All the analytes currently in the control material are: Acid Phosphatase Lactate Pancreatic Amylase Lipase Cholinesterase Direct TIBC The intention of this submission is to add the assigned values to the labeling claims for: Direct TIBC

AI/ML Overview

The provided text is a summary of a 510(k) premarket notification for a medical device: "Bayer ADVIA Chemistry Special Chemistry Control Quality Control Material." It is important to note that this document is for a quality control material, not a diagnostic device that directly analyzes patient samples. Therefore, the typical "acceptance criteria" and "study" framework for a diagnostic device (e.g., sensitivity, specificity, clinical outcome studies) does not directly apply in the same way.

The "study" here is essentially the demonstration of substantial equivalence to a legally marketed predicate device, with the addition of a new analyte, Direct TIBC, to the control material's labeling claims.

Here's an analysis of the provided information within the context of a quality control material:

1. Table of Acceptance Criteria and Reported Device Performance

For quality control materials, acceptance criteria typically revolve around the stability and accuracy of the assigned values for the analytes. The "performance" is the successful establishment of these assigned values and the demonstration that the material functions as intended for monitoring analytical systems.

Acceptance Criterion	Reported Device Performance
Intended Use: For in vitro diagnostic use to monitor precision and accuracy of certain chemistry test procedures for ADVIA Chemistry analyzers.	The device is identical in intended use to the previously cleared Special Chemistry Controls (K030801). It aids in monitoring analytical systems.
Stability:	Identical in storage and handling, and stability to the predicate device.
Source Material: Human serum with non-serum constituents.	Identical in source material (human serum) to the predicate device.
Required Reconstitution: Lyophilized, requires reconstitution with 5.0 mL distilled water.	Identical to the predicate device.
Compatibility: For use only on Bayer Chemistry Analyzers.	Identical to the predicate device.
New Analyte (Direct TIBC) Values: Assigned values for Direct TIBC.	The submission's intention is to add assigned values to the labeling claims for Direct TIBC. While the specific assigned values are not in this summary, the FDA's clearance implies these values were established appropriately.
Substantial Equivalence: Demonstrate equivalence to a predicate device (Bayer Special Chemistry Control, K030801).	The device is deemed substantially equivalent to the predicate device for all current analytes, with the only difference being the addition of Direct TIBC assigned values.

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

The concept of a "test set" in the context of clinical performance (like patient samples) is not directly applicable here. The "test" for this quality control material involves establishing the assigned values for the various analytes, particularly the newly added Direct TIBC.

Sample Size: Not explicitly stated as a "sample size" in relation to a patient cohort. For quality control materials, this usually refers to the number of lots or runs used to establish the target values and ranges. The document states "The intention of this submission is to add the assigned values to the labeling claims for: Direct TIBC." This implies that internal studies were conducted by Bayer to determine these assigned values experimentally.
Data Provenance: Not specified in the document. It's internal data generated by the manufacturer during the development and validation of the quality control material. Given the manufacturer's location, the data would likely originate from their facilities (e.g., Tarrytown, NY, or Randox Laboratories in the UK). This would be prospective data generation for the purpose of establishing the control material's characteristics.

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

This type of information (number of experts, their qualifications, and adjudication) is typically relevant for studies involving subjective interpretation of patient images or complex diagnostic results. It is not applicable to the establishment of assigned values for a chemistry quality control material.

The "ground truth" for a quality control material's assigned values is established through rigorous analytical testing using reference methods or highly characterized instruments, often in multiple laboratories.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

As explained above, an adjudication method in the sense of expert consensus for subjective interpretation is not applicable to this type of device and its "test set." The determination of assigned values is based on analytical measurements and statistical analysis.

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

This type of study is relevant for AI-powered diagnostic devices that assist human readers. This device is a quality control material for chemistry analyzers, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not applicable.

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

This refers to the performance of an AI algorithm without human involvement. Since this is a quality control material and not an AI algorithm, a standalone performance study in this context is not applicable.

7. The Type of Ground Truth Used

For a quality control material, the "ground truth" for the assigned values is established through:

Reference Methods: Often, the performance of the control material is assessed against highly accurate reference methods or primary calibrators.
Target Value Assignment: This typically involves running the control material on multiple analytical instruments (often of the same type for which the control is intended) over a period of time, using validated methods, and then statistically determining the mean and acceptable ranges for each analyte. This is an analytical ground truth.
In this specific case, the "ground truth" for the added Direct TIBC would have been established by performing assays for Direct TIBC using the designated Bayer Chemistry Analyzers and statistically determining the target values and ranges for the control material levels.

8. The Sample Size for the Training Set

The concept of a "training set" is primarily associated with machine learning or AI algorithms. As this is a quality control material, a "training set" in that sense is not applicable.

Instead, the "development" or "characterization" of the control material involves thorough analytical testing. The "sample size" here would refer to the number of vials, lots, or analytical runs used to establish the assigned values. This information is not provided in the summary but would be part of the manufacturer's internal validation data.

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

Since there is no "training set" in the AI sense for this device, how its "ground truth" (assigned values) was established is described in point 7. It involves analytical testing and characterization of the control material using accepted laboratory practices and statistical methods to determine the target values and acceptable ranges for each analyte on the intended analytical platforms.

Summary

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

DEC 1 9 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: K033379

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

Special Chemistry Control Device Name: Bayer ADVIA Chemistry Special Proprietary/Trade Name Chemistry Control Quality Control Material Common Name: Classification Name: Enzyme Controls (assayed and unassayed) Class I

Classification: 21 CFR 862.1660 Regulation Number: Chemistry (75) Panel: JJY Product Code: Predicate Device: Bayer Special Chemistry Control Premarket Notification Number: K030801

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

Device Description:

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

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 Chemistry analyzers.

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 a new analyte: Direct TIBC.

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 Chemistry Analyzers.

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

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 image of three birds in flight, depicted with thick, black lines. The birds are stacked vertically, with the largest bird at the top and the smallest at the bottom, creating a sense of upward movement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 9 2003

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

K033379 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: October 16, 2003 Received: October 22, 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. Iisting 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}------------------------------------------------

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 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

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

Page 1 of 1 0333 510(k) Number (if known):

Device Name: Special Chemistry Control

Indications for Use:

For in vitro diagnostic use in the control of ADVIA Chemistry systems 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

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

Over-The-Counter

(Optional Format

Carol C Benson for Jean Cooper, DV
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033379

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.