(25 days)
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No
The document describes calibrators for an immunodiagnostic system and does not mention any AI or ML components.
No
The device is an in vitro diagnostic calibrator, used to calibrate laboratory systems for measuring insulin, not to treat or cure a disease.
No
The device is a calibrator for in vitro diagnostic systems, not a diagnostic device itself. Its purpose is to help calibrate other devices that perform quantitative measurements, as stated in the 'Intended Use / Indications for Use' section ("For use in the calibration of the VITROS ECVECiQ Immunodiagnostic Systems... for the quantitative measurement of insulin").
No
The device description clearly states the device is comprised of liquid calibrators in vials, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
- Purpose: The device is used for the calibration of immunodiagnostic systems to quantitatively measure insulin in human serum and plasma. This is a diagnostic process performed outside of the body (in vitro) on biological samples.
- Device Description: The description details the composition and purpose of the calibrators, which are reagents used in a diagnostic test.
The information provided strongly indicates that this product is intended for use in a laboratory setting to aid in the diagnosis or monitoring of a medical condition by analyzing biological samples.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only. For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of insulin in human serum and plasma (Li Heparin).
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
The VITROS® Immunodiagnostic Products Insulin Calibrators contain three levels of calibrator, Calibrator 1, 2, 3. Nominal values are 1 uIU/mL, 25 µIU/mL and 250 µIU/mL respectively. The calibrators are liquid and comprised of recombinant human insulin in buffer containing BSA with an antimicrobial agent. VITROS® Immunodiagnostic Products Insulin Calibrators kit contains 1 vial of each calibrator 1, 2, and 3. Each vial contains 1mL of calibrator.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Stability: Shelf-life of the VITROS Immunodiagnostic Products Insulin Calibrators will be determined by a real time stability study. The stability study is designed to determine shelflife for calibrators. The final shelf life claim will be based on the completed real time study results. Storage life for open vials of VITROS Immunodiagnostic Products Insulin Calibrators will be determined by a real time stability study and will support the open off board shelf life statement in the Instructions for Use.
Summary of Traceability and Value assignment: Values assigned to the VITROS Immunodiagnostic Products Insulin Calibrators are traceable to the WHO 1st International Reference Preparation 66/304. The Value assignment process transfers the calibration from the WHO Standard (66/304) to reference standards and then to calibrators used by the end user to establish a valid calibration curve on the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three human profiles facing to the right, stacked on top of each other, with flowing lines extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 16, 2017
ORTHO-CLINICAL DIAGNOSTICS, INC. BRADLEY P. BOYER SENIOR REGULATORY ASSOCIATE 100 INDIGO CREEK DRIVE ROCHESTER NY 14626
Re: K171168
Trade/Device Name: VITROS Immunodiagnostic Products Insulin Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: April 20, 2017 Received: April 21, 2017
Dear Bradley P. Boyer:
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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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/Resourcesfor You/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) K171168
Device Name
VITROS® Immunodiagnostic Products Insulin Calibrators
Indications for Use (Describe) For in vitro diagnostic use only.
For use in the calibration of the VITROS ECVECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of insulin in human serum and plasma (Li Heparin).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary of Safety and Effectiveness for the VITROS® Immunodiagnostic Products Insulin Calibrators
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1. 510(k) Number:
The assigned 510(k) number is: K171168
2. Applicant
| Contact Person: | Bradley P. Boyer |
|---|---|
| Senior Regulatory Associate | |
| Address: | Ortho-Clinical Diagnostics, Inc. |
| 100 Indigo Creek Drive | |
| Rochester, New York 14626-5101 | |
| Phone: | (585) 453-3421 |
| Facsimile: | (585) 453-3368 |
| Email: | bradley.boyer@orthoclinicaldiagnostics.com |
3. Date April 20, 2017
4. Device Name
Trade or Proprietary Names: VITROS® Immunodiagnostic Products Insulin Calibrators
Common Names:
Insulin Calibrators
5. Regulatory Information
Regulation section: 21 CFR 862.1150; calibrator, secondary Classification Class II Product Code: JIT Panel: Clinical Chemistry
6. Predicate Device
| Device Name | Architect Insulin Calibrators |
|---|---|
| 510(k) number: | K060359 |
| Manufacturer: | Produced for Abbott by Denka Seiken Co., Ltd. |
7. Intended Use
See Indications for Use
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8. Indications for Use VITROS® Immunodiagnostic Products Insulin Calibrators
VITROS Immunodiagnostic Products Insulin Calibr
For in vitro diagnostic use only.
For use in the calibration of the VITROS ECi/ECiO Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of insulin in human serum and plasma (Li Heparin).
Special Conditions for use statement: For prescription use
9. Device Description
Calibrator description
The VITROS® Immunodiagnostic Products Insulin Calibrators contain three levels of calibrator, Calibrator 1, 2, 3. Nominal values are 1 uIU/mL, 25 µIU/mL and 250 µIU/mL respectively. The calibrators are liquid and comprised of recombinant human insulin in buffer containing BSA with an antimicrobial agent. VITROS® Immunodiagnostic Products Insulin Calibrators kit contains 1 vial of each calibrator 1, 2, and 3. Each vial contains 1mL of calibrator.
10. Test Principle:
VITROS® Immunodiagnostic Products Insulin Calibrators are intended for in vitro diagnostic use in the calibration of the VITROS Immunodiagnostic Products Insulin test on VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System.
11. Substantial Equivalence Information:
VITROS® Immunodiagnostic Products Insulin Calibrators are substantially equivalent to predicate device Architect Insulin Calibrators (K060359) which was cleared by FDA for IVD use.
Comparison with predicate tables highlight similarities and differences, respectively, of the VITROS® Immunodiagnostic Products Insulin Calibrators as compared to the predicate device.
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| Device
Characteristic | VITROS® Immunodiagnostic
Products Insulin Calibrators
(New device) | K060359
(Architect Insulin Calibrators) |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in the calibration of the
VITROS ECi/ECiQ
Immunodiagnostic Systems, the
VITROS 3600 Immunodiagnostic
System and the VITROS 5600
Integrated System for the
quantitative measurement of insulin
in human serum and plasma (Li
Heparin). | The Architect Insulin Calibrators
are for the calibration of the
Architect i System when used for
the quantitative determination of
human insulin in human serum or
plasma |
| Measured Analyte | Insulin | same |
| Form | Liquid | same |
| Traceability | WHO 1st International Reference
Preparation 66/304 | same |
| Assay Protocol | Direct, quantitative immunoassay | same |
Comparison with Predicate - Similarities
Comparison with Predicate - Differences
| Device
Characteristic | VITROS® Immunodiagnostic
Products Insulin Calibrators
(New device) | K060359
(Architect Insulin Calibrators) |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Instrumentation | VITROS® ECi/ECiQ
Immunodiagnostic Systems,
VITROS® 3600
Immunodiagnostic System and the
VITROS® 5600 Integrated System | Architect i System |
| Concentration /
Levels | 3 levels: 1, 25, 250 µIU/mL | Calibrators A-F.
Cal A is acetate buffer, B-F are
levels: 0, 3, 10, 30, 100 µU/mL |
| Matrix | Buffer containing BSA and
antimicrobial agent | Acetate buffer with sodium azide
and preservatives |
| Stability | Unopened
Store at 2-8°C until expiration date
Opened
13 weeks | Unopened
Store at 2-8°C until expiration date
Opened
Store at 2-8°C until expiration date |
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12. Standard/Guidance Document Reference
The following recognized standard and guidance documents were used: CLSI EP25-A – Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline Sept 2009.
CDRH Guidance for Industry: Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators, issued on February 22, 1999,
13. Performance Characteristics
The following studies are not applicable for the purpose of this submission:
- Precision/Reproducibility .
- Linearity/Assay Reportable Range ●
- Detection limit ●
- Method and Matrix Comparison Studies ●
- Analytical Specificity
- Assay cut-off
- Expected Values/Reference Interval ●
Summary of Stability
Shelf-life of the VITROS Immunodiagnostic Products Insulin Calibrators will be determined by a real time stability study. The stability study is designed to determine shelflife for calibrators. The final shelf life claim will be based on the completed real time study results.
Storage life for open vials of VITROS Immunodiagnostic Products Insulin Calibrators will be determined by a real time stability study and will support the open off board shelf life statement in the Instructions for Use.
Summary of Traceability and Value assignment
Values assigned to the VITROS Immunodiagnostic Products Insulin Calibrators are traceable to the WHO 1st International Reference Preparation 66/304.
The Value assignment process transfers the calibration from the WHO Standard (66/304) to reference standards and then to calibrators used by the end user to establish a valid calibration curve on the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System.
14. Conclusion
Based on the comparison with the predicate device, the VITROS Immunodiagnostic Products Insulin Calibrators are substantially equivalent to the Architect Insulin Calibrators (K060359) cleared by FDA for IVD use.