Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on PCR technology and real-time fluorescence detection on a specific instrument system (m2000). There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.

Therapeutic

No
The device is an in vitro diagnostic assay used for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA, which means it aids in diagnosis rather than providing therapy.

Diagnostic

Yes.

The device is an in vitro diagnostic assay used for the direct, qualitative detection of specific DNA, which is a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the device consists of reagent kits and utilizes the Abbott m2000 System, which includes the m2000sp and m2000rt instruments. These are hardware components used for sample processing, amplification, and detection.

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 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" means "in glass" or "in the lab," referring to tests performed outside of the living body.
Specimen Types: The assay is designed to test various human specimens (swabs and urine), which are collected from individuals to provide diagnostic information.
Purpose: The purpose of the assay is to detect the presence of specific DNA from Chlamydia trachomatis and Neisseria gonorrhoeae, which are pathogens causing sexually transmitted infections. This detection is used to aid in the diagnosis of these infections.
Device Description: The description details reagent kits and instruments used to perform the assay on these specimens.

All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended to be used in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Abbott RealTime CT/NG (List No. 8L07-91) 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.

Product codes

LSL, MKZ

Device Description

Abbott RealTime CT/NG consists of two reagent kits:

· Abbott RealTime CT/NG Amplification Reagent Kit (List No. 8L07-91)
· 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 results. The Abbott m2000sp is used for processing samples and the Abbott m2000rt is used for amplification and detection.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Female: endocervical, vaginal, urine. Male: urethral, urine.

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 characteristics of the Abbott RealTime CT/NG assay were established in a multi-center clinical study conducted in the United States. Specimens were collected from subjects at 16 geographically diverse sites that included physician private practices, public and private STD clinics, and a hospital emergency room. A total of 3,832 male and female, asymptomatic and symptomatic subjects were enrolled. Study subjects were classified as symptomatic if the subject reported STD-related symptoms. Specimens collected from each female subject included urine, endocervical swabs, self-collected 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) was reported. For CT, female subjects with positive results on both reference urine specimens and negative results on all three reference swab specimens (clinician-collected vaginal swab from NAAT 1 and endocervical swab specimens from both reference assays) were categorized as infected for urine and not infected for swab specimens. A male subject was categorized as infected for CT or NG if a minimum of two positive results was 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 and if the NG culture assay result was negative. 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 and if the NG culture assay result was negative.

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 determined for 4 subjects for CT and 7 subjects for NG.

Summary of Performance Studies

Study Type: Multi-center clinical study and analytical studies

Sample Size:
Clinical study: 3,832 male and female, asymptomatic and symptomatic subjects. A total of 6,555 CT and 6,569 NG results were used in the analysis.
Analytical sensitivity: Multiple dilutions and isolates tested, 405 replicates for CT, 403 for nvCT, 405 for NG in the LOD confirmation study.
Cross-reactivity: 111 strains of bacteria, viruses, parasites, yeast, and fungi for molecular testing, 32 culture isolates for culture testing.
Interfering substances: Substances spiked into swab and/or urine matrix.
Precision study: Fifteen-member panel, 5 replicates per run, 30 runs (10 per site) for a total of 150 replicates per panel member.

Key Results:
Overall sensitivity and specificity for CT was 95.2% and 99.3%, respectively.
Overall sensitivity and specificity for NG was 97.5% and 99.7%, respectively.

Analytical Sensitivity:
The Limit of Detection (LOD) claim: 320 copies of Chlamydia trachomatis (CT) target DNA and 320 copies of Neisseria gonorrhoeae (NG) target DNA per assay.
Detection rate at claimed LOD: 100% (405/405) for CT, 100% (403/403) for nvCT, and 99.5% (403/405) for NG.
Detection rate in presence of high opposite analyte: 100% (405/405) for 320 copies CT or nvCT DNA with high NG, 100% (405/405) for 320 copies NG DNA with high CT or nvCT.
Detection of CT serovars A-L and nvCT: less than 1 Inclusion Forming Units (IFU) per assay.
Detection of NG isolates: less than 1 Colony Forming Unit (CFU)/assay.

Evaluation of Potential Cross-Reactants:
All 111 strains of bacteria, viruses, parasites, yeast, and fungi, and 32 culture isolates tested yielded negative results for both CT and NG.

Evaluation of Potentially Interfering Substances:
No interference observed with listed substances in Table 3.7.
Interference observed with: Talcum powder > 0.1% in urine; Phenazopyridine hydrochloride > 3 mg/mL in urine; Mucus > 0.1% for urine and > 1% for swab specimens.

Carryover:
Carryover rate: 0.91% (5 false positive and 1 equivocal out of 656 valid negative samples).

Precision Study:
CT Results (mean Delta Cycle and Total SD): Ranges from 1.59 to 17.35 and 0.371 to 0.860, respectively.
NG Results (mean Delta Cycle and Total SD): Ranges from 0.50 to 13.45 and 0.297 to 0.539, respectively.

Key Metrics

Sensitivity (Overall):
CT: 95.2%
NG: 97.5%

Specificity (Overall):
CT: 99.3%
NG: 99.7%

PPV (Positive Predictive Value) for CT at various prevalence rates:
0.5% prevalence: 40.6%
1.0% prevalence: 57.9%
2.0% prevalence: 73.5%
5.0% prevalence: 87.7%
10.0% prevalence: 93.8%
15.0% prevalence: 96.0%
20.0% prevalence: 97.1%
25.0% prevalence: 97.8%
30.0% prevalence: 98.3%

NPV (Negative Predictive Value) for CT at various prevalence rates:
0.5% prevalence: 100.0%
1.0% prevalence: 100.0%
2.0% prevalence: 99.9%
5.0% prevalence: 99.7%
10.0% prevalence: 99.5%
15.0% prevalence: 99.2%
20.0% prevalence: 98.8%
25.0% prevalence: 98.4%
30.0% prevalence: 98.0%

PPV for NG at various prevalence rates:
0.5% prevalence: 62.0%
1.0% prevalence: 76.7%
2.0% prevalence: 86.9%
5.0% prevalence: 94.5%
10.0% prevalence: 97.3%
15.0% prevalence: 98.3%
20.0% prevalence: 98.8%
25.0% prevalence: 99.1%
30.0% prevalence: 99.3%

NPV for NG at various prevalence rates:
0.5% prevalence: 100.0%
1.0% prevalence: 100.0%
2.0% prevalence: 99.9%
5.0% prevalence: 99.9%
10.0% prevalence: 99.7%
15.0% prevalence: 99.6%
20.0% prevalence: 99.4%
25.0% prevalence: 99.2%
30.0% prevalence: 98.9%

Predicate Device(s)

K043224, K012351

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

1092704

MAY 2 8 2010

Abbott RealTime CT/NG List No. 8L07-91

510(k) Summary

Abbott RealTime CT/NG // multi-Co!lect Specimen Collection Kit May 2010 Admin Sec 3_510(k) Summary_mw019

Admin. Sec. 3 510(k) Summary Page 1 of 44

:

1

		Page
3.0	Abbott RealTime CT/NG 510(k) Summary	3
3.1	Official Correspondent to the File	3
3.2	Trade Name:	3
3.3	Common Name:	3
3.4	Classification Name:	3
3.5	Registration Number and Classification Code:	3
3.6	Substantially Equivalent Devices	4
3.7	Purpose of the Submission	4
3.8	Date of Preparation	4
3.9	Manufacturer	4
3.10	Intended Use	5
3.11	Device Description	5
3.12	Background on Chlamydia and Gonorrheal Disease	5
3.13	Technological Characteristics of the Device as Compared to the Predicate	7
3.14	Summary of Nonclinical Studies	10
3.15	Summary of Clinical Studies	19
3.16	Conclusion Drawn from Clinical Studies	42
3.17	References	43

:

.

:

.

. .

:

.

:

·

2

3.0 Abbott RealTime CT/NG 510(k) Summary

A summary of the Abbott® RealTime CT/NG assay

3.1 Official Correspondent to the File

Submitted By:

Abbott Molecular Inc. 1300 E. Touhy Avenue Des Plaines, IL 60018 phone: (224) 361-7000 eFAX (847) 775-6777

Company Contact:

Paula Martin Senior Manager Regulatory and Clinical Affairs Phone (224) 361-7333, eFAX (847) 775-6777 e-mail: paula.martin@abbott.com

3.2 Trade Name:

Abbott RealTime CT/NG (List No. 8L07-91)

3.3 Common Name:

In vitro polymerase chain reaction (PCR) assay for Chlamydia trachomatis and Neisseria gonorrhoeae.

3.4 Classification Name:

Nucleic acid test (NAT)

3.5 Registration Number and Classification Code:

21 CFR 866.3390 (Class II, Code LSL) describes test reagents used to identifiy Neisseria from clinical specimens.

21 CFR 866.3120 (Class I, Code MKZ) describes test reagents used to identify Chlamydia from clinical specimens.

3

3.6 Substantially Equivalent Devices

Abbott RealTime CT/NG (List No. 8L07-91) Predicate 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).

The Abbott RealTime CT/NG assay was also compared to cell culture methods intended for the qualitative detection of Neisseria gonorrhoeae. The predicate culture methods are:

bioMerieux API® NH Assay,

EY Laboratories Gonocheck® II (Assigned 510(k) No. 940162) Assay,

Pharmacia Diagnostics Phadebact® Monoclonal GC test.

3.7 Purpose of the Submission

The purpose of this 510(k) is to gain clearance to market the Abbott RealTime CT/NG (List No. 8L07-91) assay.

3.8 Date of Preparation: August, 2009

3.9 Manufacturer

Abbott Molecular Inc. is the legal manufacturer of the Abbott RealTime CTNG (List No. 8L07-91) assay and the Abbott multi-Collect Specimen Collection Kit (List No. 9K12-03).

Timothy Zurow Director Manufacturing Operations Phone (224) 361-7379. eFAX (847) 775-6777 e-mail: timothy.zurow(@abbott.com

Abbott Molecular Inc. 1300 E. Touhy Avenue Des Plaines, IL 60018

Abbott Molecular Inc. Establishment Registration No .: 3005248192

4

Intended Use 3.10

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

The Abbott RealTime CT/NG (List No. 8L07-91) 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.

3.11 Device Description

Abbott RealTime CT/NG consists of two reagent kits:

· Abbott RealTime CT/NG Amplification Reagent Kit (List No. 8L07-91)
· 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 results. The Abbott m2000sp is used for processing samples and the Abbott m2000rt is used for amplification and detection.

3.12 Background on Chlamydia 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, cervicitis, ectopic pregnancies and tubal factor infertility in women as well as

Admin, Sec, 3 510(k) Summary Page 5 of 44

5

nongonococcal urethritis and epididymitis in men. 1-4 The genital site most commonly affected in women is the cervix, 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). Neonates born of infected mothers can contract inclusion conjunctivitis, nasopharyngeal infections, and pneumonia due to Chlamydia trachomatis . 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.7 Chlamydia infections may not respond well to recommended regimens for treating Neisseria gonorrhoeae. Therefore, unless chlamydial infection has been ruled out in patients treated for gonorrhea, dual therapy for gonococcal and chlamydia infections is recommended.5

Cell culture, commonly used to detect Chlamydia trachomatis, has been replaced by more sensitive nucleic acid tests. Since a specific diagnosis of chlamydia may improve treatment compliance and enhance partner notification, the use of these highly sensitive and specific tests is strongly recommended.3

Gonorrhea is one of the most common sexually transmitted diseases in the United States. Over 700,000 new infections of Neisseria gonorrhoeae are estimated to occur each year. In men, gonorrhea infection usually results in acute anterior urethritis accompanied by a purulent exudate.19,11 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. 10.11 Rarely, 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

Abbott RealTime CT/NG // multi-Collect Specimen Collection Kit May 2010 Admin Sec 3_510(k) Summary_mw019

Admin. Sec. 3 510(k) Summary Page 6 of 44

6

stain, and oxidase measurement of the culture isolate. Confirmation procedures have been used for definitive identification of Neisseria gonorrhoeae including sugar fermentation, fluorescent antibody staining, nucleic acid hybridization, and agglutination. 4315 Nucleic acid tests are widely available for the sensitive detection of Neisseria gonorrhoeae .

3.13 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).

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 Attachment Tables 3.1 and 3.2.

7

l
న

le
q
C
r
1

milarities and Differences Between Abbott RealTime CT/NG and Nucleic Acid Amplification Predicate Devices

Feature	Abbott RealTime CT/NG	Gen-Probe Aptima Combo 2	Becton Dickenson ProbeTec ET
Intended Use	The Abbott RealTime CT/NG (List
No. 8L07-91) assay is an in vitro
polymerase chain reaction (PCR)
assay for the direct, qualitative
detection of the plasmid DNA of
Chlamydia trachomatis and the
genomic DNA of Neisseria
gonorrhoeae . The assay may be
used to test the following
specimens from symptomatic
individuals: female endocervical
swab, clinician-collected vaginal
swab, and patient-collected vaginal
swab specimens; male urethral
swab specimens; and female and
male urine specimens. The assay
may be used to test the following
specimens from asymptomatic
individuals: clinician-collected
vaginal swab and patient-collected
vaginal swab specimens; female
and male urine specimens.	The APTIMA Combo 2 Assay is a target
amplification nucleic acid probe test that
utilizes target capture for the in vitro
qualitative detection and differentiation of
ribosomal RNA (rRNA) from Chlamydia
trachomatis and/or Neisseria gonorrhoeae
in clinician collected endocervical, vaginal,
and male urethral swab specimens,
patientcollected vaginal swab specimens,
and female and male urine specimens. The
assay may be used to test specimens from
symptomatic and asymptomatic individuals
to aid in the diagnosis of gonococcal
and/or chlamydial urogenital disease using
the TIGRIS DTS Automated Analyzer or
semiautomated instrumentation as
specified.

The assay is also intended for use with
testing of gynecological specimens
collected in the PreservCyt Solution and
processed with the Cytyc ThinPrep 2000
System. | The BD ProbeTec ET Chlamydia
trachomatis (CT) and Neisseria
gonorrhoeae (GC) Amplified DNA
Assays, when tested with the BD
ProbeTec ET System, use Strand
Displacement Amplification (SDA)
technology for the direct, qualitative
detection of Chlamydia trachomatis
and Neisseria gonorrhoeae DNA in
endocervical swabs, male urethral,
swabs, and in female and male urine
specimens as evidence of infection
with C. trachomatis, N. gonorrhoeae ,
or of coinfection with both C.
trachomatis and N. gonorrhoeae .
Specimens may be from symptomatic
or asymptomatic females and males. A
separate Amplification Control is an
option for inhibition testing (BD
ProbeTec ET CT/GC/AC Reagent
Pack). The BD ProbeTec ET CT/GC
assays may be performed using either
the BD ProbeTec ET System or a
combination of the BD ProbeTec ET
System and BD Viper instrument. | |
| Feature | Current Application
Abbott RealTime CT/NG | | Amplified Nucleic Acid Predicate Devices | |
| | | | 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 | Endocervical swab specimens
Self-collected vaginal swab
specimens
Clinician-collected vaginal
swab specimens
Male urethral swab specimens
Male and female urine
specimens | • | Endocervical swab specimens
Self-collected vaginal swab
specimens
Clinician-collected vaginal
swab specimens
Male urethral swab specimens
Male and female urine
specimens
PreservCyt liquid Pap specimens | Endocervical swab 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 | | Ribosomal RNA transcriptionmediated
amplification (TMA) | Strand displacement DNA
amplification (SDA) |
| Assay
Controls | Negative Control
Cutoff Control
Internal Control | • | Negative Control
Positive Control | Negative Control
Positive Control
Optional Amplification Control |

Abbott RealTime CT/NG // multi-Collect Specimen Collection Kit May 2010 Admin Sec 3_510(k) Summary_mw019

Admin. Sec. 3 510(k) Summary

8

Similarities and Differences Between Abbott RealTime CT/NG and Nucleic Acid Amplification Predicate Devices

Abbott RealTime CT/NG // multi-Collect Specimen Collection Kit May 2010 Admin Sec 3_510(k) Summary_mw019

Page 9 of 44

'

9

Summary of Nonclinical Studies 3.14

Analytical Sensitivity 3.14.1

The Limit of Detection (LOD) claim for the Abbott RealTime CT/NG assay is 320 copies of Chlamydia trachomatis (CT) target DNA and 320 copies of Neisseria gonorrhoeae (NG) target DNA per assay. The assay targets the Chlamydia trachomatis cryptic plasmid (present at approximately 7 to 10 copies per Chlamydia organism) and the multicopy opacity gene of Neisseria gonorrhoeae (repeated up to 11 times per organism). Thus, 320 copies of target DNA is equivalent to approximately 30 to 40 organisms per assay.

The LOD of the Abbott RealTime CT/NG assay is defined as CT and NG target DNA concentration detected with a probability of 95% or greater. The CT and NG DNA concentrations detected with 95% probability were determined by testing dilutions of CT and NG target DNA. Probit analysis of the data determined that the concentration of CT DNA detected with 95% probability was 21 copies/assay (95% CI 18 - 28), the concentration of nvCT DNA detected with 95% probability was 29 copies/assay (95% CI 24 - 41), and the concentration of NG DNA detected with 95% probability was 149 copies/assay (95% CI 130 - 176).

The claimed assay LOD was confirmed by testing samples that contained 320 copies of CT, nvCT and NG target DNA per assay. The detection rate was 100% (405/405) for CT, 100% (403/403) for nvCT, and 99.5% (403/405) for NG in the assay.

An additional study was conducted to challenge the performance of the Abbott RealTime CT/NG assay in samples containing high target numbers of CT, nvCT, or NG in the presence of low target numbers of the opposite analyte. Samples were prepared to contain 320 CT or nvCT target DNA copies and 1 x 10' NG target DNA copies per assay, or 1 x 107 CT or nvCT target DNA copies and 320 NG target DNA copies per assay. The detection rate of 320 copies of CT or nvCT DNA in the presence of high NG target was 100% (405/405). The detection rate of 320 copies of NG DNA in the presence of high CT or nvCT target was 100% (405/405).

Abbott Rea!Time CT/NG // multi-Collect Specimen Collection Kit May 2010 Admin Sec 3_510{k) Summary_mw019

Admin. Sec. 3 510(k) Summary Page 10 of 44

10

The analytical sensitivity of the Abbott RealTime CT/NG assay for detecting Chlumydia trachomatis serovars A through L was determined by testing dilutions of each serovar. Serovars A through K and L1 through L3 were detected at less than 1 Inclusion Forming Units (IFU) per assay. Additionally, nvCT was diluted and was also detected at less than 1 IFU per 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 each isolate. All isolates were detected at less than 1 Colony Forming Unit (CFU)/assay.

3.14.2 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 3.6). These included organisms that are phylogenetically 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 4 x 105 and 6 x 10° copies per reaction, respectively. All results were negative for both CT and NG.

Additionally, a total of 32 culture isolates were tested for potential cross reactivity in the Abbott RealTime assay. These included 27 organisms listed in Table 3.6, 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 were tested at 106 cells per assay, C. pneumoniae and C. psittaci were tested at 106 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.

Abbott RealTime CT/NG // multi-Collect Specimen Collection Kit May 2010 Admin Sec 3_510(k) Summary_mw019

11

Microorganism/Virus
Achromobacter xerosis	Haemophilus ducreyi*	Proteus vulgaris
Acinetobacter calcoaceticus	Haemophilus influenzae	Providencia stuartii
Acinetobacter Iwoffii	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 typhimurium
Bacteroides fragilis	Human Papilloma Virus 18	Salmonella enterica
Bacteroides ureolyticus	Kingella denitrificans	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 bovis
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
	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	Pantoea agglomerans
Escherichia coli*	Peptostreptococcus anaerobius
Fusobacterium nucleatum	Plesiomonas shigelloides
Gardnerella vaginalis	Propionibacterium acnes
Gemella haemolysans	Proteus mirabilis*

Table 3.6 Potentially Cross-Reactive Microorganisms/Viruses

Tested with purified DNA or RNA and with culture isolates.

12

Table 3.6 (Continued)

Potentially Cross-Reactive Microorganisms/Viruses

Tested with purified DNA or RNA and with culture isolates.

.

13

Evaluation of Potentially Interfering Substances 3.14.3

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 urine 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 3.7.

Abbott RealTime CT/NG // multi-Collect Specimen Collection Kit May 2010 Admin Sec 3_510(k) Summary_mw019

Admin. Sec. 3 510(k) Summary Page 14 of 44

14

| able

1	1
-----------	---	--	--

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-1TM Dose 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	Urine	10 mg/mL
Glucose	Urine	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 106 cell/mL

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.

15

3.14.4 Carryover

Potential carryover was determined by performing a study in which high copy CT positive samples were interspersed with negative samples arranged in a checkerboard pattern. The positive samples were CT DNA at a concentration of 101 copies/ml. The carryover rate is defined as the number of CT negative samples that are reported as positive or equivocal over the total number of CT-negative samples tested. Each run included 47 negative samples and 46 positive samples. A total of 14 runs were evaluated using two lots of the RealTime CTNG amplification reagents on four m2000sp and m2000rt instrument pairs.

A total of 656 valid negative samples were evaluated for potential carryover effect. A total of 5 false positive and 1 equivocal results were observed. The carryover rate was 0.91%.

Precision Study 3.14.5

A precision study was performed at three sites, two external and one internal. Each site was provided a fifteen-member panel. Nine panel members targeted different combinations of CT and NG concentrations and six panel members targeted different combinations of nvCT and NG concentrations. The source material for CT was Vero/LGV-II, strain 434. The source material for nvCT was strain 68226. The source material for NG was ATCC isolate 27628 and 31426. 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 panel 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 3.8 and 3.9, respectively,

Admin. Sec. 3 510(k) Summary Page 16 of 44

16

| 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 | 15.29 | 0.265 | 0.204 | 0.110 | 0.135 | 0.377 |
| 2 | 150 | 150 | 15.67 | 0.411 | 0.245 | 0.000 | 0.179 | 0.511 |
| 3 | 150 | 150 | 3.75 | 0.466 | 0.234 | 0.255 | 0.000 | 0.581 |
| 4 | 150 | 150 | 9.45 | 0.503 | 0.103 | 0.022 | 0.000 | 0.514 |
| 5 | 150 | 0 | ... | ... | ... | ... | ... | ... |
| 6 | 149 | 149 | 17.35 | 0.229 | 0.193 | 0.153 | 0.159 | 0.371 |
| 7 | 150 | 0 | ... | ... | ... | ... | ... | ... |
| 8 | 147 | 0 | ... | ... | ... | ... | ... | ... |
| 9 | 150 | 125 | 1.59 | 0.674 | 0.248 | 0.312 | 0.000 | 0.783 |
| 10 | 149 | 149 | 15.69 | 0.334 | 0.250 | 0.205 | 0.286 | 0.545 |
| 11 | 150 | 150 | 15.59 | 0.428 | 0.180 | 0.216 | 0.289 | 0.588 |
| 12 | 150 | 140 | 3.79 | 0.461 | 0.458 | 0.329 | 0.000 | 0.728 |
| 13 | 150 | 150 | 9.02 | 0.269 | 0.274 | 0.165 | 0.261 | 0.493 |
| 14 | 150 | 150 | 15.63 | 0.284 | 0.265 | 0.109 | 0.413 | 0.578 |
| 15 | 147 | 50 | 1.81 | 0.575 | 0.376 | 0.518 | 0.000 | 0.860 |

Table 3.8

Precision Study: CT Results

ª Chlamydia trachomatis (CT) concentrations were targeted approximately to 4500 IFU/assay in members 1, 2, and 6 and to 45 IFU/assay in member 4. Member 3 was targeted approximately to 0.75 IFU/assay and member 9 to 0.2 IFU/assay both below the claimed assay LOD. New variant strain (nvCT) concentrations were targeted approximately to 50 IFU/assay in members 10, 11, and 14 and 1 IFU/assay in member 13. Members 12 and 15 were targeted to less than 0.1 IFU/assay, below the claimed assay LOD. Members 5, 7, and 8 did not contain any CT or nvCT 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=133), including those beyond the assay cutoff, resulted in a total SD of 0.960. For member 15, analysis of all replicates with a cycle number (n=52), including those beyond the assay cutoff, resulted in a total SD of 1.037.

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

17

| Table | 1
0
J.J | |
|-------|---------------|--|
| | | |

| 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 | 13.32 | 0.295 | 0.157 | 0.048 | 0.000 | 0.337 |
| 2 | 150 | 150 | 7.64 | 0.419 | 0.182 | 0.000 | 0.123 | 0.473 |
| 3 | 150 | 150 | 8.03 | 0.288 | 0.146 | 0.000 | 0.000 | 0.323 |
| 4 | 149 | 0 | ... | ... | ... | ... | ... | ... |
| 5 | 150 | 150 | 7.59 | 0.245 | 0.184 | 0.028 | 0.000 | 0.308 |
| 6 | 149 | 0 | ... | ... | ... | ... | ... | ... |
| 7 | 150 | 150 | 13.45 | 0.512 | 0.105 | 0.133 | 0.000 | 0.539 |
| 8 | 147 | 0 | ... | ... | ... | ... | ... | ... |
| 9 | 150 | 69 | 0.51 | 0.326 | 0.000 | 0.000 | 0.029 | 0.327 |
| 10 | 149 | 149 | 13.29 | 0.207 | 0.147 | 0.051 | 0.213 | 0.335 |
| 11 | 150 | 150 | 7.27 | 0.271 | 0.159 | 0.046 | 0.110 | 0.336 |
| 12 | 150 | 150 | 7.24 | 0.220 | 0.180 | 0.000 | 0.088 | 0.297 |
| 13 | 150 | 0 | ... | ... | ... | ... | ... | ... |
| 14 | 150 | 0 | ... | ... | ... | ... | ... | ... |
| 15 | 147 | 47 | 0.50 | 0.348 | 0.102 | 0.000 | 0.103 | 0.377 |

Precision Study: NG Results

ª Neisseria gonorrhoeae (NG) concentrations were targeted approximately to 2000 CFU/assay in members 1, 7, and 10; to 20 to 50 CFU/assay in members 2, 3, 11, and 12. Members 9 and 15 were targeted to 0.1 CFU/assay, below the claimed assay LOD. Members 4, 6, 8, 13, and 14 did not contain any NG organisms.

b Invalid replicates were excluded from the analysis.

6 For member 9, analysis of all replicates with a cycle number (n=147), including those beyond the assay cutoff, resulted in a total SD of 1.156. For member 15, analysis of all replicates with a cycle number (n=138), including those beyond the assay cutoff, resulted in a total SD of 1.201.

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

18

3.15 Summary of Clinical Studies

Performance characteristics of the Abbott RealTime CT/NG assay were established in a multi-center clinical study conducted in the United States. Specimens were collected from subjects at 16 geographically diverse sites that included physician private practices, public and private STD clinics, and a hospital emergency room. A total of 3,832 male and female, asymptomatic and symptomatic subjects were enrolled. Study subjects were classified as symptomatic if the subject reported STD-related symptoms. Specimens collected from each female subject included urine, endocervical swabs, self-collected 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) was reported. For CT, female subjects with positive results on both reference urine specimens and negative results on all three reference swab specimens (clinician-collected vaginal swab from NAAT 1 and endocervical swab specimens from both reference assays) were categorized as infected for urine and not infected for swab specimens. A male subject was categorized as infected for CT or NG if a minimum of two positive results was reported. If the reference NG culture assay result was positive, the subject was categorized as infected regardless of NAAT results.

Admin. Sec. 3 510(k) Summary Page 19 of 44

19

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 and if the NG culture assay result was negative. 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 and if the NG culture assay result was negative.

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 determined for 4 subjects for CT and 7 subjects for NG.

Tables 3.10 through 3.28 summarize the clinical trial data.

Abbott RealTime CT/NG test results were compared to the patient infected status for calculation of assay sensitivity and specificity. A total of 6,555 CT and 6,569 NG results were used in the analysis. The results were analyzed by gender, sample type, and the presence of symptoms. The overall sensitivity and specificity for CT was 95.2% and 99.3%, respectively. The overall sensitivity and specificity for NG was 97.5% and 99.7%, respectively. Sensitivity and specificity for CT for female subjects and male subjects are presented in Tables 3.10 and 3.11, respectively. Sensitivity and specificity for NG for female subjects and male subjects are presented in Tables 3.12 and 3.13, respectively.

A comparison of patient infected status, individual test results from the reference assays and Abbott RealTime CT/NG assay was performed. CT results for infected and noninfected female subjects are presented in Tables 3.14 and 3.15, and for infected and noninfected male subjects in Tables 3.16 and 3.17. NG results for infected and non-infected female subjects are presented in Tables 3.18 and 3.19, and for infected and non-infected male subjects in Tables 3.20 and 3.21.

The prevalence of CT and NG in this study was dependent on several factors including age, gender, clinic type, and the method of testing. The prevalence per collection site determined by the Abbott RealTime CT/NG assay for endocervical swab specimens is presented in Table 3.22, for clinician-collected and self-collected vaginal swab specimens

Admin. Sec. 3 510(k) Summary Page 20 of 44

20

is presented in Table 3.23; for female urine specimens in Table 3.24; and for male urethral swab and male urine specimens in Tables 3.25 and 3.26, respectively.

The Positive and Negative Predictive Values (PPV and NPV) were calculated using hypothetical prevalence rates and the Abbott RealTime CT/NG assay sensitivity and specificity determined from the clinical study. The overall sensitivity and specificity for CT was 95.2% and 99.3%, respectively. The overall sensitivity and specificity for NG was 97.5% and 99.7%, respectively. Estimates of the PPV and NPV for the Abbott RealTime CT/NG assay are presented in Table 3.27 for CT and Table 3.28 for NG.

.

21

hlamydia trachomatis Clinical Sensitivity and Specificit

Specimen	Symptoms	n	True Pos	False Pos	True Neg	False Neg	Sensitivity (95% C.I.)	Specificity (95% C.I.)
Endocervical Swab	Symptomatic	616	60	1	551	4	93.8 (84.8, 98.3)	99.8 (99.0, 100.0)
Clinician-Collected	Symptomatic	615	63	0	551	1	98.4 (91.6, 100.0)	100.0 (99.3, 100.0)
Vaginal Swab	Asymptomatic	594	35	4	554	1	97.2 (85.5, 99.9)	99.3 (98.2, 99.8)
Self-Collected	Symptomatic	587	62	6	518	1	98.4 (91.5, 100.0)	98.9 (97.5, 99.6)
Vaginal Swab	Asymptomatic	586	36	5	544	1	97.3 (85.8, 99.9)	99.1 (97.9, 99.7)
Urine	Symptomatic	737	73	2	655	7	91.3 (82.8, 96.4)	99.7 (98.9, 100.0)
	Asymptomatic	686	43	2	638	3	93.5 (82.1, 98.6)	99.7 (98.9, 100.0)

Abbott May 2010 Admin Sec 3_510(k) Summary_mw019 Admin. Sec. 3
510(k) Summary
Page 22 of 44

22

hlamydia trachomatis Clinical Sensitivity and Specificit

Abbott RealTime CT/NG // multi-Collect Specimen Collection Kit
May 2010
Admin Sec 3_510(k) Summary_mw019

Admin. Sec. 3
510(k) Summary
Page 23 of 44

| Specimen | Symptoms | n | True
Pos | False
Pos | True
Neg | False
Neg | Sensitivity (95% C.I.) | Specificity (95% C.I.) |
|------------------|--------------|-----|-------------|--------------|-------------|--------------|------------------------|------------------------|
| Urethral
Swab | Symptomatic | 669 | 128 | 9 | 523 | 9 | 93.4
(87.9, 97.0) | 98.3
(96.8, 99.2) |
| Urine | Symptomatic | 822 | 171 | 6 | 637 | 8 | 95.5
(91.4, 98.1) | 99.1
(98.0, 99.7) |
| | Asymptomatic | 643 | 84 | 4 | 552 | 3 | 96.6
(90.3, 99.3) | 99.3
(98.2, 99.8) |

23

leisseria gonorrhoeae Clinical Sensitivity and Specifici
Female Specimens

Abbott RealTime CT/NG // multi-Collect Specimen Collection Kit
May 2010

・

Admin Sec 3_510(k) Sunmary_mw019 ·

·

Admin. Sec. 3 510(k) Summary Page 24 of 44

.

24

sitivity Clinical Sen able 3.13

Neisseria gonorrhoeae Clinical Sensitivity and Specificity
Male Specimens

Abbott RealTime CT/NG // multi-Collect Specimen Collection Kit
May 2010
Admin Ser 3 510(k) Summary mw019

Urethra
Swab

(98.0, 99.7)

99.2

(96.3, 99.7)

98.7

ಕ

587

ഗ

228

823

Symptomatic

Urine

(99.4, 100.0

100.0

(71.5, 100.0)

100.0

0

632

0

l |

643

symptomati

(97.6, 99.7

99.0

(97.1, 100.0)

99.5

I

482

S

188

676

Symptomatic

Specificity (95% C.)

Sensitivity (95% C.I.

iləsi Bənə əsasən
Esma

Şəsi
Əni J

so
astronomic

so fi

u

Symptoms

Specimen

Admin. Sec. 3
510(k) Summary
Page 25 of 44

Admin. Sec. 3
0(k) Summary
Page 25 of 44

25

	NAAT 1			NAAT 2		RealTime CT/NG					No. of Subjects
	E	CCV	FU	E	FU	E	CCV	SCV	FU	Symptomatic
(E/SCV/CCV/FU)	Asymptomatic
(SCV/CCV/FU)	Total
	+	+	+	+	+	+	+	+	+	38	24	62
	+	+	+	+	NA	+	+	+	+	1	0	1
	+	+	+	+	NA	+	+	NA	+	1	0	1
	+	+	+	+	NA	+	NA	NA	+	1	0	1
	+	+	NA	+	NA	+	NA	+	NA	0	1	1
	+	+	+	+	+	+	+	NA	+	4	2	6
	+	+	+	+	+	+	NA	+	+	2	1	3
	+	+	+	+	+	NA	+	+	+	4	2	6
	+	+	+	+	+	+	NA	NA	+	1	0	1
	+	+	+	+	+	NA	+	NA	+	1	0	1
	+	+	+	+	+	NA	NA	+	+	1	0	1
	+	+	+	+	+	NA	NA	NA	+	3	1	4
	+	+	+	+	-	+	+	+	+	1	2	3
	+	+	+	-	+	+	+	+	+	1	2	3
	+	+	+	-	+	NA	NA	NA	+	1	0	1
	+	-	+	-	+	+	+	+	+	2	0	2
	+	+	+	+	-	+	+	+	+	1	0	1
	-	+	+	-	+	NA	+	+	+	0	1	1
	-	+	-	+	+	+	+	+	+	1	0	1
	-	+	-	+	+	NA	+	+	+	1	0	1
	-	-	+	-	+	NA	NA	NA	+	0	1	1
	+	+	+	NA	+	+	+	NA	-	1	0	1
	+	+	+	+	-	NA	NA	+	-	1	0	1
	+	+	+	+	-	+	+	+	-	3	0	3
	+	+	-	+	NA	+	+	+	-	1	0	1
	+	NA	-	+	-	+	+	+	-	1	0	1
	+	+	-	+	-	NA	NA	NA	-	0	1	1
	-	+	-	+	-	NA	NA	+	-	0	1	1
	+	+	+	+	+	-	+	+	+	1	1	2
	+	+	+	-	+	-	NA	NA	+	1	0	1
	-	+	+	-	+	-	NA	+	+	2	0	2
	-	-	+	-	+	-	NA	+	+	1	1	2
	-	+	-	-	+	-	NA	+	-	0	1	1
	+	-	+	-	+	NA	-	+	+	1	0	1
	-	-	+	NA	+	-	-	-	+	0	1	1
	-	-	+	-	+	-	-	+	+	2	4	6

Table 3.14 CT Analysis According to Patient Infected Status INFECTED FEMALE Subjects

E = Endocervical Swab Specimen; CCV = Clinician-Collected Vaginal Swab Specimen;

FU = Female Urine Specimen; SCV = Self-Collected Vaginal Swab Specimen.

NA includes "indeterminate" results from reference assays, specimens not available, or missing results.

Subjects with positive results on both reference urine specimens and negative results on all three reference swab specimens (clinician-collected vaginal swab from NAAT 1 and endocervical swab specimens from both reference assays) were categorized as infected for urine and not infected for swab specimens.

Abbott RealTime CT/NG // multi-Collect Specimen Collection Kit May 2010 Admin Sec 3_510(k) Summary_mw019

Admin. Sec. 3 510(k) Summary Page 26 of 44

26

NAAT 1			NAAT 2	RealTime CT/NG				No. of Subjects
									Symptomatic	Asymptomatic
E	CCV	ទប្រ	E	FU	E	CCV	SCV	FU	(E/SCV/CCV/FU)	(SCV/CCV/FU)	Total
-	-	-	-	—	-	ー	-	ﺴ	392	414	806
-	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	=	-	NA	-	-	=	-	43	24	67
ﺖ	--	-	-	NA	ﺖ	-	-	NA	l	0	l
-	--	-	-	NA	ー	-	NA	-	2	3	5
ﺳﮯ	--	--	-	NA	-	NA	—	-	3	3	6
-	--	-	-	NA	NA	-	-	-	4	l	5
-	—	-	-	NA	NA	-	ా	NA	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	l	2
	-	-	1	NA	l	NA	NA	1	l	1	2
-	—	-	ー	NA	NA	NA	NA	1	7	2	9
-	--	-	NA	l	-	1	!	၊	9	24	33
-	--	-	NA	-	-	—	NA	-	0	l	ﻌﺴﺴ
-	মঙ্গলবার বিষয়ক বিষয়ক বিষয়ক বিশ্বকাপ করে আর করে আর করে আর করে আর করে আর করে আর করে আমাকে আমার করে আমাকে আমার করে আমাকে আমার করে আমাকে আমার করে আমাকে আমার করে আমাকে আমার কর	-	NA	----	-	NA	-	-	0	l	-
-	---	ﯩﺴ	NA	-	NA	l	-	-	0	1	-
-	-	-	NA	-	NA	NA	NA	-	0	2	2
-	l	NA	l	-	-	-	-	ー	0	l	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
-	NA	ー	ー	--	ー	-	一	-	0	l	-
ー	NA	-	-	-	NA	ー	NA	-	0	l	1
NA	ー	-	-	ﺴﺘ	ー	NA	l	-	0	l	1
—	—	-	**	—	ー	—	-	NA	2	7	9
-	--	-	ﯿﺖ	-	ー	-	NA	l	49	32	8 I
-	--	-	-	-	-	NA	-	-	20	25	45
-	—	-	-	-	NA	-	-	ー	22	।	41
-	-	--	ﮮ	-	-	-	NA	NA	l	2	3
-	-	-	-	-	NA	-	ー	NA	2	l	3
-	—	-	-	-	—	NA	NA	-	6	3	9
-	—	-	-	-	NA	।	NA	-	7	5	12
-	—	-	ー	-	NA	NA	-	-	0	3	9
--	—	—	-	-	NA	NA	NA	l	64	રે રે	114
-	—	-	-	+	—	--	-	-	l	l	2
-	ー	—	-	+	—	NA	ー	-	0	l	l

CT Analysis According to Patient Infected Status NON-INFECTED FEMALE Subjects

E = Endocervical Swab Specimen; CCV = Clinician-Collected Vaginal Swab Specimen;

FU = Female Urine Specimen; SCV = Self-Collected Vaginal Swab Specimen.

NA includes "indeterminate" results from reference assays, specimens not available, or missing results.

Abbott RealTime CT/NG // multi-Collect Specimen Collection Kit May 2010 Admin Sec 3_510(k) Summary_mw019

Admin. Sec. 3 510(k) Summary Page 27 of 44

27

Table 3.15 (Continued)

	NAAT 1			NAAT 2		RealTime CT/NG				No. of Subjects
	E	CCV	FU	E	FU	E	CCV	SCV	FU	Symptomatic
(E/SCV/CCV/FU)	Asymptomatic
(SCV/CCV/FU)	Total
	-	-	-	NA	+	-	-	-	-	1	0	1
	-	-	-	+	-	-	-	-	-	3	0	3
	-	-	-	+	NA	-	-	-	-	0	1	1
	-	-	-	+	-	-	NA	-	-	2	0	2
	-	-	-	+	-	NA	NA	NA	-	1	0	1
	-	-	+	-	-	-	-	-	-	0	2	2
	-	-	+	-	-	-	-	-	NA	0	1	1
	-	+	-	-	-	NA	NA	NA	-	1	0	1
	-	+	-	-	-	-	-	-	-	2	2	4
	-	+	-	-	-	-	NA	NA	-	1	0	1
	-	+	-	-	-	-	NA	NA	NA	1	1	2
	-	+	-	-	-	-	NA	NA	NA	0	1	1
	+	-	-	-	-	-	-	-	-	2	2	4
	+	+	-	-	-	-	NA	NA	-	1	0	1
	+	+	-	-	-	NA	NA	NA	-	0	2	2
	-	-	-	-	NA	-	-	-	+	0	1	1
	-	-	-	-	-	-	-	+	-	2	1	3
	-	-	-	-	NA	-	-	+	-	1	0	1
	-	-	-	-	-	-	+	NA	-	0	1	1
	-	-	+	-	-	-	-	-	+	0	1	1
	-	+	-	-	-	-	NA	+	-	1	0	1
	-	+	-	-	-	+	NA	NA	-	0	1	1
	-	+	+	-	-	-	-	NA	+	1	0	1
	-	+	+	-	-	NA	NA	NA	+	1	0	1
	+	+	-	-	-	-	+	-	-	0	1	1
	+	+	-	-	-	+	NA	NA	-	0	1	1
	+	+	+	-	-	+	+	+	-	0	2	2
	+	+	+	-	-	+	NA	+	-	0	1	1
	+	+	+	-	-	+	NA	+	NA	1	0	1

CT Analysis According to Patient Infected Status NON-INFECTED FEMALE Subjects

E = Endocervical Swab Specimen; CCV = Clinician-Collected Vaginal Swab Specimen;

FU = Female Urine Specimen; SCV = Self-Collected Vaginal Swab Specimen.

NA includes "indeterminate" results from reference assays, specimens not available, or missing results.

Admin. Sec. 3 510(k) Summary Page 28 of 44

28

NAAT 1		NAAT 2	RealTime CT/NG		No. of Subjects
MUS	MU	MU	MUS	MU	Symptomatic
(MSU/MU)	Asymptomatic
(Urine Only)	Total
+	+	+	+	+	114	56	170
+	+	+	+	NA	1	0	1
+	+	+	NA	+	30	12	42
+	+	NA	+	+	5	1	6
+	+	NA	NA	+	2	1	3
+	+	-	+	+	5	3	8
+	+	-	NA	+	5	0	5
+	-	+	+	+	1	0	1
-	+	+	+	+	0	1	1
NA	+	+	NA	+	1	0	1
-	+	+	NA	+	0	2	2
+	+	+	-	+	5	3	8
-	+	+	-	+	3	5	8
+	+	+	+	-	1	1	2
+	+	+	NA	-	3	0	3
+	+	-	+	-	1	0	1
+	+	+	NA	-	2	0	2
+	-	+	NA	-	0	1	1
+	+	-	-	-	1	1	2

CT Analysis According to Patient Infected Status INFECTED MALE Subjects

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

NA includes "indeterminate" results from reference assays, specimens not available, or missing results.

Admin. Sec. 3 510(k) Summary Page 29 of 44

29

NAAT 1		NAAT 2	RealTime CT/NG		No. of Subjects
MUS	MU	MU	MUS	MU	Symptomatic
(MSU/MU)	Asymptomatic
(Urine Only)	Total
—	ー	ー	—	-	479	42 l	900
-	-	ﺴﺖ	-	NA	б	2	8
---	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-	NA	—	100	83	183
--	-	NA	—	--	25	36	QI
-	-	NA	NA	-	8	4	12
-	NA	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	—	-	l	0	l
NA	-	-	NA	-	1	0	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
-	-	+	-	ﯩﺴ	3	0	3
-	十	-	ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ	-	3	2	5
+	-	-	-	-	4	0	4
-	-	+	NA	-	l	2	3
-	+	-	NA	-	-	0	1
+	-	-	NA	-	3	4	7
-	-	-	+	-	5	0	5
-	-	-f-	+	-	l	0	l
+	-	-	+	-	2	0	2
-	-	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-	+	2	0	2
-	-	-	NA	+	2	1	3
---	--	+	NA	+	0	l	-
-	十	-	—	+	0	-	1
+	ﺴﺘ	ﺖ	NA	+	1	l	2
—	-	+	十	+	1	0	l

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

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

NA includes "indeterminate" results from reference assays, specimens not available, or missing results.

Admin. Sec. 3 510(k) Summary Page 30 of 44

30

Culture	NAAT 1			NAAT 2		RealTime CT/NG				No. of Subjects
E	E	CCV	FU	E	FU	E	CCV	SCV	FU	Symptomatic
(E/SCV/CCV/FU)	Asymptomatic
(SCV/CCV/FU)	Total
+	+	+	+	+	+	+	+	+	+	9	6	15
+	+	+	+	+	NA	+	+	NA	+	1	0	1
+	+	+	+	+	+	+	+	NA	+	1	1	2
+	+	+	+	+	+	NA	+	+	+	0	1	1
+	+	+	+	+	+	NA	+	+	+	1	0	1
+	+	+	+	+	+	NA	NA	NA	+	2	0	2
-	+	+	+	+	+	+	+	+	+	4	5	9
-	+	+	+	+	+	+	NA	+	+	0	1	1
-	+	+	+	+	+	NA	+	+	+	0	1	1
-	+	+	+	+	+	+	NA	NA	+	0	1	1
-	+	+	+	+	-	+	+	+	+	3	0	3
-	+	+	+	+	-	NA	NA	NA	+	1	0	1
-	-	+	+	-	+	NA	+	+	+	1	0	1
+	-	+	+	+	+	+	+	+	+	1	0	1
-	+	+	-	+	NA	NA	NA	NA	+	1	0	1
-	+	+	-	-	+	NA	+	+	+	1	0	1
-	+	-	+	-	+	+	NA	+	+	1	0	1
-	-	+	-	+	NA	NA	NA	NA	+	0	1	1
-	-	-	+	-	+	NA	NA	NA	+	0	1	1
+	+	+	+	+	-	NA	NA	NA	-	0	1	1
+	+	+	+	+	NA	+	+	NA	-	0	1	1
+	+	+	+	+	-	+	+	+	-	0	1	1
-	+	+	+	+	-	+	+	+	-	1	1	2
-	+	+	+	+	+	-	+	+	+	1	0	1
-	NA	+	+	-	+	-	+	+	+	0	1	1
-	-	+	+	+	-	-	+	+	+	1	0	1
-	-	-	+	+	-	-	-	-	+	1	0	1

NG Analysis According to Patient Infected Status INFECTED FEMALE Subjects

E = Endocervical Swab Specimen; CCV = Clinician-Collected Vaginal Swab Specimen;

FU = Female Urine Specimen; SCV = Self-Collected Vaginal Swab Specimen.

NA includes "indeterminate" results from reference assays, specimens not available, or missing results.

Abbott RealTime CT/NG // multi-Collect Specimen Collection Kit May 2010 Admin Sec 3_510(k) Summary_mw019

Admin. Sec. 3 510(k) Summary Page 31 of 44

31

| Culture | NAAT 2 | |---------|----|--- | E | E | CCV | FU (E/SCV/CCV/FU) | Asymptomatic
(SCV/CCV/FU) | Total | - | - | - | ﺴﺖ | - | ﯿﺖ | — | | - | - | - | - | ー | | - | - | | - | -- | | - | - | — | - | - | - | - | - | -- | - | - | - | NA | - | -- | NA | - | - | NA | - | - | ー | - | NA | -- | l | NA | - | NA | - | NA | ー | NA | - | NA | ー | - | NA | = | - | - | - | - | - | - | - | - | - | - | - | - | -- | - | - | - | - | | - | - | | - | - | | — | - | | - | . I | - | -- | — | - | NAAT 1 | RealTime CT/NG
| | | | | No. of Subjects | | | |
-----|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|-----------------|-------------------------------|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| E | FU | E | CCV | SCV | FU | Symptomatic
|
| - | - | - | - | - | l | … | 409 | 423 | 832 |
| - | -- | ﺴﺖ | - | NA | - | - | - | ﺳﺘ | ਟ 2 | 27 | 79 |
| | ー | NA | - | ー | NA | - | 2 | 3 | 5 |
| - | - | NA | l | NA | - | - | 4 | 3 | 7 |
| - | - | NA | NA | — | - | i | 4 | 0 | 4 |
| - | - | NA | NA | l | - | NA | l | 0 | l |
| = | NA | ー | NA | NA | ー | l | l | 2 |
| - | - | NA | NA | NA | NA | - | ర | 2 | 8 |
| - | NA | - | -- | - | - | - | 7 | 24 | 31 |
| ー | NA | - | - | ー | NA | - | l | l | 2 |
| - | NA | - | NA | NA | NA | - | 0 | 2 | 2 |
| ﺴﺘ | NA | - | - | ー | ー | - | 0 | 2 | 2 |
| - | NA | - | - | NA | - | … | 0 | l | 1 |
| ー | NA | - | NA | = | - | - | 0 | 1 | 1 |
| ー | - | - | । | ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ | - | - | 0 | - | - |
| -- | - | NA | - | NA | ー | 0 | - | - |
| ー | - | ﺖ | - | - | - | - | 0 | 1 | 1 |
| - | - | - | - | NA | 1 | - | 0 | - | - |
| - | - | - | — | ー | - | - | l | 0 | l |
| - | - | - | - | - | NA | ー | 0 | l | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| - | - | - | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | - | NA | 4 | 9 | 13 |
| - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ー | ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ | - | NA | - | રુભ | 28 | 78 |
| - | - | - | - | NA | । | - | 22 | 26 | 48 |
| | - | NA | - | - | - | 21 | । ਰੇ | 40 |
| - | - | - | - | - | NA | NA | 1 | 3 | 4 |
| ー | - | - | ! | NA | ー | NA | 1 | 0 | 1 |
| - | - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | NA | --- | - | NA | l | l | 2 |
| | - | - | ー | NA | NA | - | 9 | 4 | 13 |
| -- | - | NA | ー | NA | - | 6 | 4 | 10 |
| - | - | - | NA | NA | ﺒﺴﻬﻤ | ー | 7 | 4 | 11 |

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

E = Endocervical Swab Specimen; CCV = Clinician-Collected Vaginal Swab Specimen;

FU = Female Urine Specimen; SCV = Self-Collected Vaginal Swab Specimen.

NA includes "indeterminate" results from reference assays, specimens not available, or missing results.

32

Table 3.19 (Continued)

Culture		NAAT 1			NAAT 2		RealTime CT/NG				No. of Subjects
E	E	CCV	FU		E	FU	E	CCV	SCV	FU	Symptomatic
(E/SCV/CCV/FU)	Asymptomatic
(SCV/CCV/FU)	Total
-	-	-	-	-	-	-	NA	NA	NA	-	59	50	109
-	-	-	-	-	-	+	-	-	-	-	17	13	30
-	-	-	-	-	-	+	-	-	NA	-	2	1	3
-	-	-	-	-	-	+	-	NA	-	-	2	1	3
-	-	-	-	-	-	+	NA	-	-	-	1	0	1
-	-	-	-	-	-	+	NA	-	NA	-	1	0	1
-	-	-	-	-	-	+	NA	NA	NA	-	6	4	10
-	-	-	-	+	-	-	-	-	-	-	1	6	7
-	-	-	-	+	-	-	NA	NA	-	-	1	0	1
-	-	-	-	+	-	NA	-	-	-	NA	1	0	1
-	-	-	+	-	-	-	-	-	-	-	1	0	1
-	-	-	+	-	-	-	-	-	NA	-	0	1	1
-	-	+	-	-	-	-	-	-	-	-	1	1	2
-	-	+	-	-	-	-	NA	NA	NA	-	1	0	1
-	+	-	-	-	-	-	-	-	NA	-	1	0	1
-	+	-	-	-	-	-	NA	-	NA	-	0	1	1
	+	-	-	-	-	-	NA	NA	NA	-	2	0	2
-	+	+	-	-	-	+	-	-	-	-	0	1	1
-	+	+	-	-	-	-	-	NA	-	-	0	1
-	-	-	-	-	-	-	-	-	-	+	1	0	-
-	-	-	-	-	-	-	NA	NA	NA	+	1	0	1
-	-	-	+	-	-	-	-	-	-	+	0	3	3
-	+	+	+	-	-	-	NA	NA	NA	+	1	0	1
	-	+	-	-	-	+	-	-	+	-	1	0
-	-	+	+	-	-	-	-	NA	+	-	1	0	1
-	-	+	-	1	-	-	+	-	-	-	1	0	1
-	-	-	1	-	-	-	+	NA	-	-	0	1	1

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

E = Endocervical Swab Specimen; CCV = Clinician-Collected Vaginal Swab Specimen;

FU = Female Urine Specimen; SCV = Self-Collected Vaginal Swab Specimen.

NA includes "indeterminate" results from reference assays, specimens not available, or missing results.

Admin. Sec. 3 510(k) Summary Page 33 of 44

33

Culture	NAAT 1		NAAT 2		RealTime CT/NG		No. of Subjects
	MUS	MU	MUS	MU	MUS	MU	Symptomatic
(MSU/MU)	Asymptomatic
(Urine Only)	Total
+	+	+	+	+	+	+	140	1	141
+	+	+	+	NA	+	32	1	33
+	+	+	NA	+	+	2	1	3
+	+	NA	+	+	+	1	0	1
+	+	NA	NA	+	NA	1	0	1
NA	+	+	+	+	+	+	2	0	2
NA	+	+	+	+	NA	+	4	0	4
+	+	+	+	-	+	+	8	0	8
+	+	+	-	+	+	+	2	0	2
-	+	+	+	+	+	+	27	4	31
-	+	+	+	NA	+	+	5	2	7
-	+	+	NA	+	+	+	1	0	1
-	NA	+	+	NA	+	+	1	0	1
-	+	+	NA	NA	+	+	1	0	1
-	+	+	+	-	+	+	1	0	1
+	-	-	+	+	+	+	1	0	1
+	-	-	+	+	+	+	0	1	1
+	+	-	-	+	+	-	1	0	1
-	+	+	+	+	+	+	1	0	1
-	-	+	+	-	-	+	0	1	1
+	-	-	-	-	-	-	1	0	1

NG Analysis According to Patient Infected Status . INFECTED MALE Subjects

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

NA includes "indeterminate" results from reference assays, specimens not available, or missing results.

34

Culture	NAAT 1		NAAT 2		RealTime CT/NG		No. of Subjects
MUS	MUS	MU	MU	MUS	MU	Symptomatic
(MSU/MU)	Asymptomatic
(Urine Only)	Total
-	-	-	-	-	-	418	456	874
-	-	-	NA	-	-	32	36	68
-	-	-	NA	NA	-	9	6	15
-	-	NA	-	-	-	1	1	2
-	-	NA	-	NA	-	1	0	1
NA	-	-	-	-	-	7	6	13
-	-	-	-	-	NA	7	2	9
-	-	-	-	NA	-	96	96	192
-	-	-	+	-	-	13	21	34
NA	-	-	+	-	-	0	1	1
-	-	-	+	NA	-	3	4	7
-	-	+	-	-	-	2	2	4
-	-	+	-	NA	-	0	1	1
-	+	-	-	-	-	2	2	4
-	-	+	-	+	-	1	0	1
-	+	-	-	+	-	2	0	2
-	-	-	-	NA	+	3	0	3
-	-	-	+	+	+	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.

NA includes "indeterminate" results from reference assays, specimens not available, or missing results.

Abbott RealTime CT/NG // multi-Collect Specimen Collection Kit May 2010 Admin Sec 3_510(k) Summary_mw019

Admin. Sec. 3 510(k) Summary Page 35 of 44

35

3.22

ਰ
10
Ta

revalence of C. trachomatis and/or N. gonorrhoeae by Collection 2

Female Endocervical
% Prevalence (Number Positive/Number Tested)
Sitea	CT+/NG+	CT+/NG-b	CT-/NG+b
1	0.0
(0/17)	0.0
(0/17)	0.0
(0/17)
3	3.2
(2/63)	6.3
(4/63)	1.6
(1/63)
4	0.0
(0/26)	11.5
(3/26)	0.0
(0/26)
5	0.0
(0/12)	0.0
(0/12)	0.0
(0/12)
6	0.0
(0/8)	12.5
(1/8)	0.0
(0/8)
7	2.3
(4/172)	9.3
(16/172)	2.3
(4/172)
8	0.0
(0/38)	7.9
(3/38)	2.6
(1/38)
9	7.7
(3/39)	15.4
(6/39)	0.0
(0/39)
10	2.6
(3/116)	6.9
(8/116)	2.6
(3/116)
11	3.4
(1/29)	17.2
(5/29)	3.4
(1/29)
12	0.0
(0/10)	0.0
(0/10)	0.0
(0/10)
13	0.0
(0/16)	0.0
(0/16)	0.0
(0/16)
14	0.0
(0/34)	2.9
(1/34)	0.0
(0/34)
15	3.8
(1/26)	0.0
(0/26)	0.0
(0/26)
16	0.0
(0/10)	0.0
(0/10)	0.0
(0/10)
All	2.3
(14/616)	7.6
(47/616)	1.6
(10/616)

Abbott RealTime CT/NG // multi-Collect Specimen Collection Kit May 2010 Admin Sec 3_510(k) Summary_mw019

Admin. Sec. 3
510(k) Summary Page 36 of 44

36

Chlamydia trachomatis | | | |

| Prevalence
Rate
(%) | Sensitivity
(%) | Specificity
(%) | Positive
Predictive
Value (%) | Negative
Predictive
Value (%) |
|---------------------------|--------------------|--------------------|-------------------------------------|-------------------------------------|
| 0.5 | 95.2 | 99.3 | 40.6 | 100.0 |
| 1.0 | 95.2 | 99.3 | 57.9 | 100.0 |
| 2.0 | 95.2 | 99.3 | 73.5 | 99.9 |
| 5.0 | 95.2 | 99.3 | 87.7 | 99.7 |
| 10.0 | 95.2 | 99.3 | 93.8 | 99.5 |
| 15.0 | 95.2 | 99.3 | 96.0 | 99.2 |
| 20.0 | 95.2 | 99.3 | 97.1 | 98.8 |
| 25.0 | 95.2 | 99.3 | 97.8 | 98.4 |
| 30.0 | 95.2 | 99.3 | 98.3 | 98.0 |

| T

able 3.28
----------------	--

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

| Prevalence
Rate
(%) | Sensitivity
(%) | Specificity
(%) | Positive
Predictive
Value (%) | Negative
Predictive
Value (%) |
|---------------------------|--------------------|--------------------|-------------------------------------|-------------------------------------|
| 0.5 | 97.5 | 99.7 | 62.0 | 100.0 |
| 1.0 | 97.5 | 99.7 | 76.7 | 100.0 |
| 2.0 | 97.5 | 99.7 | 86.9 | 99.9 |
| 5.0 | 97.5 | 99.7 | 94.5 | 99.9 |
| 10.0 | 97.5 | 99.7 | 97.3 | 99.7 |
| 15.0 | 97.5 | 99.7 | 98.3 | 99.6 |
| 20.0 | 97.5 | 99.7 | 98.8 | 99.4 |
| 25.0 | 97.5 | 99.7 | 99.1 | 99.2 |
| 30.0 | 97.5 | 99.7 | 99.3 | 98.9 |

.

Admin. Sec. 3
510(k) Summary
Page 41 of 44

:

41

Conclusion Drawn from Clinical Studies 3.16

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

Abbott RealTime CT/NG // multi-Collect Specimen Collection Kit May 2010 Admin Sec 3_510(k) Summary_mw018

Admin. Sec. 3
510(k) Summary Page 42 of 44

42

References 3.17

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 urethritis in men. N Eng J Med 1984;311(1):1-6.
1. MMWR. Sexually transmitted diseases treatment guidelines 2002. Morb Mortal Wikly Rep [serial online] 2002;51 (RR-06). Available at http://www.cdc.gov/STD/treatment/4-2002TG.htm. Accessed 01/31/2005.
1. Alexander ER, Harrison HR. Role of Chlamydia trachomatis in perinatal 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. 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. Bøyre 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, Handsfield HH, Neisseria gonorrhoeae. In: Mandell GL, Bennett JE, Dolin R, editors. Mandell, Douglas, and Bennet's Principles and Practice of Infectious Diseases. 510 Ed. Philadelphia, PA: Churchill Livingstone, Inc. 2000:2242-58.
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 Morexella 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.

.

43

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 May 2010 Admin Sec 3_510(k) Summary_mw018

Admin. Sec. 3 510(k) Summary Page 44 of 44

44

Image /page/44/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird-like figure, composed of three curved lines that suggest wings and a stylized head.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

MAY 2 8 2010

Abbott Molecular, Inc.. c/o Paula Martin Senior Manager, Regulatory and Clinical Affairs 1300 E. Touhy Ave. Des Plaines, IL 60018

Re:	K092704
-----	---------

Trade/Device Name:	Abbott RealTime CT/NG assay
Regulation Number:	21CFR §866.3390 and 21CFR §866.3120
Regulation Name:	In vitro polymerase chain reaction (PCR) assay for Chlamydia
trachomatis and Neisserua gonorrhoeae and Microbiological
Specimen Collection and Transport Device
Regulatory Class:	Class I, Class II
Product Code:	LSL, MKZ
Dated:	May 21, 2010
Received:	May 24, 2010

Dear Ms. 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such 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

45

Page 2 – Paula Martin

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. 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 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sak, atArra

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

46

Indications of Use

510(k) Number: K092704 Device Name: Abbott RealTime CT/NG assay

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

The Abbott RealTime CT/NG (List No. 8L07-91) 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.

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

Page 1 of 1

Office of In Vitro Diagnostic Device
Evaluation and Safety

c092704

Abbott RealTime CT/NG // multi-Collect Specimen Collection Kit
May 2010	510(k)
Admin Sec 5_510(k) Indications of Use_mw004

Page Last Updated: 04/30/2009

Admin. Sec. 5 510(k) Indications of Use Page I of I

Intended Use / Indications for Use

Product codes

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies

Key Metrics

Predicate Device(s)

Reference Device(s)

Predetermined Change Control Plan (PCCP) - All Relevant Information

§ 866.3120 Chlamydia serological reagents.

1092704

Abbott RealTime CT/NG List No. 8L07-91

Table of Contents

3.0 Abbott RealTime CT/NG 510(k) Summary

3.1 Official Correspondent to the File

Submitted By:

Company Contact:

3.2 Trade Name:

3.3 Common Name:

3.4 Classification Name:

3.5 Registration Number and Classification Code:

3.6 Substantially Equivalent Devices

Abbott RealTime CT/NG (List No. 8L07-91) Predicate Devices:

3.7 Purpose of the Submission

3.8 Date of Preparation: August, 2009

3.9 Manufacturer

Intended Use 3.10

3.11 Device Description

3.12 Background on Chlamydia and Gonorrheal Disease

3.13 Technological Characteristics of the Device as Compared to the Predicate

Abbott RealTime CT/NG // multi-Collect Specimen Collection Kit May 2010 Admin Sec 3_510(k) Summary_mw019

Summary of Nonclinical Studies 3.14

Analytical Sensitivity 3.14.1

3.14.2 Evaluation of Potential Cross-Reactants

Table 3.6 (Continued)

Potentially Cross-Reactive Microorganisms/Viruses

Evaluation of Potentially Interfering Substances 3.14.3

3.14.4 Carryover

Precision Study 3.14.5

3.15 Summary of Clinical Studies

CT Analysis According to Patient Infected Status NON-INFECTED FEMALE Subjects

Table 3.15 (Continued)

CT Analysis According to Patient Infected Status NON-INFECTED FEMALE Subjects

CT Analysis According to Patient Infected Status INFECTED MALE Subjects

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

NG Analysis According to Patient Infected Status INFECTED FEMALE Subjects

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

Table 3.19 (Continued)

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

NG Analysis According to Patient Infected Status . INFECTED MALE Subjects

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

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

Conclusion Drawn from Clinical Studies 3.16

References 3.17

MAY 2 8 2010

Enclosure

Indications of Use

Prescription Use X (Per 21 CFR 801.119)

AND/OR