Who is the manufacturer of CalSet IGF-1?

Roche Diagnostics filed the 510(k) submission for CalSet IGF-1 (K170938).

What is the FDA product code for CalSet IGF-1?

JIT. It is classified under 21 CFR 862.1150 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for CalSet IGF-1?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CalSet IGF-1?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CalSet IGF-1

K170938 · Roche Diagnostics · JIT · Apr 26, 2017 · Clinical Chemistry

Device Facts

Record ID	K170938
Device Name	CalSet IGF-1
Applicant	Roche Diagnostics
Product Code	JIT · Clinical Chemistry
Decision Date	Apr 26, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1150
Device Class	Class 2

Intended Use

CalSet IGF-1 is used for calibrating the quantitative Elecsys IGF-1 assay on the Elecsys and cobas e immunoassay analyzers.

Device Story

CalSet IGF-1 is a two-level lyophilized human serum matrix calibrator used to calibrate quantitative Elecsys IGF-1 assays on Elecsys and cobas e immunoassay analyzers. The device consists of two concentration levels (approx. 20 ng/mL and 500 ng/mL) traceable to WHO IS 02/254. It is used in clinical laboratory settings by trained laboratory personnel. The calibrator is reconstituted with distilled or deionized water before use. By establishing a calibration curve on the analyzer, it enables accurate quantification of IGF-1 in patient samples, supporting clinical assessment of growth hormone-related disorders. The device ensures analytical accuracy and consistency of the immunoassay results.

Clinical Evidence

Bench testing only. Stability studies (real-time, accelerated, and in-use) confirmed the stability of the lyophilized product and reconstituted calibrator under various storage conditions (-20°C, 2-8°C, and on-board). Traceability was established via the WHO IS 02/254 reference material. Value assignment was validated across multiple analyzer modules (cobas e 411, MODULAR ANALYTICS E170, cobas e 602) to ensure performance within specified ranges.

Technological Characteristics

Lyophilized human serum matrix; two concentration levels; traceable to WHO IS 02/254. Reconstituted with 1.0 mL distilled/deionized water. Stability: 31 days at -20°C, 72 hours at 2-8°C, 6 hours on-board at 20-25°C. Used on Elecsys and cobas e immunoassay analyzers.

Indications for Use

Indicated for use as a calibrator for the quantitative Elecsys IGF-1 assay on Elecsys and cobas e immunoassay analyzers. No specific patient population is described as this is an in vitro diagnostic calibrator.

Regulatory Classification

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.)

Special Controls

*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.

Related Devices

K103221 — ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 · Roche Diagnostics · Dec 23, 2010
K122141 — IDS-ISYS IGF-I CALIBRATION VERIFIERS · Immunodiagnostic Systems , Ltd. · Aug 7, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 26, 2017 ROCHE DIAGNOSTICS LISA KLINEDINST REGULATORY AFFAIRS PRINCIPAL 9115 HAGUE ROAD INDIANAPOLIS IN 46250 Re: K170938 Trade/Device Name: CalSet IGF-1 Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: March 29, 2017 Received: March 30, 2017 Dear Lisa Klinedinst: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the {1}------------------------------------------------ electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, **Kellie B. Kelm -S** for Courtney H. Lias,, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) k170938 Device Name CalSet IGF-1 Indications for Use (Describe) CalSet IGF-1 is used for calibrating the quantitative Elecsys IGF-1 assay on the Elecsys and cobas e immunoassay analyzers. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # CalSet IGF-1: 510(k) Summary for k170938 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits official notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics Act of our intention to market the devices described in this Premarket Notification 510(k). The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA review and clearance for CalSet IGF-1. {4}------------------------------------------------ | Submitter Name | Roche Diagnostics | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address | 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250-0457 | | Contact | Lisa K. Klinedinst Phone: (317) 521-1942 FAX: (317) 521-2324 Email: lisa.klinedinst@roche.com | | Date Prepared | April 26, 2017 | | 510(k) | k170938 | | Proprietary Name | CalSet IGF-1 | | Common Name | CalSet IGF-1 | | Classification Name | Calibrator, Secondary | | Product Codes, Regulation Numbers | JIT, 862.1150 | | Predicate Devices | CalSet Vitamin D total II (k162840) | | Establishment Registration | The establishment registration numbers: Roche Diagnostics GmbH in Mannheim, Germany is 9610126, Roche Diagnostics Penzberg, Germany is 9610529 Roche Diagnostics in the United States is 1823260 | {5}------------------------------------------------ ### DEVICE DESCRIPTION: CALSET IGF-1 1. CalSet IGF-1 is used for calibrating the quantitative Elecsys IGF-1 assay on the Elecsys and cobas e immunoassay analyzers. CalSet IGF-1 is a two concentration level set of lyophilized human serum matrix that is traceable to the WHO IS 02/254 Reference Material. The CalSet includes: - IGF-1 Call: 2 bottles, each for 1.0 mL of calibrator 1 . - IGF-1 Cal2: 2 bottles, each for 1.0 mL of calibrator 2 . IGF-1 in two concentration ranges (approximately 20 ng/mL and approximately 500 ng/mL) in a human serum matrix. ### INTENDED USE FOR CALSET IGF-1 2. CalSet IGF-1 is used for calibrating the quantitative Elecsys IGF-1 assay on the Elecsys and cobas e immunoassay analyzers. ### 3. TECHNOLOGICAL CHARACTERISTICS The following table compares the CalSet IGF-1 with its predicate device. {6}------------------------------------------------ | Feature | Predicate Device (CalSet Vitamin D total II) | Candidate Device | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use/ Indications for Use | CalSet Vitamin D total II is used for calibrating the quantitative Elecsys Vitamin D total II assay on the cobas e 411 immunoassay analyzer. | CalSet IGF-1 is used for calibrating the quantitative Elecsys IGF-1 assay on the Elecsys and cobas e immunoassay analyzers. | | Analyte | 25-hydroxyvitamin D3 | IGF-1 | | Matrix | Human serum matrix with added 25-hydroxyvitamin D3 | Human serum matrix with added IGF-1 | | Levels | Two | Same | | Target Ranges | Cal 1: approximately 2 ng/mL Cal 2: approximately 45 ng/mL | Cal 1: approximately 20 ng/mL Cal 2: approximately 500 ng/mL | | Format | Lyophilized | Same | | Handling | Carefully dissolve the contents of one bottle by adding exactly 1.0 mL of distilled or deionized water and allow to stand closed for 15 minutes to reconstitute. Mix carefully, avoiding the foam formation. | Same | | Storage and Stability | Reconstituted calibrators: | Reconstituted calibrators: | | | At 2-8°C – 72 hours | At 2-8°C - 72 hours | | | At -20°C - 12 weeks (freeze only once) on the cobas e 411 analyzer at 20-25°C- up to 5 hours on MODULAR ANALYTICS E170, cobas e e 601 and cobas e 602 analyzers at 20-25°C | At -20° ± 5°C - 31 days on the cobas e 411 analyzer at 20-25°C- up to 6 hours on MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers at 20-25°C - | ### Calibrator Comparison Table 1: # Non-Clinical Performance Evaluation Non-clinical performance evaluation for CalSet IGF-1 is briefly summarized below. ### Standardization and Traceability 3.1. The Elecsys IGF-1 assay is traceable to the WHO IS 02/254 Reference Material. The Reference Material (WHO IS 02/254) is used for Reference Standardization to assign values to the Working Calibrator consisting of a native human serum sample panel (single donors, pools and spiked samples covering the entire measuring range). These Working Calibrators are for routine use in subsequent standardizations. The assigned values for CalSet IGF-1 are read from the Working Calibrator Curve. {7}------------------------------------------------ ### Value Assignment 3.2. The CalSet IGF-1 assigned values are determined with the Elecsys IGF-1 assay. A Reference Material (WHO IS 02/254) is used for Reference Standardization to assign values to the Working Calibrator consisting of a native human serum sample panel (single donors, pools and spiked samples covering the entire measuring range). These Working Calibrators are for routine use in subsequent standardizations. The assigned values for CalSet IGF-1 are read from the Working Calibrator Curve. For each CalSet IGF-1 manufactured, the calibrators are run in duplicate on four (4) cobas e 411 modules and four (4) modules of the MODULAR ANALYTICS E170/cobas e 602 with all Elecsys IGF-1 reagent lots available. The assigned value of each calibrator is defined as the median value obtained over at least six (6) runs on at least three (3) modules of the respective calibrator. The assigned values for CalSet IGF-1 are read from the Working Calibrator Curve. The values must fall within specified acceptable ranges for each lot. ### Calibrator Stability 3.3. Five studies were performed in order to verify the stability claims for CalSet IGF-1. - Study 1: Stability at -20°C after reconstitution combined study . - Study 2: Stability at 2-8°C after reconstitution combined study . - Study 3: On-board stability at 20-25°C after reconstitution combined study . - Study 4: Accelerated stability at 35°C combined study . - Study 5: Real-time stability . - 3.3.1. Study 1: Stability at -20°C after reconstitution - combined study The on-test and reference materials were tested in duplicate on the cobas e 411 immunoassay analyzer. The on-test material was reconstituted and stored in closed vials for 3 weeks at 35℃ + 32 days at -20 ± 5°C + 7 hours at 20-25°C. The on-test signal recovery was calculated as percent of the reference value. The reconstituted CalSet IGF-1 is stable for at least 31 days at -20 ± 5℃. {8}------------------------------------------------ ### 3.3.2. Study 2: Stability at 2-8°C after reconstitution - combined study The on-test and reference materials were tested in duplicate on the cobas e 411 immunoassay analyzer. The on-test material was reconstituted and stored in closed vials for 3 weeks at 35°C + 73 hours at 2-8°C + 7 hours at 20-25°C. The on-test signal recovery was calculated as percent of the reference value. The reconstituted CalSet IGF-1 is stable for at least 72 hours at 2-8°C. #### 3.3.3. Study 3: On-board stability at 20-25°C after reconstitution - combined study The on-test and reference materials were tested in duplicate on the cobas e 411 immunoassav analyzer. The on-test material was reconstituted and stored in closed vials for 3 weeks at 35°C + 32 days at -20 ± 5°C + 7 hours at 20-25°C. The on-test signal recovery was calculated as percent of the reference value. The reconstituted CalSet IGF-1 is stable for at least 6 hours on-board the analyzers at 20-25°C. Study 4: Accelerated stability at 35°C – combined study 3.3.4. The on-test and reference materials were tested in duplicate on the cobas e 411 immunoassay analyzer. The on-test material was stored lyophilized (as supplied to the user) at 35°C for 3 weeks and afterwards reconstituted and stored for 73 hours at 2-8°C + 7 hours at 20-25°C. The reference material was a freshly reconstituted set of CalSet IGF-1 (stored at 2 - 8°C). After 3 weeks, the on-test and reference materials were tested in duplicate. The on-test signal recovery was calculated as a percent of the reference value. The accelerated stability model employed met the specification. #### 3.3.5. Study 5: Real-time stability For the on-going real-time stability study, the CalSet IGF-1 test material is stored at 2-8℃. The CalSets are tested in triplicate at specified intervals over the shelf life of the device up to the planned shelf life plus one month (13 months). Real-time stability is calculated based on the recovery of signal of stressed calibrator (stored at 2-8°C) vs. unstressed calibrator (stored at -80°C). At the specified intervals over the shelf life, {9}------------------------------------------------ the mean value of the stressed calibrator was calculated as a percent recovery of the unstressed value (each set is tested in duplicates at the same time point). The lyophilized CalSet IGF-1 is stable up to the stated expiration date. ### 4. CONCLUSIONS The information provided in this 510(k) Premarket Notification will support a determination of substantial equivalence for CalSet IGF-1. The data supports safe, effective devices which perform as well or better than the predicate device.