(74 days)
No
The document describes a standard real-time PCR thermocycler and its associated software, focusing on hardware function and assay performance. There is no mention of AI, ML, or related concepts.
No
The device is an in vitro diagnostic tool used to identify nucleic acids from biological samples for diagnostic purposes, not for treating or preventing disease.
Yes
The device's intended use explicitly states it is for "in vitro diagnostic use" and that it "is intended to identify nucleic acid from prepared biological samples," which are key functions of a diagnostic device.
No
The device description clearly states it is a "rapid real-time Polymerase Chain Reaction thermocycler," which is a hardware instrument. While it is controlled by software, the device itself is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The very first sentence of the "Intended Use / Indications for Use" section clearly states: "The Integrated Cycler and accompanying Studio Software are intended for in vitro diagnostic use..."
- Function: The device is a real-time PCR thermocycler used for the identification of nucleic acid from prepared biological samples. This process is a common method used in clinical laboratories to diagnose diseases or identify pathogens, which falls under the scope of in vitro diagnostics.
- Use with IVD Reagents: The intended use specifies that it is to be used "in conjunction with legally marketed Simplexa™ reagent kits and assay protocols labeled for in vitro diagnostic use." This further reinforces its role in an IVD workflow.
- Intended User and Setting: The device is intended for "laboratory professionals trained in laboratory techniques and in a laboratory environment," which is the typical setting for performing in vitro diagnostic tests.
All of these points strongly indicate that the device is designed and intended for use in performing diagnostic tests on samples outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 intended to be used by laboratory professionals trained in laboratory techniques and in a laboratory environment.
Product codes (comma separated list FDA assigned to the subject device)
OOI
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.
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
This instrument is intended to be used by laboratory professionals trained in laboratory techniques and in a laboratory environment.
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)
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 was assessed during the clearance of the assay (K100148) and will be addressed for each assay to be run on this system.
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 was assessed during the clearance of the assay (K100148) and will be addressed for each assay to be run on this system.
Clinical Agreement was assessed during the clearance of the assay (K100148) and will be addressed for each assay to be run on this system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 Street
Cypress, California 90630
USA | |
|--------------------------------|-----------------------------------------------------------------------------------------|-------------|
| Establishment Registration No. | 2023365 | OCT 29 2010 |
| Contact Person | Tara Viviani
tel 714.822.2115
fax 714.822.3898
tviviani@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 | Decision
Date | Panel | Product
Code(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 |
| Item | ||
| Name | Device | Predicate |
| Integrated Cycler | Cepheid SmartCycler Dx system | |
| 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. | (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 | ||
| clinical specimens | PCR-based system for detecting the | |
| presence / 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. | ||
| Detection | ||
| Channels | 4 channels | |
| Excitation (nm) 475, 520 nm, 580 nm, 640 | ||
| nm | ||
| Emission (nm) 520 , 560 nm, 610, 682 nm | 4 channels | |
| Excitation (nm) 450-495, 500-550, 565-590, | ||
| 630-650 | ||
| Emission (nm) 510-527, 565-590, 606-650, | ||
| 670-750 | ||
| Differences | ||
| 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. | |
| Protocol | ||
| Access | Assays using the same protocol | |
| parameters may be assayed on a single | ||
| Universal Disc. | Up to 96 individual assay protocols may be | |
| randomly 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)