DGTX FLEX REAGENT CARTRIDGE, MODEL DF36

K990251 · Dade Behring, Inc. · LFM · Mar 31, 1999 · Clinical Toxicology

Device Facts

• Record ID: K990251
• Device Name: DGTX FLEX REAGENT CARTRIDGE, MODEL DF36
• Applicant: Dade Behring, Inc.
• Product Code: LFM · Clinical Toxicology
• Decision Date: Mar 31, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3300
• Device Class: Class 2

Intended Use

The DGTX Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure digitoxin in human serum and plasma. Measurements of digitoxin are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.

Device Story

DGTX Flex™ reagent cartridge is an in vitro diagnostic assay for use on the Dimension® clinical chemistry system. It measures digitoxin levels in human serum and plasma samples. The assay utilizes an affinity particle-mediated immunoassay technique: digitoxin in the sample binds to F(ab')2-β-galactosidase antibody conjugate; magnetic particles coated with ouabain bind free antibody-enzyme conjugate. Magnetic separation isolates the digitoxin-antibody-enzyme complex. The β-galactosidase activity is measured via hydrolysis of chlorophenol red-β-D galactopyranoside (CPRG) to chlorophenol red (CPR). The system uses a bichromatic (577, 700 nm) rate technique to measure absorbance changes proportional to digitoxin concentration. Operated by laboratory personnel in clinical settings, the output provides quantitative digitoxin levels to assist clinicians in managing digitoxin therapy and diagnosing overdose.

Clinical Evidence

Bench testing only. A split-sample comparison was performed between the DGTX Flex™ reagent cartridge and the predicate aca® DGTX assay using 93 clinical patient samples. Results showed a correlation coefficient of 0.952, a slope of 1.06, and an intercept of -0.6.

Technological Characteristics

In vitro diagnostic reagent cartridge for use on the Dimension® clinical chemistry system. Employs affinity particle-mediated immunoassay with monoclonal antibodies. Detection via bichromatic rate technique (577 nm and 700 nm).

Indications for Use

Indicated for the quantitative measurement of digitoxin in human serum and plasma for the diagnosis and treatment of digitoxin overdose and monitoring of therapeutic levels.

Regulatory Classification

Identification

A digitoxin test system is a device intended to measure digitoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.

Predicate Devices

• aca® Digitoxin Method (K891094)

Submission Summary (Full Text)

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

3/31/99

K990251

# DADE BEHRING

DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714

### Summary of Safety and Effectiveness Information

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.

| Submitter's Name: | Cathy P. Craft<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|--------------------------|-------------------------------------------------------------------------------|
| Date of Preparation: | 1/22/99 |
| Name of Product: | DGTX Flex™ reagent cartridge |
| FDA Classification Name: | Digitoxin Test System |
| Predicate Device: | aca® Digitoxin Method (K891094) |

Device Description: The digitoxin assay uses an immunoassay technique in which free and digitoxin-bound antibody-enzyme species are separated using magnetic particles. Digitoxin in the sample is bound by the F(ab')2-ß-galactosidase in the Antibody Conjugate reagent. Magnetic particles coated with the digitoxin analog ouabain are added to bind free (unbound) antibody-enzyme conjugate. The reaction mixture is then separated magnetically. Following separation, the supernatant containing the digitoxin-antibody-enzyme complex is transferred and mixed with a substrate. The ß-galactosidase (ß-gal) portion of the Digoxin-F(ab')2-βgalactosidase complex catalyzes the hydrolysis of chlorophenol red-β-D galactopyranoside (CPRG) to chlorophenol red (CPR). The change in absorbance at 577 nm due to the formation of CPR is directly proportional to -B-galactosida: e activity. Since ß-galactosidase is not present in serum, its activity is directly proportional to di ¿itoxin in the patient's sample and is measured using a bichromatic (577, 700 nm) rate technique.

Intended Use: The DGTX Flex™ reagent cartridge is used in the Dimension® clinical chemistry system to quantitatively measure digitoxin (DGTX) in human serum and plasma.

## Comparison to Predicate Device:

| Item | Dimension® DGTX | aca® DGTX |
|-------------|-------------------------------------------|-----------------------------------------|
| Sample Type | serum and plasma | serum |
| Antibody | monoclonal | polyclonal |
| Methodology | Affinity particle<br>mediated immunoassay | Affinity column<br>mediated immunoassay |
| Detection | Bichromatic rate<br>(577 and 700 nm) | Monochromatic rate<br>(405 nm) |

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

# Comments on Substantial Equivalence:

Split sample comparison between the DGTX Flex™ reagent cartridge on the Dimension® clinical chemistry system and the aca® DGTX assay gave a correlation coefficient of 0.952, slope of 1.06, and an intercept of -0.6 when tested with 93 clinical patient samples.

The DGTX Flex™ reagent cartridge is substantially equivalent in principle and Conclusion: performance to the aca® DGTX assay based on the split sample comparison discussed above.

Cathy P. Craft

Cathy P. Craft Regulatory Affairs and Compliance Manager Date:

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

MAR 3 1 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Cathy P. Craft Regulatory Affairs and Compliance Manager DADE BEHRING, INC. P.O. Box 6101 Newark, Delaware 19714

K990251 Re:

Trade Name: Digitoxin (DGTX) Flex™ Reagent Cartridge Regulatory Class: II Product Code: LFM Dated: January 22, 1999 Received: January 27, 1999

Dear Ms. Craft:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

#### Indications For Use Statement

Device Name: DGTX Flex™ reagent cartridge

## Indications for Use:

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

The DGTX Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure digitoxin in human serum and plasma. Measurements of digitoxin are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.

Sean Cooper

(Division Sign-Off) Division of Clinical Laboratory Devices K 990251 510(k) Number

Cathy P. Craft Regulatory Affairs and Compliance Manager

January 22, 1999

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-the-counter Use_

(Optional format 1-2-96)