(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 | ± 0.4 °C | ± 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.
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How the ground truth for the training set was established:
- Not applicable/Not provided.
§ 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.