ELECSYS PRECICONTROL TS

K140534 · Roche Diagnostics · JJX · Mar 27, 2014 · Clinical Chemistry

Device Facts

• Record ID: K140534
• Device Name: ELECSYS PRECICONTROL TS
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 27, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Elecsys PreciControl TS is used for quality control of the Elecsys TSH immunoassay on the Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys PreciControl TS is a lyophilized quality control material consisting of recombinant human TSH in an equine serum matrix. It is used by laboratory professionals to monitor the performance of the Elecsys TSH immunoassay on Elecsys and cobas e immunoassay analyzers. The user reconstitutes the lyophilized material with distilled or deionized water, then runs the control on the analyzer. The analyzer measures the TSH concentration, and the result is compared against assigned target ranges to verify assay accuracy and precision. This process helps ensure the reliability of patient TSH test results, aiding clinicians in the diagnosis and management of thyroid disorders.

Clinical Evidence

Bench testing only. Studies included value assignment on MODULAR ANALYTICS E170 analyzers, real-time stability testing (up to 37 months), and reconstitution stability studies on the cobas e 411 analyzer. Acceptance criteria (90-110% recovery) were met for all stability and reconstitution parameters.

Technological Characteristics

Lyophilized quality control material; equine serum matrix; recombinant human TSH analyte. Reconstituted with 2.0 mL distilled/deionized water. Analyte-specific values assigned via immunoassay. Stability: 31 days at -20°C, 72 hours at 2-8°C, 5 hours on-analyzer. Traceable to 2nd IRP WHO Reference Standard 80/558.

Indications for Use

Indicated for use as a quality control material for the Elecsys TSH immunoassay on Elecsys and cobas e immunoassay analyzers. Intended for professional use in clinical laboratory settings.

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.

Submission Summary (Full Text)

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K140534

## MAR 2 7 2014

# 510(k) Summary

.

1. 1. 1. 1. 1.

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter<br>Name,<br>Address,<br>Contact | Roche Diagnostics<br>9115 Hague Road, P.O. Box 50416<br>Indianapolis, IN 46250-0416<br><br>Contact Person: Jane Phillips<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| | Date Prepared: March 12, 2014 |

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| Device Name | Proprietary name: | Elecsys PreciControl TS |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| | Common name: | Elecsys PreciControl TS |
| | Classification name: | Quality control material (assayed and unassayed) |
| Establishment<br>Registration | For the Elecsys PreciControl TS, the establishment registration number<br>(Roche Diagnostics GmbH Mannheim) is 9610126. The establishment<br>registration number for Roche Diagnostics United States is 1823260. | |

Classification The FDA has classified the product as a Class I Reserved device.

| Panel | Product<br>Code | Classification Name | Regulation<br>Citation |
|--------------------|-----------------|-----------------------------------------------------|------------------------|
| Clinical Chemistry | JJX | Quality control material<br>(assayed and unassayed) | 862.1660 |

| Predicate<br>Device | The Elecsys PreciControl TS is substantially equivalent to other products in<br>commercial distribution intended for similar use. We claim equivalency to<br>the currently marketed Elecsys PreciControl TSH (k962573). |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | The Elecsys PreciControl TS is a lyophilized product consisting of human<br>TSH at a euthyroid level in an equine serum matrix. During manufacture, the<br>analyte is spiked into the matrix at the desired concentration levels. All<br>human material should be considered potentially infectious. All products<br>derived from human blood are prepared exclusively from the blood of donors<br>tested individually and shown to be free from HBsAg and antibodies to HCV<br>and HIV. The testing methods applied were FDA-approved or cleared in<br>compliance with the European Directive 98/79/EC, Annex II, List A. |
| Intended Use | Elecsys PreciControl TS is used for quality control of the Elecsys TSH<br>immunoassay on the Elecsys and cobas e immunoassay analyzers. |
| Substantial<br>Equivalence | The Elecsys PreciControl TS is equivalent to the Elecsys PreciControl TSH<br>(k962573). |
| | Continued on next page |

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#### Table 1 below compares Elecsys PreciControl TS with the predicate device, Comparison PreciControl TSH. Table

| | | | | | | Table 1. Comparison of Candidate and Predicate Device |
|--|--|--|--|--|--|-------------------------------------------------------|
|--|--|--|--|--|--|-------------------------------------------------------|

. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

.

-- --

---- ---

| Characteristic | Elecsys PreciControl TS<br>(Candidate Device) | Elecsys® PreciControl TSH (k962573) |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | Elecsys PreciControl TS is used for<br>quality control of the Elecsys TSH<br>immunoassay on the Elecsys and<br>cobas e immunoassay analyzers. | PreciControl TSH is used for quality<br>control of the Elecsys TSH<br>immunoassay on the Elecsys and<br>cobas e immunoassay analyzers. |
| Format | Lyophilized material needs to be<br>reconstituted with 2.0 mL of distilled<br>or deionized water. | Liquid (2.0 mL) |
| Analyte | Recombinant human TSH | Same |
| Matrix | Equine serum | Same |
| Levels | One | Same |
| Target<br>Ranges | TSH: ~0.2 $ μIU/mL $ | Same |
| Stability | Lyophilized:<br>• Up until labeled expiration date at<br>2-8°C<br><br>Reconstituted:<br>• -20°C: 31 days (1 month) (freeze<br>only once)<br>• 2-8° C: 72 hours (3 days)<br>• on the analyzers (20-25°C): up to 5<br>hours | Unopened:<br>• Store at 2-8°C until expiration date<br><br>Opened:<br>• Unopened at 2-8°C: Up to the stated<br>expiration date<br>• Opened at 2-8°C: 12 weeks<br>• on the analyzers (20-25°C): up to 5<br>hours |

Continued on next page

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| Characteristic | Elecsys PreciControl TS<br>(Candidate Device) | Elecsys PreciControl TSH (k962573) |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Handling | Carefully dissolve 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 foam formation.<br><br>Transfer aliquots (500µl) of the<br>reconstituted control into empty<br>labeled snap-cap bottles (ControlSet<br>Vials)<br><br>Attach the supplied labels to the<br>additional bottles. Store the aliquots<br>immediately at -20°C.<br><br>Discard of aliquot after performing<br>the control procedure since they<br>should be used only once. | The control is supplied ready-for-use<br>in bottle compatible with the system.<br>The control should only be left on the<br>analyzer during performance of<br>quality control. After use, close the<br>bottle as soon as possible and store at<br>2-8°C. Because of possible<br>evaporation effects, not more than 20<br>quality control procedures per bottle<br>should be performed. |
| Traceability | The Elecsys TSH assay was<br>standardized against the 2nd IRP<br>WHO Reference Standard 80/558 | Same |

Table 1. Comparison of Candidate and Predicate Devices, continued

The Elecsys PreciControl TS was evaluated for value assignment, stability, and reconstitution. Characteristics

and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of

・・・・・・・・・・・・・・・・・・・・・

-

The data demonstrate that the performance of the Elecsys PreciControl TS is Conclusion substantially equivalent to that of the predicate device, Elecsys® PreciControl TSH.

Performance

. . . . . . . .

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

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## Value Assignment

#### 1. Standardization and traceability

Procedure for Value Assignment

The PreciControl TS is assigned an analyte-specific value with the Elecsys TSH immunoassay. The Elecsys TSH assay was standardized against the 2nd IRP WHO Reference Standard 80/558.

## 2. Value Assignment

Values are assigned for each lot of PreciControl TS in combination with each assay reagent lot available. The controls are run in duplicate on at least three (3) MODULAR ANALYTICS E170 measuring cells. The assigned value of each control level is defined as the median value obtained over at least six (6) determinations of the respective control level.

Acceptance Criteria for Value assignment, specified in Table 2.

- a. Precision of the control determinations
- b. Percent difference between assigned and target (nominal) values
- c. Analyzer-to-analyzer variability

For additional analyzer platforms, the same value assignment procedure is performed. The assigned values obtained on the additional analyzers are compared to those obtained on the MODULAR ANALYTICS E170 (the master analyzer).

## Table 2. Value Assignment Acceptance Criteria for PreciControl TS

| | Target<br>Value<br>[µIU/mL] | (a)<br>Precision,<br>% CV | (b)<br>Acceptance range<br>of Assigned<br>Value,<br>[%] | (c)<br>Assigned value<br>on Additional<br>vs. Master<br>Platform,<br>% |
|-----|-----------------------------|---------------------------|---------------------------------------------------------|------------------------------------------------------------------------|
| TSH | 0.2 | 9 | 60-140 | 90-110 |

Conclusion: Acceptance criteria for all stages of the process were met, supporting the target values and ranges above.

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## Stability Studies

Stability

Studies

Three studies were performed in order to verify the stability claims for the PreciControl TS.

All stability studies were performed on the cobas e 411 analyzer.

## Study 1 and 2. Stability after Reconstitution:

## Study 1

The on-test and reference materials were tested in duplicate. The on-test material was reconstituted and stored for 73 h at +2℃ to +8℃ and afterwards stored in snap-cap bottles for 6h at +20°C to 25°C. The reference material was lyophilized material stored at +2℃ to +8℃. The on-test recovery was calculated as a percent of the reference value.

The PreciControl TS lot was evaluated in duplicate on the cobas e 411. The acceptance criterion was 90-110% recovery of the reference material value.

| Table 3. Stability of Reconstituted Lyophilized PreciControl TS | | |
|-----------------------------------------------------------------|--|--|
|-----------------------------------------------------------------|--|--|

| Stability of reconstituted PreciControl TS on cobas e 411 | | | |
|-----------------------------------------------------------|-----------------------|------------------------------|------------|
| Sample | Reference<br>[µIU/mL] | Stressed control<br>[µIU/mL] | % Recovery |
| PC TS | 0.174 | 0.168 | 96.6 |

Continued on next page

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## Stability Studies

#### Stability Study 2 Studies The on-test and reference materials were tested in duplicate. The on-test material was reconstituted and stored for 32 days at -20°C and afterwards stored in snap-cap bottles for 6h at +20°C to 25°C. The reference material was lyophilized material stored at +2℃ to +8℃. The on-test recovery was calculated as a percent of the reference value.

The PreciControl TS lot was evaluated in duplicate on the cobas e 411. The acceptance criterion was 90-110% recovery of the reference material value.

| Stability of reconstituted Lyophilized on cobas e 411 | | | |
|-------------------------------------------------------|-----------------------|------------------------------|------------|
| Sample | Reference<br>[µIU/mL] | Stressed control<br>[µIU/mL] | % Recovery |
| PC TS | 0.174 | 0.177 | 101.7 |

### Table 4. Stability of Reconstituted Lyophilized PreciControl TS

Conclusion: The data support the package insert claim that reconstituted PreciControl TS is stable for up to:

> 31 days at -20°C 72 hours at 2-8°C 5 h at 20-25°C on the analyzers

> > Continued on next page

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## Stability Studies

| Stability | Study 3. Real-Time Stability: | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Studies<br>continued | The real-time stability is being evaluated as follows: | |
| | In the on-going real-time stability study, the PreciControl TS test material is<br>stored at +2 to +8°C. The controls are tested at specified intervals over the<br>shelf life of the device up to the planned shelf life plus one month. | |
| | Data for the time-points at 6, 12, 16, 19, 25 and 37 months tested in duplicate<br>will be available. The average on-test recovery value is calculated as percent<br>recovery compared to the unstressed reference value (stored at -20°C). | |
| | The acceptance criterion is a recovery of 90-110% of the unstressed<br>reference. | |
| | Currently, the shelf life claim is 24 months. This is based on real-time<br>stability data of three lots. | |
| | The testing will be continued with this stability protocol until data is available<br>to support a claim of 36 months. | |
| | A | |

Conclusion: Data support the current package insert claim of shelf life of 24 months.

| Lot | Level | On-Test as a Percent of Reference, % | | | | | | |
|------|-------|--------------------------------------|-----|-----|----|-----|-----|----|
| | | 6 | 9 | 12 | 16 | 19 | 25 | 37 |
| DR01 | TSH | 106 | 100 | 103 | 99 | 103 | 102 | |
| DR02 | TSH | 99 | 100 | 103 | 98 | 102 | 102 | |
| DR03 | TSH | 100 | 99 | 95 | 99 | 101 | 99 | |

・・・・・

:

Career States

## Table 5. Real-time Stability testing plan for PreciControl TS

Continued on next page

.

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## Reconstitution

PreciControl TS was reconstituted for 30 minutes (reference) and 60 Reconstitution minutes. Samples were evaluated in duplicate on the cobas e 411 analyzer. Time Study The average recovery after 60 minutes of reconstitution will be calculated as percent recovery compared to the value obtained at 30 minutes of reconstitution (the reference value).

> The acceptance criterion is recovery of 90-110% of the value obtained for the 30 minute reconstituted material.

| Reference result<br>(30 min reconstitution)<br>TS [µIU/mL] | On-Test result<br>(60 min<br>reconstitution)<br>TS [µIU/mL] | % Recovery |
|------------------------------------------------------------|-------------------------------------------------------------|------------|
| 0.174 | 0.174 | 100.0 |

Conclusion: The data support the package insert claim that the PreciControl TS is completely reconstituted after 30 minutes.

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Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 27, 2014

ROCHE DIAGNOSTICS JANE PHILLIPS REGULATORY PROGRAM MANAGER 9115 HAGUE ROAD INDIANAPOLIS IN 46250

Re: K140534

Trade/Device Name: Elecsys PreciControl TS Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJX Dated: February 27, 2014 Received: March 4, 2014

Dear Ms. Phillips:

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. Iisting 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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Page 2-Ms. Phillips

If you desire specific advice for your device on our labeling regulations (2) CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] 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" (21CFR 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/Safetw/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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Courtney H. Lias -S

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) k140534

Device Name Elecsys PreciControl TS

Indications for Use (Describe)

Elecsys PreciControl TS is used for quality control of the Elecsys TSH immunoassay on the Elecsys and cobas e immunoassay analyzers.

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)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

## Yung W. Chan -S

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