The provided text describes a 510(k) submission for a Special Chemistry Calibrator and does not contain information about acceptance criteria or a study proving device performance in the context of AI, imaging, or statistical metrics like sensitivity, specificity, or AUC. The document focuses on the regulatory submission for an in vitro diagnostic device and its substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request to provide acceptance criteria or a study description as the necessary information is not present in the given text.

Here's why:

The device is a "Special Chemistry Calibrator," which is a material used to calibrate laboratory instruments. It is not an AI/ML device, an imaging device, or one that would typically have performance evaluated with metrics like those requested (e.g., sensitivity, specificity, AUC).
The document's purpose is a 510(k) summary, which establishes substantial equivalence to a predicate device based on intended use, material composition, and performance on a specific analytical system. It doesn't typically detail exhaustive performance studies with statistical thresholds for AI or imaging.
The "Substantial Equivalence" section explicitly states, "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 Calibrator." The only difference is adding assigned values for two new analytes. This suggests that extensive new performance studies (especially for AI or imaging) would not be required or detailed in this type of submission.

Summary

{0}------------------------------------------------

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:

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: Proprietary/Trade Name

Common Name: Classification Name: Classification: Regulation Number: Panel: Product Code:

Special Chemistry Calibrator Bayer ADVIA 1650 Special Chemistry Calibrator Calibrator Material Calibrator Class II 21 CFR 862.1150 Chemistry (75) JIX

Predicate Device:

Bayer Special Chemistry Calibrator Premarket Notification Number: K023840

{1}------------------------------------------------

Device Description:

The Bayer Special Chemistry Calibrator 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 Pancreatic Amylase Lipase

The intention of this submission is to add the assigned values to the labeling claims for: Pancreatic Amylase Lipase

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 analyzer.

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 two new analytes: Pancreatic Amylase and Lipase.

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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 0 2003

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

Re: K030804 Trade/Device Name: Special Chemistry Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: March 10, 2003 Received: March 13, 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 (QS) regulation (21 CFR Part 820).

{3}------------------------------------------------

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,

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

{4}------------------------------------------------

Page 1 of 1
-------------

510(k) Number (if known):	K030804
---------------------------	---------

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 1 Use

Over-The-Counter

(Per 21 CFR 801.109) 1-2-96)

(Optional Format

Jean Cooper

(Division Sign-Off) Son of Clinical Laboratory 5 10(k) Number __

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.