The ACS:180 and ADVIA Centaur C-peptide are sandwich, chemiluminescence immunoassay for the quantitative determination of C-peptide in human serum for use on the automated analyzer marketed by Bayer Corporation. The ACS:180 and ADVIA Centaur C-peptide Immunoassays can be used to aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.

Device Description

The ACS:180 and ADVIA Centaur C-peptide Calibrator is a citric acid buffered saline with casein and preservatives (micro-protect).

AI/ML Overview

The provided text describes the acceptance criteria and study proving the device meets those criteria. Here's a breakdown by the requested points:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" with numerical targets for the ACS:180 and ADVIA Centaur C-peptide Calibrator. However, it indicates that substantial equivalence to the predicate device (TOSOH Corporation AIA-PACK C-Peptide Calibrator Set) is based on the comparison of control accuracy and precision. The table below presents the reported performance values that were used for this comparison.

System	Performance Metric	Predicate Device (AIA TOSOH)	Test Device (ACS:180)	Test Device (ADVIA Centaur)
Accuracy	% Recovery vs TOSOH	N/A	Level 1: 95.3%	Level 1: 83.6%
			Level 2: 99.8%	Level 2: 93.3%
			Level 3: NA	Level 3: NA
Precision	Within Run %CV (Level 1)	2.8%	4.3%	3.7%
	Within Run %CV (Level 2)	2.0%	3.2%	4.0%
	Within Run %CV (Level 3)	N/A	3.6%	4.1%
	Total %CV (Level 1)	5.7%	9.8%	6.1%
	Total %CV (Level 2)	5.8%	6.1%	5.1%
	Total %CV (Level 3)	N/A	7.6%	6.2%

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

The document states: "The commercial control dose data represented in this document was generated using the calibrators for each respective C-peptide immunoassay."

Sample Size for Test Set: Not explicitly stated. The data is presented for "Level 1," "Level 2," and "Level 3" control samples for each system, but the number of runs or individual samples contributing to the mean, within-run %CV, and total %CV is not specified.
Data Provenance: Not specified regarding country of origin or whether it was retrospective or prospective. It is implied to be internal testing by Bayer Diagnostics as part of the 510(k) submission.

3. 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)

This study involves a calibrator for an immunoassay, not a diagnostic imaging device that typically requires expert interpretation for ground truth. Therefore, the concept of "experts" establishing ground truth in this context is not applicable. The reference method for standardization is stated as WHO 84/510, which implies an established international standard for C-peptide quantification.

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

Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations (e.g., medical image reading). This is a quantitative measurement, and therefore, an adjudication method in that sense is not applicable. The ground truth for the assay values is established by the WHO 84/510 standard.

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

No, an MRMC comparative effectiveness study was not done. This study is for a medical device calibrator, not an AI-assisted diagnostic tool that would involve human readers.

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

This is a calibrator for an immunoassay, a chemical analysis and not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of an algorithm is not applicable. The device's performance is measured directly through its ability to calibrate the immunoassay accurately and precisely.

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

The ground truth for standardization of the C-peptide calibrator is the WHO 84/510 reference method. This is an internationally recognized standard for C-peptide quantification, ensuring consistency across different assays.

8. The sample size for the training set

This is a calibrator device, not a machine learning algorithm. Therefore, there is no "training set" in the conventional sense. The device is manufactured according to established chemical and analytical principles.

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

As there is no training set for an algorithm, this question is not applicable. The performance is assessed against the predicate device and the WHO 84/510 standard.

Summary

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Bayer Diagnostics ASC:180 and ADVIA Centaur C-peptide Calibrator Section 2: Summary of Safety and Effectiveness

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

1. Submitter Information

Contact person:	Kenneth T. Edds Ph.D.
Address:	Bayer Diagnostics Corporation511 Benedict Ave.Tarrytown, NY 10591
Phone:	(914) 524-2446
FAX:	(914) 524-2500
e-mail:	ken.edds.b@bayer.com
Date Summary Prepared:	April 29, 2002
2. Device Information
Proprietary Name:	ADVIA Centaur and ACS:180 C-peptideCalibrator
Common Name:	Calibrator for immunoassay analyte
Classification Name:	Calibrator §862.1150.
Class:	Class II
CFR:	862.1150
Product Code:	75 JIT
3. Predicate Device Information
Name:	AIA-PACK C-Peptide Calibrator Set
Manufacturer:	TOSOH CorporationTOSOH Kyobashi Building3-2-4 Kyobashi, Chuo-ku, Tokyo 104-0031
Japan	Phone: +81-(3)-3275-1221Fax: +81-(3)-3275-1214

510(k) Number:

K951848

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4. Device Description

The ACS:180 and ADVIA Centaur C-peptide Calibrator is a citric acid buffered saline with casein and preservatives (micro-protect).

5. Statement of Intended Use

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

6. Summary of Technological Characteristics

The ADVIA Centaur and ACS:180 C-peptide Calibrators are similar to the TOSOH Corporation AIA-PACK C-Peptide Calibrator Set (K971998) in the indications for use, and reference method for standardization, WHO 84/510. In the ACS:180 and ADVIA Centaur Cpeptide calibrator a buffer base is used to replace the protein matrix used in the TOSOH Corporation AIA-PACK C-Peptide Calibrator Set.

7. Accuracy and Precision

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

Substantial equivalence to the AIA-PACK C-Peptide 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	1.71	2.8	5.7
	Level 2	5.23	2.0	5.8
ACS:180	Level 1	1.63	4.3	9.8	95.3
	Level 2	5.22	3.2	6.1	99.8
	Level 3	11.72	3.6	7.6	NA
ADVIA Centaur	Level 1	1.43	3.7	6.1	83.6
	Level 2	4.88	4.0	5.1	93.3
	Level 3	10.60	4.1	6.2	NA

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle with three heads in profile, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 7 2002

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

Re: K021532

Trade/Device Name: Bayer Diagnostics ACS:180 and ADVIA Centaur C-peptide 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. 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 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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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 1 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 Butman

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

510(k) Number (if known):

Device Name: Bayer Diagnostics ACS:180 and ADVIA Centaur C-peptide Calibrator

Indications for Use:

The ACS:180 and ADVIA Centaur C-peptide calibrators are used for calibrating the ACS:180 and ADVIA Centaur C-peptide Immunoassays.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Clinical Laboratory Devic 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.