VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM

K063144 · Ortho-Clinical Diagnostics, Inc. · JJE · Nov 13, 2006 · Clinical Chemistry

Device Facts

• Record ID: K063144
• Device Name: VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: JJE · Clinical Chemistry
• Decision Date: Nov 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.2160
• Device Class: Class 1

Intended Use

The VITROS Chemistry Products dHDL assay is intended for the in vitro quantitative measurement of HDL cholesterol in human serum or plasma. The VITROS 5,1 FS Chemistry System with enGen™ Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)

Device Story

The VITROS Chemistry Products dHDL assay utilizes a reagent pack, calibrator kit 19, and FS calibrator 1, processed by the VITROS 5,1 FS Chemistry System integrated with the enGen Laboratory Automation System. The system performs spectrophotometric analysis on human serum or plasma samples. The Laboratory Automation System manages pre-analytical and post-analytical sample handling and data. The device is used in clinical laboratory settings by trained personnel. Output consists of quantitative HDL cholesterol measurements, which healthcare providers use to assess lipid profiles and inform clinical decision-making regarding cardiovascular health and patient management.

Clinical Evidence

Bench testing only; no clinical data provided. Verification and validation activities performed per design control requirements to assess impact of enGen system integration.

Technological Characteristics

System utilizes spectrophotometric liquid reagent methods for HDL cholesterol measurement. Integrates chemistry analyzer with laboratory automation for sample/data management. Operates via discrete photometric analysis. Reagents and calibrators are specific to the VITROS platform.

Indications for Use

Indicated for in vitro quantitative measurement of HDL cholesterol in human serum or plasma for clinical diagnostic purposes. Prescription use only.

Regulatory Classification

Identification

A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

Predicate Devices

• VITROS 5,1 FS Chemistry System (K063144)

Submission Summary (Full Text)

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## 510(k) Summary

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

The assigned 510(k) number is: K063144.

| Submitter | Ortho-Clinical Diagnostics, Inc.<br>100 Indigo Creek Drive MC00881<br>Rochester, New York 14626-5101 | NOV 13 2006 |
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Sarah Parsons Contact Person: Phone: [phone] FAX: [phone] Email: [e-mail]

October 13, 2006 Preparation date

Trade or Proprietary Name:

VITROS Chemistry Products dHDL Reagent Pack VITROS Chemistry Products Calibrator Kit 19 VITROS Chemistry Products FS Calibrator 1 VITROS® 5,1 FS Chemistry System / enGen™ Laboratory Automation System

- HDL Cholesterol assay Common Name: Clinical Chemistry Analyzer / Laboratory Automation System
- Classification Name: Lipoprotein test system: 21 CFR 862.1475 Calibrator: 21 CFR 862.1150 Discrete photometric chemistry analyzer for clinical use: 21 CFR 862.2160

Device Intended Use: The VITROS Chemistry Products dHDL assay is intended for the in vitro quantitative measurement of HDL cholesterol in human serum or plasma.

> The VITROS 5,1 FS Chemistry System with enGen™ Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)

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- The modified device is the VITROS Chemistry Products dHDL Device description: Reagent Pack, VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1 which are combined by the VITROS 5,1 FS Chemistry System with enGen Laboratory Automation System to perform the VITROS dHDL assay for HDL cholesterol. The VITROS HDL assay has not been changed.
The VITROS 5.1 FS Chemistry System (instrumentation, which provides automated use of chemistry reagents) is interfaced to a Laboratory Automation System, which conducts pre-analytical and post-analytical sample and data management.

The modified device has the same intended use, Substantial Equivalence fundamental scientific technology and operating principle as the predicate device. The VITROS dHDL assay performed on the VITROS® 5,1 FS Chemistry System with enGen™ Laboratory Automation System is substantially equivalent to the VITROS dHDL assay performed on the VITROS® 5,1 FS Chemistry System.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing to the right. The eagle is rendered in black and white. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Sarah Parsons Manager, Regulatory Affairs Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101

NOV 1 3 2006

k063144 Re:

K0051 Trade/Device Name: VITROS Chemistry Products dHDL Reagent Pack Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: LBR, JIT, JJE Dated: October 13, 2006 Received: October 16, 2006

Dear Ms. Parsons:

We have reviewed your Section 510(k) premarket notification of intent to market the device wfo nave reveal 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 for associated in the encreases)77 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, de neces that have been room require approval of a premarket approval application (PMA). and Oosmetic Prove, market the device, subject to the general controls provisions of the Act. The r ou may , most 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 it may be subject to bach adde 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 or any I oderal bathe 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,

Albert Gutt

Alberto Gutierrez, Ph.D. 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: Instrument with Automation and Assay.

510(k) Number (if known): K063144 VITROS 5,1 FS Chemistry System with enGen™ Laboratory Device Name: Automation System VITROS Chemistry Products dHDL Reagent Pack VITROS Chemistry Products Calibrator Kit 19 VITROS Chemistry Products FS Calibrator 1 The VITROS 5,1 FS Chemistry System with enGen™ Indications for Use: Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)

> The VITROS Chemistry Products dHDL Reagent Pack, VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1 are used for the quantitative measurement of HDL cholesterol in serum or plasma.

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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Division

Office & In Viro Diagnostic Device Evaluation and Safety

510(K) X63144