(74 days)
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 flourometric 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 3M Integrated Cycler is a rapid real-time Polymerase Chain Reaction thermocycler used for the identification of nucleic acid from prepared biological samples. The instrument utilizes disk media to contain and to process samples. The instrument uses real time flourometric detection to identify targets within the sample wells. The instrument is controlled by an external computer running the Integrated Cycler Studio Software.
The provided document describes the 3M Integrated Cycler, a thermocycler for real-time PCR. However, the document, being a 510(k) Summary for a device, primarily focuses on establishing "substantial equivalence" to a predicate device rather than presenting detailed performance data from a specific clinical study with granular acceptance criteria and results for the device itself.
Here's an breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria or specific numerical performance metrics for the 3M Integrated Cycler itself. Instead, it states that performance characteristics like Reproducibility, Limit of Detection, Analytical Reactivity, Cross-Reactivity, and Clinical Agreement "was assessed during the clearance of the assay (K100148) and will be addressed for each assay to be run on this system." This indicates that the performance criteria and their fulfillment are specific to the assays (reagent kits) used with the cycler, not the cycler hardware itself in this 510(k) submission.
Therefore, a table cannot be constructed from the provided text.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide information on the sample size used for a test set for the 3M Integrated Cycler itself. It defers these details to the clearance of individual assays (reference K100148).
Data provenance (country of origin, retrospective/prospective) is also not mentioned for the cycler's evaluation.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The document focuses on the device (thermocycler) and its equivalence to a predicate, not on the performance of a specific diagnostic assay that would typically involve expert-established ground truth.
4. Adjudication Method
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention of an MRMC comparative effectiveness study, human readers, or AI assistance is found in this document. The device is a thermocycler, not an AI-powered diagnostic tool requiring human reader comparison.
6. Standalone (Algorithm Only) Performance Study
The concept of "standalone performance" for an algorithm is not applicable here as the device is a hardware thermocycler, not an algorithm. The document speaks to the functionality of the thermocycler in conjunction with accompanying software and reagent kits.
7. Type of Ground Truth Used
The type of ground truth for performance metrics (Reproducibility, LOD, etc.) "was assessed during the clearance of the assay (K100148)". This implies that the ground truth would be established based on the specific assay being cleared, likely involving known positive and negative controls, spiked samples, and potentially clinical samples with confirmed diagnoses (pathology, clinical outcomes, etc.), but this is not detailed for the cycler itself in this document.
8. Sample Size for the Training Set
The document does not provide information about a training set sample size, as it describes a hardware device rather than a machine learning algorithm that would typically require a training set.
9. How Ground Truth for the Training Set Was Established
As there's no mention of a training set or machine learning algorithm, the establishment of ground truth for a training set is not applicable to this document.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in large, bold, sans-serif font, with the word "Diagnostics" in a smaller font size underneath. A curved, swooping graphic is placed to the left of the word "FOCUS", adding a visual element to the logo. A horizontal line is placed above the word "Diagnostics".
K102314
510(k) Summarv 3M Integrated Cycler Prepared Date: October 13, 2010 Page 1 of 3
| Applicant | Focus Diagnostics, Inc.11331 Valley View StreetCypress, California 90630USA | |
|---|---|---|
| Establishment Registration No. | 2023365 | OCT 29 2010 |
| Contact Person | Tara Vivianitel 714.822.2115fax 714.822.3898tviviani@focusdx.com | |
| Summary Date | October 13, 2010 | |
| Proprietary Name | 3M Integrated Cycler | |
| Generic Name | Thermocycler | |
| Classification | Class II | |
| Predicate Devices | Cepheid SmartCycler Dx system |
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 flourometric 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 intended to be used by laboratory professionals trained in laboratory techniques and in a laboratory environment.
Device Description
The 3M Integrated Cycler is a rapid real-time Polymerase Chain Reaction thermocycler used for the identification of nucleic acid from prepared biological samples. The instrument utilizes disk media to contain and to process samples. The instrument uses real time flourometric detection to identify targets within the sample wells. The instrument is controlled by an external computer running the Integrated Cycler Studio Software.
| Trade Name / Method | 510(k)submitter | 510(k)number | DecisionDate | Panel | ProductCode(s) |
|---|---|---|---|---|---|
| SmartCycler Dx system | Cepheid | K062948 | 12/08/2006 | (83)Microbiology | NJR (assay) |
Predicate Device Information
| Item Name | Device | Predicate |
|---|---|---|
| Integrated Cycler | Cepheid SmartCycler Dx system | |
| Similarities | ||
| Intended Use | The Integrated Cycler and accompanying Studio Software are intended for in vitro | The Cepheid SmartCycler Dx System utilizes real-time polymerase chain reaction |
| ItemName | Device | Predicate |
| Integrated Cycler | Cepheid SmartCycler Dx system | |
| diagnostic use in conjunction with legallymarketed Simplexa™ reagent kits andassay protocols labeled for in vitrodiagnostic use.The Integrated Cycler is a rapid real-timePolymerase Chain Reaction (PCR)thermocycler used for identification ofnucleic acid from prepared biologicalsamples. The instrument utilizes discmedia to contain and to process samples.The instrument uses real-time flourometricdetection to identify targets within thesample wells. The instrument's operationparameters are controlled by the use of anexternal personal computer and associatedsoftware. This instrument is intended to beused by laboratory professionals trained inlaboratory techniques and in a laboratoryenvironment. | (PCR) for a unique gene-specific sequenceamplification nucleic acids recovered fromclinical samples and fluorogenic targetspecific hybridization for the detection ofthe amplified DNA. | |
| AssayMethodology | PCR-based system for detecting thepresence / absence of DNA or RNA inclinical specimens | PCR-based system for detecting thepresence / absence of DNA or RNA inclinical specimens |
| DetectionTechniques | Multiplex assay using different reporterdyes for each target. | Multiplex assay using different reporterdyes for each target. |
| DetectionChannels | 4 channelsExcitation (nm) 475, 520 nm, 580 nm, 640nmEmission (nm) 520 , 560 nm, 610, 682 nm | 4 channelsExcitation (nm) 450-495, 500-550, 565-590,630-650Emission (nm) 510-527, 565-590, 606-650,670-750 |
| Differences | ||
| SampleCapacity | Up to 96 specimens and controls in asingle run using the Universal Disc. | Up to 16 specimens and controls permodular unit. Up to 6 modules may beinstalled for a total of 96 specimens andcontrols |
| SampleHandling | 96 well Universal Disc with Universal DiscSealer | Individual Smart Tube and Smart Cap system. |
| ProtocolAccess | Assays using the same protocolparameters may be assayed on a singleUniversal Disc. | Up to 96 individual assay protocols may berandomly accessed. |
{1}------------------------------------------------
K102314
Image /page/1/Picture/1 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in bold, sans-serif font. Above and to the left of the word "FOCUS" is a curved, crescent-shaped graphic. Below the word "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin line.
510(k) Summary 3M Integrated Cycler Prepared Date: October 13, 2010
Page 2 of 3
Performance Characteristics
Reproducibility:
Reproducibility was assessed during the clearance of the assay (K100148) and will be addressed for each assay to be run on this system.
Limit of Detection
Limit of Detection was assessed during the clearance of the assay (K100148) and will be addressed for each assay to be run on this system.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in bold, sans-serif font, with the word "Diagnostics" in a smaller, non-bold, sans-serif font underneath. A curved, black shape is positioned to the left of the word "FOCUS", resembling a stylized check mark or swoosh. A horizontal line is placed directly above the word "Diagnostics".
Analytical Reactivity
Analytical Reactivity was assessed during the clearance of the assay (K100148) and will be addressed for each assay to be run on this system.
Cross-Reactivity
Cross-Reactivity was assessed during the clearance of the assay (K100148) and will be addressed for each assay to be run on this system.
Clinical Agreement
Clinical Agreement was assessed during the clearance of the assay (K100148) and will be addressed for each assay to be run on this system.
Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
OCT 2 9 2010
Focus Diagnostics Inc. c/o Tara Viviani Regulatory Affairs Project Manager 11331 Valley View St. Cypress, CA 90630
K102314 Re:
Trade/Device Name: 3M Integrated Cycler 21CFR §862.2570 Regulation Number: Instrumentation for clinical multiplex test systems Regulation Name: Regulatory Class: Class II Product Code: OOI August 13, 2010 Dated: Received: August 16, 2010
Dear Ms. Viviani:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and, if applicable, the
{4}------------------------------------------------
Page 2 - Tara Viviani
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 advice for your device on our labeling regulation (21 CFR Part 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Uve Solf for
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): K102314
OCT 2 9 2010
Device Name: 3M Integrated Cycler
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 flourometric 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of InVitro Diagnostics (OIVD)
Uve Scilf
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
2 102314 510(k)
§ 862.2570 Instrumentation for clinical multiplex test systems.
(a)
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.(b)
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.