LIPOPROTEIN CALIBRATOR

K031682 · Bayer Healthcare, LLC · JIX · Jun 25, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031682
• Device Name: LIPOPROTEIN CALIBRATOR
• Applicant: Bayer Healthcare, LLC
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jun 25, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

Bayer Lipoprotein Calibrator is intended for in vitro diagnostic use to calibrate Apolipoprotein A1 and Apolipoprotein B assays on the ADVIA IMS Chemistry systems.

Device Story

Lipoprotein Calibrator is a human serum-based, lyophilized solution containing nonhuman constituents at defined concentrations. Used in clinical laboratory settings to calibrate Apolipoprotein A1 and Apolipoprotein B assays on ADVIA IMS Chemistry systems. The calibrator ensures accuracy of clinical chemistry assays by providing known reference values for the instrument. Stability is maintained at 2-8°C until expiration; once reconstituted, it remains stable for 3 days under refrigeration. The device is intended for professional use by laboratory personnel.

Clinical Evidence

No clinical data. Performance is based on bench testing, specifically stability validation of three separate lots of calibrator material.

Technological Characteristics

Lyophilized mixture of human and bovine serum base with added human constituents. Single-level format. Designed for use with ADVIA IMS Chemistry systems. Stable at 2-8°C; 3-day stability when reconstituted and refrigerated.

Indications for Use

Indicated for in vitro diagnostic calibration of Apolipoprotein A1 and Apolipoprotein B assays on ADVIA IMS Chemistry systems. No specific patient population or contraindications described.

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)

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Assigned 510(k) number: k031682

# Bayer Healthcare Lipoprotein Calibrator Summary of Safety and Effectiveness

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

#### 1. Submitter Information

Kenneth T. Edds Ph.D. Contact person: Address: Baver 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:

Lipoprotein Calibrator Calibrator for multiple analytes

Classification Name: Class: CFR: Product Code:

Calibrator §862.1150. Class II 862.1150 75 JIX

May 21, 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

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## 4. Device Description

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

#### 5. Statement of Intended Use

Bayer Lipoprotein Calibrator is intended for in vitro diagnostic use to calibrate Apolipoprotein A1 and Apolipoprotein B assays on the ADVIA IMS Chemistry systems.

## 6. Product Performance

The stability of the Lipoprotein 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 Lipoprotein<br>Calibrator | Bayer SETpoint™<br>Calibrator for Automated<br>Systems |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Bayer Lipoprotein<br>Calibrator is intended for in<br>vitro diagnostic use to<br>calibrate apolipoprotein A1<br>and apolipoprotein B<br>assays on the ADVIA IMS<br>chemistry systems. | For use as a calibrator of<br>clinical chemistry assays for<br>automated analytical<br>procedures. |
| Format | Lyophilized mixture of<br>human and bovine serum<br>base to which appropriate<br>human constituents have<br>been added to achieve<br>specific concentrations. | Lyophilized bovine serum<br>base to which appropriate<br>nonhuman constituents<br>have been added to<br>achieve specific<br>concentrations. |
| Stability | Stable at 2-8°C until the<br>expiration date printed<br>on label. Stable 3 days when<br>reconstituted according<br>to directions when<br>refrigerated at 2-8°C. | Stable at 2-8°C until last<br>day of the month<br>(expiration date) printed<br>on the label. Stable 48 hours when<br>reconstituted according<br>to directions when<br>refrigerated at 2-8°C<br>and protected from light<br>with the exception of<br>total and direct bilirubin,<br>which are stable for<br>eight hours. |
| Levels | Single Level | Single Level |

#### 7. Comparison to Predicate Device

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Comparison of predicate device and proposed Bayer Lipoprotein Calibrator

| Bayer Lipoprotein Calibrator<br>(New Device) | Bayer SETpoint™ Chemistry Calibrator<br>(Predicate Device) |
|----------------------------------------------|------------------------------------------------------------|
| APOLIPOPROTEIN A1 | ALBUMIN |
| APOLIPOPROTEIN B | BILIRUBIN, DIRECT |
| | BILIRUBIN, TOTAL |
| | CALCIUM |
| | CHOLESTEROL |
| | CREATININE |
| | GLUCOSE |
| | IRON |
| | MAGNESIUM |
| | PHOSPHORUS, INORGANIC |
| | TOTAL PROTEIN |
| | TRIGLYCERIDES |
| | UREA NITROGEN |
| | URIC ACID |
| | SODIUM |
| | POTASSIUM |
| | CHLORIDE |

# Constituent Analytes

and and the management of the same of the same of the same of the same of the same of

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 5 2003

Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer HealthCare LLC Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591-5097

Re: k031682

> Trade/Device Name: Lipoprotein Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: May 23, 2003 Received: May 30, 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.

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/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

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

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Page __ of _1

510(k) Number: K () 31682

Device Name: Lipoprotein Calibrator

Indications for Use:

Bayer Lipoprotein Calibrator is intended for in vitro diagnostic use to calibrate Apolipoprotein A1 and Apolipoprotein B 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)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-CounterUse

(Optional Format 1-2-96)

Allent Smith
Division Sign-Off for Jean C

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k031682