The ACS:180 and ADVIA Centaur Insulin are sandwich, chemiluminescence immunoassay for the quantitative determination of Insulin in human serum for use on the automated analyzer marketed by Bayer Corporation. The ACS:180 and ADVIA Centaur Insulin Immunoassays can be used to aid in the diagnosis and treatment of diabetes mellitus and hypoglycemia.

Device Description

The ACS:180 and ADVIA Centaur Insulin Calibrator is a casein buffered solution containing potassium thiocyanate and sodium azide.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Bayer Diagnostics ACS:180 and ADVIA Centaur Insulin Calibrator:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical thresholds, but rather implied by the objective of demonstrating "substantial equivalence" to the predicate device (TOSOH Corporation AIA-PACK IRI Calibrator Set) based on accuracy and precision for control samples. The performance of the new calibrator is compared to the predicate device, with "% Recovery vs TOSOH" serving as a key metric for accuracy.

Metric	Acceptance Criteria (Implied for Substantial Equivalence)	ADVIA Centaur Performance	ACS:180 Performance
Accuracy (% Recovery vs TOSOH)	Recovery values close to 100% (indicating comparable mean values)	Level 1: 101.0% Level 2: 88.0% Level 3: 100.5%	Level 1: 97.5% Level 2: 89.9% Level 3: 99.4%
Precision (Within Run %CV)	Comparable to or better than predicate device	Level 1: 2.9% Level 2: 2.8% Level 3: 2.6%	Level 1: 4.8% Level 2: 3.9% Level 3: 3.1%
Precision (Total %CV)	Comparable to or better than predicate device	Level 1: 3.1% Level 2: 2.7% Level 3: 3.3%	Level 1: 8.1% Level 2: 7.6% Level 3: 5.9%

Note on Acceptance Criteria: The document does not specify exact thresholds (e.g., "within X% of the predicate device" or "CV must be less than Y%"). The FDA's substantial equivalence determination implies these values were deemed acceptable for the intended use in comparison to the predicate.

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

Sample Size for Test Set: The document refers to "commercial control dose data" and lists "Level 1," "Level 2," and "Level 3" for both the predicate and the new devices. However, the specific number of individual samples or replicates used to generate the "Mean," "Within Run %CV," and "Total %CV" for each level is not specified.
Data Provenance: The document does not explicitly state the country of origin for the data. The manufacturer is Bayer Diagnostics (US-based) and the predicate device manufacturer is TOSOH Corporation (Japan-based). It is implied the data was generated by Bayer Diagnostics. The study appears to be prospective in the sense that the data was generated specifically for this 510(k) submission to demonstrate equivalence.

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

This information is not applicable and not provided in the document. This study is about a calibrator for an immunoassay, which does not involve subjective interpretation or diagnosis by experts to establish a "ground truth" in the way a diagnostic imaging device might. The "ground truth" here is the established values of the control samples themselves and the performance metrics generated from repeated measurements.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers independently assess data and their discrepancies need to be resolved. This study focuses on objective quantitative measurements of a calibrator.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided. This is a study of an immunoassay calibrator, not an AI-powered diagnostic device, and thus does not involve human readers or AI assistance in this context.

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

This information is not applicable and not provided. This is a calibrator, not an algorithm or AI device. The "standalone performance" is essentially the device performance as reported in the table.

7. The Type of Ground Truth Used

The "ground truth" for this study is derived from the known concentrations/values of the commercial control samples used. The performance metrics (mean, CV, recovery) are calculated relative to these known values or in comparison to a legally marketed predicate device's performance. The reference method for standardization is WHO 66/304.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This is a calibrator, not a machine learning or AI device that requires a "training set." The device is calibrated, and its performance is tested using control samples.

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

This information is not applicable and not provided for the reasons stated above (not an AI/ML device).

Summary

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K021535

Bayer Diagnostics

ASC:180 and ADVIA Centaur Insulin Calibrator Section 2: Summary of Safety and Effectiveness

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

JUN 2 7 2002

1. Submitter Information

	Contact person:	Kenneth T. Edds Ph.D.
	Address:511 Benedict Ave.Tarrytown, NY 10591	Bayer Diagnostics Corporation
	Phone:FAX:e-mail:	(914) 524-2446(914) 524-2500ken.edds.b.@bayer.com
	Date Summary Prepared:	April 29, 2002
2.	Device Information
	Proprietary Name:	ADVIA Centaur and ACS:180 InsulinCalibrator
	Common Name:	Calibrator for immunoassay analyte
	Classification Name:Class:CFR:Product Code:	Calibrator §862.1150.Class II862.115075 JIT
3.	Predicate Device Information
	Name:	ST AIA-PACK IRI Calibrator Set
	Manufacturer:	TOSOH CorporationTOSOH Kyobashi Building3-2-4 Kyobashi, Chuo-ku, Tokyo 104-0031 Japan
	Japan	Phone: +81-(3)-3275-1221Fax: +81-(3)-3275-1214
	510(k) Number:	K903628

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4. Device Description

The ACS:180 and ADVIA Centaur Insulin Calibrator is a casein buffered solution containing potassium thiocyanate and sodium azide.

5. Statement of Intended Use

For use in calibrating the ADVIA Centaur and ACS:180 Insulin immunoassays on the automated analyzers marketed by Bayer Corporation.

6. Summary of Technological Characteristics

The ADVIA Centaur and ACS:180 Insulin Calibrators are similar to the TOSOH Corporation AIA-PACK IRI Calibrator Set (K903628) in the indications for use, and reference method for standardization, WHO 66/304. In the ACS:180 and ADVIA Centaur Insulin calibrator a buffer base is used to replace the human serum base used in the TOSOH Corporation AIA-PACK IRI Calibrator Set.

7. Accuracy and Precision

The commercial control dose data represented in this document was generated using the calibrators for each respective insulin immunoassay.

Substantial equivalence to the AIA-PACK IRI Calibrator Set is based on comparison of the control accuracy and precision of the ADVIA Centaur and ACS:180 to the predicate device.

System	Sample ID	Mean	Within Run%CV	Total%CV	% Recoveryvs TOSOH
AIA TOSOH	Level 1	14.63	2.7	3.6
AIA TOSOH	Level 2	48.71	2.1	2.9
AIA TOSOH	Level 3	121.27	2.1	3.0
ADVIA Centaur	Level 1	14.78	2.9	3.1	101.0
ADVIA Centaur	Level 2	42.85	2.8	2.7	88.0
ADVIA Centaur	Level 3	121.82	2.6	3.3	100.5
ACS:180	Level 1	14.26	4.8	8.1	97.5
ACS:180	Level 2	43.79	3.9	7.6	89.9
ACS:180	Level 3	120.58	3.1	5.9	99.4

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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JN 2 7 2002

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

Re: K021535

Trade/Device Name: Bayer Diagnostics ACS:180 and ADVIA Centaur Insulin Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: May 3, 2002 Received: May 10, 2002

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrb/dsmaldsmamain.html".

Sincerely yours.

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

510(k) Number (if known): __ K 0315 35

Device Name: Bayer Diagnostics ACS:180 and ADVIA Centaur Insulin Calibrator

Indications for Use:

The ACS:180 and ADVIA Centaur Insulin calibrators are used for calibrating the ACS:180 and ADVIA Centaur Insulin Immunoassays.

(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

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Dean Cooper

División Sian-Off) Division of Clinical Laborator 510(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.