(86 days)
Not Found
Not Found
No
The device description and performance studies focus on the collection kit and the PCR assay, with no mention of AI or ML technologies.
No
The device is an in vitro diagnostic (IVD) device used for the collection and transportation of specimens for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae, not for treating any condition.
No
The document describes the "Abbott multi-Collect Specimen Collection Kit," which is intended for the collection and transportation of specimens for the detection of Chlamydia trachomatis and Neisseria gonorrheae. It is a collection kit, not the diagnostic "Abbott RealTime CT/NG assay" itself.
No
The device description clearly outlines physical components like a transport tube, swab, and pipette, which are hardware. The performance studies also focus on the stability and performance of these physical components.
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 Abbott RealTime CT/NG assay is an "in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and the genomic DNA of Neisseria gonorthoeae." The term "in vitro" is a key indicator of an IVD, meaning it's used to test specimens outside of the living body.
- Specimen Types: The assay is designed to test various human specimens (swabs and urine) for the presence of specific DNA, which is a typical function of an IVD used for diagnostic purposes.
- Device Description: While the description focuses on the collection kit, it's part of a system used for the in vitro detection of pathogens. The Specimen Transport Buffer is specifically mentioned as being used to "stabilize DNA until sample preparation," which is a step in the in vitro diagnostic process.
- Performance Studies: The performance studies described (LOD Confirmation, Reproducibility, Stability) are standard types of studies conducted to validate the performance of an IVD.
- Predicate Device: The mention of a "Predicate Device(s)" which includes the "Abbott RealTime CT/NG (List No. 8L07)" further confirms that this device is being compared to existing IVDs.
The Abbott multi-Collect Specimen Collection Kit itself is a component used in conjunction with the Abbott RealTime CT/NG assay, which is the primary IVD. However, the collection kit is specifically designed and intended for the collection and transportation of specimens for the in vitro detection of these pathogens, making it an integral part of the IVD system.
N/A
Intended Use / Indications for Use
The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and the genomic DNA of Neisseria gonorrheae. The assay may be used to test the following specimens from symptomatic individuals: female endocervical swab, clinician-collected vaginal swab, and patient-collected vaginal swab specimens; male urethral swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected vaginal swab and patient-collected vaginal swab specimens; female and male urine specimens.
The Abbott multi-Collect Specimen Collection Kit is intended for the collection and transportation of male and female swab and urine specimens for the detection of Chlamydia trachomatis and Neisseria gonorrheae per instructions provided. Refer to the specimen collection procedure in the package insert for specimen collection instructions for specific sample types.
Self-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The Abbott multi-Collect Specimen Collection Kit is not intended for home use.
Product codes
LSL, MKZ, LIO
Device Description
The Abbott multi-Collect Specimen Collection Kit can be used to collect either a swab or a urine specimen. Each Abbott multi -Collect Specimen Collection Kit contains:
- . One capped Transport Tube containing 1.2 mL Specimen Transport Buffer
- . One Individually Packaged Sterile Specimen Collection Swab
- . One disposable transfer pipette.
The Specimen Transport Buffer is used to stabilize DNA until sample preparation. The individually packaged sterile Specimen Collection Swab is used for swab sample collection and placed directly into the Transport Tube. The transfer pipette is used to add approximately 3 mL of urine to the Transport Tube. The Abbott multi -Collect Specimen Collection Kit is for single use only.
The Abbott multi-Collect Specimen Collection Kit Swab is approximately 14 cm in length with a polyester fiber tip. The swab shaft has a polystyrene solid core that is orange in color. The swab has a molded score completely around the shaft, between 7.86 cm and 7.89 cm from the swab tip, to provide a clean break-point. The polyesterfiber swab tip is approximately 1.3 cm in length and less than 3.28 mm in diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Female endocervical, Clinician-collected vaginal, Patient-collected vaginal, Male urethral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital, Clinical Physician Office
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)
Biocompatibility: Biocompatibility of the Specimen Collection Kit Swab manufactured with the proposed polyester fiber was confirmed through cytotoxicity, irritation to skin and mucosal surfaces, and sensitization tests based on the No. G95-1 Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing guidance document.
90-Dev Specimen Stability: The stability of deoxyribonucleic acid (DNA) of a sample in the Specimen Collection Transport Tube while in the presence of the proposed swab was determined by testing simulated high and low positive swab specimens stored at 2 to 8°C and at 30°C for 14 days or longer, followed by storage at -10°C or colder for 90 Days or longer. The intermediate data supports specimen storage at 2 to 30℃ for 14 days and at -10°C or colder for 56 days.
Sample Freeze Thaw Stability: The stability of the DNA of a sample in the Specimen Collection Transport Tube while in the presence of the proposed swab was determined by testing simulated high and low positive swab specimens. Following five freeze-thaw cycles. the percent positive rate for 90 CT analyte samples and for 90 NG analyte samples was 100% (90/90) in the Abbott RealTime CT/NG assay.
LOD Confirmation: The collection and transfer of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) target analyte from the proposed Specimen Collection Swabs to Abbott multi-Collect Specimen Collection Transport Tubes Transport Buffer was determined by testing simulated low positive swab specimens. The detection rate of 320 copies/400 uL of CT DNA was 100% (234/234) in the Abbott RealTime CT/NG assay and the lower bound of the 95% one-sided confidence interval detection rate was 99%. The detection rate of 320 copies/400 uL of NG DNA was 98% (229/234) in the Abbott RealTime CT/NG assay and the lower bound of the 95% one-sided confidence interval detection rate was 96%.
Reproducibility: A reproducibility study was performed testing a four-member panel of simulated swab specimens consisting of three different analyte concentrations of CT and NG. Swab specimens from 3 separate Swab lots were prepared and tested. The targeted concentration for CT ranged from 0 to 45,000 copies in each 400 µL sample input volume and for NG from 0 to 22,000 copies in each 400 uL sample input volume. Seven replicates of each panel member were tested in each run. Nine runs were performed across 3 m2000 instrument systems for a total of 189 replicates tested of each panel member. For each panel member and for each analyte (CT or NG), percent reproducibility was calculated overall (all instruments and swab lots combined), by instrument (across swab lots), and by instrument and swab lot. The percent positive rate for the positive panel members and percent negative rate for the negative panel were greater than or equal to 99% for each analyte in the Abbott RealTime CT/NG assay.
Accelerated Stressed Swab Stability: The stability of the DNA of a sample in the Specimen Collection Transport Tube while in the presence of swabs which were subjected to accelerated stress was determined by testing simulated low positive swab specimens containing a target concentration of 320 copies of CT and 320 copies of NG in each 400 uL sample preparation input volume. The detection rate of the CT analyte was 100% and the lower bound of the 95% one-sided confidence interval detection rate was 96% for all conditions tested in the Abbott RealTime CTNG assay. The detection rate of the NG analyte ranged from 98 to 100% and the lower bound of the 95% one-sided confidence interval detection rate ranged from 93 to 96% for all conditions tested in the Abbott RealTime CT/NG assay.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3390
Neisseria spp. direct serological test reagents.(a)
Identification. Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identifyNeisseria spp. from cultured isolates. Additionally, some of these reagents consist ofNeisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence ofNeisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.(b)
Classification. Class II (performance standards).
0
MAY 0 9 2014
2.0 510(k) Summary
Abbott RealTime CT/NG assay and an ancillary kit called the Abbott multi-Collect Specimen Collection Kit
| Submitted By: | Company Contact: |
|---|---|
| Abbott Molecular Inc. | |
| 1300 E. Touhy Avenue | |
| Des Plaines, IL 60018 | |
| phone: (224) 361-7000 | |
| fax: (847) 775-6777 | Stacy Ferguson |
| Senior Regulatory Affairs Specialist | |
| (224) 361-7449 | |
| (847) 775-6777 | |
| e-mail: stacy.ferguson@abbott.com | |
| Dimitris Demirtzoglou | |
| Regulatory Affairs Associate Director | |
| (224) 361-7975 | |
| (847) 775-6777 | |
| e-mail: dimitris.demirtzoglou@abbott.com | |
| Trade Name: | Abbott RealTime CT/NG (List No. 8L07-91) and |
| Abbott multi-Collect Specimen Collection Kit (List No. 9K12) | |
| Common Name: | In vitro polymerase chain reaction (PCR) assay for |
| Chlamydia trachomatis and Neisseria gonorrhoeae and | |
| Microbiological Specimen Collection and Transport Device | |
| Classification Name: | DNA-Reagents, Chlamydia |
| DNA-Reagents, Neisseria | |
| Classification Code: | Product Code: LSL, MKZ |
| Regulation Number: 866.3390 (Neisseria), 866.3120 (Chlamydia) | |
| Device Class: 2 (Neisseria), 1 (Chlamydia) | |
| Product Code: LIO | |
| Regulation Number: 866.2900 | |
| (Microbiological specimen collection and transport device) | |
| Device Class: 1 (Specimen Collection) | |
| Predicate Device: | Abbott RealTime CT/NG (List No. 8L07) |
| Abbott multi-Collect Specimen Collection Kit (List No. 9K12) |
· 2.1 Date of Preparation
May 8, 2014.
Abbott multi-Collect Specimen Collection Kit April 2014 Specimen Collection Swab_mw009
Confidential
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1
2-2-2-2 :11:16:11 Purpose of the Submission
Abbott Molecular Inc is submitting this Traditional 510(k): Device Modification to inform FDA of a supplier change for the swab fiber component of the Abbott multi-Collect Specimen Collection Kit Swab Collection Device 655 (CD655) previously cleared as a component of Premarket Notification (K092704).
2.3 Manufacturer:
Abbott Molecular Inc. is the legal manufacturer of the Abbott RealTime CT/NG assay and the Abbott multi-Collect Specimen Collection Kit (List No. 9K12).
| Name: | Timothy Zurow, PhD |
|---|---|
| Title: | Director of Manufacturing Operations |
| Telephone: | (224) 361-7379 |
| Fax: | (847) 775-6777 |
| Email: | timothy.zurow@abbott.com |
| Address: | Abbott Molecular Inc. |
| 1300 E. Touhy Avenue | |
| Des Plaines, IL 60018 |
Establishment Registration No .: 3005248192
The Abbott multi-Collect Specimen Collection Kit (List No. 9K12) is manufactured and assembled at the MML Diagnostic Packaging, Inc. facility indicated below:
Name: Dale Pestes Title: Director Manufacturing Operations (503) 666-8398 Telephone: Fax: (503) 666-8510 Email: njndale@aol.com
MML Diagnostic Packaging, Inc. 1625 NW Sundial Road PO Box 458 Troutdale, OR 97060
Establishment Registration No .: 3018348
2
Intended Use 2.4
The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and the genomic DNA of Neisseria gonorrhoeae. The assay may be used to test the following specimens from symptomatic individuals: female endocervical swab, clinician-collected vaginal swab, and patient-collected vaginal swab specimens; male urethral swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected vaginal swab and patient-collected vaginal swab specimens; female and male urine specimens.
The Abbott multi-Collect Specimen Collection Kit is intended for the collection and transportation of male and female swab and urine specimens for the detection of Chlamydia trachomatis and Neisseria gonorrheae per instructions provided. Refer to the specimen collection procedure in the package insert for specimen collection instructions for specific sample types.
Self-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The Abbott multi-Collect Specimen Collection Kit is not intended for home use.
2.5 Device Description
The Abbott multi-Collect Specimen Collection Kit can be used to collect either a swab or a urine specimen. Each Abbott multi -Collect Specimen Collection Kit contains:
- . One capped Transport Tube containing 1.2 mL Specimen Transport Buffer
- . One Individually Packaged Sterile Specimen Collection Swab
- . One disposable transfer pipette.
The Specimen Transport Buffer is used to stabilize DNA until sample preparation. The individually packaged sterile Specimen Collection Swab is used for swab sample collection and placed directly into the Transport Tube. The transfer pipette is used to add
3
approximately 3 mL of urine to the Transport Tube. The Abbott multi -Collect Specimen Collection Kit is for single use only.
The Abbott multi-Collect Specimen Collection Kit Swab is approximately 14 cm in length with a polyester fiber tip. The swab shaft has a polystyrene solid core that is orange in color. The swab has a molded score completely around the shaft, between 7.86 cm and 7.89 cm from the swab tip, to provide a clean break-point. The polyesterfiber swab tip is approximately 1.3 cm in length and less than 3.28 mm in diameter.
2.6 Comparison with Predicate Device
The proposed Abbott multi-Collect Specimen Collection Kit Swab (SW265) has the same intended use for the collection and transportation of clinical specimens for the direct, qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) as the current on-market Specimen Collection Kit Swab (SW260).
The primary function, component composition and technological characteristics of the proposed Abbott multi-Collect Specimen Collection Kit Swab is substantially equivalent to the current on-market device. The modification proposed does not affect the manufacturing facility location, manufacturing process and quality control procedures, the principle of operation, clinical data, patient population, final release testing of the product, indications for use or product labeling.
The similarities and differences between the proposed Abbott multi-Collect Specimen Collection Kit Swab and the current on-market device are shown in Tables 1 and 2. The differences are shown in underlined italics in the tables.
4
| Feature | Current Swab (SW260) | Proposed Swab (SW265) |
|---|---|---|
| Intended Use | The Abbott multi-Collect Specimen Collection Kit Swab is | |
| intended for the collection and transportation of male urethral, | ||
| female endocervical, clinician-collected or self-collected vaginal | ||
| swab specimens for the detection of Chlamydia trachomatis and | ||
| Neisseria gonorrhoeae from symptomatic and asymptomatic | ||
| individuals. |
For use with the Abbott RealTime CT/NG Assay for the detection
of Chlamydia trachomatis and Neisseria gonorrhoeae. | Same |
| Where Used | Hospital, Clinical Physician Office | Same |
| Sample Types | Endocervical swab specimens | Same |
| | Self-collected vaginal swab specimens | Same |
| | Clinician-collected vaginal swab specimens | Same |
| | Male urethral swab specimens | Same |
| Feature | Current Swab (SW260) | Proposed Swab (SW265) |
| Manufacturing Facility | MML Diagnostics Packaging, Inc. | Same |
| | Production Procedures | |
| | Quality Control Procedures | |
| Design | Individually Packaged Sterile Specimen Collection Swab | Same |
| Swab Fiber Supplier | Dupont | William Barnet and Sons, LLC |
| Swab Bud Tip | DuPont Dacron | Barnet P-2182 |
| Swab Fiber Tip Material | Polymer Polyester | Same |
| Swab Shaft | Polystyrene Solid Core | Same |
| Storage Conditions | | |
| Unopened Kit | Stored at room temperature | Same |
| Specimen Transport | Stored at 2 to 30°C for up to
14-days after collection | Same |
| Long-term Storage | Store at -10°C or colder for up to
90 days after collection | Same |
:
·
.
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ન્ April 2014 Specimen Collection Swab_mw009
Confidential
·
5
le 2. Similarities and Differences between Current and Proposed Abbott multi-Collect Specimen Collection S-
:
Abbott multi-Collect Specimen Collection Kit April 2014 Specimen Collection Swab_mw009
.
Confidential
.
6
2.7 Summary of Studies
Biocompatibility
Biocompatibility of the Specimen Collection Kit Swab manufactured with the proposed polyester fiber was confirmed through cytotoxicity, irritation to skin and mucosal surfaces, and sensitization tests based on the No. G95-1 Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing guidance document.
90-Dav Specimen Stability
The stability of deoxyribonucleic acid (DNA) of a sample in the Specimen Collection Transport Tube while in the presence of the proposed swab was determined by testing simulated high and low positive swab specimens stored at 2 to 8°C and at 30°C for 14 days or longer, followed by storage at -10°C or colder for 90 Days or longer.
The stability study for the Abbott multi-Collect Specimen Collection Kit swab is on-going. The intermediate data supports specimen storage at 2 to 30℃ for 14 days and at -10°C or colder for 56 days.
Sample Freeze Thaw Stability
The stability of the DNA of a sample in the Specimen Collection Transport Tube while in the presence of the proposed swab was determined by testing simulated high and low positive swab specimens. Following five freeze-thaw cycles. the percent positive rate for 90 CT analyte samples and for 90 NG analyte samples was 100% (90/90) in the Abbott RealTime CT/NG assay.
LOD Confirmation
The collection and transfer of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) target analyte from the proposed Specimen Collection Swabs to Abbott multi-Collect Specimen Collection Transport Tubes Transport Buffer was determined by testing simulated low positive swab specimens.
7
The detection rate of 320 copies/400 uL of CT DNA was 100% (234/234) in the Abbott RealTime CT/NG assay and the lower bound of the 95% one-sided confidence interval detection rate was 99%. The detection rate of 320 copies/400 uL of NG DNA was 98% (229/234) in the Abbott RealTime CT/NG assay and the lower bound of the 95% one-sided confidence interval detection rate was 96%.
Reproducibility
A reproducibility study was performed testing a four-member panel of simulated swab specimens consisting of three different analyte concentrations of CT and NG. Swab specimens from 3 separate Swab lots were prepared and tested. The targeted concentration for CT ranged from 0 to 45,000 copies in each 400 µL sample input volume and for NG from 0 to 22,000 copies in each 400 uL sample input volume.
Seven replicates of each panel member were tested in each run. Nine runs were performed across 3 m2000 instrument systems for a total of 189 replicates tested of each panel member.
For each panel member and for each analyte (CT or NG), percent reproducibility was calculated overall (all instruments and swab lots combined), by instrument (across swab lots), and by instrument and swab lot.
The percent positive rate for the positive panel members and percent negative rate for the negative panel were greater than or equal to 99% for each analyte in the Abbott RealTime CT/NG assay.
Accelerated Stressed Swab Stability
The stability of the DNA of a sample in the Specimen Collection Transport Tube while in the presence of swabs which were subjected to accelerated stress was determined by testing simulated low positive swab specimens containing a target concentration of 320 copies of CT and 320 copies of NG in each 400 uL sample preparation input volume.
The detection rate of the CT analyte was 100% and the lower bound of the 95% onesided confidence interval detection rate was 96% for all conditions tested in the Abbott
8
RealTime CTNG assay. The detection rate of the NG analyte ranged from 98 to 100% and the lower bound of the 95% one-sided confidence interval detection rate ranged from 93 to 96% for all conditions tested in the Abbott RealTime CT/NG assay.
Abbott multi-Collect Specimen Collection Kit Real-time Stability
The stability study for the Abbott multi-Collect Specimen Collection Kit Stability which includes the proposed swab is on-going and scheduled to be completed in December of 2015.
Abbott multi-Collect Specimen Collection Kit April 2014 Specimen Collection Swab_mw007
9
Conclusion Drawn from Studies 2.8
. .
The submitted material in this premarket notification supports a substantial equivalence decision.
Abbott multi-Collect Specimen Collection Kit April 2014 Specimen Collection Swab_mw007
10
Image /page/10/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
May 9, 2014
Abbott Molecular Inc. Stacy Ferguson Senior Regulatory Affairs Specialist 1300 E. Touhy Avenue Des Plaines, IL 60018
Re: K140354
Trade/Device Name: Abbott Real Time CTNG Assay and Abbott multi-Collect Specimen Collection Kit Regulation Number: 21 CFR 866.3390 Regulation Name: Neisseria spp. direct serological test reagents Regulatory Class: II Product Code: LSL, MKZ, LIO Dated: February 10, 2014 Received: February 12, 2014
Dear Ms. Ferguson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
11
Page 2-Ms. Ferguson
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tamara V. Feldblyum -S for
Sally Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
12
Indications for Use
510(k) Number: K140354
Device Name: Abbott RealTime CT/NG Assay and Abbott multi-Collect Specimen Collection Kit
Indications for Use:
The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and the genomic DNA of Neisseria gonorthoeae. The assay may be used to test the following specimens from symptomatic individuals: female endocervical swab, clinician-collected vaginal swab, and patient-collected vaginal swab specimens; male urethral swab specimens; and female and male urine specimens.
The Abbott multi-Collect Specimen Collection Kit is intended for the collection and transportation of male and female swab and urine specimens for the detection of Chiamydia trachomatis and Neisseria gonorthoeae per instructions provided. Refer to the specimen collection procedure in the package insert for the specimen collection instructions for specific sample types.
Self-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The Abbott multi-Collect Specimen Collection Kit is not intended for home use.
× Prescription Use Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Tamara V. Feldblyum -S 2014.05.08 16:08:07 -04'00'