The Bayer Special Chemistry Controls are two separate levels of quality control material prepared from human serum with nonserum constituents added. All the analytes currently in the calibrator and control 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

AI/ML Overview

The provided text is a 510(k) summary for the Bayer ADVIA 1650 Special Chemistry Control. It primarily focuses on demonstrating substantial equivalence to a predicate device for the addition of two new analytes (Pancreatic Amylase and Lipase) to the control's labeling claims.

The document does not describe a study that proves the device meets acceptance criteria in the way this request asks. It's a regulatory submission for a quality control material, not a diagnostic or therapeutic device undergoing performance validation with a test set, ground truth established by experts, or MRMC studies.

Therefore, many of the requested sections cannot be filled as they are explicitly not present or applicable to this type of submission.

Here's a breakdown based on the information provided and what is missing/not applicable:

Acceptance Criteria and Reported Device Performance

The document does not detail specific acceptance criteria (e.g., accuracy, precision targets) for the new analytes themselves, nor does it present device performance data against such criteria in the format requested. The "performance" described is the establishment of assigned values for the new analytes within the control material, rather than the performance of the control material in detecting specific conditions.

Acceptance Criteria (Not Explicitly Stated for Performance)	Reported Device Performance (Implied)
Specific acceptance criteria for the performance of Pancreatic Amylase and Lipase as analytes within the quality control material are NOT explicitly stated in the provided text. The document focuses on demonstrating that the control material itself is substantially equivalent to a predicate device and that assigned values for these new analytes will be added to the labeling.	The document implies that assigned values for Pancreatic Amylase and Lipase have been established for the control material. The stated intention is "to add the assigned values to the labeling claims for: Pancreatic Amylase Lipase." This suggests that the values have been determined and meet internal quality standards for a control material.

Study Information (Applicability for this device is limited)

Given that this is a quality control material and not a diagnostic or therapeutic device, many of the requested study parameters are not relevant or described in the provided 510(k) summary. The submission is a demonstration of "substantial equivalence" for adding new analytes to an existing control material.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable/Not Provided: The document does not describe a "test set" in the context of clinical performance evaluation of a diagnostic device. It discusses controlling the precision and accuracy of chemistry test procedures, implying internal validation of the control material's stability and assigned values.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable/Not Provided: Ground truth in the context of clinical expert review is not relevant for a quality control material submission.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable/Not Provided: No adjudication method is described as there is no "test set" in this context.

4. 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/Not Provided: This type of study is entirely irrelevant for a chemistry quality control material. There are no "human readers" or "AI assistance" involved.

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

Not Applicable/Not Provided: This is not an algorithm-based device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Implicit for Training/Characterization, Not for a "Test Set": For a quality control material, the "ground truth" for the analytes (Pancreatic Amylase and Lipase) would be established through highly accurate and precise reference methods or certified reference materials, typically in a laboratory setting, to assign the target values for the control. The document states "assigned values," implying such a characterization was performed.

7. The sample size for the training set

Not Applicable/Not Provided: The concept of a "training set" in the machine learning sense is not applicable here. The control material itself is characterized, not "trained."

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

Not Applicable/Not Provided (but implied for value assignment): As mentioned in point 6, the "ground truth" (assigned values) for the control material's analytes would be established through laboratory characterization using validated reference methods.

Summary

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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:

Special Chemistry Control

Proprietary/Trade Name

Common Name: Classification Name:

Bayer ADVIA 1650 Special Chemistry Control Quality Control Material Enzyme Controls (assayed and unassayed)

Classification: Class I Regulation Number: 21 CFR 862.1660 Panel: Chemistry (75) Product Code: JJY Predicate Device: Bayer Special Chemistry Control Premarket Notification Number: K023840

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Device Description:

The Bayer Special Chemistry Controls are two separate levels of quality control material prepared from human serum with nonserum constituents added.

All the analytes currently in the calibrator and control 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 Controls are assayed control materials 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 Controls are identical in intended use, storage and handling, stability, source material (human serum), and instructions for use as the previously cleared Special Chemistry Controls. The only difference in these controls is the addition of the assigned values in the labeling of two new analytes: Pancreatic Amylase and Lipase.

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

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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 image of an eagle with three lines representing its wings and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

APR a 9 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K030801 Trade/Device Name: Special Chemistry Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I Product Code: JJY Dated: March 10, 2003 Received: March 13, 2003

Dear Mr. Holle:

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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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 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 1 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Special Chemistry Control

Indications for Use:

For in vitro diagnostic use in the control of 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	✓	OR	Over-The-Counter
Use
(Per 21 CFR 801.109)			(Optional Format)
1-2-96)

	Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	A030801

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.