The Elecsys DHEA-S CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys DHEA-S reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Device Description

The Elecsys DHEA-S CalCheck 5 is a lyophilized product consisting of DHEA-S in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

AI/ML Overview

This submission describes Elecsys DHEA-S CalCheck 5, a lyophilized product containing DHEA-S in a human serum matrix, intended for calibration verification and assay range verification of the Elecsys DHEA-S reagent.

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

The provided text does not explicitly state quantitative acceptance criteria for the Elecsys DHEA-S CalCheck 5. However, it indicates that the device was evaluated for "value assignment and stability." The comparison table with the predicate device, Elecsys C-Peptide CalCheck 5, highlights similarities in intended use, levels (five), format (lyophilized), handling, and stability (unopened and reconstituted). The primary difference is the analyte (DHEA-S vs. C-Peptide) and the matrix (human serum vs. equine serum).

Without specific numerical performance metrics, concrete acceptance criteria cannot be listed. However, based on the context of a 510(k) submission, the implicit acceptance criteria would be that the device performs equivalently to the predicate device for its intended use, particularly regarding its ability to accurately verify calibration and assay ranges.

Acceptance Criteria (Implied)	Reported Device Performance
Effective for calibration verification of Elecsys DHEA-S reagent.	Evaluated for value assignment.
Effective for verification of assay range of Elecsys DHEA-S reagent.	Evaluated for value assignment.
Stable for specified storage conditions (unopened and reconstituted).	Evaluated for stability (unopened: 2-8°C until expiration; reconstituted: 20-25°C for 4 hours).
Comparable performance to predicate device for general control functions.	Intended use, number of levels, format, handling, and stability are stated as "Same" or very similar to the predicate.

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

The document does not provide details on the sample size used for the test set, the country of origin of the data, or whether the study was retrospective or prospective. It only states that the device was "evaluated for value assignment and stability."

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 information is not provided in the document. For a product like a calibration verification control, ground truth would typically relate to the assigned target values for the analytes, which are established through rigorous analytical methods and reference materials, not typically through expert consensus in the conventional sense of clinical interpretation.

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

This information is not applicable and therefore not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., imaging studies) where multiple experts assess the same cases and discrepancies need to be resolved. For an in vitro diagnostic control, the "ground truth" for value assignment and stability is determined through analytical measurements.

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

An MRMC study is not applicable to this device. The Elecsys DHEA-S CalCheck 5 is an in vitro diagnostic control material, not an AI-assisted diagnostic tool that involves human reader interpretation. Therefore, no MRMC study was performed, and there is no discussion of human reader improvement with or without AI assistance.

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

This concept is not directly applicable to this device. The Elecsys DHEA-S CalCheck 5 is a biological control material for an immunoassay system, not an algorithm. Its "standalone performance" would relate to its inherent stability and accurate value assignment, as assessed by analytical methods, rather than an algorithm's performance. The document states it was "evaluated for value assignment and stability."

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

The ground truth for a calibration verification control like Elecsys DHEA-S CalCheck 5 would be the assigned target values and acceptable ranges (analytical ground truth) for DHEA-S concentrations at each of the five levels. These values are established through very precise analytical measurements, often using reference methods and materials, and are critical for ensuring the accuracy and reliability of the immunoassay system.

8. The sample size for the training set

The concept of a "training set" is not applicable in the context of this device. A training set is used for machine learning algorithms. The Elecsys DHEA-S CalCheck 5 is a physical control material, not an algorithm that requires training data.

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

As there is no training set for this device, this question is not applicable.

Summary

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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 Diagnostics9115 Hague Road, P.O. Box 50416Indianapolis, IN 46250-0416317-521-3501
	Contact Person: Kelly Colleen O'Maine AdamsPhone: 317-521-3577Fax: 317-521-2324Email: colleen.adams@roche.com
	Secondary Contact: Stephanie GreemanPhone: 317-521-2458Fax: 317-521-2324Email: stephanie.greeman@roche.com
	Date Prepared: December 28, 2010
Device Name	Proprietary name: Elecsys DHEA-S CalCheck 5Common name: DHEA-S CalCheck 5Classification name: Single (specified) analyte controls (assayed andunassayed)
Predicatedevice	The Elecsys DHEA-S CalCheck 5 is substantially equivalent to otherproducts in commercial distribution intended for similar use. We claimequivalency to the currently marketed Elecsys C-Peptide CalCheck 5(K100810).
DeviceDescription	The Elecsys DHEA-S CalCheck 5 is a lyophilized product consisting ofDHEA-S in a human serum matrix. During manufacture, the analyte is spikedinto the matrix at the desired concentration levels.
Intended use	The Elecsys DHEA-S CalCheck 5 is an assayed control for use in calibrationverification and for use in the verification of the assay range established bythe Elecsys DHEA-S reagent on the indicated Elecsys and cobas eimmunoassay analyzers.

Continued on next page

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- 510(k) Summary, Continued

The table below compares Elecsys DHEA-S CalCheck 5 with the predicate Comparison Table device, Elecsys C-Peptide CalCheck 5 (K100810).

Characteristic	Elecsys C-Peptide CalCheck 5(K100810)	Elecsys DHEA-S CalCheck 5(Candidate Device)
Intended Use	The Elecsys C-Peptide CalCheck 5 is anassayed control for use in calibrationverification and for use in the verificationof the serum and plasma assay rangeestablished by the Elecsys C-Peptidereagent on the indicated Elecsys and cobase immunoassay analyzers.	The Elecsys DHEA-S CalCheck 5 is anassayed control for use in calibrationverification and for use in the verificationof the assay range established by theElecsys DHEA-S reagent on the indicatedElecsys and cobas e immunoassayanalyzers.
Analyte	C-Peptide	DHEA-S
Levels	Five	Same
Format	Lyophilized	Same
Handling	Reconstitute Check 1, Check 2, Check 3,Check 4, and Check 5 with exactly 1.0 mLdistilled or deionized water. Allow to standclosed for 15 minutes, then mix gently byinversion.	Same
Stability	Unopened:• Store at 2-8°C until expiration dateReconstituted:• 20-25°C: 4 hours	Unopened:• SameReconstituted:• Same
Matrix	Equine serum matrix	Human serum matrix

Performance Characteristics

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The Elecsys DHEA-S CalCheck 5 was evaluated for value assignment and stability. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Image /page/2/Picture/0 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 tail feathers. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA."

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Roche Diagnostics

Roche Professional Diagnostics c/o Ms. Kelly Colleen O' Maine Adams Regulatory Affairs Consultant 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250-0416

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Jan 0 7 2011

Re: K103402 Trade Name: Elecsys DHEA-S CalCheck 5 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I reserved Product Codes: JJX Dated: November 18, 2010 Received: November 19, 2010

Dear Ms. O'Maine Adams:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301).796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known):

K103402

JAN - 7 2011

Device Name: Elecsys DHEA-S CalCheck 5

Indication For Use:

The Elecsys DHEA-S CalCheck 5 is an assayed control for use in calibration verification
for the same of the and and and stablished by the Flective DHFA-S The Elecsys DHEA-S CalCheck J is an assay range established by the Elecsys DHEA-S
and for use in the verification of the assay range established by the Elecsys on buyers and for use in the vertricultion of the active immunoassay analyzers.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k/03402

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.