IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT

K974110 · Beckman Instruments, Inc. · JBQ · Dec 24, 1997 · Hematology

Device Facts

• Record ID: K974110
• Device Name: IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: JBQ · Hematology
• Decision Date: Dec 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7060
• Device Class: Class 2

Intended Use

The IMMAGE Immunochemistry System Antithrombin III (AT3) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human Antithrombin III by rate nephelometry.

Device Story

The IMMAGE Immunochemistry System Antithrombin III (AT3) Reagent is an in vitro diagnostic reagent used with the Beckman IMMAGE Immunochemistry System and Beckman Calibrator 2. It utilizes rate nephelometry to measure Antithrombin III concentrations in human plasma samples. The system automates the assay process, providing quantitative results that clinicians use to monitor heparin therapy and assess thrombophilia. The device is intended for professional use in clinical laboratory settings. By measuring Antithrombin III levels, the system assists healthcare providers in managing anticoagulant therapy and identifying coagulation disorders, potentially improving patient outcomes in thrombotic conditions.

Clinical Evidence

Bench testing only. Method comparison study (n=136 plasma samples) between IMMAGE AT3 Reagent and Array 360 System AT3 Reagent showed a slope of 1.088, intercept of -0.10, and correlation coefficient (r) of 0.996. Stability studies confirmed a 24-month shelf-life and 14-day open container/calibration stability.

Technological Characteristics

Rate nephelometry assay; goat-derived antibodies; liquid reagent format. Designed for use on the automated IMMAGE Immunochemistry System. No specific materials or software algorithm architecture details provided beyond standard clinical chemistry instrumentation requirements.

Indications for Use

Indicated for quantitative determination of human Antithrombin III in plasma to monitor heparin administration in thrombosis treatment and to diagnose thrombophilia (congenital Antithrombin III deficiency).

Regulatory Classification

Identification

An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

Predicate Devices

• Array Systems Antithrombin III(AT3) (K901977)

Reference Devices

• Array 360 System (used in method comparison)

Submission Summary (Full Text)

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# DEC 2 4 1997

### Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Antithrombin III (AT3) Reagent

#### 1.0 Submitted By:

Annette Hellie Sr. Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted:

October 30, 1997

#### 3.0 Device Name(s):

## 3.1 Proprietary Names

IMMAGE™ Immunochemistry System Antithrombin III (AT3) Reagent

#### Classification Name 3.2

Antithrombin III assay (21 CFR § 864.7060)

#### 4.0 Predicate Device(s):

| IMMAGE System<br>Reagent | Predicate | Manufacturer | Docket<br>Number |
|-----------------------------------------|----------------------------------------|------------------------------|------------------|
| IMMAGE System<br>Antithrombin III (AT3) | Array Systems<br>Antithrombin III(AT3) | Beckman Instruments,<br>Inc. | K901977 |

#### 5.0 Description:

The IMMAGE Immunochemistry System AT3 Reagent, in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of Antithrombin III concentrations on Beckman's IMMAGE Immunochemistry System.

#### 6.0 Intended Use:

The IMMAGE Immunochemistry System Antithrombin III (AT3) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human Antithrombin III by rate nephelometry.

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#### Comparison to Predicate(s): 7.0

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

| Reagent | Aspect/Characteristic | Comments |
|---------------------------|---------------------------|------------------------------------------------------------------------------------------------|
| SIMILARITIES | | |
| IMMAGE System AT3 Reagent | Analytic Range | Same as<br>Beckman Antithrombin III reagent |
| | Nephelometric methodology | |
| | Antibody source (goat) | |
| DIFFERENCES | | |
| IMMAGE System AT3 Reagent | Buffer/Reagent volumes | IMMAGE System uses half of the<br>volumes than are utilized by the Array<br>System for AT3. |
| | Antibody concentration | IMMAGE AT3 has a higher antibody<br>concentration than the Beckman<br>Antithrombin III reagent |

#### Summary of Performance Data: 8.0

.

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from the Beckman Reagent on the Array® 360 System to the IMMAGE System Reagent.

### Method Comparison Study Results IMMAGE Antithrombin III (AT3) Reagent

| Analyte | Sample<br>Type | Slope | Intercept | r | n | Predicate Method |
|-----------------------|----------------|-------|-----------|-------|-----|---------------------------------|
| IMMAGE AT3<br>Reagent | plasma | 1.088 | -0.10 | 0.996 | 136 | Array 360 System<br>AT3 Reagent |

### Stability Study Results

| Reagent | Product Claim |
|------------|----------------------------------------------------------------------------------------|
| IMMAGE AT3 | 24 month shelf-life<br>14 day open container stability<br>14 day calibration stability |

### Estimated Imprecision

| <br><br><br>. Fall . Fall 24 . 1 . 1 . 1<br><br><br><br><br><br><br><br><br><br>.<br>STATIST AND CHARACT FOR THE FOR THE FITT | <br><br><br><br><br><br><br><br><br><br><br><br>SELECTRES ENRESERSEMENT FREEDE<br><br> | <br><br><br><br><br><br><br><br><br><br><br><br> | .<br><br><br><br><br><br><br><br>111 FA 1 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 | <br><br><br><br><br><br><br> |
|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| | | Within-Run Imprecision | | |
| | | | | |
| | | | | |
| evel 3<br>LANT OR BOOK IL AN OR LEAR LEAR LEASE OF CHARACT CHA | | | | |

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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510(k) Number (if known):

Device Name: IMMAGE™ Immunochemistry System Antithrombin III (AT3) Reagent

Indications for Use:

The IMMAGE Immunochemistry System Antithrombin III (AT3) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human Antithrombin III by rate nephelometry.

21 CFR 864.7060 Antithrombin III assay

(a) Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coaqulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

(b) Classification. Class II (performance standards).

L.M. Cesark of the Air Marong

Division Sign-O Division of Clinical Laboratory Devices 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

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2 1 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Annette Hellie · Senior Requlatory Specialist Beckman Instruments, Inc. 200 S. Kraemer Boulevard, W-104 P.O. Box 8000 92822-8000 Brea, California

Re : K974110 IMAGE™ System Antithrombin III (AT3) Reagent Requlatory Class: II Product Code: DDQ, JBQ Dated: December 11, 1997 Received: December 12, 1997

Dear Ms. Hellie:

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 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 reqistration, 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 Requlations, 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 requlatory In addition, FDA may publish further announcements action. 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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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 marroos process 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 compreadios and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to the regulation chercred, "Mibranding by 10ther 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/dsmamain.html".

Sincerely yours,
Steven Sitman

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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of page

510(k) Number (if known):

Device Name: IMMAGE™ Immunochemistry System Antithrombin III (AT3) Reagent

Indications for Use:

The IMMAGE Immunochemistry System Antithrombin III (AT3) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human Antithrombin III by rate nephelometry.

21 CFR 864.7060 Antithrombin III assay

(a) Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

(b) Classification. Class II (performance standards).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|---------------------|--|
|---------------------|--|

Division of Clinical Laboratory Devices

| 510(k) Number | K974110 |
|---------------|---------|
|---------------|---------|

Prescription Use (per 21 CFR 801.109)

్రాఫ్ట్

OR

Over-the-Counter Use Optional Format 1-2-96