The Elecsys® C-Peptide CalSet is a lyophilized product consisting of synthetic human C-Peptide in a buffered horse serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

AI/ML Overview

This is a 510(k) premarket notification for the Elecsys® C-Peptide CalSet, a calibrator used with an immunoassay system. As such, the concept of "device performance" in terms of clinical accuracy, sensitivity, or specificity as typically understood for diagnostic devices is not directly applicable. Instead, the performance relates to its function as a calibrator, specifically its value assignment and stability.

Here's an analysis of the provided text in relation to your request:

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

The document does not explicitly state quantitative acceptance criteria or detailed reported performance data for the Elecsys® C-Peptide CalSet beyond a general statement that it was "evaluated for value assignment and stability." For calibrators, acceptance criteria typically involve demonstrating that the assigned values are accurate and that the calibrator remains stable over its claimed shelf life and in-use period, ensuring reliable calibration of the assay.

Acceptance Criteria (Implied for Calibrators)	Reported Device Performance (Summary from Document)
Accurate value assignment	The Elecsys® C-Peptide CalSet was evaluated for value assignment.
Stability over claimed shelf life	The Elecsys® C-Peptide CalSet was evaluated for stability.
	Unopened: Store at 2-8°C until expiration date.
	Reconstituted: -20°C for 1 month (freeze only once).
	Reconstituted: On the analyzers, use only once.

Note: The document only provides a summary that these evaluations were performed, not the specific quantitative results or defined acceptance limits. This is common in a 510(k) summary, where detailed study reports are typically submitted separately.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the value assignment or stability testing, nor does it detail the data provenance (e.g., country of origin, retrospective/prospective). For calibrator studies, the "sample size" would refer to the number of lots of calibrator tested, the number of measurements taken, and potentially the number of instruments used in the evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to a calibrator. Ground truth for a calibrator's value assignment would typically be established through a reference measurement procedure and/or comparison to a higher-order reference material, not by expert consensus in the same way clinical ground truth is established for diagnostic devices evaluating patient conditions.

4. Adjudication method for the test set

Not applicable to a calibrator's value assignment or stability testing. These are analytical performance studies.

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

Not applicable. This device is a calibrator for an immunoassay system, not an AI-powered diagnostic device involving human readers or interpretation of clinical cases.

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

This concept is not directly applicable to a calibrator. The "performance" of a calibrator is inherent to its physical and chemical properties and how it functions within the immunoassay system to assign values. There isn't an "algorithm-only" performance in the sense of a standalone diagnostic algorithm.

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

For calibrators, the "ground truth" for value assignment is typically established through:

Reference measurement procedures: Highly accurate and precise analytical methods.
Reference materials: Certified reference materials (CRMs) with known analyte concentrations traceable to international standards.
Gravimetric or volumetric preparation: For primary calibrators, the concentration might be known by precise preparation.

The document does not specify the exact method used to establish the "ground truth" for the Elecsys® C-Peptide CalSet's value assignment, but it would align with the principles above.

8. The sample size for the training set

Not applicable. This device is a calibrator, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set for a calibrator device.

Summary

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

K033873

FEB 1 3 2004

く、

510(k) Summary
Introduction	According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence.
Submittername, address,contact	Roche Diagnostics Corporation9115 Hague RoadIndianapolis, IN 46250317-521-3723Contact Person: Theresa M. AmbroseDate Prepared: December 12, 2003
Device Name	Proprietary name: Elecsys® C-Peptide CalSetCommon name: CalibratorClassification name: Calibrator, secondary
Predicatedevice	The Elecsys® C-Peptide CalSet is substantially equivalent to the currentlymarketed Elecsys® LH CalSet II (K031299).
DeviceDescription	The Elecsys® C-Peptide CalSet is a lyophilized product consisting ofsynthetic human C-Peptide in a buffered horse serum matrix. Duringmanufacture, the analyte is spiked into the matrix at the desired concentrationlevels.
Intended use	The Elecsys® C-Peptide CalSet is used to calibrate the quantitative ElecsysC-Peptide assay on the Elecsys immunoassay systems.

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

510(k) summary, continued

い

Comparison topredicate	The Elecsys® C-Peptide CalSet is substantially equivalent to the currentlymarketed Elecsys® LH CalSet II (K031299). The below tables compare
device	Elecsys® C-Peptide CalSet with the predicate device, Elecsys® LH CalSet II
Similarities

Characteristic	Elecsys® C-PeptideCalSet	Predicate deviceElecsys® LH CalSet II
Intended Use	For calibrating thequantitative Elecsys C-Peptide assay on theElecsys immunoassaysystems.	For calibrating thequantitative Elecsys LHassay on the Elecsysimmunoassay systems.
Levels	Two	Same
Format	Lyophilized	Same
Handling	Add exactly 1.0 mLdistilled water andallow to stand closedfor 15 minutes toreconsititute. Mixcarefully, avoiding theformation of foam.	Same

Differences

Characteristic	Elecsys® C-PeptideCalSet	Predicate deviceElecsys® LH CalSet II
Matrix	Equine serum withadded synthetic humanC-peptide	Human serum withadded human LH
Stability	Unopened:• Store at 2-8°C untilexpiration dateReconstituted:• -20°C : 1 month(freeze only once)• On the analyzers: useonly once	Unopened:• Store at 2-8°C untilexpiration dateReconstituted:• -20°C : 3 months(freeze only once)• On the analyzers: useonly once

Performance Characteristics

The Elecsys® C-Peptide CalSet was evaluated for value assignment and stability.

{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 stylized eagle with three lines representing its wings and body. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 3 2004

Theresa M. Ambrose, Ph.D. Regulatory Principal Centralized Diagnostics Regulatory Submissions Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

Re: K033873

Trade/Device Name: Elecsys® C-Peptide CalSet Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: December 12, 2003 Received: December 15, 2003

Dear Dr. Ambrose:

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,

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

Indications for Use Statement

510(k) Number (if known): N/A

Device Name: Elecsys® C-Peptide CalSet

Indications For Use:

The Elecsys® C-Peptide CalSet is used for calibrating the quantitative C-Peptide assay on the Elecsys immunoassay systems.

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _

(Optional Format 1-2-96)

Alberto Sati'

Revision Sign-Off

Office of In Vitro Diagnostic Device _valuation and Safety

10(k) K 033873

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.