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 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.

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.

AI/ML Overview

This document describes the regulatory submission for a modification to the Abbott multi-Collect Specimen Collection Kit, specifically a change in the swab fiber component. The submission focuses on demonstrating that the new swab is substantially equivalent to the previously cleared swab and does not impact the performance of the Abbott RealTime CT/NG assay.

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't explicitly state "acceptance criteria" in a numerical, threshold-based format. Instead, the studies demonstrate performance relative to the existing device and expected assay performance (e.g., detection rates approaching 100% for low positive samples). The goal of these studies is to confirm that the new swab material does not negatively impact the assay's performance.

Study Category	Study Description	Reported Device Performance/Findings
Biocompatibility	Tested cytotoxicity, irritation to skin and mucosal surfaces, and sensitization based on ISO-10993.	Confirmed. (The document states "Biocompatibility... was confirmed through cytotoxicity, irritation..., and sensitization tests"). This implies the tests passed established criteria for these biological endpoints.
90-Day Specimen Stability	Evaluated DNA stability in transport tubes with the proposed swab for simulated high and low positive samples stored at 2-8°C and 30°C for 14 days, then -10°C or colder for 90 days.	Intermediate data supports specimen storage at 2-30°C for 14 days and at -10°C or colder for 56 days. (The study was ongoing at the time of submission, indicating confidence in meeting the full 90-day claim eventually, and showing acceptable stability for relevant periods. The statement "The intermediate data supports..." implies that at least for these shorter durations, stability was maintained.)
Sample Freeze-Thaw Stability	Tested simulated high and low positive swab specimens for DNA stability after five freeze-thaw cycles.	CT analyte: 100% positive rate (90/90).NG analyte: 100% positive rate (90/90).
LOD Confirmation (Analytical Sensitivity)	Determined the collection and transfer efficiency of CT and NG target analyte from the proposed swabs to transport buffer using simulated low positive swab specimens.	CT detection: 100% (234/234) at 320 copies/400 µL. Lower bound 95% one-sided CI: 99%.NG detection: 98% (229/234) at 320 copies/400 µL. Lower bound 95% one-sided CI: 96%.
Reproducibility	Evaluated reproducibility using a four-member panel of simulated swab specimens with three different analyte concentrations (CT and NG) across 3 swab lots, 3 instruments, and 9 runs.	Positive panel members: ≥ 99% positive rate for each analyte.Negative panel members: ≥ 99% negative rate for each analyte.
Accelerated Stressed Swab Stability	Determined DNA stability in transport tubes with swabs subjected to accelerated stress, using simulated low positive swab specimens (320 copies of CT and NG/400 µL).	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. 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.
Real-time (Kit) Stability	Ongoing study for the entire Abbott multi-Collect Specimen Collection Kit, including the proposed swab.	Scheduled for completion in December 2015. (This indicates that while full long-term data was not available at submission, shorter claims were supported by the 90-Day Specimen Stability study, and comprehensive data was being collected.)

2. Sample Size Used for the Test Set and Data Provenance

Biocompatibility: The specific sample sizes for cytotoxicity, irritation, and sensitization tests are not provided in the summary.
90-Day Specimen Stability: Not explicitly stated, but involved testing "simulated high and low positive swab specimens."
Sample Freeze-Thaw Stability: 90 CT analyte samples and 90 NG analyte samples (total 180 samples) were tested.
LOD Confirmation: 234 samples were tested for both CT and NG.
Reproducibility: 189 replicates were tested for each panel member. There were 4 panel members (3 concentrations + 1 negative) for each analyte (CT and NG). This suggests a total of 189 replicates/panel member * 4 panel members * 2 analytes = 1512 individual tests for quantification, or more accurately, 189 replicates per panel member across the different conditions. Seven replicates of each panel member were tested in each run, with nine runs performed across three m2000 instrument systems.
Accelerated Stressed Swab Stability: Not explicitly stated, but involved "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."
Provenance: All data appears to be retrospective experimental data generated in a laboratory setting using simulated specimens rather than prospective clinical samples. The country of origin of the data is not explicitly stated but is implicitly associated with Abbott Molecular Inc. in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

No human experts were used to establish the "ground truth" in these studies. The studies are analytical performance studies, not clinical studies involving patient diagnoses. The "ground truth" (e.g., presence and concentration of CT/NG DNA) was established by spiking known concentrations of target analytes into simulated specimens in a laboratory setting.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth was established by precise laboratory spiking of analytes, not by expert consensus or clinical adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an MRMC study. The device is a specimen collection kit the performance of which is measured using an in vitro assay (Abbott RealTime CT/NG assay). There are no human readers or interpretation involved in the performance evaluation of the collection device itself. The studies focus on the analytical performance of the kit to collect and preserve DNA for subsequent automated testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this is an algorithm-only (assay-only) performance evaluation. The "device" being evaluated is the Abbott multi-Collect Specimen Collection Kit, specifically its swab component. Its performance is assessed by how effectively it allows the Abbott RealTime CT/NG assay (an automated PCR assay) to detect targets. Therefore, the performance demonstrated is that of the collection kit in conjunction with the fully automated assay, without any human interpretation steps directly related to the collection kit's function.

7. The Type of Ground Truth Used

The ground truth used was based on known concentrations of spiked target analytes (DNA for Chlamydia trachomatis and Neisseria gonorrhoeae) in simulated laboratory specimens. This is a form of analytical truth or definitive measurement through controlled experimental design.

8. The Sample Size for the Training Set

These studies are analytical validation studies for a medical device modification (swab component), not a machine learning or AI model development. Therefore, there is no concept of a "training set" in the context of these studies. The experiments described are test/validation studies for the physical collection device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set for an AI model.

Summary

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K140354

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 AvenueDes Plaines, IL 60018phone: (224) 361-7000fax: (847) 775-6777	Stacy FergusonSenior Regulatory Affairs Specialist(224) 361-7449(847) 775-6777e-mail: stacy.ferguson@abbott.com
	Dimitris DemirtzoglouRegulatory Affairs Associate Director(224) 361-7975(847) 775-6777e-mail: dimitris.demirtzoglou@abbott.com
Trade Name:	Abbott RealTime CT/NG (List No. 8L07-91) andAbbott multi-Collect Specimen Collection Kit (List No. 9K12)
Common Name:	In vitro polymerase chain reaction (PCR) assay forChlamydia trachomatis and Neisseria gonorrhoeae andMicrobiological Specimen Collection and Transport Device
Classification Name:	DNA-Reagents, ChlamydiaDNA-Reagents, Neisseria
Classification Code:	Product Code: LSL, MKZRegulation Number: 866.3390 (Neisseria), 866.3120 (Chlamydia)Device Class: 2 (Neisseria), 1 (Chlamydia)Product Code: LIORegulation 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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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 AvenueDes 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

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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.

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.

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approximately 3 mL of urine to the Transport Tube. The Abbott multi -Collect Specimen Collection Kit is for single use only.

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.

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Feature	Current Swab (SW260)	Proposed Swab (SW265)
Intended Use	The Abbott multi-Collect Specimen Collection Kit Swab isintended for the collection and transportation of male urethral,female endocervical, clinician-collected or self-collected vaginalswab specimens for the detection of Chlamydia trachomatis andNeisseria gonorrhoeae from symptomatic and asymptomaticindividuals.For use with the Abbott RealTime CT/NG Assay for the detectionof 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 to14-days after collection	Same
Long-term Storage	Store at -10°C or colder for up to90 days after collection	Same

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ન્ April 2014 Specimen Collection Swab_mw009

Confidential

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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

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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.

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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

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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

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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

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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.

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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

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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 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'

Regulation Number and Section

§ 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).