(27 days)
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No
The device is a calibrator for an immunoassay, consisting of lyophilized human serum matrix. The description focuses on the composition, traceability, value assignment, and stability of the calibrator material. There is no mention of any computational or algorithmic components, let alone AI/ML.
No
The device is a calibrator used for an immunoassay, not for treating any condition. Its purpose is to ensure the accuracy of a diagnostic test.
No.
Explanation: The device is described as a calibrator for a quantitative assay, meaning it is used to ensure the accuracy of the diagnostic device (the Elecsys IGF-1 assay), not to provide a diagnosis itself. Calibrators are typically considered accessories to diagnostic devices.
No
The device description explicitly states that CalSet IGF-1 is a "two concentration level set of lyophilized human serum matrix" and includes physical components ("2 bottles, each for 1.0 mL of calibrator 1", "2 bottles, each for 1.0 mL of calibrator 2"). This indicates it is a physical reagent, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that CalSet IGF-1 is used for "calibrating the quantitative Elecsys IGF-1 assay". Calibration is a crucial step in ensuring the accuracy of an in vitro diagnostic test.
- Device Description: The description details the composition of the device (lyophilized human serum matrix with IGF-1 at specific concentrations) and its purpose (calibrating an immunoassay). This aligns with the nature of calibrators used in IVD testing.
- Performance Studies: The document describes performance studies related to standardization, traceability, value assignment, and stability. These are typical evaluations performed for IVD components like calibrators to ensure their quality and reliability in the diagnostic process.
- Predicate Device: The mention of a predicate device (K162840; CalSet Vitamin D total II) which is also a calibrator, further supports the classification of this device as an IVD. Predicate devices are used in regulatory submissions for new IVDs.
In summary, the device's function as a calibrator for an in vitro diagnostic assay, its composition, and the type of performance studies conducted all indicate that CalSet IGF-1 is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CalSet IGF-1 is used for calibrating the quantitative Elecsys IGF-1 assay on the Elecsys and cobas e immunoassay analyzers.
Product codes
JIT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Non-clinical performance evaluation for CalSet IGF-1 included Standardization and Traceability, Value Assignment, and Calibrator Stability studies.
- Standardization and Traceability: 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.
- Value Assignment: The CalSet IGF-1 assigned values are determined with the Elecsys IGF-1 assay. 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: Five studies were performed:
- Study 1: Stability at -20°C after reconstitution - combined study: 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. Results: The reconstituted CalSet IGF-1 is stable for at least 31 days at -20 ± 5℃.
- Study 2: Stability at 2-8°C after reconstitution - combined study: 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. Results: The reconstituted CalSet IGF-1 is stable for at least 72 hours at 2-8°C.
- Study 3: On-board stability at 20-25°C after reconstitution - combined study: 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. Results: 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: 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). Results: The accelerated stability model employed met the specification.
- Study 5: Real-time stability: 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). Results: The lyophilized CalSet IGF-1 is stable up to the stated expiration date.
Key Metrics
Not Found
Predicate Device(s)
CalSet Vitamin D total II (K162840)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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
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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
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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)
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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.
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| 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 |
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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.
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| 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.
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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℃.
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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,
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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.