LIPOPROTEIN FOR MULTIPLE ANALYTES

K051619 · Bayer Healthcare, LLC · JIX · Aug 1, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051619
• Device Name: LIPOPROTEIN FOR MULTIPLE ANALYTES
• Applicant: Bayer Healthcare, LLC
• Product Code: JIX · Clinical Chemistry
• Decision Date: Aug 1, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

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

Device Story

Lipoprotein Calibrator is a human serum-based solution containing human and nonhuman constituents; used to calibrate Apolipoprotein A1, Apolipoprotein B, and Direct HDL assays on ADVIA IMS Chemistry systems. Device provides six levels for apoA1 and apoB, and a single level for Direct HDL Cholesterol. Calibrator values for apoA1/apoB are traceable to WHO-IFCC international reference materials; Direct HDL values derived from human serum correlation studies versus National Cholesterol Education Program Designated Comparison Method. Product is lyophilized, stable for 24 months unopened at 2-8°C, and stable for 3 days at 2-8°C after reconstitution.

Clinical Evidence

No clinical data. Performance validated via bench testing of three separate lots of calibrator material to ensure stability and accuracy of assigned values.

Technological Characteristics

Lyophilized mixture of human and bovine serum base. Six levels for Apo A1/B; one level for Direct HDL. Stable at 2-8°C until expiration; stable 3 days post-reconstitution at 2-8°C. Used for calibration of ADVIA IMS Chemistry systems.

Indications for Use

Indicated for in vitro diagnostic calibration of Apolipoprotein A1, Apolipoprotein B, and Direct HDL assays on ADVIA IMS Chemistry systems. Prescription use only.

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

• Lipoprotein Calibrator (K031682)

Submission Summary (Full Text)

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## AUG 1 - 2002

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Lipoprotein Calibrator

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:

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

## 1. Submitter's name, address and telephone number:

Andres Holle Manager, Regulatory Affairs Bayer HealthCare LLC A subsidiary of Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591 TEL: [phone] FAX: [phone] Email: [e-mail]

#### 2. Name of the device:

| a) Classification Names: | Calibrator, §862.1150 | |
|--------------------------|-----------------------|--|
| Classification: | Class II | |
| Product Code: | 75 JIX | |

- b) Common name: Calibrator for multiple assays
- c) Proprietary name: Lipoprotein Calibrator
- d) The device:

| Product Name | Calibrator Part<br># / BAN Number |
|------------------------|-----------------------------------|
| Lipoprotein Calibrator | 00848903 |

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

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#### 3. Predicate Device:

| Product Name | Calibrator Part # |
|------------------------|-------------------|
| Lipoprotein Calibrator | 00848903 |

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

510(k) Number: K031682

#### 4. Description of the device:

The Lipoprotein Calibrator is a human serum based solution containing various non human and human constituents,

#### 5. Statement of Intended Use

Bayer Lipoprotein Calibrator is intended for in vitro diagnostic use to calibrate Apolipoprotein A1, Apolipoprotein B assays and Direct HDL 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.

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## 7. Substantial Equivalence:

| Feature | Predicate Lipoprotein<br>Calibrator (K031682) | Proposed Lipoprotein<br>Calibrator (addition of<br>assigned value for Direct<br>HDL Cholesterol Method) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Bayer Lipoprotein Calibrator<br>is intended for in vitro<br>diagnostic use to calibrate<br>apolipoprotein A1 and<br>apolipoprotein B assays on<br>the ADVIA IMS chemistry<br>systems | Bayer Lipoprotein Calibrator<br>is intended for in vitro<br>diagnostic use to calibrate<br>apolipoprotein A1,<br>apolipoprotein B and Direct<br>HDL cholesterol assays on<br>the ADVIA IMS chemistry<br>systems |
| Format | Lyophilized mixture of human<br>and bovine serum base to<br>which appropriate human and<br>bovine constituents have<br>been added to achieve<br>specific concentrations. | Same |
| Constituent Analytes | Apolipoprotein A1 Apolipoprotein B HDL Cholesterol* | Apolipoprotein A1 Apolipoprotein B HDL Cholesterol |
| Stability | Stable at 2-8°C until the<br>expiration date printed on<br>the label. Stable 3 days when<br>reconstituted according to<br>directions when<br>refrigerated at 2-8°C | Same |
| Levels | Six levels for Apolipoprotein<br>A1 and Apolipoprotein B | Six levels for Apolipoprotein<br>A1 and Apolipoprotein B and<br>a single level for the Direct<br>HDL Cholesterol method |

* Please note: The predicate device already contained HDL Cholesterol as an analyte so the manufacturing process did not change, however Bayer did not assign any values for Direct HDL Cholesterol method at the time of the predicate device submission.

ea 27

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

6/14/2005

Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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AUG 1 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k051619 Trade/Device Name: Lipoprotein for Multiple Analytes Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: June 9, 2005 Received: June 17, 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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cc: HFZ-401 DMC
D.O.

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# Indications for Use

510(k) Number (if known): K051619

Device Name: Lipoprotein Calibrator

Indications For Use:

The Bayer Lipoprotein Calibrator is intended for in vitro diagnostic use to The Bayer Lipoprotein Oalibrator in Internation in the Direct HDL assays on the ADVIA® IMS Chemistry 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)

AC

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K051619

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