EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229

K011920 · Syva Co., Dade Behring, Inc. · KXT · Jul 2, 2001 · Clinical Toxicology

Device Facts

• Record ID: K011920
• Device Name: EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229
• Applicant: Syva Co., Dade Behring, Inc.
• Product Code: KXT · Clinical Toxicology
• Decision Date: Jul 2, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3320
• Device Class: Class 2

Intended Use

The Emit® 2000 Digoxin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of digoxin in human serum or plasma. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.

Device Story

The Emit® 2000 Digoxin Assay is a homogeneous enzyme immunoassay used for the quantitative measurement of digoxin in human serum or plasma. The assay utilizes specific reagents packaged in HDPE wedge-shaped bottles, which are compatible with OLYMPUS® AU400/600™, AU800/1000™, and AU2700™ series analyzers. The reagent bottles include barcode labels containing assay-specific information for automated processing. The device is intended for clinical laboratory use to assist healthcare providers in managing digoxin therapy and identifying potential overdose. By providing accurate serum or plasma digoxin concentrations, the assay supports clinical decision-making regarding dosage adjustments and toxicity assessment, ultimately benefiting patients by maintaining therapeutic drug levels.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical operating principles, design, and performance characteristics to the predicate device.

Technological Characteristics

Homogeneous enzyme immunoassay. Reagents packaged in HDPE wedge-shaped bottles with barcode labels. Compatible with OLYMPUS® AU400/600™, AU800/1000™, and AU2700™ series analyzers.

Indications for Use

Indicated for quantitative analysis of digoxin in human serum or plasma to aid in the diagnosis and treatment of digoxin overdose or to monitor digoxin levels to ensure appropriate therapy.

Regulatory Classification

Identification

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

Predicate Devices

• Emit® 2000 Digoxin Assay (K011920)

Submission Summary (Full Text)

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K011920

# JUL - 2 2001

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Emit® 2000 Digoxin Assay

#### Manufacturer and Contact Information: ﮩ

| Manufacturer: | Syva Company – Dade Behring Inc.<br>20400 Mariani Ave.<br>Cupertino, CA 95014 |
|---------------|-------------------------------------------------------------------------------|
|---------------|-------------------------------------------------------------------------------|

Susan L. Collins Contact Information: Regulatory Affairs Syva Company - Dade Behring, Inc. 20400 Mariani Avenue Cupertino, CA 95014 Tel: 408 - 366-3908 Fax: 408 - 366-3725

- Date Summary Prepared: 2. June 19, 2001
#### Device Trade Name: 3. Emit® 2000 Digoxin Assay

#### Common Name: ৰ্ব Enzyme Immunoassay, Digoxin

### 5. Device Classification Name:

The Clinical Chemistry and Clinical Toxicology Devices Panel have classified "Digoxin test system" as Class II, 21 CFR Part 862.3320, 91 KXT.

#### 6. Intended Use:

The Emit® 2000 Digoxin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of digoxin in human serum or plasma. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.

#### 7. Device Description:

The modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles. Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.

#### 8. Substantial Equivalence

The modified device has the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device. In conclusion the modified Emit® 2000 Digoxin Assay is substantially equivalent to the predicate Emit® 2000 Digoxin Assay.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL - 2 2001

Ms. Susan L. Collins Regulatory Affairs Syva Company - Dade Behring Inc. 20400 Mariani Avenue Cupertino, CA 95014

510(k) Number: K011920 Re: Trade/Device Name: Emit® 2000 Digoxin Assay Regulation Number: 862.3320 Regulatory Class: II Product Code: KXT Dated: June 19, 2001 Received: June 20, 2001

Dear Ms. Collins:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have love have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, 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 (Frenances in provide in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing 11 becommany of a variaes: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

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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 noutication. The FDA inding of baction 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 CFF Part 801 and IT you desire specific advice to: your as ic devices), please contact the Office of Compliance at additionally 607.10 for in This dagliestions on the promotion and advertising of your device, [phone]. Additionally, for quose 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 Information on your responsionnel tax toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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

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## Indications for Use Statement

#### Device Name: Emit® 2000 Digoxin Assay 510(k) Number (if known): Koll920

## Indications for Use:

The Emit® 2000 Digoxin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of digoxin in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of digoxin overdose or in monitoring levels of digoxin to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.

Fred Lacy

(Division Sign-Off) Division of Clinical Laboratory Devices Koll920 510(k) Number

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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)