ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800

K060543 · Clinical Micro Sensors, Inc. · NUA · Mar 28, 2006 · Immunology

Device Facts

• Record ID: K060543
• Device Name: ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800
• Applicant: Clinical Micro Sensors, Inc.
• Product Code: NUA · Immunology
• Decision Date: Mar 28, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5900
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The eSensor® Cystic Fibrosis Carrier Detection (CFCD) System is a device for the detection of carrier status for cystic fibrosis for all adult couples contemplating pregnancy, regardless of ethnicity. It is a qualitative genotyping assay that simultaneously detects mutations currently recommended by the American College of Medical Genetics and American College of Obstetricians and Gynecologists (ACMG/ACOG). The eSensor® CFCD System is not indicated for prenatal screening or for diagnostic purposes, and is for Rx only professional use within the confines of a licensed laboratory, as defined by the Clinical Laboratory Improvement Amminents (CLIA) of 1988.

Device Story

eSensor Cystic Fibrosis Carrier Detection (CFCD) System; in vitro diagnostic device; detects CFTR gene mutations in human genomic DNA from whole blood. Modification adds 5/7/9T genotyping reflex test for samples identified as R117H mutation carriers. System utilizes electrochemical detection technology. Software version 1.10 updated to enable reporting of 5/7/9T results. Used in clinical laboratory settings by trained personnel. Output provides genotype information to assist clinicians in carrier status determination and diagnostic screening. Benefits include expanded mutation coverage consistent with ACOG/ACMG recommendations.

Clinical Evidence

Clinical trial method comparison of 486 samples analyzed by CFCD System vs. DNA sequencing. Overall per-sample agreement was 98.8% (99.6% excluding no-calls). Per-mutation agreement was 98.9% (99.97% excluding no-calls). Reproducibility tested at three sites with three kit lots using 21 cell line DNA samples; overall per-sample agreement 99.8%, per-mutation agreement 99.9%. First-pass no-call rate 3.3%, reduced to 1.0% after repeat testing.

Technological Characteristics

In vitro diagnostic system; electrochemical detection via ferrocene-labeled signal probes. Uses multiplex PCR, exonuclease digestion, and hybridization to electrode-bound capture probes. Detection via alternating current voltammetry. System includes eSensor 4800 Instrument and DNA Detection System Application Software. Analyzes 24 CFTR mutations from human whole blood gDNA.

Indications for Use

Indicated for carrier screening in adults of reproductive age, newborn screening, and confirmatory diagnostic testing in newborns and children for CFTR gene mutations. Not for fetal diagnostic, preimplantation, or stand-alone diagnostic use.

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

• eSensor® Cystic Fibrosis Carrier Detection System (K051435)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K060543

eSensor Cystic Fibrosis Carrier Detection System

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: eSensor Cystic Fibrosis Carrier Detection (CFCD) System (K051435)
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.

This change was for:

- The addition of 5/7/9T genotyping reflex test to the CFCD system. 23 mutations are recommended to determined carrier status for population screening by the ACOG/ACMG. However, a 5/7/9T reflex test is also recommended in those cases when a sample genotypes as a carrier for the R117H mutation.
- Additional software changes to the cleared Application Software, to be released as version 1.10, to enable reporting of the 5/7/9T results.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device included labeling, intended use, sample type, 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 (Appendix 12-2)
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 (Appendix 12-2).
c) A declaration of conformity with design controls (see Section 8, p. 1). 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, 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 CFR 820.30 and the records are available for review.

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

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 (or their preamendment) device.