The Bayer Special Chemistry Calibrators are for one absolute value of calibrator material prepared in human serum with nonserum constituents added. All the analytes currently in the calibrator material are: Acid Phosphatase Lactate Lipase Direct TIBC. The intention of this submission is to add the assigned values to the labeling claims for: Direct TIBC. As with the predicate device, the calibrator materials are lyophilized and require reconstitution with 5.0 mL distilled water. These calibrators are only for use on the Bayer ADVIA 1650 Chemistry Analyzer.

AI/ML Overview

The provided text describes a submission for a Special Chemistry Calibrator from Bayer Healthcare LLC. It focuses on regulatory approval (510(k)) and states that the device is substantially equivalent to a previously cleared predicate device. The key difference in this submission is the addition of assigned values for "Direct TIBC" to the labeling claims.

However, the document does not contain the detailed acceptance criteria or a study proving the device meets those criteria, as typically requested in your prompt. The document is a regulatory submission for premarket notification, establishing substantial equivalence based on the device's similarity to an existing one, rather than presenting a detailed performance study with acceptance criteria.

Therefore, I cannot provide the requested information. The document explicitly states:

No acceptance criteria: The document does not define specific performance metrics or acceptance criteria for the "Direct TIBC" calibration.
No study proving acceptance criteria: Since no acceptance criteria are given, there is no study described that proves the device meets them. The basis for approval is substantial equivalence to a predicate device.
No sample sizes, data provenance, expert details, adjudication methods, MRMC studies, or standalone performance details: These are all elements of a detailed performance study, which is not present in this 510(k) summary. The nature of the submission focuses on demonstrating equivalence, not on extensive de novo performance testing against new criteria.
Type of ground truth, training set size, and ground truth establishment for the training set: These details are also absent as no new substantial performance study is being presented. The device is a calibrator, and its "ground truth" would be related to its assigned values and stability, which are stated to be similar to the predicate device.

The main points from the document pertinent to its "performance" (as understood in a regulatory context for this type of device) are:

Device Name: Special Chemistry Calibrator
Proprietary/Trade Name: Bayer ADVIA 1650 Special Chemistry Calibrator
Intended Use: Calibrators for in vitro diagnostic use to monitor the precision and accuracy of certain chemistry test procedures for the ADVIA 1650 Chemistry analyzer.
Key Change: Addition of assigned values to the labeling claims for "Direct TIBC".
Substantial Equivalence: The device is stated to be "identical in intended use, storage and handling, stability, source material (human serum), and instructions for use as the previously cleared Special Chemistry Calibrators." The only difference is the added analyte value for Direct TIBC.

Due to the nature of the provided text, which is a 510(k) summary focused on substantial equivalence rather than a detailed performance study, I cannot extract the specific information requested in your prompt regarding acceptance criteria and a proving study.

Summary

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DEC 1 6 2003

Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number is: K033380

Submitter's Name and Address

Bayer Healthcare LLC 511 Benedict Avenue Tarrytown, NY 10591 Establishment Registration Number: 2432235

Contact Person: Andres Holle Telephone: 914-524-3494 Fax: 914-524-2500 e-mail: andres.holle.b@bayer.com

Contract Manufacturer

Randox Laboratories 55 Diamond Road Crumlin, County Antrim, UK Establishment Registration: 8020890

Device Name:	Special Chemistry Calibrator
Proprietary/Trade Name	Bayer ADVIA 1650 SpecialChemistry Calibrator
Common Name:	Calibrator Material
Classification Name:	Calibrator
Classification:	Class II
Regulation Number:	21 CFR 862.1150
Panel:	Chemistry (75)
Product Code:	JIX
Predicate Device:	Bayer Special Chemistry CalibratorPremarket Notification Number: K030804

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Device Description:

The Bayer Special Chemistry Calibrators are for one absolute value of calibrator material prepared in human serum with nonserum constituents added.

All the analytes currently in the calibrator material are: Acid Phosphatase Lactate Lipase Direct TIBC

The intention of this submission is to add the assigned values to the labeling claims for: Direct TIBC

Intended Use:

The Special Chemistry Calibrators are calibrators for in vitro diagnostic use to monitor the precision and accuracy of certain chemistry test procedures for the ADVIA 1650 Chemistry analvzer.

Substantial Equivalence:

The Special Chemistry Calibrators are identical in intended use, storage and handling, stability, source material (human serum), and instructions for use as the previously cleared Special Chemistry Calibrators. The only difference in these calibrators is the addition of the assigned values in the labeling of one new analyte: Direct TIBC.

As with the predicate device, the calibrator materials are lyophilized and require reconstitution with 5.0 mL distilled water. These calibrators are only for use on the Bayer ADVIA 1650 Chemistry Analyzer.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures connected by flowing lines, representing the department's focus on health and human well-being. The logo is rendered in black and white.

DEC 1 6 2003

Food and Drug Administration 2098 Gaither Road

Public Health Service

Rockville MD 20850

Mr. Andres Holle Manager, Regulatory Affairs Bayer HealthCare LLC Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591

Re: K033380

Trade/Device Name: Special Chemistry Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: October 16, 2003 Received: October 23, 2003

Dear Mr. Holle:

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 (OS) 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 Butman

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

510(k) Number (if known):	K033380
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Device Name: Special Chemistry Calibrator

Indications for Use:

For in vitro diagnostic use in the calibration of the ADVIA 1650 Chemistry system for certain chemistry methods.

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

Concurrence of CDRH, Office of Device Evaluation
(ODE)

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

Carol C Benem for Jean Cooper, DVM

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033380

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.