(19 days)
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.
The LightCycler Instrument consists of a microvolume fluorimeter integrated with a thermal cycler. It combines rapid-cycler PCR in glass capillaries heated with hot-air with real-time fluorescence monitoring. The system is designed to reduce the time needed to achieve results from PCR and to enable the user to monitor the amplification of the PCR product simultaneously, in real-time and on-line.
The provided text is a 510(k) summary for the LightCycler Instrument Version 1.2, which is an automated analyzer for nucleic acid amplification and detection. The core purpose of this document is to demonstrate "substantial equivalence" to a predicate device, the COBAS TaqMan Analyzer (K012966), rather than to present a study proving the device meets specific acceptance criteria through performance metrics.
Therefore, many of the requested categories (acceptance criteria, reported device performance, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, sample size for training set, and how ground truth was established for the training set) are not applicable or not explicitly detailed in this 510(k) summary.
The document primarily focuses on comparing the features and intended use of the LightCycler Instrument to its predicate device to argue for substantial equivalence. It does not contain information about a prospective study with specific acceptance criteria and performance data for the LightCycler Instrument Version 1.2.
However, based on the provided text, here's what can be extracted:
- A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as pass/fail criteria for a new study. The acceptance is based on demonstrating "substantial equivalence" to the predicate device.
- Reported Device Performance: While not acceptance criteria in the traditional sense of a performance study, the document reports technical specifications for the LightCycler Instrument that are compared to the predicate.
| Feature | LightCycler Reported Performance (as stated in comparison) | Predicate (COBAS TaqMan Analyzer) |
|---|---|---|
| Intended Use | Fully automated amplification and detection system for nucleic acids using fluorescence detection. Intended for laboratory professionals. | Fully automated amplification and detection system for nucleic acids using 5' nuclease technology. Intended for laboratory professionals. |
| Primary operational components | Integrated thermocycler and microvolume fluorimeter for walkaway PCR amplification and detection | Integrated thermocycler and microvolume fluorimeter for walkaway PCR amplification and detection |
| Detection Procedure | Optical detection of stimulated fluorescence | Optical detection of stimulated fluorescence |
| Specimen type | Purified nucleic acids | Purified nucleic acids |
| Specimen Preparation | Performed off-line | Performed off-line |
| Temperature range | 40 - 98 °C | 40 - 98 °C |
| User interface | PC with instrument-specific software (LightCycler version 3.5 or higher) | PC with instrument-specific software (Amplilink Software version 3.0 or higher) |
| Heating method thermal cycling | Hot air cycling with glass capillaries | Peltier device with sample block |
| Number of thermal 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 detection channels | Three with fixed wavelengths (530 nm, 640 nm, 710 nm) | Four with wavelength ranges 510-710 nm |
| Detection chemistry | Paired hybridization probes using fluorescence resonance energy transfer (FRET) | 5' nuclease hydrolysis probes using FRET ('TaqMan technology') |
| Detection timing | Detection occurs at defined intervals during PCR cycle and can be viewed in real-time | Detection occurs only at end of each PCR cycle and can be viewed at completion of run |
| Absolute temperature accuracy | $\pm$ 0.4 °C | $\pm$ 1.5 °C |
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not provided. The document describes the device and compares its technical specifications to a predicate, but does not detail a specific performance study with a test set of samples.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not provided. No human-expert-based ground truth establishment is mentioned as this is a device for nucleic acid analysis, not an imaging or diagnostic interpretation device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a fully automated instrument for nucleic acid amplification and detection. It is not an AI-assisted diagnostic tool that aids human readers, and therefore, an MRMC study is not relevant here.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The document describes the LightCycler Instrument as a "fully automated amplification and detection system," implying it operates in a standalone manner. However, no specific standalone performance study with detailed methodology and results is presented in this 510(k) summary; rather, its operational specifications are presented for comparison.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not provided. For a device like this, the "ground truth" would typically refer to the known presence or absence of specific nucleic acid targets based on validated reference methods. This 510(k) summary does not contain details of such a validation study.
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The sample size for the training set:
- Not applicable/Not provided. This document describes a physical instrument, not a machine learning algorithm that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable/Not provided.
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DEC 1 7 2003
:
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| Submittername, address,contact | Roche Diagnostics Corporation9115 Hague RoadIndianapolis, IN 46250317-521-2386 |
| 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 anddetection | |
| Classification name: Analyzer, Chemistry, Micro, for clinical use. | |
| DeviceDescription | The LightCycler Instrument consists of a microvolume fluorimeter integratedwith a thermal cycler. It combines rapid-cycler PCR in glass capillariesheated with hot-air with real-time fluorescence monitoring. The system isdesigned to reduce the time needed to achieve results from PCR and to enablethe user to monitor the amplification of the PCR product simultaneously, inreal-time and on-line. |
| The LightCycler instrument has been CE marked with regards toelectromagnetic compatibility and electrical safety. | |
| Further details about the LightCycler Instrument can be found in theLightCycler Operator's Manual. | |
| Intended use | The LightCycler Instrument is a fully automated amplification and detectionsystem for nucleic acids using fluorescence detection.The LightCycler is intended to be used by laboratory professionals trained inlaboratory 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 topredicatedevice | The following tables compares the LightCycler with the predicate device, theCOBAS TaqMan Analyzer |
|---|---|
| Similarities: |
| Feature | LightCycler | COBAS TaqMan Analyzer |
|---|---|---|
| Intended use | The LightCycler Instrument is afully automated amplificationand detection system for nucleicacids using fluorescencedetection.The LightCycler is intended tobe used by laboratoryprofessionals trained inlaboratory techniques and onthe use of the Analyzer. | The COBAS TaqManAnalyzer is a fully automatedamplification and detectionsystem for nucleic acids using5' nuclease technology. TheCOBAS TaqMan Analyzer isintended to be used bylaboratory professionalstrained in laboratorytechniques and on the use ofthe Analyzer. |
| Primary operationalcomponents | Integrated thermocycler andmicrovolume fluorimeter forwalkaway PCR amplificationand detection | Same |
| Detection Procedure | Optical detection of stimulatedfluorescence | Same |
| Specimen type | Purified nucleic acids | Same |
| SpecimenPreparation | Performed off-line | Same |
| Temperature range | 40 - 98 °C | Same |
| User interface | PC with instrument -specificsoftware (LightCycler version3.5 or higher) | PC with instrument -specificsoftware (Amplilink Softwareversion 3.0 or higher) |
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Differences
| Feature | LightCycler | COBAS TaqMan Analyzer |
|---|---|---|
| Heating methodthermal cycling | Hot air cycling with glasscapillaries | Peltier device with sampleblock |
| Number of thermalcyclers | One | Four |
| Sample positions | 32 | 96 |
| Sample Size | 10-20 uL in glass capillaries | 100 uL in 200 uL K-tubes |
| Number of opticaldetection channels | Three with fixed wavelengths(530 nm, 640 nm, 710 nm) | Four with wavelength ranges510-710 nm |
| Detection chemistry | Paired hybridization probesusing fluorescence resonanceenergy transfer (FRET) | 5' nuclease hydrolysis probesusing FRET ('TaqMantechnology') |
| Detection timing | Detection occurs at definedintervals during PCR cycle andcan be viewed in real-time | Detection occurs only at end ofeach PCR cycle and can beviewed at completion of run |
| Absolutetemperatureaccuracy | $\pm$ 0.4 °C | $\pm$ 1.5 °C |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the branches of government. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the symbol.
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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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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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)
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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
§ 862.2170 Micro chemistry analyzer for clinical use.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.