ELECSYS PRECICONTROL VARIA 3

K111506 · Roche Diagnostics · JJY · Jul 8, 2011 · Clinical Chemistry

Device Facts

• Record ID: K111506
• Device Name: ELECSYS PRECICONTROL VARIA 3
• Applicant: Roche Diagnostics
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Elecsys® PreciControl Varia 3 is used for quality control of specified Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys® PreciControl Varia 3 is a multi-analyte, lyophilized quality control product consisting of human serum matrix spiked with specific analytes (Ferritin, Folate, Vitamin B12, β-CTx, Osteocalcin, PTH). It is used in clinical laboratory settings by technicians to monitor the performance of Elecsys and cobas e immunoassay analyzers. The product requires reconstitution with distilled or deionized water before use. By measuring these control samples, healthcare providers verify the accuracy and precision of the immunoassay systems, ensuring reliable diagnostic results for patients. It combines analytes previously found in separate predicate controls (Anemia and Bone panels) into a single product.

Clinical Evidence

No clinical data. Bench testing only. Stability testing confirmed shelf life (15 months unopened) and reconstituted stability (5 hours at 20-25°C, 72 hours at 2-8°C, 31 days at -20°C). Value assignment was performed using median values from eight determinations across multiple analyzers.

Technological Characteristics

Lyophilized human serum matrix; multi-analyte control. Reconstituted with 3.0 mL distilled/deionized water. Analyte traceability via NIBSC standards, radio-binding assays, and in-house reference systems. Intended for use on Elecsys and cobas e immunoassay analyzers.

Indications for Use

Indicated for quality control of specified Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers. No specific patient population or contraindications described.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Elecsys® PreciControl Anemia (K082340)
• Elecsys® PreciControl Bone (K051543)

Submission Summary (Full Text)

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Roche Diagnostics

RMS 00

Elecsys® PreciControl Varia 3

510(k) Summary

## 510(k) Summary— Elecsys® PreciControl Varia 3

JUL - 8 - 2011

| Introduction | In accordance with 21 CFR 807.92, Roche Diagnostics hereby submits<br>official notification as required by Section 510(k) of the Federal Food, Drug<br>and Cosmetics Act of our intention to market the device described in this<br>Premarket Notification [510(k)]. |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter<br>Name, Address,<br>Contact | Roche Diagnostics<br>9115 Hague Road<br>Indianapolis, IN 46250 |
| | Contact Person: Sarah Baumann<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| | Secondary Contact: Stephanie Greeman<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| | Date Prepared: May 31, 2011 |
| Device name | Proprietary name: Elecsys® PreciControl Varia 3<br>Common name: PreciControl Varia 3<br>Classification: Multi-Analyte Controls, All Kinds (assayed and unassayed) |
| Device<br>description | Elecsys® PreciControl Varia 3 is a lyophilized product consisting of analytes<br>in a human serum matrix. During manufacture, the analytes are spiked into<br>the matrix at the desired concentration levels. |
| Predicate<br>devices | Elecsys® PreciControl Varia 3 is substantially equivalent to other products in<br>commercial distribution intended for similar use. We claim equivalency to the<br>currently marketed Elecsys® PreciControl Anemia (K082340) and Elecsys®<br>PreciControl Bone (K051543). |
| | Elecsys® PreciControl Varia 3 is a multi-analyte control that combines the<br>analytes in the Elecsys® PreciControl Anemia (K082340) and Elecsys®<br>PreciControl Bone (K051543) multi-analyte controls. |
| | Continued on next page |
| Intended use | Elecsys® PreciControl Varia 3 is used for quality control of specified Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers. |
| Device<br>Comparison—<br>Similarities | Elecsys® PreciControl Varia 3 is a multi-analyte control that combines the analytes in the Elecsys® PreciControl Anemia (K082340) and Elecsys® PreciControl Bone (K051543) multi-analyte controls. |
| | Tables 1 and 2 below present the similarities between Elecsys® PreciControl Varia 3 and the predicate devices, Elecsys® PreciControl Anemia (K082340, Table 1) and Elecsys® PreciControl Bone (K051543, Table 2). |

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| Table 1. Comparison of Candidate (Elecsys® PreciControl Varia 3) and Predicate (Elecsyse | | |
|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| PreciControl Anemia)-Similarities | | |
| Characteristic | Candidate Device<br>Elecsys® PreciControl Varia 3 | Predicate Device<br>Elecsys® PreciControl Anemia<br>(K082340) |
| Analyzer<br>system | Elecsys and cobas e immunoassay<br>analyzers | Same |
| Format | Lyophilized | Same |
| Matrix | Human serum | Same |
| Levels | Three | Same |
| Traceability | • Vitamin B12—Commercially available<br>radio-binding assay<br>• Ferritin—NIBSC Standard 80/602<br>• Folate—Elecsys Folate II Assay | Same |

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Tables 1 and 2 present the similarities between Elecsys® PreciControl Varia 3 Device and the predicate devices, Elecsys® PreciControl Anemia (K082340, Table 1) Comparison-Similarities and Elecsys® PreciControl Bone (K051543, Table 2). (continued)

#### Table 2. Comparison of Candidate (Elecsys® PreciControl Varia 3) and Predicate (Elecsys® PreciControl Bone)-Similarities

| Characteristic | Candidate Device<br>Elecsys® PreciControl Varia 3 | Predicate Device<br>Elecsys® PreciControl Bone<br>(K051543) |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Analyzer<br>system | Elecsys and cobas e immunoassay<br>analyzers | Same |
| Format | Lyophilized | Same |
| Levels | Three | Same |
| Traceability | • β-CrossLaps/serum (β-CTx)—<br>Gravimetry<br>• Osteocalcin—In-house reference<br>system (commercially available<br>osteocalcin immuno/radio-binding<br>assay)<br>• Parathyroid Hormone (PTH and PTH<br>STAT)—In-house reference system<br>(commercially available PTH radio-<br>binding assay) | Same |

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Elecsys® PreciControl Varia 3 is a multi-analyte control that combines the Device analytes in the Elecsys® PreciControl Anemia (K082340) and Elecsys® Comparison-Differences PreciControl Bone (K051543) multi-analyte controls.

Tables 3 and 4 below present the differences between Elecsys® PreciControl Varia 3 and the predicate devices, Elecsys® PreciControl Anemia (K082340, Table 3) and Elecsys® PreciControl Bone (K051543, Table 4).

#### Table 3. Comparison of Candidate (Elecsys® PreciControl Varia 3) and Predicate (Elecsys® PreciControl Anemia)—Differences

| Characteristic | Candidate Device<br>Elecsys® PreciControl Varia 3 | Predicate Device<br>Elecsys® PreciControl Anemia<br>(K082340) |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Elecsys PreciControl Varia 3 is used<br>for quality control of specified Elecsys<br>immunoassays on the Elecsys and<br>cobas e immunoassay analyzers. | Elecsys PreciControl Anemia is<br>used for quality control of Elecsys<br>immunoassays on the Elecsys and<br>cobas e immunoassay analyzers. |
| Analyte<br>concentration | Ferritin (ng/mL)<br>Level 0 = 14<br>Level 1 = 150<br>Level 2 = 1000 Folate (ng/mL)<br>Level 0 = N/A<br>Level 1 = 3.9<br>Level 2 = 12 Vitamin B12 (pg/mL)<br>Level 0 = 230<br>Level 1 = 500<br>Level 2 = 1000 | Ferritin (ng/mL)<br>Level 1 = 15<br>Level 2 = 500<br>Level 3 = 1500 Folate (ng/mL)<br>Level 1 = 3<br>Level 2 = 8<br>Level 3 = 14 Vitamin B12 (pg/mL)<br>Level 1 = 350<br>Level 2 = 700<br>Level 3 = 1500 |
| Handling | Dissolve carefully the contents of one<br>bottle by adding exactly 3.0 mL of<br>distilled or deionized water and allow<br>to stand closed for 30 minutes to<br>reconstitute. Mix carefully, avoiding<br>the formation of foam. | Dissolve carefully the contents of<br>one bottle by adding exactly 2.0 mL<br>of distilled or deionized water and<br>allow to stand closed for 30 minutes<br>to reconstitute. Mix carefully,<br>avoiding the formation of foam. |
| Volume<br>(reconstituted) | 3.0 mL | 2.0 mL |

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Tables 3 and 4 present the differences between Elecsys® PreciControl Varia 3 Device and the predicate devices, Elecsys® PreciControl Anemia (K082340, Table 3) Comparison-Differences and Elecsys® PreciControl Bone (K051543, Table 4). (continued)

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#### Table 3. Comparison of Candidate (Elecsys® PreciControl Varia 3) and Predicate (Elecsys® PreciControl Anemia)-Differences, continued

| Characteristic | Candidate Device<br>Elecsys® PreciControl Varia 3 | Predicate Device<br>Elecsys® PreciControl Anemia<br>(K082340) |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stability | Unopened at 2 - 8 °C:<br>up to the stated expiration date | Unopened at 2 - 8 °C:<br>up to the stated expiration date |
| | Reconstituted/thawed serum:<br>o at - 20 °C: 31 days (freeze only once)<br>o at 2 – 8 °C: 72 hours<br>o at 20 – 25 °C on-board the analyzers: up to 5 hours | Reconstituted serum:<br>o at - 20 °C: 1 month (freeze only once)<br>o at 2 - 8 °C: 3 days<br>o at 20 – 25 °C on-board the analyzers: up to 5 hours<br>o at 20 – 25 °C: up to 8 hours after thawing: use only once |

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Tables 3 and 4 present the differences between Elecsys® PreciControl Varia 3 Device Comparisonand the predicate devices, Elecsys® PreciControl Anemia (K082340, Table 3) Differences and Elecsys® PreciControl Bone (K051543, Table 4). (continued)

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#### Table 4. Comparison of Candidate (Elecsys® PreciControl Varia 3) and Predicate (Elecsys® PreciControl Bone)-Differences

| Characteristic | Candidate Device<br>Elecsys® PreciControl Varia 3 | Predicate Device<br>Elecsys® PreciControl Bone<br>(K051543) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Elecsys PreciControl Varia 3 is used<br>for quality control of specified Elecsys<br>immunoassays on the Elecsys and<br>cobas e immunoassay analyzers. | Elecsys PreciControl Bone is used<br>for quality control of Elecsys<br>immunoassays on the Elecsys and<br>cobas e immunoassay analyzers. |
| Analyte<br>concentration | $\beta$ -CTx (pg/mL)<br>Level 0 = N/A<br>Level 1 = 320<br>Level 2 = 750 Osteocalcin (ng/mL)<br>Level 0 = N/A<br>Level 1 = 20<br>Level 2 = 100 PTH (pg/mL)<br>Level 0 = 25<br>Level 1 = 60<br>Level 2 = 200 | $\beta$ -CTx (pg/mL)<br>Level 1 = 315<br>Level 2 = 750<br>Level 3 = 3000 Osteocalcin (ng/mL)<br>Level 1 = 20<br>Level 2 = 100<br>Level 3 = 205 PTH (pg/mL)<br>Level 1 = 60<br>Level 2 = 205<br>Level 3 = 850 |
| Handling | Dissolve carefully the contents of one<br>bottle by adding exactly 3.0 mL of<br>distilled or deionized water and allow<br>to stand closed for 30 minutes to<br>reconstitute. Mix carefully, avoiding<br>the formation of foam. | Dissolve carefully the contents of<br>one bottle by adding exactly 2.0 mL<br>of distilled or deionized water and<br>allow to stand closed for 15 minutes<br>to reconstitute. Mix carefully,<br>avoiding the formation of foam. |

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Tables 3 and 4 present the differences between Elecsys® PreciControl Varia 3 Device and the predicate devices, Elecsys® PreciControl Anemia (K082340, Table 3) Comparison-Differences and Elecsys® PreciControl Bone (K051543, Table 4). (continued)

#### Table 4. Comparison of Candidate (Elecsys® PreciControl Varia 3) and Predicate (Elecsyse PreciControl Bone)—Differences, continued

| Characteristic | Candidate Device<br>Elecsys® PreciControl Varia 3 | Predicate Device<br>Elecsys® PreciControl Bone<br>(K051543) |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Volume<br>(reconstituted) | 3.0 mL | 2.0 mL |
| Stability | Unopened at 2 – 8 °C:<br>up to the stated expiration date<br><br>Reconstituted/thawed serum:<br>o at – 20 °C: 31 days (freeze only<br>once)<br>o at 2 – 8 °C: 72 hours<br>o at 20 – 25 °C on-board the<br>analyzers: up to 5 hours | Unopened at 2 – 8 °C:<br>up to the stated expiration date<br><br>Reconstituted/thawed serum:<br>o at – 20 °C: 1 month (4<br>freeze/thaw cycles possible)<br>o at 2 – 8 °C: 5 days<br>o at 20 – 25 °C: up to 8 hours |

| Performance | Elecsys® PreciControl Varia 3 was evaluated for value assignment, stability,<br>and duration of reconstitution. |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | |
| Conclusion | The data demonstrate that the performance of Elecsys® PreciControl Varia 3<br>is substantially equivalent to that of the predicate devices, Elecsys®<br>PreciControl Anemia (K082340) and Elecsys® PreciControl Bone (K051543). |

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Image /page/7/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

#### JUL 0 8 2011

Roche Diagnostics c/o Sarah Baumann Regulatory Affairs Consultant 9115 Hague Road P.O. Box 50410 Indianapolis. IN, 46250-0416

Re: k111506

> Trade Name: Elecsys PreciControl Varia 3 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material Regulatory Class: Class I, Reserved Product Code: JJY Dated: May 31, 2011 Received: June 1, 2011

Dear Ms. Baumann:

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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premyaket 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 tolli-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.

Sincerely yours.

CJC.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Enclosure

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# Indications for Use Form

510(k) Number (if known): K11 | 500

Device Name: Elecsys® PreciControl Varia 3

Indications for Use:

Elecsys® PreciControl Varia 3 is used for quality control of specified Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers. See the package insert for the list of all analytes claimed.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Benson

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

510(k) K110506