TOX AMMONIA CALIBRATOR

K031683 · Bayer Healthcare, LLC · JIX · Aug 6, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031683
• Device Name: TOX AMMONIA CALIBRATOR
• Applicant: Bayer Healthcare, LLC
• Product Code: JIX · Clinical Chemistry
• Decision Date: Aug 6, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

Bayer ToxAmmonia calibrator is intended for in vitro diagnostic use to calibrate acetaminophen, ammonia, ethanol and salicylate assays on the ADVIA IMS Chemistry systems.

Device Story

ToxAmmonia Calibrator is a lyophilized mixture of human serum base with added nonhuman constituents; designed for use with ADVIA IMS Chemistry systems. Device serves as a calibration tool for clinical chemistry assays (acetaminophen, ammonia, ethanol, salicylate). Used in clinical laboratory settings by trained personnel. Provides specific analyte concentrations to calibrate system performance; ensures accuracy of patient sample testing. Reconstituted product stable for three days at 2-8°C.

Clinical Evidence

Bench testing only. Stability of calibrator values validated across three separate lots according to Bayer procedures.

Technological Characteristics

Lyophilized human serum base with nonhuman constituents. Reconstituted form stable for 3 days at 2-8°C. Designed for use with ADVIA IMS Chemistry systems. Traceability to reference materials.

Indications for Use

Indicated for in vitro diagnostic calibration of acetaminophen, ammonia, ethanol, and salicylate assays on ADVIA IMS Chemistry systems.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• SetPoint Chemistry Calibrator (K030169)

Submission Summary (Full Text)

{0}------------------------------------------------

## Assigned 510(k) number: K031683

## Bayer Healthcare

#### ToxAmmonia Calibrator

## Summary of Safety and Effectiveness

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

## 1. Submitter Information

Contact person:

Kenneth T. Edds Ph.D.

Address: Bayer Healthcare Diagnostics Division 511 Benedict Ave. Tarrytown, NY 10591

| Phone: | [phone] |
|---------|-----------------------|
| FAX: | [phone] |
| e-mail: | [e-mail] |

Date Summary Prepared:

2. Device Information

Proprietary Name: Common Name:

Toxammonia Calibrator Calibrator for multiple analytes

Classification Name: Class: CFR: Product Code:

Calibrator §862.1150. Class II 862.1150 75 JIX

August 6, 2003

Contract Manufacturing Site: Medical Analysis Systems, Inc. (MAS) 5300 Adolfo Rd. Camarillo, CA 93012

## 3. Predicate Device Information

Name: SetPoint Chemistry Calibrator

Contract Manufacturing Site: Fisher Diagnostics 8365 Valley Pike Middletown, VA 22645

510(k) Number:

## K030169

{1}------------------------------------------------

## 4. Device Description

The Toxammonia Calibrator is a human serum based solution containing various nonhuman constituents at defined concentrations.

## 5. Statement of Intended Use

Bayer Toxammonia Calibrator is intended for in vitro diagnostic use to calibrate Acetaminophen, Ammonia, Ethanol and Salicylate assays on the ADVIA IMS Chemistry systems.

## 6. Product Performance

The stability of the Toxammonia calibrator values has been validated according to Bayer procedures and is based on the results of three separate lots of calibrator material. The performance of the calibrator is similar to other products in commercial distribution intended for similar use.

| Characteristic | Bayer ToxAmmonia<br>Calibrator | Bayer SETpoint™<br>Calibrator for<br>Automated Systems |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Bayer ToxAmmonia<br>Calibrator is intended for<br><i>in vitro</i> diagnostic use to<br>calibrate acetaminophen,<br>ammonia, ethanol and<br>salicylate assays on the<br>ADVIA IMS chemistry<br>systems. | For use as a calibrator of<br>clinical chemistry assays<br>for automated analytical<br>procedures. |
| Format | Liquid human serum<br>albumin base to which<br>appropriate nonhuman<br>constituents have been<br>added to achieve specific<br>concentrations. | Lyophilized bovine serum<br>base to which<br>appropriate nonhuman<br>constituents have been<br>added to achieve specific<br>concentrations. |
| Stability | Stable at 2-8°C until<br>the expiration date<br>printed on label. Stable 3 days after<br>opening when<br>refrigerated at 2-8°C. | Stable at 2-8°C until<br>last day of the month<br>(expiration date)<br>printed on the label. Stable 48 hours when<br>reconstituted<br>according to<br>directions when<br>refrigerated at 2-8°C<br>and protected from<br>light with the<br>exception of total and<br>direct bilirubin, which |

## 7. Comparison to Predicate Device

{2}------------------------------------------------

| | | are stable for eight<br>hours. |
|--------|--------------|--------------------------------|
| Levels | Single Level | Single Level |

# Comparison of Constituent Analytes in predicate device and proposed Bayer ToxAmmonia Calibrator

| Bayer ToxAmmonia Calibrator<br>(New Device) | Bayer SETpoint™ Chemistry Calibrator<br>(Predicate Device) |
|---------------------------------------------|------------------------------------------------------------|
| ACETAMINOPHEN | ALBUMIN |
| AMMONIA | BILIRUBIN, DIRECT |
| ETHANOL | BILIRUBIN, TOTAL |
| SALICYLATE | CALCIUM |
| | CHOLESTEROL |
| | CREATININE |
| | GLUCOSE |
| | IRON |
| | MAGNESIUM |
| | PHOSPHORUS, INORGANIC |
| | TOTAL PROTEIN |
| | TRIGLYCERIDES |
| | UREA NITROGEN |
| | URIC ACID |
| | SODIUM |
| | POTASSIUM |
| | CHLORIDE |

{3}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle's head is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Kenneth T. Edds. Ph.D. Manager. Regulatory Affairs Bayer HealthCare 511 Benedict Avenue Tarrytown, New York 10591-5097

Re: k031683

> Trade/Device Name: ToxAmmonia Calibrator Regulation Number: 21 CFR § 862.1150 Regulation Name: Multianalyte Calibrator Regulatory Class: II Product Code: JIX Dated: May 23, 2003 Received: June 12, 2003

Dear Dr. Edds:

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.

AUG - 6 2003

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). 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.

{4}------------------------------------------------

Page 2 -

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/dsma/dsmamain.html.

Sincerely yours,

steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Page 1 of 1

510(k) Number: Қозы 683

Device Name: ToxAmmonia Calibrator

Indications for Use:

Bayer ToxAmmonia Calibrator is intended for in vitro diagnostic use to calibrate Acetaminophen, Ammonia, Ethanol and Salicylate assays on the ADVIA IMS Chemistry systems.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
| <i>Carol C Benson for Jean Cooper, DVM</i> |
| Division Sign-Off |

Office of In Vitro Diagnostic Device
Evaluation and Safety

| 510(k) | K031683 |
|---------------------------------------|------------------------|
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-CounterUse |

(Optional Format 1-2-96)