Predicate Devices

K043224, K012351, K043224, K043144, K032554, K052224

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on PCR technology and standard analytical methods for determining sensitivity, specificity, and other performance metrics. There is no mention of AI, ML, or any algorithms that would suggest their use in data analysis or result interpretation beyond standard statistical methods.

Therapeutic

No.

The device is an in vitro diagnostic assay used for the qualitative detection of DNA from Chlamydia trachomatis and Neisseria gonorrhoeae. It is intended for diagnostic purposes, not for treating a disease or condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the assay is for the "direct, qualitative detection" of Chlamydia trachomatis and Neisseria gonorrhoeae DNA, indicating its use in identifying the presence of these pathogens. The performance studies also detail sensitivity and specificity, which are metrics relevant to a diagnostic accuracy.

SaMD (Software as a Medical Device)

No

The device description explicitly details reagent kits, instruments (m2000sp and m2000rt), and a specimen collection kit containing physical components like tubes, swabs, and pipettes. This indicates the device is a system involving hardware and reagents, not solely software.

IVD (In Vitro Diagnostic)

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 gonorrhoeae." The term "in vitro" is a key indicator of an IVD.
Specimen Types: The assay is designed to test various human specimens (vaginal swabs, urethral swabs, urine), which are collected from the human body but tested outside of it. This is characteristic of IVDs.
Purpose: The purpose of the assay is to detect the presence of specific pathogens (Chlamydia trachomatis and Neisseria gonorrhoeae) in these specimens to aid in the diagnosis of infections. This diagnostic purpose is central to the definition of an IVD.
Device Description: The description details the components of the assay (reagent kits, control kit) and the system used for processing and analysis (m2000 System), all of which are used to perform the in vitro test.
Clinical Studies: The document describes extensive clinical studies using human specimens to evaluate the performance (sensitivity and specificity) of the assay in detecting the target analytes. This is a standard part of the validation process for IVDs.
Predicate Devices: The listed predicate devices are also IVDs (nucleic acid amplification tests and specimen collection kits for diagnostic testing).

The Abbott RealTime CT/NG assay fits the definition of an In Vitro Diagnostic device because it is intended for use in the examination of specimens derived from the human body to provide information for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 gonorrhoeae. The assay may be used to test the following specimens from symptomatic individuals: clinician-collected vaginal swab and male urethral swab specimens; patient-collected vaginal swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: male and female urine.

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 (comma separated list FDA assigned to the subject device)

LSL, MKZ

Device Description

Abbott RealTime CT/NG consists of two reagent kits:
. Abbott RealTime CT/NG Amplification Reagent Kit (List No. 8L07-90)
. Abbott RealTime CT/NG Control Kit (List No. 8L07-80) .

The Abbott RealTime CT/NG assay uses PCR technology with homogenous real-time fluorescence detection on the m2000 System. The Abbott m2000 System consists of the Abbott m2000sp and Abbott m2000rt instruments. The Abbott m2000 System integrates sample preparation with nucleic acid amplification and detection to generate assay rcsults. The Abbott m2000sp is used for processing samples and the Abbott m2000rt is used for amplification and detection.

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 (List No. 9K12) contains:

One Transport Tube containing 1.2 mL Specimen Transport Buffer .
. One Individually Packaged Sterile Specimen Collection Swab (Part No. CD650)
. One disposable transfer pipette.

The Specimen Transport Buffer consists of guanidine thiocyanate, a chaotropic salt, in Tris buffer and 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Clinician-collected vaginal swab, male urethral swab specimens, patient-collected vaginal swab specimens, female urine specimens, male urine specimens.

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

Performance charactcristics of the Abbott RealTime CT/NG assay were established in a multi-center clinical study conducted in the United States. Specimens were prospectively collected from subjects at 16 geographically diverse sites that included physician private practices, public and private STD clinics, and a hospital cmergency room. A total of 3,832 malc and female, asymptomatic and symptomatic subjects were enrolled. Study subjects were classified as symptomatic if the subject reported STD-related symptoms. Specimens collected from cach female subject included urine, endocervical swabs, selfcollected vaginal swab, and clinician-collected vaginal swabs. Specimens collected from each male subject included urine and urethral swabs. Specimen testing methods included the Abbott RealTime CT/NG assay, two commercially available nucleic acid amplification tests (NAAT) for CT and NG, and culture for NG. The NAATs and the NG culture were used as reference assays in the clinical study.

For females, self-collected vaginal swab and urine specimens were collected first, followed by endocervical swab for culture. Remaining swab specimen collection was randomized to minimize bias. For males, urethral swab for culture was collected first. Remaining swab specimen collection was randomized to minimize bias. Urine specimen was collected after the swab specimens.

For each subject, a patient infected status was determined based on the combined results from the reference assays. A female subject was categorized as infected for CT or NG if a minimum of two positive results (at least one from each reference NAAT) were reported. A male subject was categorized as infected for CT or NG if a minimum of two positive results were reported. If the reference NG culture assay result was positive, the subject was categorized as infected regardless of NAAT results.

A female subject was categorized as not infected with CT or NG if at least one of the reference NAATs reported negative results for all sample types. A male subject was categorized as not infected with CT or NG if a total of at least two negative results were reported by the reference NAATs.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Analytical Sensitivity:

Chlamydia trachomatis (CT) target DNA: 39 copies/assay (95% CI 33 - 51) detected with 95% probability.
Neisseria gonorrhoeae (NG) target DNA: 192 copies/assay (95% CI 176-220) detected with 95% probability.
Limit of Detection (LOD) claim: 320 copies of CT target DNA and 320 copies of NG target DNA per assay, meaning 30 to 40 organisms per assay.
Confirmation of LOD: 100% detection rate (403/403) for both CT and NG.
Co-infection challenge: 100% detection for 320 copies of CT DNA in high NG target (400/400); 98.5% detection for 320 copies of NG DNA in high CT target (398/404).
CT serovars: A through K, L1, L2 detected at less than 1 Inclusion Forming Units (IFU) per assay; L3 detected at less than 3 IFU/assay.
NG isolates: All 28 isolates detected at less than 1 Colony Forming Unit (CFU)/assay.

Evaluation of Potential Cross-Reactants:

111 strains of bacteria, viruses, parasites, yeast, and fungi tested; all results negative for both CT and NG.
32 culture isolates (including C. pneumoniae, C. psittaci, HSV-1, HSV-2, N. cinerea, N. lactamica, N. sicca, HPV 16 in Ca Ski cells, HPV 18 in Hela cells) tested; all results negative for both CT and NG at specified concentrations.

Evaluation of Potentially Interfering Substances:

No interference observed with common substances found in swab and urine specimens at concentrations listed in Table 2.6.
Interference observed with Talcum powder (>0.1% in urine), Phenazopyridine hydrochloride (>3 mg/mL in urine), and Mucus (>0.1% for urine, >1% for swab).

Precision Study:

Multi-site study (3 sites) with a nine-member panel. 150 replicates total per panel member (5 replicates/run, 30 runs).
Results for CT (Table 2.7):
- Panel member 1: Mean Delta Cycle 14.78, Total SD 0.388
- Panel member 2: Mean Delta Cycle 15.15, Total SD 0.499
- Panel member 3: Mean Delta Cycle 3.12, Total SD 0.640
- Panel member 4: Mean Delta Cycle 8.89, Total SD 0.477
- Panel member 6: Mean Delta Cycle 16.88, Total SD 0.373
- Panel member 9 (below LOD): Mean Delta Cycle 1.09, Total SD 0.665 (0.966 for all replicates)
Results for NG (Table 2.8):
- Panel member 1: Mean Delta Cycle 13.43, Total SD 0.444
- Panel member 2: Mean Delta Cycle 7.89, Total SD 0.475
- Panel member 3: Mean Delta Cycle 8.24, Total SD 0.319
- Panel member 5: Mean Delta Cycle 7.80, Total SD 0.358
- Panel member 7: Mean Delta Cycle 13.59, Total SD 0.608
- Panel member 9 (below LOD): Mean Delta Cycle 0.58, Total SD 0.404 (0.978 for all replicates)

Summary of Clinical Studies:

Multi-center clinical study in the United States, prospective collection from 3,832 male and female, asymptomatic and symptomatic subjects.
Reference assays: two commercially available nucleic acid amplification tests (NAAT) for CT and NG, and culture for NG.
Patient infected status determination:
- Female: minimum of two positive results (at least one from each reference NAAT).
- Male: minimum of two positive results.
- Positive NG culture considered infected regardless of NAAT results.
Patient not infected determination:
- Female: at least one reference NAAT negative for all sample types.
- Male: at least two negative results from reference NAATs.

Key results (representative data from tables 2.9, 2.11, 2.13, 2.14, 2.22, 2.25, 2.28):

Chlamydia trachomatis Clinical Sensitivity and Specificity - Female Specimens (Table 2.9):

Clinician-Collected Vaginal Swab (Symptomatic, n=732): Sensitivity 92.5%, Specificity 99.8%
Self-Collected Vaginal Swab (Symptomatic, n=699): Sensitivity 94.7%, Specificity 99.0%
Urine (Symptomatic, n=746): Sensitivity 92.6%, Specificity 99.5%
Urine (Asymptomatic, n=692): Sensitivity 95.7%, Specificity 99.2%

Chlamydia trachomatis Clinical Sensitivity and Specificity - Male Specimens (Table 2.10):

Urethral Swab (Symptomatic, n=825): Sensitivity 93.3%, Specificity 98.3%
Urine (Symptomatic, n=839): Sensitivity 97.3%, Specificity 99.7%
Urine (Asymptomatic, n=659): Sensitivity 97.8%, Specificity 99.6%

Neisseria gonorrhoeae Clinical Sensitivity and Specificity - Female Specimens (Table 2.11):

Clinician-Collected Vaginal Swab (Symptomatic, n=733): Sensitivity 96.8%, Specificity 99.9%
Self-Collected Vaginal Swab (Symptomatic, n=700): Sensitivity 96.7%, Specificity 99.7%
Urine (Symptomatic, n=746): Sensitivity 93.8%, Specificity 99.7%
Urine (Asymptomatic, n=693): Sensitivity 87.0%, Specificity 99.6%

Neisseria gonorrhoeae Clinical Sensitivity and Specificity - Male Specimens (Table 2.12):

Urethral Swab (Symptomatic, n=829): Sensitivity 99.2%, Specificity 99.3%
Urine (Symptomatic, n=840): Sensitivity 98.8%, Specificity 99.5%
Urine (Asymptomatic, n=658): Sensitivity 100.0%, Specificity 100.0%

CT Analysis According to Patient Infected Status - INFECTED FEMALE Subjects (Table 2.15):

Total Infected Subjects: 83 symptomatic, 30 asymptomatic. Exemplary row: 53 symptomatic, 30 asymptomatic subjects where all NAATs and RealTime CT/NG were positive for both CCV and FU.

CT Analysis According to Patient Infected Status - NON-INFECTED FEMALE Subjects (Table 2.16):

Total Non-Infected Subjects: 1052 symptomatic, 528 asymptomatic via urine only. Exemplary row: 224 symptomatic, 528 asymptomatic subjects where all NAATs and RealTime CT/NG were negative for all specimen types.

NG Analysis According to Patient Infected Status - INFECTED FEMALE Subjects (Table 2.19):

Total Infected Subjects: 70 symptomatic, 19 asymptomatic. Exemplary row: 12 symptomatic, 8 asymptomatic subjects where culture, all NAATs and RealTime CT/NG were positive for all specimen types.

Positive and Negative Predictive Values for Hypothetical Prevalence Rates for Chlamydia trachomatis (Table 2.28):

Sensitivity 95.0%, Specificity 99.2%
Example: At 0.5% prevalence, PPV 37.4%, NPV 100.0%
Example: At 30.0% prevalence, PPV 98.1%, NPV 97.9%

Positive and Negative Predictive Values for Hypothetical Prevalence Rates for Neisseria gonorrhoeae (Table 2.29):

Sensitivity 98.0%, Specificity 99.7%
Example: At 0.5% prevalence, PPV 62.1%, NPV 100.0%
Example: At 30.0% prevalence, PPV 99.3%, NPV 99.1%

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

See "Summary of Performance Studies" section above.

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.

K043224, K012351, K043224, K043144, K032554, K052224

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

Regulation Number and Section

§ 866.3120 Chlamydia serological reagents.

(a)
Identification. Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).(b)
Classification. Class I (general controls).

Summary

0

K080739

2.0 510(k) Summary

JUL 1 0 2008

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: (224) 361-7438)	Paula Martin
Senior Manager Regulatory and Clinical Affairs
(224) 361-7333
(224) 361-7438
e-mail: paula.martin@abbott.com
	Morteza Minaee
Director of Regulatory and Clinical Affairs
(224) 361-7468
(224) 361-7438
e-mail: mort.minaee@abbott.com

| Trade Name: | Abbott® RealTime CT/NG (List No. 8L07) 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: Nucleic acid test (NAT)

Classification Code: Product Codc: LSL, MKZ Registration Number: 866.3390 (Neisseria), 866.3120 (Chlamydia) Device Class: 2 (Neisseria), 1 (Chlamydia

Substantially Equivalent Devices:

GEN-PROBE® APTIMA® Combo 2 Assay (Assigned 510(k) No. K043224);

Becton Dickenson ProbeTec™ ET Chlamydia trachomatis /Neisseria gonorrhoeae Amplified DNA Assay (Assigned 510(k) No. K012351);

Gen-Probe® APTIMA™ Unisex Swab Specimen Collection Kit for Endoccrvical and Urethral Swab Specimens (K043224);

Gen-Probe APTIMA Urine Specimen Collection Kit for Male and Female Urine (Assigned 510(k) No. 043144);

Gen-Probe APTIMA Vaginal Swab Specimen Collection Kit (Assigned 510(k) No. K032554);

BD ProbeTec ET Urine Processing Kit Assigned 510(k) No. (K052224).

1

2.1 Purpose of the Submission

The purpose of this 510(k) is to gain clearance to market the Abbott RealTime CT/NG (List No. 8L07) assay and the Abbott multi-Collect Specimen Collection Kit (List No. 9K12).

2.2 Date of Preparation

March 11, 2008.

2.3 Manufacturer:

Abbott Molecular Inc. is the legal manufacturer of the Abbott RealTime CT/NG (List No. 8L07) assay and the Abbott multi-Collect Specimen Collection Kit (List No. 9K12).

Name:	Patrick Groody, PhD
Title:	Vice President Quality Assurance and Operations
Telephone	(224) 361-7424
Fax:	(224) 361-7438
Email:	patrick.groody@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: Lynn Creitz Title: Director Manufacturing Operations Telephone: (503) 666-8398 Fax: (503) 666-8510 lynnc@mmldiag.com Email:

MML Diagnostic Packaging, Inc. 1625 NW Sundial Road PO Box 458 Troutdale, OR 97060

Establishment Registration No .: 3018348

Abbott RealTime CT/NG // multi-Collect Specimen Collection Kit March 2008 Soc 2 511Kk) Summary_mw9

Volume l Section 2 Pagc 2

2

2.4 Intended Use

The proposed intended use for the Abbott RealTime CT/NG assay is:

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: clinician-collected vaginal swab and male urethral swab specimens; patient-collected vaginal swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: male and female urine.

The proposed intended use for the Abbott multi-Collect Specimen Collection Kit is:

The Abbott multi-Collect Specimen Collection Kit is intended for the collection and transportation of malc and female swab and urine specimens for the detection of Chlamydia trachomatis and Neisseria gonorrheae per instructions provided.

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

Abbott RealTime CT/NG consists of two reagent kits:

. Abbott RealTime CT/NG Amplification Reagent Kit (List No. 8L07-90)
Abbott RealTime CT/NG Control Kit (List No. 8L07-80) .

The Abbott RealTime CT/NG assay uses PCR technology with homogenous real-time fluorescence detection on the m2000 System. The Abbott m2000 System consists of the Abbott m2000sp and Abbott m2000rt instruments. The Abbott m2000 System integrates sample preparation with nucleic acid amplification and detection to generate assay rcsults. The Abbott m2000sp is used for processing samples and the Abbott m2000rt is used for amplification and detection.

3

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 (List No. 9K12) contains:

One Transport Tube containing 1.2 mL Specimen Transport Buffer .
. One Individually Packaged Sterile Specimen Collection Swab (Part No. CD650)
. One disposable transfer pipette.

The Specimen Transport Buffer consists of guanidine thiocyanate, a chaotropic salt, in Tris buffer and 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.

2.6 Background on Chlamydial and Gonorrheal Disease

Chlamydia are non-motile, Gram-negative, obligate intracellular parasites of eukaryotic cells. They form inclusions in the cytoplasm of the host cell. Chlamydia trachomatis, one of three chlamydial species, is the causative agent of the sexually transmitted disease (STD) chlamydia. Chlamydial infections of the urogenital tract are associated with salpingitis, ectopic pregnancies and tubal factor infertility in women as well as nongonococcal urethritis and epididymitis in men. 13. The genital site most commonly affected in women is the ccrvix, but the infection can be asymptomatic and, if untreated, is likely to ascend to the uterus, fallopian tubes and ovaries causing pelvic inflammatory disease (PID).4 Neonates born of infected mothers can contract inclusion conjunctivitis. nasopharyngeal infections, and pneumonia due to Chlamydia trachomatis.5 Infection by Chlamydia trachomatis in men is also often asymptomatic and, if untreated, may lead to epididymitis, a major complication.3 Patients infected with Chlamydia trachomatis may be co-infected with Neisseria gonorrhoeae, the causative agent of gonorrhea. Further, patients with treatment indications for gonorrhea but not chlamydia often harbor Chlamydia trachomatis. Chlamydia infections may not respond well to recommended regimens for treating Neisseria gonorrhoeae. Therefore, unless chlamydial infection has

Volume I Section 2 Page 4

4

been ruled out in patients treated for gonorrhea, dual therapy for gonococcal and chlamydial infections is recommended.7

Cell culture, commonly used to detect Chlamydia trachomatis, has been replaced by more sensitive nucleic acid tests.8 Since a specific diagnosis of chlamydia may improve treatment compliance and cnhance partner notification, the use of these highly sensitive and specific tests is strongly recommended.7

Gonorrhea is one of the most common sexually transmitted diseases in the United States. Over 700,000 new infections of Neisseria gonorrhoeue are estimated to occur each year." In men, gonorthea infection usually results in acute anterior urethritis accompanied by a purulent exudate. "0.1 In women, the infection is most often found in the cervix, but the vagina and uterus also may be infected. Frequently the infection is asymptomatic. especially in women. Without treatment, local complications of gonococcal infection can occur including pelvic inflammatory disease (PID) or acute salpingitis for women and epididymitis for men.1011 Rarcly, disseminated gonococcal infection, DGI, may occur in untreated patients.13

Neisseria gonorrhoeae is a Gram-negative, oxidase-positive diplococcus without flagellae.12 Culture is commonly used for the detection of Neisseria gonorrhoeae. Presumptive diagnosis of gonorrhea is based on the morphological examination, Gram stain, and oxidase measurement of the culture isolate. Confirmation proccdures have been used for definitive identification of Neisseria gonorrhoeae including sugar fermentation, fluorescent antibody staining, nucleic acid hybridization, and agglutination.'4.15 Nucleic acid tests are widely available for the sensitive detection of Neisseria gonorrhoeae.

2.7 Technological Characteristics of the Device as Compared to the Predicate

The primary functional components of the Abbott RealTime CT/NG assay are substantially equivalent to other legally marketed nucleic acid amplification tests (NAAT) intended for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG).

5

The Abbott RealTime CT/NG assay has the same general intended uses as the predicate devices. Although there are some technological differences between the Abbott RealTime CT/NG and the predicate devices, these differences do not raise new types of safety or effectiveness questions.

These devices are similar in that they are designed to prepare nucleic acids for amplification, amplify specific Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) sequences, detect the amplified products, and report qualitative results.

The primary similarities and differences between the Abbott RealTime CT/NG assay and the NAAT predicate devices are shown in Table 2.1.

The primary functional components of the Abbott multi-CollectSpecimen Collection Kit are substantially equivalent to other legally marketed devices intended for the collection and transportation of clinical specimens for the direct, qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG).

The Abbott multi-Collect Specimen Collection Kit has the same general intended use as the predicate devices. Although there are some technological differences between the Abbott multi-Collect Specimen Collection Kit and the prodicate devices, these differences do not raise new types of safety or effectiveness questions.

These devices are similar in that they are designed to collect urogenital specimens and to stabilize the nucleic acid of the specimen during transport and storage prior to nucleic acid testing.

The primary similarities and differences between the Abbott multi-Collect Specimen Collection Kit and the predicate devices are shown in Tables 2.2 through 2.4.

6

	Current Application	Amplified Nucleic Acid Predicate Devices
Feature	Abbott RealTime CT/NG	Gen-Probe Aptima Combo 2	Becton Dickenson ProbeTec ET
Assay Type	Qualitative •	Qualitative •	Qualitative •
CT Analyte
Targets	CT cryptic plasmid
DNA •	CT ribosomal RNA •	CT cryptic plasmid DNA •
NG Analyte
Targets	NG genomic DNA •	NG ribosomal RNA •	NG genomic DNA •
Input Sample
Types	Self-collected vaginal
swab specimens •	Endocervical swab specimens •
Self-collected vaginal swab
specimens •
Clinician-collected vaginal swab
specimens •	Endocervical swab specimens •
Male urethral swab specimens •
Male and female urine specimens •
	Clinician-collected
vaginal swab
specimens •
Male urethral swab
specimens •
Male and female urine
specimens •	PreservCyt liquid Pap specimens •
Male urethral swab specimens •
Male and female urine specimens. •
Sample
Preparation
Procedure	Automated •	Semi-automated/automated •	Manual/ semi-automated •
Amplification
Technology	Real-time PCR •	TMA •	SDA •
Assay Controls	Negative Control •
Cutoff Control •
Internal Control •	Negative Control •
Positive Control •	Negative Control •
Positive Control •

Valums I
Socialon 2
Page 7

7

Similarities and Differences between Abbott multi-Collect Specimen Collection Kit and the Predicate Devices (Urine Specimen Collection) ・・

	Current Application	Predicate Devices for Urine Specimens
Feature	Abbott multi-Collect
Specimen Collection Kit	Gen-Probe Aptima
Urine Specimen Collection Kit	BDProbeTec
Urine Processing Kit
Device Description	Contains a transfer pipette for adding
approximately 3.0 mL of urine to the
Transport Tube. The Transport Tube
contains 1.2 mL of Specimen Transport
Buffer and is used to stabilize DNA until
sample preparation.	Contains a disposable transfer
pipette for adding approximately 2
mL of urine to a Specimen
Transport Tube containing
2.0 mL of Transport Buffer.	Contains a disposable transfer
pipette for adding approximately
2.5 to 3.5 mL of urine to one
Urine Preservative Transport or
Urine Processing Pouch.

8

	Current Application	Predicate Device for Male Urethral Swab Specimens
Table 2.3
Similarities and Differences between Abbott multi-Collect Specimen Collection Kit and the Predicate Devices
(Urethral Swab Specimen Collection)
		Gen-Probe Aptima Unisex Swab
Specimen Collection Kit for
Feature	Abbott multi-Collect Specimen Collection Kit	Endocervical and Male Urethral
Swab Specimens
Device Description	Contains an individually packaged sterile Specimen
Collection Swab that is placed into the Transport
Tube after swab sampling. The Transport Tube
contains 1.2 mL of Specimen Transport Buffer and
is used to stabilize DNA until sample preparation.	Contains an individually packaged sterile Endocervical
Cleaning Swab and an individually packaged sterile
Specimen Collection Swab that is placed into the
Transport Tube after swab sampling. The Transport
Tube contains 2.9 mL of Specimen Transport Buffer
and is used to stabilize DNA until sample preparation.
The Gen-Probe Aptima Unisex Swab Specimen
Collection Kit can be used to collect either
Endocervical or Male Urethral Swab specimens.

9

Table 2.4 Similarities and Differences between Abbott multi-Collect Specimen Collection Kit and the Predicate Devices (Vaginal Swab Specimen Collection)

	Current Application	Predicate Device for Vaginal Swab Specimens
Feature	Abbott multi-Collect Specimen Collection Kit	Gen-Probe Aptima Vaginal Swab
Specimen Collection Kit
Device
Description	The Abbott multi-Collect Specimen Collection Kit
contains a transfer pipette for adding approximately 3.0
mL of urine to the Transport Tube and an individually
packaged sterile Specimen Collection Swab that is placed
into the Transport Tube after swab sampling. The
Transport Tube contains
1.2 mL of Specimen Transport Buffer and is used to
stabilize DNA until sample preparation. The Abbott multi-
Collect Specimen Collection Kit can be used to collect
either a swab or a urine specimen.	The Gen-Probe Aptima Vaginal Swab Specimen
Collection Kit contains an individually packaged sterile
Specimen Collection Swab that is placed into the
Transport Tube after swab sampling. The Transport Tube
contains 2.9 mL of Specimen Transport Buffer and is
used to stabilize DNA until sample preparation. The Gen-
Probe Aptima Vaginal Swab Specimen Collection Kit is
used to collect Vaginal Swab Specimens.

10

2.8 Summary of Nonclinical Studies

Analytical Sensitivity

The analytical sensitivity of the Abbott RealTime CT/NG assay was determined by testing dilutions of Chlamydia trachomatis (CT) target DNA and Neisseria gonorrhoeae (NG) target DNA. Testing was performed with three lots of amplification reagents on three m2000 Systems. Probit analysis of the data determined that the concentration of CT DNA detected with 95% probability was 39 copies/assay (95% CI 33 - 51), and the concentration of NG DNA detected with 95% probability was 192 copies/assay (95% CI 176-220).

The limit of detection (LOD) claim for the RealTime CT/NG assay is 320 copies of CT target DNA and 320 copies of NG target DNA per assay. The limit of detection (LOD) is defined as the CT and NG DNA concentration detected with a probability of 95% or greater.

The CTNG assay targets the Chlamydia cryptic plasmid (present at approximately 7 to 10 copies per Chlumydia organism) and the multicopy opacity gene of Neisseria gonorrhoeae (repeated up to 11 times per organism). Thus, 320 copics of target DNA translates to approximately 30 to 40 organisms per assay.

The claimed LOD for the Abbott RealTime CT/NG assay was confirmed by testing a sample containing 320 copies of CT target DNA and 320 copies of NG target DNA per assay. The detection rate was 100% (403/403) for both CT and NG in the assay.

A study was conducted to challenge the performance of the Abbott RealTime CT/NG assay in samples containing high target numbers of either CT or NG in the presence of low target numbers of the opposite analyte. The detection rate of 320 copies of CT DNA in the presence of high NG target was 100% (400/400). The detection rate of 320 copies of NG DNA in the presence of high CT target was 98.5% (398/404).

The analytical sensitivity of the Abbott RealTime CT/NG assay for detecting Chlamydia trachomatis serovars A through L was determined by testing dilutions of each serovar.

11

Serovars A through K, L1, and L2 were detected at less than 1 Inclusion Forming Units (IFU) per assay and scrovar L3 was detected at less than 3 IFU/assay.

The analytical sensitivity of the Abbott RealTime CT/NG assay for detecting 28 different isolates of Neisseria gonorrhoeae was determined by testing dilutions of cach isolate. All isolates were detected at less than I Colony Forming Unit (CFU)/assay.

12

Evaluation of Potential Cross-Reactants

A total of 111 strains of bacteria, viruses, parasites, yeast, and fungi were tested for potential cross reactivity in the Abbott RealTime CT/NG assay (Table 2.5). These included organisms that are phylogenctically related to CT and NG, and those that can be found in the urogenital tract. Purified DNA or RNA was diluted to a final concentration of 1 x 10' copies/assay. HBV DNA and HCV RNA were added directly into the PCR reaction at approximately 3 x 105 and 9 x 106 copies per reaction, respectively. All results were negative for both CT and NG.

A total of 32 culture isolates were tested for potential cross reactivity in the Abbott RealTime assay. Thesc included 27 organisms listed in Table 7.5, and Neisseria cinerea, Neisseria lactamica, Neisseria sicca, Ca Ski cells containing HPV 16, and Hela cells containing HPV 18. Ca Ski cells containing HPV 16 and Hela cells containing HPV 18 wcre tested at 105 cells per assay, C. pneumoniae and C. psittaci were tested at 10° EB per assay. HSV-1 and HSV-2 were tested at 106 genomes per assay, and the rest of the organisms were tested at 106 Colony Forming Units (CFU) per assay. All results were negative for both CT and NG.

13

	Microorganism/Virus
Achromobacter xerosis	Haemophilus ducreyi*	Proteus vulgaris
Acinetobacter calcoaceticus	Haemophilus influenzae	Providencia stuartii
Acinetobacter lwoffii	Helicobacter pylori	Pseudomonas aeruginosa*
Actinomyces israelii	Hepatitis B virus (HBV)	Pseudomonas putida
Aerococcus viridans	Hepatitis C virus (HCV)	Rahnella aquatilis
Aeromonas hydrophila	Herpes Simplex Virus, type I*	Rhizobium radiobacter
Alcaligenes faecalis	Herpes Simplex Virus, type II*	Rhodospirillum rubrum
Arcanobacterium pyogenes	Human immunodeficiency virus (HIV-1)	Ruminococcus productus
Bacillus subtilis	Human Papilloma Virus 16	Salmonella choleraesuis
Bacteroides fragilis	Human Papilloma Virus 18	Salmonella enterica
Bacteroides ureolyticus	Kingella denifricans	Serratia marcescens*
Bifidobacterium adolescentis	Kingella kingae	Staphylococcus aureus*
Bifidobacterium breve	Klebsiella oxytoca	Staphylococcus epidermidis*
Brevibacterium linens	Klebsiella pneumoniae	Staphylococcus saprophyticus*
Campylobacter jejuni	Lactobacillus acidophilus*	Streptococcus agalactiae*
Candida albicans*	Lactobacillus brevis*	Streptococcus hovis
Candida glabrata	Lactobacillus delbrueckii subsp. lactis	Streptococcus mitis
Candida parapsilosis	Lactobacillus jensenii	Streptococcus mutans
Candida tropicalis	Legionella pneumophila	Streptococcus pneumoniae
Chlamydia pneumoniae*	Listeria monocytogenes	Streptococcus pyogenes
Chlamydia psittaci*	Micrococcus luteus*	Streptococcus salivarius
Chromobacterium violaceum	Mobiluncus mulieris	Streptococcus sanguinis
Chryseobacterium
meningosepticum	Moraxella (Branhamella) catarrhalis	Streptomyces griseinus
Citrobacter freundii	Moraxella lacunata	Trichomonas vaginalis
Clostridium perfringens	Moraxella osloensis	Ureaplasma urealyticum
Corynebacterium genitalium*	Morganella morganii	Veillonella parvula
Corynebacterium xerosis	Mycobacterium gordonae	Vibrio parahaemolyticus
Cryptococcus neoformans	Mycobacterium smegmatis*	Weissella paramesenteroides
Cytomegalovirus	Mycoplasma genitalium	Yersinia enterocolitica

・

Table 2.5 Potentially Cross-Reactive Microorganisms/Viruses

Tested with purified DNA or RNA und with culture isolates.

14

Table 2.5 (Continued)

Potentially Cross-Reactive Microorganisms/Viruses

Microorganism/Virus	Microorganism/Virus
Deinococcus radiodurans	Mycoplasma hominis
Derxia gummosa	Neisseria flava*
Eikenella corrodens	Neisseria meningitidis-A*
Enterobacter cloacae*	Neisseria meningitidis-B*
Enterobacter aerogenes	Neisseria meningitidis-C*
Enterococcus avium	Neisseria meningitidis-D*
Enterococcus faecalis*	Neisseria perflava*
Enterococcus faecium	Puntoea agglomerans
Escherichia coli*	Peptostreptococcus anaerobius
Fusobacterium nucleatum	Plesiomonas shigelloides
Gardnerella vaginalis	Propionibacterium acnes
Gemella haemolysans	Proteus mirabilis*

Tested with purified DNA or RNA and with culture isolates.

・

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15

Evaluation of Potentially Interfering Substances

The potential for interference in the Abbott RealTime CT/NG assay was assessed with substances that may be found in swab and/or urine specimens. Substances were spiked into a swab and/or urinc matrix containing 320 copies of CT and NG target DNA per assay, and into a swab and/or urine matrix without CT or NG DNA.

No interference in the performance of the Abbott RealTime CT/NG assay was observed in the presence of the substances listed in Table 2.6.

16

Substance	Matrix	Highest Concentration Tested
Zovirax® Cream 5%	Swab	0.25
CLOTRIMAZOLE Vaginal Cream (2%)	Swab	0.25%
Delfen®	Swab	0.25%
KY® Jelly	Swab	0.25%
Lubrin®	Swab	0.25%
Metrogel-Vaginal®	Swab	0.25%
Miconazole® 3 Suppository	Swab	0.25%
Monostat-IT™ Dosc Treatment (tioconazole ointment)	Swab	0.25%
Norforms® Deodorant Suppositories	Swab	0.25%
Terazol-3® Vaginal Cream	Swab	0.25%
Vagi gard® Povidone-Iodine Medicated Douche	Swab	0.25%
Vagi gard® Moisturizing Gel	Swab	0.25%
Vagisil® Anti-itch Creme	Swab	0.25%
Vagisil® Intimate Lubricant	Swab	0.25%
Yeast gard®	Swab	0.25%
Bilirubin	Urinc	10 mg/mL
Glucose	Urinc	10 mg/mL
pH 4 (acidic) Urine	Urine	N/A
pH 9 (alkaline) Urine	Urine	N/A
Protein: BGG	Urine	5%
Blood	Swab and Urine	5%
Leukocytes	Swab and Urine	1 x 10° cell/mL

Table 2.6

Substances That Do Not Interfere with the Abbott RealTime CT/NG Assay

Interference in the performance of the Abbott RealTime CT/NG assay may be observed with the following substances:

Talcum powder at concentrations greater than 0.1% in urine specimens. .
Phenazopyridine hydrochloride (the active ingredient in URISTAT) at concentrations . greater than 3 mg/mL in urine specimens.
Mucus at concentrations greater than 0.1% for urine specimens and 1% for swab . specimens.

17

2.9 Precision Study

A precision study was performed at three sites, two external and onc internal. Each site was provided with a nine-member panel that was prepared targeting different combinations of CT and NG concentrations. The targeted concentration for CT ranged from 0 to 4,500 IFU/assay and for NG from 0 to 2,000 CFU/assay. Five replicates of each panel member were tested in each run. Thirty runs (10 per site) were performed for a total of 150 replicates of each pancl member. The study included three amplification reagent lots. Each site tested two amplification reagent lots. A variance components analysis for a nested model was performed on delta cycle (DC) values, and the results are summarized in Tables 2.7 and 2.8, respectively.

18

| Panel
Membera | No.
Testedb | No.
Positive | Mean
Delta
Cycle | Within-
Run
Component
SDc | Between-
Run
Component
SDc | Between-
Lot
Component
SDc | Between-
Site
Component
SDc | Total
SDc,d |
|------------------|----------------|-----------------|------------------------|------------------------------------|-------------------------------------|-------------------------------------|--------------------------------------|----------------|
| 1 | 150 | 150 | 14.78 | 0.300 | 0.194 | 0.066 | 0.137 | 0.388 |
| 2 | 149 | 149 | 15.15 | 0.385 | 0.139 | 0.285 | 0.000 | 0.499 |
| 3 | 149 | 149 | 3.12 | 0.591 | 0.241 | 0.000 | 0.047 | 0.640 |
| 4 | 150 | 150 | 8.89 | 0.385 | 0.156 | 0.169 | 0.162 | 0.477 |
| 5 | 148 | 0 | ... | ... | ... | ... | ... | ... |
| 6 | 148 | 148 | 16.88 | 0.167 | 0.207 | 0.149 | 0.215 | 0.373 |
| 7 | 150 | 0 | ... | ... | ... | ... | ... | ... |
| 8 | 149 | 1 | 0.67 | ... | ... | ... | ... | ... |
| 9 | 148 | 103 | 1.09 | 0.637 | 0.000 | 0.192 | 0.000 | 0.665 |

		Table 2.7
--	--	-----------	--	--	--

Precision Study: CT Results

2 CT concentrations were urgeted approximately to 4500 IFU/assay in members 1, 2, and 6 and to 45 IFU/assay in e of othermanent was argeted upproximately to 0.75 IFU/assay and member 9 to 0.2 IFU/assay both below the claimed assay LOD. Members 5, 7, and 8 did not contain any CT organisms.

Invalid replicates were excluded from the unalysis.

& The SD is based on positive replicates only. For member 9, analysis of all replicates with a cycle number (n=133),

including those beyond the assay cutoff, resulted in a total SD of 0.966.

d The total variability contains within-run, between-lot, and between-site variability.

Table 2.8

| Panel
Membera | No.
Testedb | No.
Positive | Mean
Delta
Cycle | Within-Run
Component
SDc | Between-
Run
Component
SDc | Between-
Lot
Component
SDc | Between-
Site
Component
SDc | Total
SDc,d |
|------------------|----------------|-----------------|------------------------|--------------------------------|-------------------------------------|-------------------------------------|--------------------------------------|----------------|
| 1 | 150 | 150 | 13.43 | 0.382 | 0.172 | 0.000 | 0.147 | 0.444 |
| 2 | 149 | 149 | 7.89 | 0.430 | 0.064 | 0.097 | 0.166 | 0.475 |
| 3 | 149 | 149 | 8.24 | 0.270 | 0.149 | 0.057 | 0.060 | 0.319 |
| 4 | 150 | 0 | ... | ... | ... | ... | ... | ... |
| 5 | 148 | 148 | 7.80 | 0.231 | 0.198 | 0.040 | 0.185 | 0.358 |
| 6 | 147 | 0 | ... | ... | ... | ... | ... | ... |
| 7 | 150 | 150 | 13.59 | 0.539 | 0.191 | 0.000 | 0.205 | 0.608 |
| 8 | 149 | 0 | ... | ... | ... | ... | ... | ... |
| 9 | 148 | 56 | 0.58 | 0.386 | 0.000 | 0.000 | 0.120 | 0.404 |

Precision Study: NG Results

° NG concentrations were targeted approximately to 2000 CFU/assay in members I and 7; to 20 CFU/assay in nembers 2, 3, und 5. Member 9 was targeted to 0.1 CFU/assay, below the claimed assay LOD. Members 4, 6, and 8 did not contain any NG organisms.

b Invalid replicates were excluded from the analysis.

& The SD is based on positive replicates only. For member 9, analysis of all replicates with a cycle number (n-148), including those beyond the assay cutoff, resulted in a total SD of 0.978.
4 The total variability contains within-run, between-lot, and between-site variability.

^d The total variability contains within-run, between-run, between-lot, and between-site variability.

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19

Summary of Clinical Studies 2.10

Performance charactcristics of the Abbott RealTime CT/NG assay were established in a multi-center clinical study conducted in the United States. Specimens were prospectively collected from subjects at 16 geographically diverse sites that included physician private practices, public and private STD clinics, and a hospital cmergency room. A total of 3,832 malc and female, asymptomatic and symptomatic subjects were enrolled. Study subjects were classified as symptomatic if the subject reported STD-related symptoms. Specimens collected from cach female subject included urine, endocervical swabs, selfcollected vaginal swab, and clinician-collected vaginal swabs. Specimens collected from each male subject included urine and urethral swabs. Specimen testing methods included the Abbott RealTime CT/NG assay, two commercially available nucleic acid amplification tests (NAAT) for CT and NG, and culture for NG. The NAATs and the NG culture were used as reference assays in the clinical study.

For females, self-collected vaginal swab and urine specimens were collected first, followed by endocervical swab for culture. Remaining swab specimen collection was randomized to minimize bias. For males, urethral swab for culture was collected first. Remaining swab specimen collection was randomized to minimize bias. Urine specimen was collected after the swab specimens.

For each subject, a patient infected status was determined based on the combined results from the reference assays. A female subject was categorized as infected for CT or NG if a minimum of two positive results (at least one from each reference NAAT) were reported. A male subject was categorized as infected for CT or NG if a minimum of two positive results were reported. If the reference NG culture assay result was positive, the subject was categorized as infected regardless of NAAT results.

A female subject was categorized as not infected with CT or NG if at least one of the reference NAATs reported negative results for all sample types. A male subject was categorized as not infected with CT or NG if a total of at least two negative results were reported by the reference NAATs.

20

If patient infected status could not be determined due to missing and/or indeterminate results from the reference assays, the subject was excluded from the analysis. Patient infected status could not be determincd for 33 subjects for CT and 35 subjects for NG.

Tables 2.9 through 2.28 summarize the clinical trial data.

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Arouning	8



-

| ਤੇ

િત્વ

Female Specimens
Specimen	Symptoms	n	True Pos	False Pos	True Neg	False Neg	Sensitivity (95% C.I.)	Specificity (95% C.I.)
Clinician-Collected
Vaginal Swab	Symptomatic	732	74	8	644	6	92.5 (84.4, 97.2)	99.8 (97.6, 99.5)
Self-Collected
Vaginal Swab	Symptomatic	699	71	6	618	4	94.7 (86.9, 98.5)	99.0 (97.9, 99.6)
Urine	Symptomatic	746	75	3	662	6	92.6 (84.6, 97.2)	99.5 (98.7, 99.9)
	Asymptomatic	692	44	5	641	2	95.7 (85.2, 99.5)	99.2 (98.2, 99.7)

Table 2.9 Chlamydia trachomatis Clinical Sensitivity and Specificity

Female Specimens

22

Specimen	Symptoms	n	True Pos	False Pos	True Neg	False Neg	Sensitivity (95% C.I.)	Specificity (95% C.I.)
Urethral
Swab	Symptomatic	825	167	11	635	12	93.3 (88.6, 96.5)	98.3 (97.0, 99.1)
Urine	Symptomatic	839	178	2	654	5	97.3 (93.7, 99.1)	99.7 (98.9, 100.0)
	Asymptomatic	659	89	2	566	2	97.8 (92.3, 99.7)	99.6 (98.7, 100.0)

.

$\frac{8}{3}$

ຽງ ແຜ່ນວັລ
ປີ ແລະມວລຽ

23

/s

Specimen	Symptoms
Clinician-
Collected
Vaginal Swab	Symptomatic
Self-
Collected
Vaginal Swab	Symptomatic
Urine	Symptomatic

Table 2.11 Neisseria gonorrhoeae Clinical Sensitivity and Specificity Female Specimens

| | Symptoms | n | True
Pos | False
Pos | True
Neg | False
Neg | Sensitivity (95% C.I.) | Specificity (95% C.I.) |
|--|--------------|-----|-------------|--------------|-------------|--------------|------------------------|------------------------|
| | Symptomatic | 733 | 30 | 1 | 701 | 1 | 96.8 (83.3, 99.9) | 99.9 (99.2, 100.0) |
| | Symptomatic | 700 | 29 | 2 | 688 | 1 | 96.7 (82.8, 99.9) | 99.7 (98.9, 100.0) |
| | Symptomatic | 746 | 30 | 2 | 712 | 2 | 93.8 (79.2, 99.2) | 99.7 (99.0, 100.0) |
| | Asymptomatic | 693 | 20 | 3 | 667 | 3 | 87.0 (66.4, 97.2) | 99.6 (98.7, 99.9) |

24

Specimen	Symptoms	n	True Pos	False Pos	True Neg	False Neg	Sensitivity (95% C.I.)	Specificity (95% C.I.)
Urethral Swab	Symptomatic	829	234	4	589	2	99.2 (97.0, 99.9)	99.3 (98.3, 99.8)
Urine	Symptomatic	840	237	3	597	3	98.8 (96.4, 99.7)	99.5 (98.5, 99.9)
	Asymptomatic	658	11	0	647	0	100.0 (71.5, 100.0)	100.0 (99.4, 100.0)

.

1 อัตรา 1 อัลบี 1 เมตร 1 เมตร 1 เมตร 2 เวลา 1

.
6

25

CT Clinical Sensitivity and Specificity by Clinical Testing Site
Specimen	Testing
Site	n	True
Pos	False
Pos	True
Neg	False
Neg	Sensitivity (95% C.I.)	Specificity (95% C.I.)
Clinician-
Collected
Vaginal
Swab	1	391	41	4	342	4	91.1 (78.8-97.5)	98.8 (97.1 - 99.7)
Clinician-
Collected
Vaginal
Swab	2	229	22	2	203	2	91.7 (73.0-99.0)	99.0 (96.5 -99.9)
Clinician-
Collected
Vaginal
Swab	3	112	11	2	99	0	100.0 (71.5 - 100.0)	98.0 (93.0-99.8)
Clinician-
Collected
Vaginal
Swab	All	732	74	8	644	6	92.5 (84.4-97.2)	98.8 (97.6 - 99.5)
Self-
Collected
Vaginal
Swab	1	373	38	4	329	2	95.0 (83.1 - 99.4)	98.8 (97.0 - 99.7)
Self-
Collected
Vaginal
Swab	2	220	22	1	195	2	91.7 (73.0-99.0)	99.5 (97.2 - 100.0)
Self-
Collected
Vaginal
Swab	3	106	11	1	94	0	100.0 (71.5 - 100.0)	98.9 (94.3 - 100.0)
Self-
Collected
Vaginal
Swab	All	699	71	6	618	4	94.7 (86.9 - 98.5)	99.0 (97.9-99.6)
Female
Urine	1	751	74	4	669	4	94.9 (87.4 - 98.6)	99.4 (98.5 - 99.8)
Female
Urine	2	388	28	1	357	2	93.3 (77.9 - 99.2)	99.7 (98.5 - 100.0)
Female
Urine	3	299	17	3	277	2	89.5 (66.9 - 98.7)	98.9 (96.9 - 99.8)
Female
Urine	All	1438	119	8	1303	8	93.7 (88.0-97.2)	99.4 (98.8 - 99.7)

Table 2.13 1 NG Analysis According to Patient Infected Status
NON-INFECTED FEMALE Subjects

Culture	NAAT 1			NAAT 2		RealTime CT/NG			No. of Subjects
E	CCV	FU	E	FU	CCV	SCV	FU	Symptomatic
(SCV/CCV/U)	Asymptomatic
(Urine Only)
-	-	-	+	-	-	-	-	2	6	8
-	-	-	+	NA	-	-	NA	1	0	1
-	-	+	-	-	-	-	-	1	1	2
-	+	-	-	-	-	-	-	2	0	2
-	+	-	-	-	-	-	-	2	1	3
-	+	-	-	-	NA	-	-	1	0	1
-	-	+	+	+	-	-	-	0	1	1
-	-	+	-	-	-	-	+	0	3	3
-	+	+	-	-	-	NA	+	1	0	1
-	+	+	-	-	-	+	-	1	0	1
-	-	-	-	-	+	-	-	0	1	1
-	-	-	-	NA	+	-	-	0	1	1
-	-	+	-	-	+	-	-	0	1	1
-	+	+	-	-	+	-	-	0	1	1
-	+	+	+	-	+	+	+	1	0	1

E = Endocervical Swab Specimen; CCV = Clinician-Collected Vaginal Swab Specimen; FU = Female Urine Specimen; SCV = Self-Collected Vaginal Swab Specimen; U = Urine.

37

Culture	NAAT 1		NAAT 2		RealTime CT/NG		No. of Subjects
MUS	MUS	MU	MU	MUS	MU	Symptomatic
(SCV/CCV/U)	Asymptomatic
(Urine Only)	Total
+	+	+	+	+	+	169	2	171
+	+	+	NA	+	+	3	1	4
+	+	NA	NA	+	NA	1	0	1
+	+	NA	+	+	+	1	0	1
NA	+	+	+	+	+	6	0	6
+	+	+	+	NA	+	6	0	6
+	+	+	+	+	+	9	0	9
+	+	+	+	+	+	2	0	2
-	+	+	+	+	+	35	6	41
+	+	+	NA	+	NA	1	0	1
-	+	NA	+	+	+	2	0	2
-	NA	+	+	+	+	1	0	1
-	+	+	+	+	+	1	0	1
+	-	-	+	+	+	1	0	1
-	+	+	+	+	+	1	0	1
+	+	-	-	+	-	1	0	1
+	+	+	+	-	+	1	0	1
-	-	+	+	+	+	0	2	2
+	-	-	-	-	-	1	0	1

NG Analysis According to Patient Infected Status INFECTED MALE Subjects

MUS = Male Urethral Swab Specimen; MU = Male Urine Specimen; U = Urine. NA includes "indeterminate" results from reference assays, specimens not available, or missing results.

·

38

| Culture | NAAT 1 | CT/NG | | No. of Subjects |---------|--------|----|-- | MUS | MUS | MU | MU (SCV/CCV/U) | Asymptomatic
(Urine Only) | Total |
| MUS | - | - | - | - | - | - | NA | - | - | - | NA | - | - | NA | - | - | NA | - | - | - | NA | - | - | NA | - | - | - | - | - | - | - | - | - | - | - | - | - | - | + | NA | - | - | + | - | - | + | - | - | + | - | - | - | - | - | - | - | - | - | - | - | + | - | - | - | - | - | + | - | + | - | - | NAAT 2 | RealTime
| | |
------|-------------------|----|----------------------------|------------------------------|-------|
| MUS | MU | Symptomatic
| - | - | 516 | 559 | 1075 |
| - | - | 40 | 42 | 82 |
| NA | - | 1 | 1 | 2 |
| - | - | 1 | 0 | 1 |
| - | - | 1 | 1 | 2 |
| NA | - | 1 | 0 | 1 |
| - | - | 7 | 6 | 13 |
| - | NA | 3 | 4 | 7 |
| NA | - | 8 | 6 | 14 |
| - | - | 16 | 25 | 41 |
| - | - | 0 | 1 | 1 |
| - | - | 2 | 3 | 5 |
| - | - | 2 | 2 | 4 |
| - | + | 1 | 0 | 1 |
| + | - | 0 | 1 | 1 |
| + | - | 2 | 0 | 2 |
| + | + | 1 | 0 | 1 |
| + | + | 1 | 0 | 1 |

NG Analysis According to Patient Infected Status NON-INFECTED MALE Subjects

MUS = Male Urethral Swab Specimen; MU = Male Urine Specimen; U = Urine.

39

Prevalence of C. trachomatis and/or N. gonorrhoeae by Collection Site: Symptomatic and Asymptomatic Female Urine Specimens

	Female Urine
	% Prevalence (Number Positive/Number Tested)
Sitea	CT+/NG+	CT+/NG-b	CT-/NG+b
1	0.0 (0/61)	0.0 (0/61)	0.0 (0/61)
3	1.6 (3/183)	4.4 (8/183)	1.1 (2/183)
4	0.0 (0/50)	8.0 (4/50)	2.0 (1/50)
5	0.0 (0/21)	0.0 (0/21)	0.0 (0/21)
6	0.0 (0/16)	6.3 (1/16)	6.3 (1/16)
7	3.1 (9/295)	8.5 (25/295)	3.7 (11/295)
8	0.0 (0/56)	7.1 (4/56)	3.6 (2/56)
9	4.6 (3/65)	16.9 (11/65)	6.2 (4/65)
10	2.4 (4/168)	10.7 (18/168)	1.8 (3/168)
11	2.1 (6/289)	9.3 (27/289)	1.4 (4/289)
12	0.0 (0/11)	0.0 (0/11)	0.0 (0/11)
13	0.0 (0/71)	0.0 (0/71)	0.0 (0/71)
14	0.0 (0/80)	3.8 (3/80)	0.0 (0/80)
15	1.7 (1/60)	0.0 (0/60)	0.0 (0/60)
16	0.0 (0/25)	0.0 (0/25)	4.0 (1/25)
All	1.8 (26/1451)	7.0 (101/1451)	2.0 (29/1451)

ª No evaluable results were available from Site 2.

b Does not include specimens that were positive for both CT and NG.

40

	Clinician-Collected Vaginal Swab			Self-Collected Vaginal Swab
Sitea	CT+/NG+	CT+/NG-b	CT-/NG+b	CT+/NG+	CT+/NG-b	CT-/NG+b
1	0.0
(0/23)	0.0
(0/23)	0.0
(0/23)	0.0
(0/24)	0.0
(0/24)	0.0
(0/24)
3	2.3
(2/88)	4.5
(4/88)	2.3
(2/88)	2.4
(2/84)	4.8
(4/84)	2.4
(2/84)
4	0.0
(0/42)	9.5
(4/42)	2.4
(1/42)	0.0
(0/37)	10.8
(4/37)	2.7
(1/37)
5	0.0
(0/15)	0.0
(0/15)	0.0
(0/15)	0.0
(0/15)	0.0
(0/15)	0.0
(0/15)
6	0.0
(0/16)	12.5
(2/16)	6.3
(1/16)	0.0
(0/14)	7.1
(1/14)	7.1
(1/14)
7	3.4
(7/207)	10.6
(22/207)	3.4
(7/207)	3.6
(7/196)	10.2
(20/196)	4.1
(8/196)
8	0.0
(0/47)	6.4
(3/47)	2.1
(1/47)	0.0
(0/49)	8.2
(4/49)	2.0
(1/49)
9	7.0
(3/43)	14.0
(6/43)	0.0
(0/43)	5.6
(2/36)	11.1
(4/36)	0.0
(0/36)
10	2.4
(3/125)	11.2
(14/125)	1.6
(2/125)	2.5
(3/120)	12.5
(15/120)	1.7
(2/120)
11	2.9
(1/34)	23.5
(8/34)	2.9
(1/34)	2.9
(1/34)	23.5
(8/34)	2.9
(1/34)
12	0.0
(0/10)	0.0
(0/10)	0.0
(0/10)	0.0
(0/10)	0.0
(0/10)	0.0
(0/10)
13	0.0
(0/17)	0.0
(0/17)	0.0
(0/17)	0.0
(0/17)	0.0
(0/17)	0.0
(0/17)
14	0.0
(0/38)	5.3
(2/38)	0.0
(0/38)	0.0
(0/36)	2.8
(1/36)	0.0
(0/36)
15	3.7
(1/27)	0.0
(0/27)	0.0
(0/27)	3.6
(1/28)	0.0
(0/28)	0.0
(0/28)
16	0.0
(0/12)	0.0
(0/12)	0.0
(0/12)	0.0
(0/12)	0.0
(0/12)	0.0
(0/12)
All	2.3
(17/744)	8.7
(65/744)	2.0
(15/744)	2.2
(16/712)	8.6
(61/712)	2.2
(16/712)

ອການໄປ ປະກວດຄວາມອົງ ການສະໜາລິດ ເວລາໄດ້ ປະເທດໄທ ປີ ເປັນຕົວ ຈາກເປັນນາງງາມ ແລະປິດສາຫານ

ເປນນັກງານປ່ຽງ ແລະແນວລາວ ການປະກວດຄວາມງາມ ແລະ ເພນາ ລາຍສະຖານ ເປັນນັ້ນ ແລະປິດ
ເປນນັກສະແດງ ແລະ

"No evaluable results were available from Site 2.

No evaluable results were available from Site 2.
Does not include specimens that were positive for both CT and NG.

41

ડ્ટેટ ગવદ્યુ

dry& landterU elsM oitemotqmyS :ว่าริ แบบุว่าวอllog yd อยออกเขาอมารถ M 10/6แห รัฐมหาวิทยา

| Urethral Swab

% Prevalence (Number Positive/Number Tested)	CT+/NG+	CT+/NG-	CT-/NG+
14.2 (17/120)	13.3 (16/120)	19.2 (23/120)	3
9.0 (6/67)	6.0 (4/67)	9.0 (6/67)	4
0.0 (0/23)	8.7 (2/23)	4.3 (1/23)	5
0.0 (0/11)	18.2 (2/11)	9.1 (1/11)	6
9.5 (9/95)	17.9 (17/95)	20.0 (19/95)	7
7.3 (13/178)	16.3 (29/178)	20.2 (36/178)	8
12.0 (20/167)	13.8 (23/167)	37.1 (62/167)	9
4.9 (4/81)	18.5 (15/81)	12.3 (10/81)	10
0.0 (0/3)	0.0 (0/3)	0.0 (0/3)	12
0.0 (0/26)	3.8 (1/26)	0.0 (0/26)	13
0.0 (0/15)	0.0 (0/15)	13.3 (2/15)	14
0.0 (0/7)	0.0 (0/7)	0.0 (0/7)	15
3.0 (1/33)	0.0 (0/33)	18.2 (6/33)	16
8.5 (70/826)	13.2 (109/826)	20.1 (166/826)	All

. I

. DN bns TO dood of evirisod arew tedt susmisses abulari 100 seen 2 .[ I bus 2 sits mort aldelieve arew susmisser demission of the

42

97.7 એવા પ

รตอนที่วอประจากทาง จโรไท วิทิ่หนึ่งขันที่สุรรค :ອຸບັບ ແບ່ນ້າງອຸປິດ 7 vd ອຸດອອກສຽງຄວາມ ເປັນສະໜາດການປະກວດນັ້ນ ວັນ ອວການສຽງຈາກ

Site	CT+/NG+	CT+/NG-b	CT-/NG+b
2	0.0 (0/6)	0.0 (0/6)	0.0 (0/6)
3	13.7 (25/183)	9.8 (18/183)	12.6 (23/183)
4	4.0 (4/101)	5.9 (6/101)	6.9 (7/101)
5	0.0 (0/34)	5.9 (2/34)	2.9 (1/34)
6	0.0 (0/53)	18.9 (10/53)	1.9 (1/53)
7	6.7 (12/179)	16.8 (30/179)	10.1 (18/179)
8	4.8 (14/291)	14.8 (43/291)	12.7 (37/291)
9	10.1 (21/208)	20.2 (42/208)	31.3 (65/208)
10	2.8 (4/145)	21.4 (31/145)	6.9 (10/145)
11	0.0 (0/2)	100.0 (2/2)	0.0 (0/2)
12	0.0 (0/3)	0.0 (0/3)	0.0 (0/3)
13	0.0 (0/60)	1.7 (1/60)	0.0 (0/60)
14	0.0 (0/75)	1.3 (1/75)	2.7 (2/75)
15	0.0 (0/55)	3.6 (2/55)	0.0 (0/55)
16	0.0 (0/101)	2.0 (2/101)	5.9 (6/101)
All	5.3 (80/1496)	12.7 (190/1496)	11.4 (170/1496)

. I

. OM bus TO drod 101 avidisoq arew tech snamicsas abslubri 100 2900 a

43

| Prevalence
Rate
(%) | Sensitivity
(%) | Specificity
(%) | Positive
Predictive
Value (%) | Negative
Predictive
Value (%) |
|---------------------------|--------------------|--------------------|-------------------------------------|-------------------------------------|
| 0.5 | 95.0 | 99.2 | 37.4 | 100.0 |
| 1.0 | 95.0 | 99.2 | 54.5 | 99.9 |
| 2.0 | 95.0 | 99.2 | 70.8 | 99.9 |
| 5.0 | 95.0 | 99.2 | 86.2 | 99.7 |
| 10.0 | 95.0 | 99.2 | 93.0 | 99.4 |
| 15.0 | 95.0 | 99.2 | 95.4 | 99.1 |
| 20.0 | 95.0 | 99.2 | 96.7 | 98.8 |
| 25.0 | 95.0 | 99.2 | 97.5 | 98.3 |
| 30.0 | 95.0 | 99.2 | 98.1 | 97.9 |

Positive and Negative Predictive Values for Hypothetical Prevalence Rates for Chlamydia trachomatis

Table 2.28

Positive and Negative Predictive Values for Hypothetical Prevalence Rates for Neisseria gonorrhoeae

| Prevalence
Rate
(%) | Sensitivity
(%) | Specificity
(%) | Positive
Predictive
Value (%) | Negative
Predictive
Value (%) |
|---------------------------|--------------------|--------------------|-------------------------------------|-------------------------------------|
| 0.5 | 98.0 | 99.7 | 62.1 | 100.0 |
| 1.0 | 98.0 | 99.7 | 76.7 | 100.0 |
| 2.0 | 98.0 | 99.7 | 87.0 | 100.0 |
| 5.0 | 98.0 | 99.7 | 94.5 | 99.9 |
| 10.0 | 98.0 | 99.7 | 97.3 | 99.8 |
| 15.0 | 98.0 | 99.7 | 98.3 | 99.6 |
| 20.0 | 98.0 | 99.7 | 98.8 | 99.5 |
| 25.0 | 98.0 | 99.7 | 99.1 | 99.3 |
| 30.0 | 98.0 | 99.7 | 99.3 | 99.1 |

44

2.11 Conclusion Drawn from Clinical Studies

The submitted material in this premarket notification is complete and supports a substantial equivalence decision.

Abbott RealTune CT/NG // multi-Collect Specimen Collection Kit Sec 2 21(x)(x) Sunwary_mwy
See 2 21(x)(x) Sunwary_mwy
2008 21(x(x) Sunwary_mwy
1

Volume I
Sceion 2 Page 45

45

2.12 References

1. Schachter J. Chlamydial infections. West J Med 1990;153(5):523-34.
1. Cates W Jr. Wasserheit JN. Genital chlamydial infections: epidemiology and reproductive sequelae. Am J Obstet Gynecol 1991;164(6 Pt 2):1771-81.
1. Berger RE, Alexander ER, Harnisch JP, et al. Etiology, manifestations and therapy of acute epididymitis: prospective study of 50 cases. J Urol 1979;121(6):750-4.
1. Brunham RC, Paavonen J, Stevens CE, et al. Mucopurulent cervicitis-the ignored counterpart in women of urcthritis in men. N Eng J Med 1984;311(1):1-6.
1. Alexander ER, Harrison HR. Role of Chlamydia trachomatis in pcrinatal infection. Rev Infect Dis 1983;5(4):713-9.
1. Lyss SB, Kamb ML, Peterman TA, et al. Chlamydia trachomatis among patients infected with and treated for Neisseria gonorrhoeae in sexually transmitted disease clinics in the United States. Ann Intern Med 2003;139(3):178-85.
1. MMWR. Sexually transmitted diseases treatment guidelines 2002. Morb Mortal WRly Rep [serial online] 2002;51 (RR-06). Available at http://www.cdc.gov/STD/treatmcnt/4-2002TG.htm. Accessed 01/31/2005.
1. Johnson RE, Newhall WJ, Papp JR, et al. Screening tests to detect Chlamydia trachomatis and Neisseria gonorrhoeae infections-2002. MMRW Recomm Rep 2002;51 (RR-15):1-27.
1. Bøvre K. Family VIII Neisseriaceae Prévot 1933; 119. In: Krieg NR, Holt JG, editors. Bergey's Manual of Systematic Bacteriology. Baltimore, MD: Williams and Wilkins; 1984:288-96.
1. Hook EW, and Hansfield HH. Gonococcal infection in the adult. In: Holmes KK, Mardh PA, Sparling PF, Lemon SM, Stamm WE, Piot P, Wasserheit J, (ed.) Sexually Transmitted Diseases. 31d Ed. New York, NY: McGraw-Hill Book Co. 1999:451-66.
1. Sparling PF, Handsficld HH, Neisseria gonorrhoeae. In: Mandell GL, Bennett JE, Dolin R, editors. Mandell, Douglas, and Bennet's Principles and Practice of Infectious Diseases. 5th Ed. Philadelphia, PA: Churchill Livingstone, Inc. 2000:2242-રજ.
1. Eisenstein BI, Masi AT. Disseminated gonococcal infection (DGI) and gonococcal arthritis (GCA): I. Bacteriology, epidemiology, host factors, pathogen factors, and pathology. Semin Arthritis Rheum 1981;10(3):155-72.
1. Janda WM, Knapp JS. Neisseria and Morexclla catarrhalis. In: Murray PR, Baron EJ, Jorgensen JH, Pfaller MA, Yolken RH, (ed.) Manual of Clinical Microbiology. 8th Ed. Washington DC: Amer. Soc. for Microbiology, 2003;585-608.

46

1. Hale YM, Melton ME, Lewis JS, et al. Evaluation of the PACE 2 Neisseria gonorrhoeae assay by three public health laboratories. J Clin Microbiol 1993;31(2):451-3.
1. Palmer L, Falkow S. A common plasmid of Chlamydia trachomatis. Plasmid 1986;16(1):52-62.

Abbott RealTime CT/NG // multi-Collect Specimen Collection Kit March 2008 Scc 2 510(k) Summary 18w9

Volume 1 Section 2 Page 47

47

Image /page/47/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Paula Martin Senior Manager, Regulatory and Clinical Affairs Abbott Molecular Inc. 1300 East Touhy Avenue Des Plaines, IL 60018

JUL 1 0 2008

Re: K080739

Trade/Device Name: Regulation Number: 21 CFR 866.3120/866.3390 Regulation Name: Chlamydia trachomatis reagents/Neisseria gonorrhoeae reagents, Regulatory Class: Class I/II Product Code: MKZ/LSL Dated: March 12, 2008 Received: March 17, 2008

Dear Paula Martin:

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. Ilsting 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 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

48

Page 2 -

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,

Sally attayma

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

49

1.0 Indications of Use Statement

510(k) Number

Device Name: Abbott RealTime CT/NG assay and

Abbott multi-Collect Specimen Collection Kit

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: clinician-collected vaginal swab and male urethral swab specimens; patient-collected vaginal swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: male and female urine.

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.

Prescription Use X (Per 21 CFR 801.119) AND/OR

Over-The-Counter Use (Per 21 CFR Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

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(Posted November 13, 2003

Office of In Vitro Diagnostic Device Evaluation and Safety

Abbott RealTime CT/NG // multi-Collect Specimen Collection July 2008 Sec I Ladications of Use Statement_mw3

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