stability.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Bayer SETpoint Calibrator)
Intended Use	Calibrate specified chemistry systems (Technicon RA, opeRA, RA-100, DAX, ADVIA 1650/2400, ADVIA IMS Chemistry systems)	Intended for in vitro diagnostic use to calibrate the listed systems. (Matches intended use)
Stability (Unreconstituted)	Stable at 2-8°C until expiration date printed on label.	Stable at 2-8°C until last day of the month (expiration date) printed on label. (Meets implied criteria)
Stability (Reconstituted)	Stable for a specified period when refrigerated at 2-8°C and protected from light.	Stable 48 hours when reconstituted according to directions when refrigerated at 2-8°C and protected from light, with the exception of total and direct bilirubin, which are stable for eight hours. (Meets implied criteria, with specific exceptions noted)
Calibrator Format	Lyophilized solution with appropriate constituents	Lyophilized bovine serum base to which appropriate nonhuman constituents have been added to achieve specific concentrations. (Consistent with calibrator format)
Levels	Single level calibrator	Single Level (Consistent with predicate)

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

The document states, "The stability of the SETpoint calibrator values has been validated according to Bayer procedures and is based on the results of three separate lots of calibrator material."

Sample Size for Test Set: Three separate lots of calibrator material.
Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by Bayer Healthcare Diagnostics Division. The data is prospective, as it involves the testing of the newly developed lots.

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

This type of information is typically not applicable to calibrator performance studies. The "ground truth" for a calibrator's performance lies in its ability to consistently produce accurate and stable values for the analytes it is designed to measure. This is assessed through analytical methods and comparisons to established reference standards, not through consensus of human experts.

4. Adjudication Method for the Test Set

Not applicable. Statistical or analytical methods are used to determine stability and performance, not human 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 calibrator device, not an AI-powered diagnostic tool that involves human readers interpreting cases.

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

This information is not directly applicable in the terms of an "algorithm only" study, as this is a physical calibrator product. However, the stability validation of the calibrator itself can be considered a standalone performance assessment. The document states: "The stability of the SETpoint calibrator values has been validated according to Bayer procedures..." This indicates that the performance of the calibrator material itself was evaluated independently to ensure it met internal specifications for stability.

7. The Type of Ground Truth Used

The ground truth for the performance of a chemical calibrator is established by:

Reference Standards: The manufacturer uses highly accurate reference methods and/or certified reference materials to assign target values to the analytes within the calibrator.
Analytical Methods: The stability and accuracy of the calibrator's assigned values are verified through a series of analytical tests over time and under various conditions to ensure they remain within acceptable specifications.

In this document, the "ground truth" for stability is established by Bayer's internal procedures and validated against those procedures, which would involve comparison to expected values or reference standards for the analytes.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for a calibrator happens during its manufacturing process to ensure proper formulation and assigned values, rather than through data input.

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

Not applicable, as there is no training set in the context of an AI algorithm. The quality and "ground truth" of a calibrator are established through manufacturing, quality control, and testing against recognized analytical standards, as mentioned in point 7.

Summary

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JAN 3 1 2003

Image /page/0/Picture/1 description: The image shows the Bayer company logo. The word "Bayer" is written in a bold, sans-serif font on the left side of the image. To the right of the word is a circle with the word "Bayer" written vertically inside of it. The letters are stacked on top of each other, with the "A" in the middle.

Assigned 510(k) number: 13030109

Bayer Healthcare SETpoint Chemistry Calibrator 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: FAX: e-mail: (914) 524-2446 (914) 524-2500 ken.edds.b.@bayer.com

Date Summary Prepared:

January 15, 2003

2. Device Information

Proprietary Name: Common Name:

Classification Name:

Product Code:

Class:

CFR:

SETpoint Chemistry Calibrator Calibrator for multiple analytes

Calibrator §862.1150. Class II 862.1150 75 JIX

3. Predicate Device Information

Name:

Calibrator for automated systems

Roche Diagnostics Corp.

Indianapolis, IN 46250

510(k) Number:

Manufacturer:

K990460

9115 Hague Rd.

Business Group Diagnostics

Baver Corporation 511 Benedict Avenue
Tarrytown, NY 10591-5097 Phone: 914 631-8000 Fax: 914 524-2132 http://www.bayerdiag.com

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4. Device Description

The SETpoint Chemistry Calibrator is a bovine serum based solution containing various nonhuman constituents at defined concentrations.

5. Statement of Intended Use

6. Product Performance

The stability of the SETpoint calibrator values 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.

Characteristic	Bayer SETpoint Calibrator	Roche Calibrator forAutomated Systems
Intended Use	Bayer SETpoint Calibrator isintended for in vitro diagnosticuse to calibrate the followingsystems: Technicon RA andopeRA Chemistry Systems,Technicon RA-100, TechniconDAX, ADVIA 1650/ADVIA2400 Chemistry systems, andADVIA IMS Chemistry systems.	For use as a calibrator of clinicalchemistry assays for automatedanalytical procedures.
Format	Lyophilized bovine serum base towhich appropriate nonhumanconstituents have been added toachieve specific concentrations.	Lyophilized pooled human serumwith constituents added asrequired to obtain desiredcomponent levels.
Stability	Stable at 2-8°C until last dayof the month (expirationdate) printed on label. Stable 48 hours whenreconstituted according todirections when refrigeratedat 2-8°C and protected fromlight with the exception oftotal and direct bilirubin,which are stable for eighthours.	Stable at 2-8°C untilexpiration date. Stable 2 days whenreconstituted, stoppered,protected from light andstored at 2-8°C, withexceptions noted in labeling.
Levels	Single Level	Single Level

7. Product Characteristics

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Constituent Analytes
Bayer SETpoint(New Device)	Roche Calibrator for Automated Systems (C.f.a.s)(Predicate Device)
ALBUMIN	ALBUMIN
BILIRUBIN, DIRECT	BILIRUBIN, DIRECT
BILIRUBIN, TOTAL	BILIRUBIN, TOTAL
CALCIUM	CALCIUM
CHOLESTEROL	CHOLESTEROL
CREATININE	CREATININE
GLUCOSE	GLUCOSE
IRON	IRON
MAGNESIUM	MAGNESIUM
PHOSPHORUS, INORGANIC	PHOSPHORUS, INORGANIC
TOTAL PROTEIN	TOTAL PROTEIN
TRIGLYCERIDES	TRIGLYCERIDES
UREA NITROGEN	UREA NITROGEN
URIC ACID	URIC ACID
SODIUM	SODIUM
POTASSIUM	POTASSIUM
CHLORIDE	CHLORIDE
	LACTATE
	PHOSPHOLIPIDS
	SALICYLATE
	UNSATURATED IRON-BINDING CAPACITY
	ACID PHOSPHATASE
	ALKALINE PHOSPHATASE
	ALANINE AMINOTRANSFERASE
	ALPHA-AMYLASE
	PANCREATIC ALPHA-AMYLASE
	ASPARTATE AMINOTRANSFERASE
	CHOLINESTERASE
	CREATINE KINASE
	GAMMA-GLUTAMYLTRANSERASE
	GLUTAMATE DEHYDROGENASE
	ALPHA-HYDROXYBUTYRATE DEHYDROGENASE
	LACTATE DEHYDROGENASE
	LIPASE
	BICARBONATE
	UIBC
	LDI

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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 or bird-like figure with three curved lines representing its body and wings. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 3 1 2003

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

Re: K030169

Trade/Device Name: SETpoint Chemistry Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: January 16, 2003 Received: January 17, 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 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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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,

Steven Putman

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

K030169 510(k) Number (if known):

Device Name: SETpoint Chemistry Calibrator

Indications for Use:

. . .

・

1000

Jean Cooper

Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number _

(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 1-2-96)

(Per 21 CFR 801.109)

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.