The Elecsys hGH 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 hGH reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Device Description

The Elecsys hGH CalSet and hGH CalCheck 5 are lyophilized products consisting of human growth hormone (hGH) in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

AI/ML Overview

The provided 510(k) summary (K103221) for the "Elecsys hGH CalSet" and "Elecsys hGH CalCheck 5" focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance acceptance criteria for the devices themselves. These devices are calibrators and quality control materials, not diagnostic tools that produce a diagnostic result or image. Therefore, the information typically requested for AI/diagnostic devices regarding sample size, expert review, ground truth, and MRMC studies is not directly applicable to this submission.

However, based on the document, here's a description of what is presented regarding performance and equivalence:

Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria in terms of sensitivity, specificity, accuracy, or similar metrics typically associated with AI diagnostic devices. Instead, it demonstrates substantial equivalence to predicate devices (Elecsys C-Peptide CalSet and Elecsys C-Peptide CalCheck 5) based on shared characteristics and equivalent performance evaluations. The performance evaluations described are "value assignment" and "stability."

The "acceptance criteria" here implicitly refer to demonstrating similar intended use, analytical characteristics, and comparable stability and value assignment performance to the predicate devices.

Characteristic	Acceptance Criteria (Implied by Predicate Comparison)	Reported Device Performance (Elecsys hGH CalSet / Elecsys hGH CalCheck 5)
Intended Use	For calibrating/verifying a quantitative immunoassay on Elecsys/cobas e analyzers, for an analyte.	Elecsys hGH CalSet: Used for calibrating the quantitative Elecsys hGH assay on Elecsys and cobas e immunoassay analyzers.Elecsys hGH CalCheck 5: Assayed control for calibration verification and assay range verification for Elecsys hGH reagent on Elecsys and cobas e immunoassay analyzers.
Analyte	Specific to its target.	Elecsys hGH CalSet: Human growth hormone (hGH)Elecsys hGH CalCheck 5: Human growth hormone (hGH)
Levels	Two (for CalSet) / Five (for CalCheck).	Elecsys hGH CalSet: TwoElecsys hGH CalCheck 5: Five
Format	Lyophilized.	Lyophilized.
Handling	Reconstitution instructions.	Elecsys hGH CalSet: Add 1.0 mL distilled/deionized water, stand 15 min, mix.Elecsys hGH CalCheck 5: Add 1.0 mL distilled/deionized water to each Check, stand 15 min, mix.
Stability	Comparable unopened and reconstituted stability to predicate (e.g., unopened at 2-8°C until expiration; reconstituted at -20°C or 20-25°C).	Elecsys hGH CalSet: Unopened: 2-8°C until expiration. Reconstituted: -20°C: 28 days (freeze once); 20-25°C (analyzers): Up to 5 hours (Elecsys 2010, cobas e 411), Use only once (MODULAR ANALYTICS E170, cobas e 601, cobas e 602).Elecsys hGH CalCheck 5: Unopened: 2-8°C until expiration. Reconstituted: 20-25°C: 5 hours.
Matrix	Biological matrix suitable for the intended use.	Human serum matrix. (Note: Predicate Elecsys C-Peptide CalSet uses Equine serum matrix, a difference acknowledged but not highlighted as an issue for equivalence, likely due to the nature of calibrators and controls).
Study Outcomes	Demonstrated appropriate "value assignment" and "stability." (No specific metrics provided in the summary).	The Elecsys hGH CalSet and Elecsys hGH CalCheck 5 "were evaluated for value assignment and stability." The implication of successful review by FDA is that these evaluations demonstrated performance comparable to predicate.

Study Information (Not applicable in the context of an AI/diagnostic device)

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

Not applicable. This is a premarket notification for calibrators and controls, not a diagnostic device with a clinical test set. The "test set" would refer to the experiments conducted for value assignment and stability. The number of samples/replicates used in these analytical studies is not specified in the summary.

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)

Not applicable. Ground truth, in the context of diagnostic devices, refers to the definitive diagnosis or condition. For calibrators and controls, the "truth" is their assigned value and stability, which are determined through analytical testing procedures and validated methods, not expert consensus on clinical cases.

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

Not applicable. Adjudication methods are for reconciling discrepancies among human readers of diagnostic images/results. This device is a calibrator/control material.

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 is not an AI diagnostic device, nor does it assist human readers in interpreting results.

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

Not applicable. This is not an algorithm or AI system.

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

For calibrators and controls, the "ground truth" relates to the assigned concentration values and stability characteristics. This is established through rigorous analytical methods, often traceable to reference materials and International Standards, rather than clinical 'ground truth' such as pathology or outcomes data. The summary states "value assignment" and "stability" were evaluated, implying these analytical parameters serve as the basis for performance.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary

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K10322.1

510(k) Summary	DEC 22 2010
Introduction	According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter Name and Contact Information	Roche Diagnostics9115 Hague Road, P.O. Box 50416Indianapolis, IN 46250-0416317-521-3577
	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: October 29, 2010
Device Name	Proprietary name: (1) Elecsys hGH CalSet(2) Elecsys hGH CalCheck 5
	Common name: (1) hGH CalSet(2) hGH CalCheck 5
	Classification name: (1) Calibrator, secondary(2) Single (specified) analyte controls (assayed and unassayed)
Predicate Devices	The Elecsys hGH CalSet is substantially equivalent to other products in commercial distribution for similar use. We claim equivalency to the current marketed Elecsys C-Peptide CalSet (K033873).
	The Elecsys hGH CalCheck 5 is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys C-Peptide CalCheck 5 (K100810).
	Continued on next page

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510(k) Summary, Continued

DeviceDescription	The Elecsys hGH CalSet and hGH CalCheck 5 are lyophilized productsconsisting of human growth hormone (hGH) in human serum matrix. Duringmanufacture, the analyte is spiked into the matrix at the desired concentrationlevels.
Intended Use	The Elecsys hGH CalSet is used for calibrating the quantitative Elecsys hGHassay on the Elecsys and cobas e immunoassay analyzers.The Elecsys hGH CalCheck 5 is an assayed control for use in calibrationverification and for use in the verification of the assay range established bythe Elecsys hGH reagent on the indicated Elecsys and cobas e immunoassayanalyzers.
ComparisonTables	The tables below compare the Elecsys hGH CalSet and Elecsys hGHCalCheck 5 with their predicate devices, Elecsys C-Peptide CalSet (K033873)and Elecsys C-Peptide CalCheck 5 (K100810), respectively.

	Elecsys hGH CalSet	Elecsys C-Peptide CalSet
Characteristic	(Candidate Device)	(K033873)
Intended Use	Elecsys hGH CalSet is used for calibratingthe quantitative Elecsys hGH assay on theElecsys and cobas e immunoassayanalyzers.	Elecsys C-Peptide CalSet is used forcalibrating the quantitative Elecsys C-Peptide assay on the Elecsys and cobas eimmunoassay analyzers.
Analyte	Human growth hormone (hGH)	C-Peptide
Levels	Two	Same
Format	Lyophilized	Same
Handling	Add exactly 1.0 mL of distilled or deionizedwater and allow to stand closed for 15minutes to reconstitute. Mix carefully,avoiding the formation of foam.	Same
Stability	Unopened:Store at 2-8°C until expiration dateReconstituted:-20°C: 28 days (freeze only once) On Elecsys 2010 and cobas e 411(20-25°C):Up to 5 hours On MODULAR ANALYTICS E170,cobas e 601, and cobas e 602:Use only once.	Unopened:SameReconstituted:-20°C: 1 month (freeze only once) On analyzers (20-25 °C):Use only once.
Matrix	Human serum matrix	Equine serum matrix

Table 1. Elecsys hGH CalSet Comparison Table

Continued on next page

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510(k) Summary, Continued

Comparison Tables, continued

Characteristic	Elecsys hGH CalCheck 5(Candidate Device)	Elecsys C-Peptide CalCheck 5(K100810)
Intended Use	The Elecsys hGH 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 hGH reagent on the indicated Elecsys and cobas e immunoassay analyzers.	The Elecsys C-Peptide 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 C-Peptide reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Analyte	Human growth hormone (hGH)	C-Peptide
Levels	Five	Same
Format	Lyophilized	Same
Handling	Reconstitute Check 1, Check 2, Check 3, Check 4, and Check 5 with exactly 1.0 mL distilled or deionized water. Allow to stand closed for 15 minutes, then mix gently by inversion.	Same
Stability	Unopened:● Store at 2-8°C until expiration dateReconstituted:● 20-25°C: 5 hours	Unopened:● SameReconstituted:● 20-25°C: 4 hours
Matrix	Human serum matrix	Equine serum matrix

Table 2. Elecsys hGH CalCheck 5 Comparison Table

Performance Characteristics The Elecsys hGH CalSet and Elecsys hGH CalCheck 5 were evaluated for value assignment and stability.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing upwards.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Roche Diagnostics c/o Ms. Kelly Collen O'Maine Adams Regulatory Affairs Specialist 9115 Hague Road, P.O. Box 50416 Indianapolis. IN 46250-0416

Re: K103221

Trade Name: The Elecsys hGH CalSet, The Elecsys hGH CalCheck 5 Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIT, JJX Dated: October 29, 2010 Received: November 01, 2010

DEC 2 3 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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Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 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-fre ne (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

CJC.

Courmey 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

KI0322/

510(k) Number (if known):

DEC 2 3 2010

Device Name: Elecsys hGH CalSet

Indication For Use:

Elecsys hGH CalSet is used for calibrating the quantitative Elecsys hGH assay on the Elecsys and cobas e immunoassay analyzers.

Prescription Use X _ (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)

Carol Benson

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

510(k) K103221

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K10322/

Indication for Use

DEC 2 3 2010

510(k) Number (if known):

Device Name: Elecsys hGH CalCheck 5

Indication For Use:

Prescription Use _ X (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)

Carol Benson
Division Sign Off

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

510(k) < 163221

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.