ADVIA IMS CARBAMAZEPINE METHOD

K042808 · Bayer Healthcare, LLC · KLT · Feb 8, 2005 · Clinical Toxicology

Device Facts

• Record ID: K042808
• Device Name: ADVIA IMS CARBAMAZEPINE METHOD
• Applicant: Bayer Healthcare, LLC
• Product Code: KLT · Clinical Toxicology
• Decision Date: Feb 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3645
• Device Class: Class 2

Intended Use

This in vitro method is intended to quantitatively measure the antiepileptic drug carbamazepine in human serum and plasma on the Bayer ADVIA® IMS systems. Measurements of carbamazepine are used to aid in monitoring therapeutic levels of carbamazepine to ensure appropriate therapy and in the treatment of carbamazepine overdose.

Device Story

In vitro diagnostic assay for quantitative measurement of Carbamazepine in human serum and plasma; utilizes competitive, homogenous immunoassay with chemiluminescence and paramagnetic particles on Bayer ADVIA IMS Analyzer; intended for clinical laboratory use; provides quantitative results to clinicians for therapeutic drug monitoring and overdose management; aids in ensuring appropriate therapy.

Clinical Evidence

Bench testing only. Precision evaluated over 10 days (n=79-80, total CV 2.5-4.6%). Linearity confirmed 1-20 μg/mL. Method comparison with predicate (n=48) showed slope 1.00, r=0.988. Matrix equivalency (serum vs heparinized/EDTA plasma) showed high correlation (r=0.999). Analytical specificity tested against common antiepileptics and potential interferents (hemoglobin, bilirubin, triglycerides) with no significant effect.

Technological Characteristics

In vitro diagnostic immunoassay reagent and calibrator system. Designed for use on Bayer ADVIA IMS automated clinical chemistry analyzers. Analytical range: 0.20 µg/mL to 22.14 µg/mL. Quantitative measurement via automated photometric detection.

Indications for Use

Indicated for in vitro diagnostic quantitative measurement of carbamazepine in human serum and plasma to aid in monitoring therapeutic levels and treating overdose. Prescription use only.

Regulatory Classification

Identification

A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.

Predicate Devices

• Bayer Centaur Carbamazepine (K013488)

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS -- 516(R) SUMMART OF SALD For AND 21 2 000 -----------------------------------------------------------------------------------------------------------------------------------

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K042808 (leave blank)

### 1. Intended Use

This in vitro method is intended to quantitatively measure the antiepileptic drug carbamazepine in human serum and plasma on the Bayer ADVIA® IMS systems. Measurements of carbamazepine are used to aid in monitoring therapeutic levels of carbamazepine to ensure appropriate therapy and in the treatment of carbamazepine overdose.

#### Predicate Device 2.

| Product Name | Reagent Part # | Calibrator Part # |
|---------------|----------------|-------------------|
| Bayer Centaur | 07862715 | 05706449 |
| Carbamazepine | (119933) | (107585) |

#### Device / Method 3.

| <b>Product Name</b> | <b>Reagent</b> | <b>Calibrator</b> |
|----------------------------|----------------|-------------------|
| ADVIA IMS<br>Carbamazepine | 00328780 | 00417120 |

#### Performance 4.

### A. Minimum Detectable Concentration

| Method | ADVIA IMS | Centaur |
|--------|-----------------|-----------------|
| MDC | $0.20 \mu g/mL$ | $0.25 \mu g/mL$ |

#### B. Imprecision

| ADVIA IMS | |
|----------------|-----------------|
| Level<br>µg/mL | Total<br>CV (%) |
| 2.62 | 4.6 |
| 5.63 | 2.6 |
| 9.19 | 2.5 |

| Bayer Centaur | |
|----------------|----------------|
| Level<br>µg/mL | Total<br>CV(%) |
| 3.28 | 9.2 |
| 5.79 | 8.2 |
| 9.85 | 8.4 |

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| C. Correlation (Y-ADVIA IMS, X-Comparison system) | | | | | | |
|---------------------------------------------------|-----------------------|----|---------------------|-----------|-------|------------------------|
| Specimen type | Comparison System (X) | N | Regression Equation | Syx μg/mL | R | IMS Sample Range μg/mL |
| Serum | Centaur | 48 | $Y=1.00X + 0.01$ | 0.80 | 0.988 | 1.2 to 17.6 |

### C Correlation (V=ADVIA IMS. X = Comparison system)

### D. Interfering Substances

| Interfering<br>Substance | Interfering Sub.<br>Conc. (mg/dL) | Carbamazepine<br>Concentration<br>µg/mL | Effect<br>(% change) |
|-----------------------------|-----------------------------------|-----------------------------------------|----------------------|
| Bilirubin<br>(unconjugated) | 25 | 14.47 | 2.0 |
| Bilirubin<br>(conjugated) | 25 | 14.64 | -3.9 |
| Hemoglobin | 600 | 14.59 | -0.7 |
| Lipids<br>(Triglycerides) | 750 | 13.60 | -8.4 |

## E. Analytical Range

0.20 µg/mL to carbamazepine concentration in highest calibrator (Level 6) (22.14 µg/mL).

A. Auda

10/4/04
Date

Date

Andres Holle Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York, 10591 - 5097

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes extending from its head, representing health, human services, and the pursuit of well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB - 8 2005

Mr. Andres Holle Manager, Regulatory Affairs Bayer HealthCare LLC Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591

Re: k042808

Trade/Device Name: ADVIA® IMS Carbamazepine Method ADVIA® IMS Carbamazepine Calibrator Regulation Number: 21 CFR 862.3645 Regulation Name: Neuroleptic drugs radioreceptor assay test system Regulatory Class: Class II Product Code: KLT, DKB Dated: October 4, 2004 Received: October 13, 2004

Dear Mr. Holle:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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#### Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Jean M. Cooper MS, DUM

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: ADVIA® IMS Carbamazepine Method

Indications For Use:

The Bayer ADVIA IMS Carbamazepine method is for in vitro diagnostic use to The Bayer ADVIA The Ourbancepine in human serum and plasma. measure the anticplicplio drug carbarness, mazepine-5-carboxamide) are Measurements of ourbamazepine (17) (17) and treatment of carbamazepine overdose, and used as an ald in the diagnools and treamezepine to ensure appropriate therapy.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D)

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AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mert
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042808

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# Indications for Use

510(k) Number (if known): _ K042808

Device Name: ADVIA® IMS Carbamazepine Calibrator

Indications For Use:

The Bayer ADVIA IMS Carbamazepine calibrator is for in vitro diagnostic use in the calibration of carbamazepine using the ADVIA® IMS system.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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5100

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