BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL

K031644 · Bayer Healthcare, LLC · JJY · Jun 25, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031644
• Device Name: BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL
• Applicant: Bayer Healthcare, LLC
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 25, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Special Chemistry Controls are assayed control materials for in vitro diagnostic use to monitor the precision and accuracy of certain chemistry test procedures for the ADVIA Chemistry analyzers.

Device Story

Special Chemistry Controls are lyophilized, human serum-based quality control materials used to monitor precision and accuracy of chemistry assays on Bayer ADVIA Chemistry analyzers. The device is prepared from human serum with non-serum constituents added. It requires reconstitution with 5.0 mL of distilled water before use. The control is used by laboratory personnel in a clinical setting to verify the performance of chemistry test procedures. By comparing the measured values of the control against assigned values, clinicians can assess the reliability of patient test results, ensuring the accuracy of diagnostic testing for analytes including Acid Phosphatase, Lactate, Pancreatic Amylase, Lipase, and Cholinesterase.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Lyophilized human serum-based control material with added non-serum constituents. Requires reconstitution with 5.0 mL distilled water. Designed for use on Bayer ADVIA Chemistry analyzers. No software or electronic components.

Indications for Use

Indicated for in vitro diagnostic use to monitor the precision and accuracy of chemistry test procedures on ADVIA Chemistry systems.

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

• Bayer Special Chemistry Control (K030801)

Submission Summary (Full Text)

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# JUN 2 5 2003

### Summary of Safety and Effectiveness

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.

The assigned 510(k) Number is: K031644

# Submitter's Name and Address

Bayer Healthcare LLC 511 Benedict Avenue Tarrytown, NY 10591 Establishment Registration Number: 2432235

Contact Person: Andres Holle Telephone: [phone] Fax: [phone] e-mail: [e-mail]

### Contract Manufacturer

Randox Laboratories 55 Diamond Road Crumlin, County Antrim, UK Establishment Registration: 8020890

Device Name:

Special Chemistry Control

Proprietary/Trade Name

Common Name: Classification Name: Bayer ADVIA Chemistry Special Chemistry Control Quality Control Material Enzyme Controls (assayed and unassaved)

Classification: Class I Regulation Number: 21 CFR 862.1660 Panel: Chemistry (75) Product Code: JJY Predicate Device: Bayer Special Chemistry Control Premarket Notification Number: K030801

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## Device Description:

The Bayer Special Chemistry Controls are two separate levels of quality control material prepared from human serum with nonserum constituents added.

All the analytes currently in the control material are: Acid Phosphatase Lactate Pancreatic Amylase Lipase Cholinesterase

The intention of this submission is to add the assigned values to the labeling claims for: Cholinesterase

## Intended Use:

The Special Chemistry Controls are assayed control materials for in vitro diagnostic use to monitor the precision and accuracy of certain chemistry test procedures for the ADVIA Chemistry analyzers.

## Substantial Equivalence:

The Special Chemistry Controls are identical in intended use, storage and handling, stability, source material (human serum), and instructions for use as the previously cleared Special Chemistry Controls. The only difference in these controls is the addition of the assigned values in the labeling of a new analyte: Cholinesterase.

As with the predicate device, the control materials are lyophilized and require reconstitution with 5.0 mL distilled water. These controls are only for use on the Bayer Chemistry Analyzers.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 5 2003

Mr. Andres Holle Manager, Regulatory Affairs Bayer HealthCare LLC Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591-5097

k031644 Re:

> Trade/Device Name: Special Chemistry Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: May 22, 2003 Received: May 29, 2003

Dear Mr. Holle:

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); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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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 a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Special Chemistry Control

# Indications for Use:

For in vitro diagnostic use in the control of ADVIA Chemistry systems for certain chemistry methods.

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Concurrence of CDRH, Office of Device Evaluation

(ODE)

| Prescription Use Use | <span style="text-decoration: overline;">X</span> | OR | Over-The-Counter |
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| (Per 21 CFR 801.109) 1-2-96) | | | (Optional Format |

| | <div style="border-top: 1px solid black;">Division Sign-Off for Jean Cooper</div> |
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Office of In Vitro Diagnostic Device Evaluation and Safety

| 510(k) | <div style="border-bottom: 1px solid black;">K031644</div> |
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