(90 days)
No
The description focuses on genetic testing methodologies (PCR, ASPE, bead hybridization) and mentions "Tag-It™ Data Analysis Software (TDAS CF-I)" but provides no indication of AI/ML being used for data analysis or interpretation. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is a qualitative genotyping test designed to detect and identify mutations and variants in the CFTR gene for diagnostic and screening purposes, not to treat or alleviate a disease.
Yes
The device is explicitly stated to be used for "confirmatory diagnostic testing in newborns and children." While it also notes it's "not indicated for stand-alone diagnostic purposes," its use in confirmatory diagnosis qualifies it as a diagnostic device.
No
The device description explicitly lists multiple physical components, including primer mixes, bead suspension, and wash buffer, in addition to the software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens." This indicates that the device is used to examine specimens derived from the human body.
- Device Description: The components listed, such as primer mixes, bead suspension, and wash buffer, are typical reagents and materials used in laboratory testing of biological samples.
- Anatomical Site: The specified anatomical site is "human blood specimens," which are biological samples taken from the human body.
- Purpose: The purpose is to provide "qualitative genotyping information" for various clinical applications like carrier testing, newborn screening, and confirmatory diagnostic testing. This information is used to aid in clinical decision-making.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Tag-It™ Cystic Fibrosis Kit fits this description.
N/A
Intended Use / Indications for Use
The Tag-It™ Cystic Fibrosis Kit is a device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens. The panel includes mutations and variants currently recommended by the American College of Medical Genetics and American College of Obstetricians and Gynecologists (ACMG/ACOG), plus some of the worlds most common and North American-prevalent mutations. The Tag-It™ Cystic Fibrosis Kit is a qualitative genotyping test which provides information intended to be used for carrier testing in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children.
The kit is not indicated for use in fetal diagnostic or pre-implantation testing. This kit is also not indicated for stand-alone diagnostic purposes.
Product codes
NUA
Device Description
Tag-It™ Cystic Fibrosis Kit includes the following components:
- Multiplex PCR Primer Mix including dNTPs designed to simultaneously produce 16 amplimers of the CFTR gene
- Multiplex ASPE Primer Mix including dNTPs (86 primers designed to hybridize to either wild-type or mutant alleles with proprietary sequences at their 5' ends designed to specifically hybridize to complementary sequences coupled to the bead component of the kit)
- Coupled Bead Suspension (86 spectrally distinguishable populations of 5.0 micron polystyrene beads internally dyed with red and infrared fluorochromes coupled to proprietary DNA sequences designed to specifically hybridize to complementary sequences on the ASPE primers)
- 10X Wash Buffer
- Tag-It™ Data Analysis Software (TDAS CF-I)
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
adults of reproductive age, newborns and children.
Intended User / Care Setting
Not Found
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)
Performance data from validation testing supports equivalency.
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
This Special 510(k): Device Modification submission is prepared pursuant to the FDA publication: The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications Issue Date: March 20, 1998
§ 866.5900 Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
(a)
Identification. The CFTR gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the CFTR gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), carrier identification, and newborn screening. This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation, or population screening.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: CFTR Gene Mutation Detection System.” See § 866.1(e) for the availability of this guidance document.
0
510(k) SUMMARY
JUN - 7 ---
1.0 Submitted By:
Nancy Krunic, Ph.D. Director, QA, Clinical and Regulatory Affairs Tm Bioscience Corporation 439 University Ave., Suite 2000 Toronto, Ontario, M5G IY8 Canada Tel: 416-593-4323 Fax: 416-593-2500 e-mail: nkrunic@tmbioscience.com
2.0 Date Submitted
March 8, 2006
3.0 Device Name(s):
- Proprietary Names: Tag-It™ Cystic Fibrosis Kit 3.1
- Classification Names: CFTR (cystic fibrosis transmembrane conductance 3.2 regulator) gene mutation detection system [866.5900]
4.0 Legally Marketed Device
Tag-It™ Cystic Fibrosis Kit claims substantial equivalence to the Tag-It™ Cystic Fibrosis Kit originally cleared under FDA 510(k) Number K043011
5.0 Device Description
Tag-It™ Cystic Fibrosis Kit includes the following components:
- Multiplex PCR Primer Mix including dNTPs designed to simultaneously produce 16 amplimers of the CFTR gene
- Multiplex ASPE Primer Mix including dNTPs (86 primers designed to hybridize to either wild-type or mutant alleles with proprietary sequences at their 5' ends designed to specifically hybridize to complementary sequences coupled to the bead component of the kit)
- Coupled Bead Suspension (86 spectrally distinguishable populations of 5.0 micron polystyrene beads internally dyed with red and infrared fluorochromes coupled to proprietary DNA sequences designed to specifically hybridize to complementary sequences on the ASPE primers)
- 10X Wash Buffer
- · Tag-It™ Data Analysis Software (TDAS CF-I)
1
6.0 Intended Use
The Tag-It™ Cystic Fibrosis Kit is a device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens. The panel includes mutations and variants currently recommended by the American College of Medical Genetics and American College of Obstetricians and Gynecologists (ACMG/ACOG), plus some of the worlds most common and North American-prevalent mutations. The Tag-It™ Cystic Fibrosis Kit is a qualitative genotyping test which provides information intended to be used for carrier testing in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and cill in hew.
The kit is not indicated for use in fetal diagnostic or pre-implantation testing. This kit is also not indicated for stand-alone diagnostic purposes.
7.0 Comparison to the Predicate (Description of the Modification to the Legally Marketed Device)
The Tag-It™ Cystic Fibrosis Kit performance parameters remain unchanged.
Summary of Performance Data 8.0
Performance data from validation testing supports equivalency.
2
Section 1: ADMINISTRATIVE INFORMATION
1.0 Submitted By:
Tm Bioscience Corporation 439 University Ave., Suite 2000 Toronto, Ontario, M5G IY8 Canada
Primary Contact: Nancy Krunic, Ph.D. Director, QA, Clinical and Regulatory Affairs Tel: 416-593-4323 Fax: 416-593-2500 e-mail: nkrunic@tmbioscience.com
2.0 Sponsor Address/FDA Registration Number
Tm Bioscience Corporation 439 University Ave., Suite 2000 Toronto, Ontario, M5G IY8 Canada Establishment Registration No. 3002777243
3.0 Product Name/Classification Name and Number
Proprietary Names Tag-It™ Cystic Fibrosis Kit
Classification Names CFTR (cystic fibrosis transmembrane conductance regulator) gene mutation detection system [866.5900]
4.0 Device Classification
FDA has classified clinical chemistry test systems of this type into Class II
5.0 Section 514 Compliance
This Special 510(k): Device Modification submission is prepared pursuant to the FDA publication: The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications Issue Date: March 20, 1998
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing health, services, and people. The text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 7 2000
Tm Bioscience Corporation c/o Nancy Krunic, Ph.D. Director, Clinical and Regulatory Affairs 439 University Ave Toronto, Ontario M5G IY8 Canada
Re: K060627
Trade/Device Name: Tag-It™ Cystic Fibrosis Kit Regulation Number: 21 CFR 866.5900 Regulation Name: CFTR (cystic fibrosis transmembrane conductance regulator) gene mutation detection system Regulatory Class: Class II Product Code: NUA Dated: March 8, 2006 Received: March 15, 2006
Dear Dr. Krunic:
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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Maria chan for
Dr. Robert Becker
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name: Tag-It™ Cystic Fibrosis Kit
Indications For Use:
The Tag-It™ Cystic Fibrosis Kit is a device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens. The panel includes mutations and variants currently recommended by the American College of Medical Genetics and American College of Obstetricians and Gynecologists (ACMG/ACOG), plus some of the worlds most common and North American-prevalent mutations. The Tag-It™ Cystic Fibrosis Kit is a qualitative genotyping test which provides information intended to be used for carrier testing in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children.
The kit is not indicated for use in fetal diagnostic or pre-implantation testing. This kit is also not indicated for stand-alone diagnostic purposes.
Maria M chan
Division Sign-Off
ivision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
C1003 K060627
and/or
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)