BAYER LIGAND PLUS 1, 2, 3 CONTROLS

K030452 · Bayer Diagnostics Corp. · JJY · Mar 3, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030452
• Device Name: BAYER LIGAND PLUS 1, 2, 3 CONTROLS
• Applicant: Bayer Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 3, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Ligand Plus 1, 2, and 3 controls are assayed control materials for in vitro diagnostic use to monitor the precision and accuracy of immunochemistry test procedures for the ADVIA Centaur® andACS:180® Systems.

Device Story

Ligand Plus 1, 2, 3 Controls are lyophilized quality control materials derived from human serum; supplemented with non-serum constituents. Used in clinical laboratory settings to monitor precision and accuracy of immunochemistry assays on Bayer ADVIA Centaur and ACS:180 systems. Reconstituted with 5.0 mL reagent grade water before use. Provides reference values for various analytes, including newly added iPTH, Insulin, and c-Peptide. Healthcare providers compare system-generated test results against control values to verify instrument performance and assay reliability.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Lyophilized human serum-based control material. Requires reconstitution with 5.0 mL reagent grade water. Designed for use on ADVIA Centaur and ACS:180 immunochemistry systems. Contains multiple analytes including hormones, therapeutic drugs, and proteins.

Indications for Use

Indicated for in vitro diagnostic use as an assayed control material to monitor the precision and accuracy of immunochemistry test procedures on the ADVIA Centaur and ACS:180 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

• Ligand Plus 1,2,3 Controls (K901212)

Submission Summary (Full Text)

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#### 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:________________________________________________________________________________________________________________________________________________

MAR 0 3 2003

#### Submitter's Name and Address

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

Contact Person: Kenneth T. Edds, Ph.D. Telephone: [phone] Fax: [phone] e-mail: [e-mail]

## Contract Manufacturer

Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618 Establishment Registration: 2016706 Owner Operator Number: 9929003

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Ligand Plus 1,2,3 Controls Bayer Ligand Plus 1,2,3 Quality Control Material Enzyme Controls (assayed and unassayed) Class I 21 CFR 862.1660 Chemistry (75) JJY

#### Predicate Device:

Ligand Plus 1,2,3 Controls Premarket Notification Number: K901212

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#### Device Description:

The Ligand Plus 1, 2, 3 Controls are three separate levels of quality control material prepared from human serum with non-serum constituents added. The analytes currently in the control material are:

| Alphafetoprotein | Carbamazepine |
|------------------|---------------|
| CEA | Digoxin |
| Cortisol | Gentamicin |
| Estradiol | Phenobarbital |
| Ferritin | Phenytoin |
| Folic Acid | Theophylline |
| FSH | Tobramycin |
| HCG | Valproic Acid |
| IgE | Vancomycin |
| LH | |
| Progesterone | |
| Prolactin | |
| PSA | |
| T3 | |
| T3-free | |
| T4 | |
| T4-free | |
| Testosterone | |
| Thyroid Uptake | |
| TSH | |
| TSH-3 | |
| Vitamin B12 | |

The intention of this submission is to add the following three constituents to the existing control: Intact PTH (iPTH, or intact parathyroid hormone) Insulin c-Peptide

#### Intended Use:

The Ligand Plus 1, 2, and 3 controls are assayed control materials for in vitro diagnostic use to monitor the precision and accuracy of immunochemistry test procedures for the ADVIA Centaur® andACS:180® Systems.

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### Substantial Equivalence:

The Ligand Plus 1, 2, and 3 controls are identical in intended use, storage and handling, stability, source material (human serum), and instructions for use as the previously cleared Ligand Plus 1, 2, 3 Controls. The only difference in these controls is the addition of three new analytes: iPTH, Insulin, and c-Peptide.

As with the predicate device, the control material is lyophilized and requires reconstitution with 5.0 mL reagent grade water. These controls are only for use on the Bayer ADVIA Centaur and ACS:180 Systems.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above three wavy lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# MAR 0 3 2003

Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Baver HealthCare LLC Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591-5097

Re: k030452

> Trade/Device Name: Ligand Plus 1, 2, 3 Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: February 6, 2003 Received: February 11, 2003

Dear Dr. Edds:

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 (QS) 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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Page 1 of 1 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Ligand Plus1, 2, 3

#### Indications for Use:

Assayed control material for in vitro diagnostic use to monitor the precision and accuracy of immunochemistry test procedures for the ADVIA Centaur® andACS:180® Systems.

# (PLEASE DO NOT WRITE ELOW THIS LINE-CONTINUE ON ANOTHER PAGE, IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Sean Cooper

(Division Sign-Off) Division of Clinical Laboratory D 510(k) Number ________________________________________________________________________________________________________________________________________________________________