VITROS Immunodiagnostic Products Insulin Calibrators

K171168 · Ortho Clinical Diagnostics · JIT · May 16, 2017 · Clinical Chemistry

Device Facts

• Record ID: K171168
• Device Name: VITROS Immunodiagnostic Products Insulin Calibrators
• Applicant: Ortho Clinical Diagnostics
• Product Code: JIT · Clinical Chemistry
• Decision Date: May 16, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

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).

Device Story

VITROS Immunodiagnostic Products Insulin Calibrators are liquid, three-level calibrators (1, 25, 250 µIU/mL) containing recombinant human insulin in a BSA-buffered solution with antimicrobial agents. Used in clinical laboratory settings to calibrate VITROS ECi/ECiQ, 3600, and 5600 systems. The calibration process establishes a valid curve for the quantitative measurement of insulin in human serum and plasma samples. Healthcare providers use the resulting insulin measurements to aid in clinical decision-making regarding patient metabolic status. The device ensures analytical accuracy by providing traceability to the WHO 1st International Reference Preparation 66/304.

Clinical Evidence

Bench testing only. No clinical data provided. Stability and traceability were validated per CLSI EP25-A and FDA guidance for IVD calibrators. Value assignment is traceable to WHO 1st International Reference Preparation 66/304.

Technological Characteristics

Liquid calibrator kit containing three levels (1, 25, 250 µIU/mL). Composition: recombinant human insulin, BSA buffer, antimicrobial agent. Traceability: WHO 1st International Reference Preparation 66/304. Stability: 13 weeks opened, stored at 2-8°C. Standard: CLSI EP25-A.

Indications for Use

Indicated for use in the calibration of VITROS Immunodiagnostic systems for the quantitative measurement of insulin in human serum and plasma (Li Heparin). For prescription use.

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.

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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)

| <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |

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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: | [phone] |
| Facsimile: | [phone] |
| Email: | [e-mail] |

#### 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<br>Characteristic | VITROS® Immunodiagnostic<br>Products Insulin Calibrators<br>(New device) | K060359<br>(Architect Insulin Calibrators) |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in the calibration of the<br>VITROS ECi/ECiQ<br>Immunodiagnostic Systems, the<br>VITROS 3600 Immunodiagnostic<br>System and the VITROS 5600<br>Integrated System for the<br>quantitative measurement of insulin<br>in human serum and plasma (Li<br>Heparin). | The Architect Insulin Calibrators<br>are for the calibration of the<br>Architect i System when used for<br>the quantitative determination of<br>human insulin in human serum or<br>plasma |
| Measured Analyte | Insulin | same |
| Form | Liquid | same |
| Traceability | WHO 1st International Reference<br>Preparation 66/304 | same |
| Assay Protocol | Direct, quantitative immunoassay | same |

Comparison with Predicate - Similarities

Comparison with Predicate - Differences

| Device<br>Characteristic | VITROS® Immunodiagnostic<br>Products Insulin Calibrators<br>(New device) | K060359<br>(Architect Insulin Calibrators) |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Instrumentation | VITROS® ECi/ECiQ<br>Immunodiagnostic Systems,<br>VITROS® 3600<br>Immunodiagnostic System and the<br>VITROS® 5600 Integrated System | Architect <i>i</i> System |
| Concentration /<br>Levels | 3 levels: 1, 25, 250 µIU/mL | Calibrators A-F.<br>Cal A is acetate buffer, B-F are<br>levels: 0, 3, 10, 30, 100 µU/mL |
| Matrix | Buffer containing BSA and<br>antimicrobial agent | Acetate buffer with sodium azide<br>and preservatives |
| Stability | Unopened<br>Store at 2-8°C until expiration date<br>Opened<br>13 weeks | Unopened<br>Store at 2-8°C until expiration date<br>Opened<br>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.