TAG-IT CYSTIC FIBROSIS KIT

K060627 · Tm Bioscience Corporation · NUA · Jun 7, 2006 · Immunology

Device Facts

• Record ID: K060627
• Device Name: TAG-IT CYSTIC FIBROSIS KIT
• Applicant: Tm Bioscience Corporation
• Product Code: NUA · Immunology
• Decision Date: Jun 7, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5900
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Tag-It™ Cystic Fibrosis Kit is an in vitro diagnostic assay for detecting cystic fibrosis mutations in human DNA. The device utilizes multiplex ASPE (Allele-Specific Primer Extension) reactions to analyze genetic samples. Modifications include adjusted annealing temperatures for the multiplex reaction, an additional supplier for Shrimp Alkaline Phosphatase (SAP) reagent, and a software update to Version 1.01. The device is intended for use in clinical laboratory settings by trained personnel. The output provides genetic mutation status, assisting clinicians in the diagnosis or carrier screening of cystic fibrosis. The fundamental scientific technology remains consistent with the predicate device.

Clinical Evidence

Bench testing only. Verification and validation activities were performed based on Fault Tree Analysis to assess the impact of modifications. Results demonstrated that the modified device met all predetermined acceptance criteria.

Technological Characteristics

Multiplex PCR and ASPE assay. Components: Multiplex PCR primer mix, multiplex ASPE primer mix, 5.0 micron polystyrene beads (internally dyed with red/infrared fluorochromes), 10X wash buffer, and TDAS CF-I software. Connectivity: Standalone software analysis. Method: Qualitative genotyping via spectral bead identification.

Indications for Use

Indicated for the detection of cystic fibrosis mutations in human DNA samples.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Tag-It™ Cystic Fibrosis Kit (K043011)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE
RE: DOCUMENT NUMBER k060627

Tag-It™ Cystic Fibrosis Kit, Tm Bioscience Corporation

This 510(k) submission contains information/data on modifications made to the submitter's own Class II device requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the submitter's previously cleared device.
Tag-It™ Cystic Fibrosis Kit, Tm Bioscience Corporation (k043011).

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

The modifications were: a) annealing temperature adjustment for the ASPE multiplex reaction, b) additional recommended supplier of the ancillary reagent Shrimp Alkaline Phosphatase (SAP), and c) software update to the Version 1.01.

4. Comparison Information (similarities and differences) to the applicant's legally marketed predicate device include labeling, intended use, sample volume and type, scientific and method principle, instrumentation and method comparison.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis. The risk analysis method used to assess the impact of the device modification was the Fault Tree Analysis (page 2 of 14 of the 5/26/06 response).

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied (page 12 of 14 of the 5/26/06 response, also summarized in Table 1A, page 5 of 14, and 1B, page 8 of 14).

c) A summary of changes to the PI cleared in K043011 (page 14 of 14 of the 5/26/06 response) was provided, as well as the cleared and modified PI, with highlighted changes.

d) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met (Tab 11 of 3/16/06 original document), and

ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21

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CFR 820.30 and the records are available for review (Tab 11 of 3/16/06 original document).

6. A Truthful and Accurate Statement, a 510(k) Summary, and the Indications for Use Enclosure.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

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