3M INTEGRATED CYCLER (110V) & (220V)

K102314 · Focus Diagnostics, Inc. · OOI · Oct 29, 2010 · Clinical Chemistry

Device Facts

• Record ID: K102314
• Device Name: 3M INTEGRATED CYCLER (110V) & (220V)
• Applicant: Focus Diagnostics, Inc.
• Product Code: OOI · Clinical Chemistry
• Decision Date: Oct 29, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2570
• Device Class: Class 2

Indications for Use

The Integrated Cycler and accompanying Studio Software are intended for in vitro diagnostic use in conjunction with legally marketed Simplexa™ reagent kits and assay protocols labeled for in vitro diagnostic use. The Integrated Cycler is a rapid real-time Polymerase Chain Reaction (PCR) thermocycler used for identification of nucleic acid from prepared biological samples. The instrument utilizes disc media to contain and to process samples. The instrument uses real-time fluorometric detection to identify targets within the sample wells. The instrument's operation parameters are controlled by the use of an external personal computer and associated software. This instrument is intended to be used by laboratory professionals trained in laboratory techniques and in a laboratory environment.

Device Story

Integrated Cycler is a real-time PCR thermocycler for nucleic acid identification. Input: extracted nucleic acid samples in Universal Discs. Operation: instrument uses centrifugal force to mix reagents/samples; thermal control via 500W tungsten halogen bulb (heating) and internal fan (cooling); optical subsystem with LED excitation and photomultiplier detector for real-time fluorometric detection of up to four targets. Controlled by external PC and Studio Software. Used in laboratory environments by trained professionals. Output: fluorescence data used to quantify nucleic acid sequences. Benefits: rapid, multiplexed sample processing (up to 96 samples per disc).

Clinical Evidence

No clinical data provided in this summary; performance characteristics including reproducibility, limit of detection, analytical reactivity, cross-reactivity, and clinical agreement were assessed during the clearance of the associated assay (K100148).

Technological Characteristics

Thermocycler; 500W tungsten halogen bulb heating; fan cooling; centrifugal microfluidics; optical subsystem with LED excitation, filters, lenses, fiber ports, and photomultiplier detector. Dimensions: 96-well Universal Disc format. Connectivity: external PC control. Calibration: factory-set optical gain stored in firmware. Power: 110V or 220V.

Indications for Use

Indicated for laboratory professionals for the identification of nucleic acid from prepared biological samples using real-time PCR in a laboratory environment.

Regulatory Classification

Identification

Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.

The special control is FDA's guidance document entitled "Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems."

Predicate Devices

• Cepheid SmartCycler Dx system (K062948)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
K102314

B. Purpose for Submission:
Clearance of the Integrated Cycler

C. Manufacturer and Instrument Name:
Focus Diagnostic’s 3M Integrated Cycler with Integrated Cycler Studio Software

D. Type of Test or Tests Performed:
Real-Time PCR; see K100148 for more details on influenza 2009 A/H1N1 analyte

E. System Descriptions:

1. Device Description:
The Integrated Cycler is a thermocycler that is capable of heating, cooling, mixing of sample and reagents, and real-time detection of fluorophores set at four distinct wavelengths. Sensors on the instrument monitor the status of the primary functions of the system. The instrument comes in two power formats one for 110 V (MOL1001) and one at 220 V (MOL1101).

2. Principles of Operation:
Extracted nucleic acid from clinical samples is pipetted into appropriate sample injection wells on the Universal Disc. The instrument utilizes disc media to contain and to process samples and real-time fluorometric detection to identify targets within the sample reaction wells. The instrument's operation parameters are controlled by the use of an external personal computer and associated software. The disc can process up to 96 independent samples.

Thermal Control Functions
Heating is controlled by activating an optical light source until the desired temperature is reached. A 500 watt tungsten halogen bulb is mounted in an elliptical reflector and is controlled by a dimmer control to heat a portion of a rotating platform. The light source is located underneath the disc platen and causes warming of the outer ring of platen called the light ring. Cooling of the reaction chamber is achieved by activating an internal fan that draws in ambient air. Air is directed onto the light ring cooling the disc. The heating system is capable of reaching a maximum temperature of 99 °C; and is capable of

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maintaining the temperature within $\pm 0.5^{\circ}\mathrm{C}$. Heating can occur at a rate of $\geq 5^{\circ}\mathrm{C}/\mathrm{sec}$ and cooling occurs at a rate of $\geq 4^{\circ}\mathrm{C}/\mathrm{sec}$ with an ambient temperature of $22^{\circ}\mathrm{C}$.

## Motor Functions

The motor that controls the motion of the disc platen can be operated in two modes dependent on the type of processing: velocity and position modes. Velocity mode is used for maintaining a constant velocity for heater/cooler control and data acquisition of the fluorescence reader. Position mode is used for precisely positioning the sample discs at known locations for laser valving.

## Microfluidics

The instrument mixes the reagents with the extracted sample by centrifugal force. The Universal Disc spins on the platen forcing the sample from the injection well to the sample reaction well on the perimeter of the Disc.

## Optical Subsystem

The optical subsystem of the Integrated Cycler performs two distinct functions. The primary function of the system is the detection of fluorescence in each of the four optical channels. An additional function of the subsystem, for future iterations of the disposable media, is the activation of specific valves located in the media using laser light. The Integrated Cycler uses fluorescence to quantify the amount of certain nucleic acid sequences in a sample. The measurement is performed by optical modules that are optimized for specific detection dyes determined by the spectral characteristics of the dyes. Each module contains a LED excitation source, filters, lenses and a fiber port. Fluorescence is collected at the fiber port and transmitted to a single photomultiplier detector. This design allows for optimized detection of up to four targets simultaneously. A high degree of flexibility is achieved by allowing users to interchange modules for other targets. The optic system is contained within a protective housing and is controlled by a gantry system which can move the optic system into place to control the sensing optics and laser valving optics. The sensing and valving optics are mounted on the gantry to allow the ability to sense and open valves over the entire area of the sample disc.

3. Modes of Operation:

Batch

4. Specimen Identification:

Entered manually by user

5. Specimen Sampling and Handling:

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Specimens are processed according to assay instructions.

6. Calibration:
In-field calibration for the Integrated Cycler is not necessary. Calibration of the optical modules (excitation and emission gain settings) is performed during the manufacturing process and the values are stored in the instrument firmware.

7. Quality Control:
Quality control is addressed for each separately cleared specific assay to be run on the instrument.

8. Software:
FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types:
Yes ☐ X or No ☐

F. Regulatory Information:

1. Regulation section:
862.2570 Instrumentation for clinical multiplex test systems

2. Classification:
Class II

3. Product code:
OOI (Real-Time Nucleic Acid Amplification System)

4. Panel:
Clinical Chemistry (75)

G. Intended Use:

1. Indication(s) for Use:
The Integrated Cycler and accompanying Studio Software are intended for in vitro diagnostic use in conjunction with legally marketed Simplexa™ reagent kits and assay protocols labeled for in vitro diagnostic use.

The Integrated Cycler is a rapid real-time Polymerase Chain Reaction (PCR)

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thermocycler used for identification of nucleic acid from prepared biological samples. The instrument utilizes disc media to contain and to process samples. The instrument uses real-time fluorometric detection to identify targets within the sample wells. The instrument's operation parameters are controlled by the use of an external personal computer and associated software. This instrument is intended to be used by laboratory professionals trained in laboratory techniques and in a laboratory environment.

2. Special Conditions for Use Statement(s):

Prescription use only

H. Substantial Equivalence Information:

1. Predicate Device Name(s) and 510(k) numbers:

Cepheid SmartCycler Dx system, K062948

2. Comparison with Predicate Device:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | The Integrated Cycler and accompanying Studio Software are intended for in vitro diagnostic use in conjunction with legally marketed Simplexa™ reagent kits and assay protocols labeled for in vitro diagnostic use.The Integrated Cycler is a rapid real-time Polymerase Chain Reaction (PCR) thermocycler used for identification of nucleic acid from prepared biological samples. The instrument utilizes disc media to contain and to process samples. The instrument uses real-time fluorometric detection to identify targets within the sample wells. The instrument's operation parameters are controlled by the use of an external personal computer and associated software. This instrument is intended to be used by laboratory professionals trained in laboratory techniques and in a laboratory environment. | The Cepheid SmartCycler Dx System utilizes real-time polymerase chain reaction (PCR) for a unique gene-specific sequence amplification nucleic acids recovered from clinical samples and fluorogenic target specific hybridization for the detection of the amplified DNA. |
| Assay Methodology | PCR-based system for detecting the presence / absence of DNA or RNA in | PCR-based system for detecting the presence / |

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | clinical specimens | absence of DNA or RNA in clinical specimens |
| Detection Techniques | Multiplex assay using different reporter dyes for each target. | Multiplex assay using different reporter dyes for each target. |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Sample Capacity | Up to 96 specimens and controls in a single run using the Universal Disc. | Up to 16 specimens and controls per modular unit. Up to 6 modules may be installed for a total of 96 specimens and controls. |
| Sample Handling | 96 well Universal Disc with Universal Disc Sealer. | Individual Smart Tube and Smart Cap system. |

# I. Special Control/Guidance Document Referenced (if applicable):

Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077819.htm

# J. Performance Characteristics:

All assay analytical and clinical testing was reviewed in K100148. This submission is linked to the assay data presented there.

# 1. Analytical Performance:

a. Accuracy:

Accuracy was assessed during the clearance of the assay (K100148) and will be addressed for each assay to be run on this system.

b. Precision/Reproducibility:

Precision/Reproducibility was assessed during the clearance of the assay (K100148) and will be addressed for each assay to be run on this system.

c. Linearity:

N/A since 2009 A/H1N1 is a qualitative assay.

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d. Carryover:

Carryover was assessed during the clearance of the assay (K100148) and will be addressed for each assay to be run on this system.

e. Interfering Substances:

Interfering Substances were assessed during the clearance of the assay (K100148) and will be addressed for each assay to be run on this system.

2. Other Supportive Instrument Performance Data Not Covered Above:

K. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

L. Conclusion:

1. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.