(90 days)
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.
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)
The provided text is a 510(k) summary for the Tag-It™ Cystic Fibrosis Kit and describes a modification to an already cleared device. It states that "The Tag-It™ Cystic Fibrosis Kit performance parameters remain unchanged" and "Performance data from validation testing supports equivalency."
Therefore, the document does not contain explicit acceptance criteria for the modified device, nor does it detail a new study with specific performance metrics for this particular submission (K060627). It relies on the previously cleared device's performance data (K043011) to establish substantial equivalence for the unchanged performance parameters.
Given this, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory submission affirming that performance parameters are unchanged, rather than reporting new performance data against acceptance criteria for the current submission.
If I were to infer, the "acceptance criteria" would be that the performance parameters of the modified device are equivalent to those of the predicate device (K043011). The "study" for this submission is essentially the demonstration that the modification does not alter performance, which is stated as "Performance data from validation testing supports equivalency," but no details of this validation testing are provided.
§ 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.