IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3

K020237 · Consolidated Technology · JJY · Mar 19, 2002 · Clinical Chemistry

Device Facts

• Record ID: K020237
• Device Name: IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3
• Applicant: Consolidated Technology
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

IMMUNOASSAY PLUS CONTROL is a lyophilized human serum based assayed quality control material intended to monitor the performance of serum immunoassay test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert.

Device Story

Immunoassay Plus Control is a lyophilized, human serum-based quality control material; contains 0.1% sodium azide; provided in 5.0 mL glass vials at three levels. Used in clinical laboratory settings to monitor performance of immunoassay and therapeutic drug test procedures. Healthcare providers use the control to verify the accuracy and precision of diagnostic test systems; results help ensure reliability of patient test outcomes. Benefits include standardized quality assurance for clinical laboratory testing.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Lyophilized human serum-based matrix; contains 0.1% sodium azide; 5 mL glass vial packaging; storage at 2-8°C. No software or electronic components.

Indications for Use

Indicated for use as a quality control material to monitor the performance of clinical immunoassay test procedures analyzing immunochemistries and therapeutic drugs in human serum. No specific patient population or contraindications are described.

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

• QUALITROL IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3 (510K 992939)

Submission Summary (Full Text)

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

## Product Performance and Substantial Equivalency

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: 1000237

MAR 1 9 2002

January 21, 2002

- Consolidated Technologies Submitter: 4401 Freidrich Lane Building 1, Suite 100 Austin, TX 78744 Phone: [phone] [phone] Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax:
Contact: Preparation date: Candice Betz

### Product name (trade & common):

| Proprietary: | IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3 |
|--------------|---------------------------------------------|
| Common: | Ligand Plus, Level 1,2, and 3 |

- MAS Immunoassay (IAC) Control, Levels 1,2, and 3 Also sold as: ICN Immunology 1,2
### Classification name:

Class I Product code: JJY

21 CFR 862:1660: Multi-Analyte Controls, All Kinds (Assayed and Unassayed)

### Predicate device:

QUALITROL IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3 (510K 992939)

### Device description:

IMMUNOASSAY PLUS CONTROL is designed to monitor the performance of test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert. Human origin components are added to a human serum based matrix.

The product contains 0.1% sodium azide.

IMMUNOASSAY PLUS CONTROL will be offered in three levels of 5.0 mL filled vials.

### Intended use:

IMMUNOASSAY PLUS CONTROL is a lyophilized human serum based assayed quality control material intended to monitor the performance of serum immunoassay test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert.

Labeling: Immunoassay Plus Control is sold labeled and unlabeled.

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

# Product Performance and Substantial Equivalency

510(k) Summary (continued)

### Comparative analysis:

The table below provides a summary of the technological characteristics between IMMUNOASSAY PLUS CONTROL and the predicate device.

| Device<br>Characteristic | IMMUNOASSAY PLUS<br>CONTROL | QUALITROL IMMUNOASSAY PLUS<br>CONTROL |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Assayed quality control serum for<br>monitoring performance of serum<br>immunoassay and therapeutic drug<br>test procedures. | Assayed quality control serum for<br>monitoring performance of serum<br>immunoassay and therapeutic druq<br>test procedures. |
| Matrix | Human Serum | Human Serum |
| Form | Lyophilized | Lyophilized |
| Vial | 5 mL glass | 5 mL glass |
| Analytes | 59 analytes of clinical significance<br>that may be found in serum. | 68 analytes of clinical significance<br>that may be found in serum. |
| Storage | 2-8°C | 2-8°C |
| Stability | Until expiration date noted on vial<br>label. | Until expiration date noted on vial<br>label. |

### Conclusions:

Conclusions.
The information provided in the pre-market notification demonstrates that MMUNASSAY PLUS The Information provided in the pro manoe readinate device, for which there is FDA carance. This equivalence was demonstrated through comparison of intended uses and physical properties to a equivalence was demonotiation supplied in the pre-market notification provides commercially available device. The information bupplied in safe and effective for the stated intended use.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top and left side. Inside the circle is a stylized image of an abstract human figure with three curved lines representing the body and head, and two curved lines representing the legs.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 9 2002

Ms. Candice Betz Quality Manager Consolidated Technologies 4401 Freidrich Lane Building 1, Suite 100 Austin, TX 78477-1832

Re: k020237

Trade/Device Name: Immunoassay Plus Control, Levels 1, 2, and 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I reserved Product Code: JJY Dated: February 18, 2002 Received: March 13, 2002

Dear Ms. Betz:

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.

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

Page 2 -

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

### INDICATIONS FOR USE STATEMENT

510K Number: K020237

#### Device name:

IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3

### Indications for use:

IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunoassay test procedures that analyze immunochemistries and theraputic drugs as listed in this package insert.

↓ Prescription use

Kim An

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number .. 6020237