(19 days)
Not Found
No
The summary describes a standard PCR instrument with real-time fluorescence monitoring, focusing on hardware and basic automation. There is no mention of AI, ML, or related concepts.
No
The device is described as an amplification and detection system for nucleic acids, which is used for diagnostic or research purposes, not for treating a disease or condition.
Yes
The device is described as an "amplification and detection system for nucleic acids using fluorescence detection" and is intended to be used by "laboratory professionals trained in laboratory techniques." While it doesn't explicitly state "diagnostic," the detection of nucleic acids for medical purposes is typically a diagnostic activity performed in a laboratory setting. Furthermore, its predicate device, the COBAS TaqMan Analyzer (K012966), is a known diagnostic device used for in vitro diagnostic testing.
No
The device description explicitly states it is an "Instrument" consisting of a "microvolume fluorimeter integrated with a thermal cycler," which are hardware components.
Based on the provided information, the LightCycler Instrument is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's an "amplification and detection system for nucleic acids using fluorescence detection." This process is performed in vitro (outside the living body) on biological samples to provide information about a patient's health.
- Device Description: The description details a system that performs PCR and real-time fluorescence monitoring, which are common techniques used in IVD testing for detecting and quantifying nucleic acids (like DNA or RNA) from patient samples.
- Intended User: The intended users are "laboratory professionals trained in laboratory techniques," which is typical for IVD devices used in clinical or diagnostic laboratories.
- Predicate Device: The mention of a predicate device (COBAS TaqMan Analyzer) with a K number (K012966) strongly suggests that this device is being compared to a previously cleared IVD device, a common practice in the regulatory pathway for IVDs.
While the document doesn't explicitly use the term "IVD" in the intended use, the function and context clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
JJF
Device Description
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 LightCycler instrument has been CE marked with regards to electromagnetic compatibility and electrical safety.
Further details about the LightCycler Instrument can be found in the LightCycler Operator's Manual.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratory professionals trained in laboratory techniques and on the use of the analyzer.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
DEC 1 7 2003
:
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
name, address,
contact | Roche Diagnostics Corporation
9115 Hague Road
Indianapolis, IN 46250
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
detection |
| | Classification name: Analyzer, Chemistry, Micro, for clinical use. |
| Device
Description | 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 LightCycler instrument has been CE marked with regards to
electromagnetic compatibility and electrical safety. |
| | Further details about the LightCycler Instrument can be found in the
LightCycler Operator's Manual. |
| 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. |
1
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
predicate
device | The following tables compares the LightCycler with the predicate device, the
COBAS TaqMan Analyzer |
|--------------------------------------|-------------------------------------------------------------------------------------------------------|
| Similarities: | |
| Feature | LightCycler | COBAS TaqMan Analyzer |
|---|---|---|
| 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. | The COBAS TaqMan | |
| Analyzer is a fully automated | ||
| amplification and detection | ||
| system for nucleic acids using | ||
| 5' nuclease technology. The | ||
| COBAS TaqMan Analyzer is | ||
| intended to be used by | ||
| laboratory professionals | ||
| trained in laboratory | ||
| techniques and on the use of | ||
| the Analyzer. | ||
| Primary operational | ||
| components | Integrated thermocycler and | |
| microvolume fluorimeter for | ||
| walkaway PCR amplification | ||
| and detection | Same | |
| Detection Procedure | Optical detection of stimulated | |
| fluorescence | Same | |
| Specimen type | Purified nucleic acids | Same |
| Specimen | ||
| Preparation | Performed off-line | Same |
| Temperature range | 40 - 98 °C | Same |
| 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) |
2
Differences
| Feature | LightCycler | COBAS TaqMan Analyzer |
|---|---|---|
| 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 |
3
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).
4
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 (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
5
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)
Tug
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K033734