ELECSYS CA 19-9 CALCHECK

K051185 · Roche Diagnostics Corp. · JJY · Jul 6, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051185
• Device Name: ELECSYS CA 19-9 CALCHECK
• Applicant: Roche Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Elecsys® CA 19-9 CalCheck™ is intended for use in the verification of the calibration established by the Elecsys® CA 19-9 reagent on the Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.

Device Story

Elecsys® CA 19-9 CalCheck™ is a lyophilized quality control product used to verify calibration of CA 19-9 reagent on Elecsys 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers. Product consists of CA 19-9 analyte spiked into buffered human serum matrix. User reconstitutes lyophilized material with distilled or deionized water, allows to stand, and mixes gently before use on analyzer. Device provides verification of calibration performance for clinical laboratory immunoassay testing.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (accelerated and reconstituted) confirmed the product meets acceptance criteria (90%-110% of reference value). Value assignment was performed using multiple Elecsys® analyzer platforms.

Technological Characteristics

Lyophilized human serum matrix with spiked CA 19-9 analyte. Three concentration levels. Reconstitution required with 1.0 mL distilled/deionized water. Storage: 2-8°C unopened; 20-25°C for 4 hours post-reconstitution.

Indications for Use

Indicated for use as a quality control material to verify calibration of the Elecsys CA 19-9 reagent on specified Roche immunoassay analyzers.

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® C-Peptide CalCheck™ (k040157)

Submission Summary (Full Text)

{0}------------------------------------------------

K 051185

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

# 510(k) Summary

| 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<br>9115 Hague Road<br>Indianapolis, IN 46250<br>317-521-3723 |
| | Contact Person: Corina Harper |
| | Date Prepared: May 6, 2005 |
| Device Name | Proprietary name: Elecsys® CA 19-9 CalCheck™ |
| | Common name: CA 19-9 CalCheck |
| | Classification name: Single (specified) analyte controls (assayed and unassayed) |
| Predicate device | The Elecsys® CA 19-9 CalCheck™ is substantially equivalent to the currently marketed Elecsys® C-Peptide CalCheck™ (K040157). |
| Device Description | The Elecsys® CA 19-9 CalCheck™ is a lyophilized product consisting of CA 19-9 in a buffered human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels. |
| Intended use | Elecsys® CA 19-9 CalCheck™ is intended for use in the verification of the calibration established by the Elecsys® CA 19-9 reagent on the Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers. |
| | Continued on next page |

:

{1}------------------------------------------------

## 510(k) Summary, Continued

| Comparison to<br>predicate<br>device | The Elecsys® CA 19-9 CalCheck™ is substantially equivalent to the<br>currently marketed Elecsys® C-Peptide CalCheck™ (K040157). The below<br>tables compare Elecsys® CA 19-9 CalCheck™ with the predicate device,<br>Elecsys® C-Peptide CalCheck™ (K040157). |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

#### Similarities

| Characteristic | Elecsys® CA 19-9<br>CalCheck™ | Predicate device<br>Elecsys® C-Peptide<br>CalCheck™ |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Elecsys® CA 19-9<br>CalCheck™ is intended<br>for use in the verification<br>of the calibration<br>established by the<br>Elecsys® CA 19-9<br>reagent on the Elecsys®<br>1010/2010/MODULAR<br>ANALYTICS E170<br>immunoassay analyzers. | Elecsys® C-Peptide<br>CalCheck is intended for<br>use in the verification of<br>the calibration established<br>by the Elecsys® C-Peptide<br>reagent on the Elecsys®<br>immunoassay systems. |
| Levels | Three | same |
| Format | Lyophilized | same |
| Handling | Reconstitute with exactly<br>1.0 mL distilled or<br>deionized water and<br>allow standing closed for<br>15 minutes, then mixing<br>gently. | same |
| Stability | Unopened:<br>• Store at 2-8°C until<br>expiration date<br>Reconstituted:<br>• 20 - 25°C : 4 hrs | same |

Continued on next page

{2}------------------------------------------------

### 510(k) Summary, Continued

#### Differences

| Characteristic | Elecsys® CA 19-9<br>CalCheck™ | Predicate device<br>Elecsys® C-Peptide<br>CalCheck™ |
|----------------|-----------------------------------|-----------------------------------------------------|
| Matrix | Human serum with added<br>CA 19-9 | Buffered horse serum with<br>added C-Peptide |

______________________________________________________________________________________________________________________________________________________________________________

| Performance | The Elecsys® CA 19-9 CalCheck™ was evaluated for value assignment and |
|-----------------|-----------------------------------------------------------------------|
| Characteristics | stability. |

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circle around the caduceus symbol.

Public Health Service

JUL 6 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Roche Diagnostics Corp. c/o Ms Corina Harper 9115 Hague Rd. Indianapolis, IN 46250

Re: k051185

Trade/Device Name: Elecsys CA 19-9 CalCheck Regulation Number: 21 CFR 866.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: May 6, 2005 Received: May 9, 2005

Dear Ms Harper:

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 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 Part 801); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

{4}------------------------------------------------

Page 2 -

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html

Sincerely yours,

lobatz Beckerh

Robert L. Becker, Jr., MD, Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

#### Indications for Use

510(k) Number (if known): __K051185

Device Name:_Elecsys® CA_19-9 CalCheck™

Indications For Use:

The Elecsys® CA 19-9 CalCheck™ is intended for use in the verification of the calibration established by the Elecsys® CA 19-9 reagent on the Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.

Maria Chen

Division Sign-Off

Office of In Vitro Diagne Device Evaluation and Sately

510(k) K'o.s.j.i.l.s

Prescription Use XX = __

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 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)