EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229

K011605 · Syva Co., Dade Behring, Inc. · LBZ · Jun 12, 2001 · Clinical Toxicology

Device Facts

• Record ID: K011605
• Device Name: EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229
• Applicant: Syva Co., Dade Behring, Inc.
• Product Code: LBZ · Clinical Toxicology
• Decision Date: Jun 12, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3320
• Device Class: Class 2

Intended Use

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

Device Story

The Emit® 2000 Quinidine Assay is a homogeneous enzyme immunoassay for the quantitative measurement of quinidine in human serum or plasma. The device utilizes specific reagents packaged for use on OLYMPUS® AU series analyzers. The assay is intended for clinical laboratory use to assist in diagnosing quinidine overdose and monitoring therapeutic drug levels. The modified version features smaller reagent fill volumes in wedge-shaped HDPE bottles, which include barcode labels for automated identification by the analyzer. The device operates on the same principles as the predicate, providing clinicians with quantitative data to adjust patient dosage or identify toxicity, thereby optimizing therapeutic outcomes.

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. No specific software algorithm class or energy source details provided beyond standard clinical chemistry analyzer integration.

Indications for Use

Indicated for the quantitative analysis of quinidine in human serum or plasma to aid in the diagnosis and treatment of quinidine overdose or to monitor quinidine levels for therapeutic management.

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 Quinidine Assay (K011605)

Submission Summary (Full Text)

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# JUN 1 2 2001

KO11605

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

#### 1. Manufacturer and Contact Information:

Manufacturer:

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

Contact Information:

Susan L. Collins Requiatory Affairs Syva Company - Dade Behring, Inc. 3403 Yerba Buena Road San Jose, CA 95135 Tel: 408 - 239 - 4412 Fax: 408 - 239 - 2348

- 2. Date Summary Prepared: May 22, 2001
- 3. Device Trade Name: Emit® 2000 Quinidine Assay
- 4. Common Name: Enzyme Immunoassay, Quinidine

#### 5. Device Classification Name:

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

#### 6. Intended Use:

The Emit® 2000 Quinidine Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of quinidine 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 Quinidine Assay is substantially equivalent to the predicate Emit® 2000 Quinidine Assay.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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JUN 1 2 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Susan L. Collins Regulatory Affairs Syva Company-Dade Behring Inc. 3403 Yerba Buena Road San Jose, CA 95135

510(k) Number: K011605 Re: Trade/Device Name: Emit® 2000 Quinidine Assay Regulation Number: 862.3320 Regulatory Class: II Product Code: LBZ Dated: May 22, 2001 Received: May 24, 2001

Dear Ms. Collins:

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 to 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 Good Manufacturing Practice for Medical Devices: 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 I his letter will anow you to organizatial equivalence of your device to a legally marketed noutication. The I D7X Incing of backing 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 additionally 607.10 for in This alagitestions on the promotion and advertising of your device, [phone]. Frauncently, at [phone]. Also, please note the regulation prease condor and office creference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mionitation on your responsibility the 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

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# Indications for Use Statement

Device Name: Emit® 2000 Quinidine Assay 510(k) Number (if known): KO11605

## Indications for Use:

The Emit® 2000 Quinidine Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of quinidine in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of quinidine overdose or in monitoring levels of quinidine 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 K011605 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)