LIGHTCYCLER INSTRUMENT VERSION 1.2

K033734 · Roche Diagnostics Corp. · JJF · Dec 17, 2003 · Clinical Chemistry

Device Facts

• Record ID: K033734
• Device Name: LIGHTCYCLER INSTRUMENT VERSION 1.2
• Applicant: Roche Diagnostics Corp.
• Product Code: JJF · Clinical Chemistry
• Decision Date: Dec 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2170
• Device Class: Class 1

Intended Use

The LightCycler Instrument is a fully automated amplification and detection system for nucleic acids using fluorescence detection. The LightCycler is intended to be used by laboratory professionals trained in laboratory techniques and on the use of the analyzer.

Device Story

LightCycler Instrument Version 1.2 is a benchtop analyzer for nucleic acid amplification and detection. Input: purified nucleic acid samples in glass capillaries. Operation: integrates thermal cycler (hot-air heating) and microvolume fluorimeter; performs PCR amplification; monitors fluorescence in real-time. Output: real-time amplification data. Used in clinical laboratories by trained professionals. Healthcare providers use output to monitor PCR product amplification, facilitating diagnostic decision-making. Benefits include reduced time-to-result and real-time monitoring capabilities.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics, operational components, and intended use with the predicate device.

Technological Characteristics

Benchtop analyzer; hot-air thermal cycler; microvolume fluorimeter; 32-sample capacity; glass capillary sample containers; 3 optical detection channels (530, 640, 710 nm); temperature range 40-98 °C; accuracy ± 0.4 °C. Connectivity via PC with instrument-specific software. Fluorescence resonance energy transfer (FRET) detection chemistry.

Indications for Use

Indicated for laboratory professionals for the automated amplification and detection of nucleic acids using fluorescence detection.

Regulatory Classification

Identification

A micro 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. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

Predicate Devices

• COBAS TaqMan Analyzer (K012966)

Submission Summary (Full Text)

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# DEC 1 7 2003

:

## 510(k) Summary

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter<br>name, address,<br>contact | Roche Diagnostics Corporation<br>9115 Hague Road<br>Indianapolis, IN 46250<br>317-521-2386 |
| | Contact Person: Robert A. Gregg, PhD |
| | Date Prepared: November 26, 2003 |
| Device Name | Proprietary name: LightCycler Instrument Version 1.2 |
| | Common name: Automated analyzer for nucleic acid amplification and<br>detection |
| | Classification name: Analyzer, Chemistry, Micro, for clinical use. |
| Device<br>Description | The LightCycler Instrument consists of a microvolume fluorimeter integrated<br>with a thermal cycler. It combines rapid-cycler PCR in glass capillaries<br>heated with hot-air with real-time fluorescence monitoring. The system is<br>designed to reduce the time needed to achieve results from PCR and to enable<br>the user to monitor the amplification of the PCR product simultaneously, in<br>real-time and on-line. |
| | The LightCycler instrument has been CE marked with regards to<br>electromagnetic compatibility and electrical safety. |
| | Further details about the LightCycler Instrument can be found in the<br>LightCycler Operator's Manual. |
| Intended use | The LightCycler Instrument is a fully automated amplification and detection<br>system for nucleic acids using fluorescence detection.<br>The LightCycler is intended to be used by laboratory professionals trained in<br>laboratory techniques and on the use of the analyzer. |

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#### The LightCycler Instrument Version 1.2 is substantially equivalent to other Substantial equivalence products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed COBAS TaqMan Analyzer K012966.

The LightCycler Instrument is a flexible benchtop analyzer that automates the amplification and detection steps of the Polymerase Chain Reaction (PCR). The principles of operation of the LightCycler are substantially equivalent to those used for the predicate, COBAS TaqMan Analyzer. Both analyzers perform various steps such as heating and measurement of light intensity. The primary operational components of both analyzers are the thermal cycler and the photometer.

| Comparison to<br>predicate<br>device | The following tables compares the LightCycler with the predicate device, the<br>COBAS TaqMan Analyzer |
|--------------------------------------|-------------------------------------------------------------------------------------------------------|
| Similarities: | |

| Feature | LightCycler | COBAS TaqMan Analyzer |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The LightCycler Instrument is a<br>fully automated amplification<br>and detection system for nucleic<br>acids using fluorescence<br>detection.<br>The LightCycler is intended to<br>be used by laboratory<br>professionals trained in<br>laboratory techniques and on<br>the use of the Analyzer. | The COBAS TaqMan<br>Analyzer is a fully automated<br>amplification and detection<br>system for nucleic acids using<br>5' nuclease technology. The<br>COBAS TaqMan Analyzer is<br>intended to be used by<br>laboratory professionals<br>trained in laboratory<br>techniques and on the use of<br>the Analyzer. |
| Primary operational<br>components | Integrated thermocycler and<br>microvolume fluorimeter for<br>walkaway PCR amplification<br>and detection | Same |
| Detection Procedure | Optical detection of stimulated<br>fluorescence | Same |
| Specimen type | Purified nucleic acids | Same |
| Specimen<br>Preparation | Performed off-line | Same |
| Temperature range | 40 - 98 °C | Same |
| User interface | PC with instrument -specific<br>software (LightCycler version<br>3.5 or higher) | PC with instrument -specific<br>software (Amplilink Software<br>version 3.0 or higher) |

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### Differences

| Feature | LightCycler | COBAS TaqMan Analyzer |
|-----------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Heating method<br>thermal cycling | Hot air cycling with glass<br>capillaries | Peltier device with sample<br>block |
| Number of thermal<br>cyclers | One | Four |
| Sample positions | 32 | 96 |
| Sample Size | 10-20 uL in glass capillaries | 100 uL in 200 uL K-tubes |
| Number of optical<br>detection channels | Three with fixed wavelengths<br>(530 nm, 640 nm, 710 nm) | Four with wavelength ranges<br>510-710 nm |
| Detection chemistry | Paired hybridization probes<br>using fluorescence resonance<br>energy transfer (FRET) | 5' nuclease hydrolysis probes<br>using FRET ('TaqMan<br>technology') |
| Detection timing | Detection occurs at defined<br>intervals during PCR cycle and<br>can be viewed in real-time | Detection occurs only at end of<br>each PCR cycle and can be<br>viewed at completion of run |
| Absolute<br>temperature<br>accuracy | $\pm$ 0.4 °C | $\pm$ 1.5 °C |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

### DEC 1 7 2003

Robert A. Gregg, Ph.D Director, Regulatory Submissions Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46250

Re: k033734

> Trade/Device Name: LightCycler Instrument Version 1.2 Regulation Number: 21 CFR 862.2170 Regulation Name: Analyzer, Chemistry, Micro, for clinical use Regulatory Class: Class I Product Code: JJF Dated: November 26, 2003 Received: November 28, 2003

Dear Dr. Gregg:

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 (OS) 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). Other general information on your responsibilities under the Act may be obtained 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

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## Indications for Use Statement

K033734 510(k) Number (if known): N/A

Device Name: LightCycler Instrument Version 1.2

Indications For Use:

The LightCycler Instrument is a fully automated amplification and detection system for nucleic acids using fluorescence detection.

The LightCycler is intended to be used by laboratory professionals trained in laboratory techniques and on the use of the analyzer.

Prescription Use
(Per 21 CFR 801.109)
✓

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033734