ADVIA IMS LITHIUM ASSAY

K050374 · Bayer Healthcare, LLC · NDW · Jun 15, 2005 · Clinical Toxicology

Device Facts

• Record ID: K050374
• Device Name: ADVIA IMS LITHIUM ASSAY
• Applicant: Bayer Healthcare, LLC
• Product Code: NDW · Clinical Toxicology
• Decision Date: Jun 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3560
• Device Class: Class 2

Indications for Use

The Bayer ADVIA IMS Lithium (LITH) method is an in vitro diagnostic device intended to measure lithium in human serum and plasma. Such measurements are used as an aid in the treatment of bipolar disorder.

Device Story

ADVIA IMS Lithium method is an in vitro diagnostic assay for measuring lithium concentrations in human serum and plasma; used as an aid in monitoring lithium therapy for bipolar disorder. The assay is performed on the ADVIA IMS chemistry system. The system processes patient samples to provide quantitative lithium measurements within an analytical range of 0.10 - 3.00 mmol/L. Results are utilized by clinicians to assess therapeutic lithium levels and adjust patient treatment plans. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Performance evaluated via imprecision studies and method comparison. Imprecision (total CV) ranged from 1.8% to 2.3% for the ADVIA IMS system. Method comparison (N=49) against CDC Flame method yielded a regression equation of Y=1.045X-0.06 (R=0.997) and against ThermoTrace yielded Y=1.116X-0.09 (R=0.997) across a range of 0.3 - 2.8 mmol/L. Interference testing conducted for bilirubin, hemoglobin, and lipids.

Technological Characteristics

In vitro diagnostic reagent system for lithium measurement. Analytical range: 0.10 - 3.00 mmol/L. Designed for use on the ADVIA IMS chemistry analyzer platform. Utilizes standard clinical chemistry photometric or ion-selective methodology (implied by system type).

Indications for Use

Indicated for monitoring lithium levels in human serum and plasma in patients undergoing treatment for bipolar disorder.

Regulatory Classification

Identification

A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

Predicate Devices

• ThermoTrace Lithium (K013488)

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Lithium Method for ADVIA IMS

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.

Image /page/0/Picture/3 description: The image shows the text "The assigned 510(k) number is:" followed by the number K050374. The number is written in a large, bold font and is underlined. The text indicates that K050374 is a 510(k) number, which is a premarket submission made to the Food and Drug Administration (FDA) to demonstrate that the device to be marketed is safe and effective.

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#### 1. Intended Use

The Bayer ADVIA IMS Lithium (LITH) method is an in vitro diagnostic device intended to measure lithium in human serum and plasma. Such measurements are used as an aid in the treatment of bipolar disorder.

#### 2. Predicate Device

| Product Name | Reagent Part # | Calibrator Part # |
|---------------------|------------------|-------------------|
| ThermoTrace Lithium | TR66056, TR66028 | TR66901 |

#### 3. Device / Method

| Product Name | Reagent BAN # | Calibrator BAN # |
|-------------------|---------------|------------------|
| ADVIA IMS Lithium | 00416019 | 06798711 |

### A. Imprecision (serum)

| ADVIA IMS | | ThermoTrace | |
|-------------------|-----------------|-------------------|----------------|
| Level<br>(mmol/L) | Total<br>CV (%) | Level<br>(mmol/L) | Total<br>CV(%) |
| 1.15 | 2.3 | 1.00 | 3.9 |
| 2.06 | 1.8 | 2.49 | 3.6 |

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| Specimen type | Comparison<br>System (X) | N | Regression<br>Equation | Syx<br>(mmol/L) | R | Sample<br>Range<br>(mmol/L) |
|---------------|--------------------------|----|------------------------|-----------------|-------|-----------------------------|
| Serum | CDC Flame | 49 | Y=1.045X-0.06 | 0.06 | 0.997 | 0.3 - 2.8 |
| Serum | ThermoTrace | 49 | Y=1.116X-0.09 | 0.05 | 0.997 | 0.3 - 2.8 |

### B. Correlation (Y=ADVIA IMS, X=Comparison system)

### C. Interfering Substances

| Interfering<br>Substance | Interfering Sub.<br>Conc. (mg/dL) | Lithium Conc.<br>(mmol/L) | Effect<br>(% change) |
|-----------------------------|-----------------------------------|---------------------------|----------------------|
| Bilirubin<br>(unconjugated) | 30 | 1.08 | 6 |
| Bilirubin<br>(conjugated) | 30 | 0.99 | -2 |
| Hemoglobin | 1000 | 1.12 | -2 |
| Lipids<br>(Triglycerides) | 500 | 1.05 | -9 |

Analytical Range (serum/plasma): 0.10 - 3.00 mmol/L

Aran H. Zeller

2/9/2005
Date

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

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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 & Human Services. The logo consists of a stylized human figure with three arms or branches extending upwards, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.

JUN 1 5 2005

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k050374 Trade/Device Name: Lithium Assay for ADVIA IMS Assayed Chemistry Control 1 and Control 2 Chemistry Calibrator Regulation Number: 21 CFR 862.3560 Regulation Name: Lithium test system Regulatory Class: Class II Product Code: NDW, JIX, JJY Dated: May 23, 2005 Received: May 25, 2005

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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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,

Carol C. Benem

Carol C. Benson, M.A. Acting 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

Image /page/4/Picture/1 description: The image shows the text '510(k) Number:' followed by the number 'K050374'. The text is written in a clear, legible font. The number appears to be a reference or identification code, possibly related to a regulatory submission or approval process.

Device Name: Lithium Assay for the ADVIA IMS

Indications for Use:

The Bayer ADV/A IMS Lithium (LITH) method is an in vitro diagnostic device intended to measure lithium in human serum and plasma. Such measurements are used as an aid in monitoring lithium levels during the treatment of bipolar disorder.

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)

Alata Sato

ਤੇ Page 1 of

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K050374

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# Indications for Use

510(k) Number (if known):_

Device Name: Assayed Chemistry Control 1 and Control 2

Indications For Use:

The Assayed Chemistry Control 1 and Control 2 are for in vitro diagnostic use to monitor the performance of chemistry systems, including the ADVIA® IMS, ADVIA® Chemistry, and Technicon RA® and opeRA systems.

Prescription Use × (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)

Division Sign-On

Page 2 of 3

**Office of In Vitro**
**Device Evaluation**

510(K) K050374

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# Indications for Use

510(k) Number (if known):_

Device Name: Chemistry Calibrator

Indications For Use:

The Chemistry Calibrator is for in vitro diagnostic use in the calibration of chemistry assays on chemistry systems, including the ADVIA® IMS, ADVIA® Chemistry, and Technicon RA® and opeRA systems.

Prescription Use (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)

Nllet Cutz

**Division Sign-Out**

Office of In Vitro Diagno Devine Evaluation and S

510ik, _

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