EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229

K011620 · Syva Co., Dade Behring, Inc. · LAN · Jun 18, 2001 · Clinical Toxicology

Device Facts

• Record ID: K011620
• Device Name: EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
• Applicant: Syva Co., Dade Behring, Inc.
• Product Code: LAN · Clinical Toxicology
• Decision Date: Jun 18, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3320
• Device Class: Class 2

Intended Use

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

Device Story

Homogeneous enzyme immunoassay for quantitative analysis of N-Acetylprocainamide in human serum or plasma; reagents packaged for use on OLYMPUS® AU400/600™, AU800/1000™, and AU2700™ series analyzers. Device utilizes barcode-labeled HDPE wedge-shaped reagent bottles. Clinical laboratory personnel operate analyzers to measure drug concentrations; results assist clinicians in monitoring therapeutic levels or managing overdose cases.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design comparison.

Technological Characteristics

Homogeneous enzyme immunoassay; HDPE reagent bottles; barcode-labeled; compatible with OLYMPUS® AU series analyzers.

Indications for Use

Indicated for quantitative analysis of N-Acetylprocainamide in human serum or plasma to aid in diagnosis and treatment of overdose or monitoring therapeutic levels.

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 N-Acetylprocainamide Assay (K011620)

Submission Summary (Full Text)

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K0 11620

## JUN 1 8 2001

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Emit® 2000 N-Acetylprocainamide Assay

### 1. Manufacturer and Contact Information:

Manufacturer:

Syva Company - Dade Behring Inc. 20400 Mariani Ave. Cupertino, CA 95014

Contact Information:

Cynthia Arredondo Requlatory Affairs Syva Company - Dade Behring, Inc. 3403 Yerba Buena Road San Jose, CA 95135 Tel: 408 - 239 - 2671 Fax: 408 - 239 - 2348

- Date Summary Prepared: 2. May 24, 2001
#### 3. Device Trade Name:

Emit® 2000 N-Acetylprocainamide Assay

#### 4. Common Name:

Enzyme Immunoassay, N-Acetylprocainamide

#### 5. Device Classification Name:

The Clinical Chemistry and Clinical Toxicology Devices Panel have classified "N-Acetylprocainamide test system" as Class II, 21 CFR Part 862. 3450.

#### 6. Intended Use:

The Emit® 2000 N-Acetylprocainamide Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of N-Acetylprocainamide 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 N-Acety|procainamide Assay is substantially equivalent to the predicate Emit® 2000 N-AcetyIprocainamide Assay.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# JUN 1 8 2001

Ms. Cynthia Arredondo Regulatory Affairs Syva Company - Dade Behring Inc. 3403 Yerba Buena Road San Jose, CA 95135

510(K) Number: K011620 Re: Trade/Device Name: Emit® 2000 N-Acetylprocainamide Assay Regulation Number: 862.3450 Regulatory Class: II Product Code: LAN Dated: May 24, 2001 Received: May 25, 2001

Dear Ms. Arredondo:

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.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket This icitication. The FDA finding of substantial equivalence of your device to a legally marketed notification. The I Dri inding of bassification 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 If you desire specific acrise to jiagnostic devices), please contact the Office of Compliance at additionally 607.10 for in This chargestions on the promotion and advertising of your device, [phone]. predac one of the orelov creference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on your responsibilities as a mober [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

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## Indications for Use Statement

#### Device Name: Emit® 2000 N-Acetylprocainamide Assay 510(k) Number (if known): Koll620

### Indications for Use:

The Emit® 2000 N-Acetylprocainamide Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of N-Acetylprocainamide in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of N-Acetylprocainamide overdose or in monitoring levels of N-Acetylprocainamide 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
510(k) Number K011620

510(k) Number.

(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)