ELECSYS PRECICONTROL UNIVERSAL

K051687 · Roche Diagnostics Corp. · JJY · Jul 25, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051687
• Device Name: ELECSYS PRECICONTROL UNIVERSAL
• Applicant: Roche Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Elecsys® PreciControl Universal is used for quality control of the Elecsys® immunoassays on the Elecsys® immunoassay systems. For Prescription Use Only

Device Story

Elecsys® PreciControl Universal is a lyophilized quality control product consisting of human serum matrix spiked with various antigens (AFP, Cortisol, DHEAS, Estradiol, Ferritin, Folate, FSH, L-Thyroxin, hCG, IgE, Insulin, LH, Progesterone, Prolactin, Testosterone, SHBG, T3, TSH, Vitamin B12). It is used by laboratory professionals to monitor the performance and accuracy of Elecsys® immunoassay systems. The product requires reconstitution with distilled water before use. By comparing the measured values of the control against established target ranges, clinicians verify the reliability of patient sample testing. This process ensures the analytical validity of immunoassay results, supporting accurate clinical decision-making and patient diagnosis.

Clinical Evidence

No clinical data. The device was evaluated through bench testing for value assignment and stability characteristics.

Technological Characteristics

Lyophilized human serum matrix with added synthetic and human-derived antigens. Requires reconstitution with 3.0 mL distilled water. Stability varies by analyte and storage condition (refrigerated, frozen, or on-analyzer).

Indications for Use

Indicated for quality control of Elecsys® immunoassays on Elecsys® immunoassay systems. 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.

Predicate Devices

• Elecsys® PreciControl MultiAnalyte (K033937)

Submission Summary (Full Text)

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K 051687

# JUL 25 2005

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 317-521-3723 |
| | Contact Person: Corina Harper |
| | Date Prepared: June 22 , 2005 |
| Device Name | Proprietary name: Elecsys® PreciControl Universal Common name: PreciControl Universal |
| | Classification name: Multi-Analyte Controls, All Kinds (assayed and unassayed) |
| Predicate Device | The Elecsys® PreciControl Universal is substantially equivalent to the currently marketed Elecsys® PreciControl MultiAnalyte (K033937). |
| Device Description | The Elecsys® PreciControl Universal is a lyophilized product consisting of added antigens in human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels. |
| Intended use | Elecsys® PreciControl Universal is used for quality control of the Elecsys® immunoassays on Elecsys® immunoassay systems. |
| | Continued on next page |

.

510(k) Summary

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## 510(k) Summary, Continued

| Comparison to<br>Predicate<br>Device | The Elecsys® PreciControl Universal is substantially equivalent to the<br>currently marketed Elecsys® PreciControl MultiAnalyte (K033937). The<br>table below compares Elecsys® PreciControl Universal with the predicate<br>device, Elecsys® PreciControl MultiAnalyte (K033937). |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

#### Similarities

| Characteristics | Elecsys® PreciControl<br>Universal | Predicate Device<br>Elecsys® PreciControl<br>MultiAnalyte<br>(K033937) |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Elecsys® PreciControl<br>Universal is used for<br>quality control of the<br>Elecsys® immunoassays<br>on the Elecsys®<br>immunoassay systems. | Elecsys® PreciControl<br>MultiAnalyte is used for<br>quality control of the<br>Elecsys® C-Peptide and<br>Elecsys® Insulin<br>immunoassays on the<br>Elecsys® immunoassay<br>systems. |
| Levels | Two | Same |
| Format | Lyophilized | Same |

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Continued on next page

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# 510(k) Summary, Continued

| Characteristics | Elecsys® PreciControl<br>Universal | Predicate Device<br>Elecsys® PreciControl<br>MultiAnalyte<br>(K033937) |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Handling | Reconstitute with exactly<br>3.0 mL of distilled water<br>and allow to stand closed<br>for 30 minutes to<br>reconstitute, and then mix<br>gently. | Reconstitute with exactly<br>2.0 mL of distilled water<br>and allow to stand closed<br>for 15 minutes to<br>reconstitute, and then mix<br>gently. |
| Stability | Unopened:<br>• Store at 2-8°C until<br>expiration date<br>Reconstituted (except for<br>Insulin):<br>• on the analyzers at 20-<br>25°C: up to 5 hrs<br>• 20 - 25°C: up to 8 hrs<br>• at 2-8°C: 3 days<br>• at -20°C: 1 month (freeze<br>only once)<br>Reconstituted of Insulin:<br>• on the analyzers at 20-<br>25°C: up to 5 hrs<br>• 20 - 25°C: up to 5 hrs<br>• at -20°C: 1 month (freeze<br>only once) | Unopened:<br>• Same<br>Reconstituted:<br>• on the analyzers at 20-<br>25°C: up to 3 hrs<br>• at -20°C: 1 month (freeze<br>only once)<br>• after thawing: use only<br>once |

... ..........................................................................................................................................................................

Comparison to Predicate Device (continued) - Similarities

Differences

| Characteristics | Elecsys® PreciControl<br>Universal | Predicate Device<br>Elecsys® PreciControl<br>MultiAnalyte<br>(K033937) |
|-----------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Matrix | Human serum matrix with<br>added Antigens (see Table<br>1: "Matrix Composition") | Equine serum with added<br>C-Peptide and insulin |

Continued on next page

Roche Diagnostics Confidential

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### 510(k) Summary, Continued

The table below lists all active ingredients for Elecsys® PreciControl Matrix Composition Universal.

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The active ingredients are spiked into a buffered human serum matrix

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| | Component | Concentration |
|---------------------|---------------------------|---------------------------------------------------------|
| Reactive Components | AFP (human, cell culture) | please refer to target value<br>sheet of package insert |
| | Cortisol (synthetic) | |
| | DHEAS (synthetic) | |
| | Estradiol (synthetic) | |
| | Ferritin (human) | |
| | Folate (synthetic) | |
| | FSH (human) | |
| | L-Thyroxin (synthetic) | |
| | hCG (human) | |
| | IgE (human) | |
| | Insulin (human, recomb.) | |
| | LH (human) | |
| | Progesterone (vegetable) | |
| | Prolactin (human) | |
| | Testosterone (vegetable) | |
| | SHBG (human) | |
| | T3 (synthetic) | |
| | TSH (human, recomb.) | |
| | Vitamin B12 (synthetic) | |

#### Table 1

The Elecsys® PreciControl Universal was evaluated for value assignment and Performance Characteristics stability.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 25 2005

Ms. Corina Harper, RAC Regulatory Consultant Roche Diagnostics Corporation ... ... 9115 Hague Road Indianapolis, IN 46250

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k051687 Re:

Trade/Device Name: Elecsys® PreciControl Universal Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: June 22, 2005 Received: June 24, 2005

Dear Ms. Harper:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because a substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the Medical Device 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). and Oosmetore, market the device, subject to the general controls provisions of the Act. The r ournal 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 or any I 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin manceling your av revealerse of your device to a legally premarked notification. "The I DA miding of bassance of the and thus, permits your device to proceed to the market. ..

If you desire specific information about the application of labeling requirements to your device, If you desire specific imorination acour tis appears device, please contact the Office of In
or questions on the promotion and advertising of your device the contact of the or questions on the promotion and advertising or your can be and Safety at [phone]. V Ito Diagnosite Device Devilance and barrey ... (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the You may outlier general miormations on your of the [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benam

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### Indications for Use

1

\$\frac{1}{2} \times 10^{-12}\$

510(k) Number (if known):

Device Name:

Elecsys® PreciControl Universal

Indications For Use:

Elecsys® PreciControl Universal is used for quality control of the Elecsys® immunoassays on the Elecsys® immunoassay systems.

Prescription Use XXXX (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 IF NEEDED)

| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) |
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| (Division Sign-Off) |

Division of Clinical Laboratory Devices 510(k) Number KOS 168

Roche Diagnostics Contidential

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