(50 days)
Not Found
No
The device is a quality control material for genetic testing, not a diagnostic or analytical device that would typically incorporate AI/ML. The description focuses on the composition and intended use as a control, with no mention of AI/ML algorithms or data processing.
No
This device is an in vitro diagnostic quality control for monitoring the performance of genetic testing assays, not a treatment device for patients.
No
Explanation: The device is a quality control material intended to monitor the performance of diagnostic assays, not to diagnose a patient directly. It ensures the accuracy of other diagnostic tests.
No
The device description clearly states it is a physical product consisting of synthetic DNA suspended in a matrix, intended for in vitro diagnostic use. It is a control material, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use as a quality control to monitor analytical performance of the extraction, amplification and detection steps of diagnostic assays used in the detection of the Cystic Fibrosis Transmembrane Regulator (CFTR) gene mutations and variants." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The description details the composition of the control material, which is designed to be processed and analyzed in a laboratory setting, mimicking a human specimen.
- Quality Control: The primary function of the device is to serve as a quality control for diagnostic assays. Quality controls are essential components of IVD testing to ensure the accuracy and reliability of the results.
Therefore, based on the provided information, the INTROL™ CF Panel I Control is clearly an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The INTROL™ CF Panel I Control is intended for in vitro diagnostic use as a quality control to monitor analytical performance of the extraction, amplification and detection steps of diagnostic assays used in the detection of the Cystic FibrosisTransmembrane Regulator (CFTR) gene mutations and variants. This product is intended to be extracted and analyzed routinely with each CFTR assay run. The INTROL™ CF Panel I Control is designed to monitor the detection of 38 CFTR mutations associated with cystic fibrosis, including the 23 mutations recommended for testing by American College of Medical Genetics (ACMG) and American College of Obstetricians and Gynecologists (ACOG). The INTROL™ CF Panel I Control also monitors 3 polymorphisms (1506V, I507V, F508C) and the 5/7/9T variants.
Product codes (comma separated list FDA assigned to the subject device)
NZB
Device Description
Modified INTROL™ CF Panel I Control consists of synthetic (recombinant) CFTR DNA suspended in a matrix of carrier DNA of non-human species, preservatives, dye, and stabilizers. CFTR DNA is stabilized in the matrix and released when processed through common extraction methods as if it were a whole blood specimen. INTROL™ CF Panel I Control was modified to contain additional wild type CFTR DNA required for primer annealing of some CFTR detection assays.
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
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)
Verification and validation testing performed as needed according to risk analysis showed that modified INTROL™ CF Panel I Control performed as well or better than INTROL™ CF Panel I Control (K060070). Test methods were the same as those used for 510(k) submission of the predicate. Design outputs of modified INTROL CF Panel I Control meet design inputs in conformance with design control requirements as specified in 21 CFR 820.30.
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.
Not Found
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
§ 866.5910 Quality control material for cystic fibrosis nucleic acid assays.
(a)
Identification. Quality control material for cystic fibrosis nucleic acid assays. A quality control material for cystic fibrosis nucleic acid assays is a device intended to help monitor reliability of a test system by detecting analytical deviations such as those that may arise from reagent or instrument variation in genetic testing. This type of device includes recombinant, synthetic, and cell line-based DNA controls.(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 § 866.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays.” See § 866.1(e) for the availability of this guidance document.
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SECTION 12
INTROL CF Panel I Control Special 510(k)
CONFIDENTIAL
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APPENDIX 4
10 Southgate Road, Suite 170 Scarborough, Maine 04074 Phone: 207-885-1072; Fax: 207-885-1079 · www.mmqci.com
083171
510 (k) Summary
DEC 1 6 2008
Applicant Contact Information:
| Applicant: | Maine Molecular Quality Controls, Inc. (MMQCI) |
|---|---|
| Address: | 10 Southgate Road, Suite 170 |
| Scarborough, Maine 04074 |
| Contact Person: | Joan H. Gordon, President |
|---|---|
| Phone Number: | 207-885-1072 |
| Fax Number: | 207-885-1079 |
October 19, 2008
Preparation Date:
Device Trade Name:
INTROLTM CF Panel I Control
Device Regulatory Information:
Regulation No .: Common name: Classification Name:
Regulatory Class: Product Code: Panel:
21 CFR 866.5910 Quality control, genetic, DNA control Ouality Control Material for Cystic Fibrosis Nucleic Acid Assays Class II NZB Immunology (82)
Predicate Device:
INTROL™ CF Panel I Control
Device Description (same as predicate):
Modified INTROL™ CF Panel I Control consists of synthetic (recombinant) CFTR DNA suspended in a matrix of carrier DNA of non-human species, preservatives, dye, and stabilizers. CFTR DNA is stabilized in the matrix and released when processed through common extraction methods as if it were a whole blood specimen. INTROL™ CF Panel I Control was modified to contain additional wild type CFTR DNA required for primer annealing of some CFTR detection assays.
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Image /page/1/Picture/0 description: The image shows a logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo is black and white and features the letters "MMQCI" in a large, bold font. Below the letters, the full name of the company is written in a smaller font. To the left of the letters, there is a graphic that appears to be a stylized representation of a strand of DNA.
10 Southgate Road, Suite 170 Scarborough, Maine 04074 Phone: 207-885-1072; Fax: 207-885-1079 www.mmqci.com
" "
510(k) Summary (Cont.)
Device Intended Use (same as predicate):
INTROL™ CF Panel I Control is intended for in vitro diagnostic use as a quality control to monitor analytical performance of the extraction, amplification and detection steps of diagnostic assays used in the detection of the Cystic FibrosisTransmembrane Regulator (CFTR) gene mutations and variants. This product is intended to be extracted and analyzed routinely with each CFTR assay run. The INTROL™ CF Panel I Control is designed to monitor the detection of 38 CFTR mutations associated with cystic fibrosis, including the 23 mutations recommended for testing by American College of Medical Genetics (ACMG) and American College of Obstetricians and Gynecologists (ACOG). The INTROL™ CF Panel I Control also monitors 3 polymorphisms (1506V, I507V, F508C) and the 5/7/9T variants.
Substantial Equivalence:
In view of technical, physical, and performance characteristics, MMQCI believes modified INTROL™ CF Panel I Control is substantially equivalent to INTROL™ CF Panel I Control (K060070) as to intended use and fundamental scientific technology.
Summary of Performance Nonclinical Data
Verification and validation testing performed as needed according to risk analysis showed that modified INTROL™ CF Panel I Control performed as well or better than INTROL™ CF Panel I Control (K060070). Test methods were the same as those used for 510(k) submission of the predicate. Design outputs of modified INTROL CF Panel I Control meet design inputs in conformance with design control requirements as specified in 21 CFR 820.30.
Conclusions
Based on analysis and performance testing, we conclude that modified INTROL™ CF Panel I Control is substantially equivalent to INTROL™ CF Panel I Control (K060070), is as safe and effective as the predicate, and performs better than the predicate in certain CFTR detection assays.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services U.S.A. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing the body and wings.
ood and Drug Administration 2098 Gaither Road Rockville MD 20850
Maine Molecular Quality Controls, Inc. c/o Ms. Joan H. Gordon President 10 Southgate Road, Suite 170 Scarborough, Maine 04074
EC 1 6 2008
Re: K083171
Trade/Device Name: INTROLTM CF Panel I Control Regulation Number: 21 CFR 866.5910 Regulation Name: DNA quality control material for genetic testing Regulatory Class: Class II Product Code: NZB Dated: October 19, 2008 Received: October 27, 2008
Dear Ms. Gordon:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice
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Page 2 - MMOCI
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Sincerely yours,
Josephine Bautista
for Maria M. Chan, Ph.D.
Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
K083171 510 (k) Number:
Device Name:
INTROL™ CF Panel I Control
Indications for Use:
The intended use for the cleared and modified INTROL™ CF Panel I Controls is the same. The INTROL™ CF Panel I Control is intended for in vitro diagnostic use as a quality control to monitor analytical performance of the extraction, amplification and detection steps of diagnostic assays used in the detection of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene mutations and variants. This product is intended to be extracted and analyzed routinely with each CFTR assay run.
The INTROL™ CF Panel I Control is designed to monitor the detection of 38 CFTR mutations associated with cystic fibrosis, including the 23 mutations recommended for testing by American College of Medical Genetics (ACMG) and American College of Obstetricians and Gynecologists (ACOG). The INTROL CF Panel I Control also monitors 3 polymorphisms (1506V, I507V, F508C) and the 5/7/9T variants.
For in vitro diagnostic use.
Prescription Use X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
H/NEEDED)
Stephanie Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K08317
SECTION 12
INTROL CF Panel I Control Special 510(k) CONFIDENTIAL
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