ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03

• K Number: K092704
• Device Name: ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03
• Manufacturer: ABBOTT MOLECULAR, INC.
• Date Cleared: 2010-05-28 ( 267 days)
• Product Code: LSK
• Regulation Number: 866.3120
• Type: Traditional
• Panel: Microbiology
• Reference & Predicate Devices: K043224 , K012351
• Predicate For: K110923

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.

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.

AI/ML Overview

Abbott RealTime CT/NG Assay: Acceptance Criteria and Supporting Study

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Abbott RealTime CT/NG assay are implied by the reported clinical sensitivity and specificity for various specimen types and Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) detection. While explicit numerical acceptance criteria are not stated in the provided text, the reported performance values demonstrate the device's efficacy.

Table 1: Clinical Performance of Abbott RealTime CT/NG Assay

Specimen Type & Symptom Status	Analyte	Reported Sensitivity (95% C.I.)	Reported Specificity (95% C.I.)
Female Endocervical Swab	CT	93.8 (84.8, 98.3)	99.8 (99.0, 100.0)
	NG	95.8 (88.7, 99.1)	99.8 (99.1, 100.0)
Female Clinician-Collected Vaginal Swab	CT (Symptomatic)	98.4 (91.6, 100.0)	100.0 (99.3, 100.0)
	CT (Asymptomatic)	97.2 (85.5, 99.9)	99.3 (98.2, 99.8)
	NG (Symptomatic)	98.4 (91.5, 100.0)	99.8 (99.1, 100.0)
	NG (Asymptomatic)	100.0 (71.5, 100.0)	99.7 (98.9, 100.0)
Female Self-Collected Vaginal Swab	CT (Symptomatic)	98.4 (91.5, 100.0)	98.9 (97.5, 99.6)
	CT (Asymptomatic)	97.3 (85.8, 99.9)	99.1 (97.9, 99.7)
	NG (Symptomatic)	100.0 (91.6, 100.0)	99.8 (99.1, 100.0)
	NG (Asymptomatic)	100.0 (71.5, 100.0)	99.9 (99.3, 100.0)
Female Urine	CT (Symptomatic)	91.3 (82.8, 96.4)	99.7 (98.9, 100.0)
	CT (Asymptomatic)	93.5 (82.1, 98.6)	99.7 (98.9, 100.0)
	NG (Symptomatic)	97.3 (89.3, 99.6)	99.8 (99.1, 100.0)
	NG (Asymptomatic)	95.7 (79.0, 99.9)	99.7 (98.9, 100.0)
Male Urethral Swab	CT (Symptomatic)	93.4 (87.9, 97.0)	98.3 (96.8, 99.2)
	NG (Symptomatic)	99.0 (95.9, 99.9)	99.6 (98.9, 99.9)
Male Urine	CT (Symptomatic)	95.5 (91.4, 98.1)	99.1 (98.0, 99.7)
	CT (Asymptomatic)	96.6 (90.3, 99.3)	99.3 (98.2, 99.8)
	NG (Symptomatic)	99.2 (96.3, 99.7)	99.5 (98.7, 99.8)
	NG (Asymptomatic)	100.0 (99.4, 100.0)	100.0 (71.5, 100.0)

2. Sample Size and Data Provenance (Clinical Study)

• Sample Size for Test Set: A total of 3,832 male and female subjects were enrolled in the multi-center clinical study. For the analysis of the Abbott RealTime CT/NG assay, 6,555 CT results and 6,569 NG results were used.
• Data Provenance: The study was conducted in the United States across 16 geographically diverse sites, including physician private practices, public and private STD clinics, and a hospital emergency room. The study design implies a prospective collection of specimens from enrolled subjects, although it's not explicitly stated as retrospective or prospective in every detail of the summary. The phrase "Specimens were collected from subjects at...sites" supports a prospective approach for the clinical data.

3. Number of Experts and Qualifications (Ground Truth)

The document does not explicitly state the "number of experts" or their specific "qualifications" used to establish the ground truth in the clinical study. Instead, the ground truth was established by comparing the Abbott RealTime CT/NG assay to reference assays.

4. Adjudication Method (Test Set)

The adjudication method for determining the "patient infected status" (ground truth) was based on a combination of reference assay results:

• For CT or NG (Female Subjects): A female was categorized as infected if a minimum of two positive results were reported (at least one from each reference NAAT). A specific condition was also applied for CT: if reference urine specimens were positive and all three reference swab specimens were negative, the subject was considered infected for urine but not swab specimens.
• For CT or NG (Male Subjects): A male was categorized as infected if a minimum of two positive results were reported.
• For NG (All Subjects): If the reference NG culture assay result was positive, the subject was categorized as infected regardless of NAAT results.
• Non-Infected Status: For females, non-infected status was assigned if at least one reference NAAT reported negative results for all sample types AND the NG culture was negative. For males, at least two negative results from reference NAATs AND a negative NG culture result were required for non-infected status.
• Subjects with missing and/or indeterminate results from reference assays were excluded from the analysis (4 subjects for CT and 7 subjects for NG).

This multi-assay, rule-based approach serves as the adjudication method for establishing the ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned in the provided document. The study is focused on the standalone performance of the Abbott RealTime CT/NG assay against established reference methods, not on comparing human reader performance with and without AI assistance.

6. Standalone Performance (Algorithm Only)

Yes, a standalone performance study was done. The entire clinical study described, measuring the sensitivity and specificity of the Abbott RealTime CT/NG assay against reference methods, represents the standalone performance of the algorithm. The results are summarized in Table 1 above, as well as Tables 3.10-3.13 in the original document.

7. Type of Ground Truth Used

The ground truth used for the clinical study was established by expert consensus using a combination of reference assays:

• Two commercially available Nucleic Acid Amplification Tests (NAATs) for CT and NG.
• Culture for NG.

This is a composite reference standard or adjudicated clinical truth based on multiple established diagnostic methods.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" or "training data" in the context of the Abbott RealTime CT/NG assay development or validation. This is expected given that the device is an in-vitro diagnostic (IVD) PCR assay, which typically relies on analytical validation and clinical performance studies described here, rather than machine learning models that require distinct training and test sets. The presented clinical study serves as the primary validation of the device's performance.

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

As noted above, the document does not refer to a distinct "training set." The Limit of Detection (LOD) and analytical sensitivity studies (Sections 3.14.1), which involve testing known concentrations of CT and NG target DNA and isolates, can be considered part of the analytical validation that informs the assay's performance characteristics. For these analytical studies:

• Known concentrations of CT and NG target DNA were used.
• Dilutions of various CT serovars and NG isolates were tested.

This is a form of defined analytical ground truth based on controlled laboratory preparations of the target organisms. For the clinical performance, the ground truth was established by the composite reference standard from the clinical study as detailed in point 7.

Summary

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1092704

MAY 2 8 2010

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

510(k) Summary

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Table of Contents

		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

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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: [phone] eFAX [phone]

Company Contact:

Paula Martin Senior Manager Regulatory and Clinical Affairs Phone [phone], eFAX [phone] e-mail: [e-mail]

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.

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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 [phone]. eFAX [phone] e-mail: timothy.zurow(@abbott.com

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

Abbott Molecular Inc. Establishment Registration No .: 3005248192

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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

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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

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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.

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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 (ListNo. 8L07-91) assay is an in vitropolymerase chain reaction (PCR)assay for the direct, qualitativedetection of the plasmid DNA ofChlamydia trachomatis and thegenomic DNA of Neisseriagonorrhoeae . The assay may beused to test the followingspecimens from symptomaticindividuals: female endocervicalswab, clinician-collected vaginalswab, and patient-collected vaginalswab specimens; male urethralswab specimens; and female andmale urine specimens. The assaymay be used to test the followingspecimens from asymptomaticindividuals: clinician-collectedvaginal swab and patient-collectedvaginal swab specimens; femaleand male urine specimens.	The APTIMA Combo 2 Assay is a targetamplification nucleic acid probe test thatutilizes target capture for the in vitroqualitative detection and differentiation ofribosomal RNA (rRNA) from Chlamydiatrachomatis and/or Neisseria gonorrhoeaein clinician collected endocervical, vaginal,and male urethral swab specimens,patientcollected vaginal swab specimens,and female and male urine specimens. Theassay may be used to test specimens fromsymptomatic and asymptomatic individualsto aid in the diagnosis of gonococcaland/or chlamydial urogenital disease usingthe TIGRIS DTS Automated Analyzer orsemiautomated instrumentation asspecified.The assay is also intended for use withtesting of gynecological specimenscollected in the PreservCyt Solution andprocessed with the Cytyc ThinPrep 2000System.	The BD ProbeTec ET Chlamydiatrachomatis (CT) and Neisseriagonorrhoeae (GC) Amplified DNAAssays, when tested with the BDProbeTec ET System, use StrandDisplacement Amplification (SDA)technology for the direct, qualitativedetection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA inendocervical swabs, male urethral,swabs, and in female and male urinespecimens as evidence of infectionwith C. trachomatis, N. gonorrhoeae ,or of coinfection with both C.trachomatis and N. gonorrhoeae .Specimens may be from symptomaticor asymptomatic females and males. Aseparate Amplification Control is anoption for inhibition testing (BDProbeTec ET CT/GC/AC ReagentPack). The BD ProbeTec ET CT/GCassays may be performed using eitherthe BD ProbeTec ET System or acombination of the BD ProbeTec ETSystem and BD Viper instrument.
Feature	Current ApplicationAbbott RealTime CT/NG		Amplified Nucleic Acid Predicate Devices
			Gen-Probe Aptima Combo 2	Becton Dickenson ProbeTec ET
Assay Type	Qualitative	•	Qualitative	Qualitative
CT AnalyteTargets	CT cryptic plasmid DNA	•	CT ribosomal RNA	CT cryptic plasmid DNA
NG AnalyteTargets	NG genomic DNA	•	NG ribosomal RNA	NG genomic DNA
Input SampleTypes	Endocervical swab specimensSelf-collected vaginal swabspecimensClinician-collected vaginalswab specimensMale urethral swab specimensMale and female urinespecimens	•	Endocervical swab specimensSelf-collected vaginal swabspecimensClinician-collected vaginalswab specimensMale urethral swab specimensMale and female urinespecimensPreservCyt liquid Pap specimens	Endocervical swab specimensMale urethral swab specimensMale and female urinespecimens
SamplePreparationProcedure	Automated	•	Semi-automated/automated	Manual/ semi-automated
AmplificationTechnology	Real-time PCR		Ribosomal RNA transcriptionmediatedamplification (TMA)	Strand displacement DNAamplification (SDA)
AssayControls	Negative ControlCutoff ControlInternal Control	•	Negative ControlPositive Control	Negative ControlPositive ControlOptional Amplification Control

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

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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).

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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.

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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
Chryseobacteriummeningosepticum	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.

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Table 3.6 (Continued)

Potentially Cross-Reactive Microorganisms/Viruses

• Tested with purified DNA or RNA and with culture isolates.

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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.

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able1	1
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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.

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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,

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PanelMembera	No.Testedb	No.Positive	MeanDeltaCycle	Within-RunComponentSDc	Between-RunComponentSDc	Between-LotComponentSDc	Between-SiteComponentSDc	TotalSDc,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.

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Table	10J.J

PanelMembera	No.Testedb	No.Positive	MeanDeltaCycle	Within-RunComponentSDc	Between-RunComponentSDc	Between-LotComponentSDc	Between-SiteComponentSDc	TotalSDc,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.

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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.

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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

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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)

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hlamydia trachomatis Clinical Sensitivity and Specificit

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Specimen	Symptoms	n	TruePos	FalsePos	TrueNeg	FalseNeg	Sensitivity (95% C.I.)	Specificity (95% C.I.)
UrethralSwab	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
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・

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·

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.

{24}------------------------------------------------

sitivity Clinical Sen able 3.13

Neisseria gonorrhoeae Clinical Sensitivity and Specificity
Male Specimens

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May 2010
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	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.

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{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.

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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.

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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 1	RealTime CT/NGNAAT 2						No. of Subjects
E	E	CCV	FU	E	FU	E	CCV	SCV	FU	Symptomatic(E/SCV/CCV/FU)	Asymptomatic(SCV/CCV/FU)	Total
-	-	-	-	-	-	-	-	l	…	409	423	832
ﺴﺖ	-	--	ﺴﺖ	-	NA	-	-	-	ﺳﺘ	ਟ 2	27	79
-	ﯿﺖ	—		ー	NA	-	ー	NA	-	2	3	5
	-	-	-	-	NA	l	NA	-	-	4	3	7
-	-	ー	-	-	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
NA	-	--	ﺴﺘ	NA	-	-	ー	ー	-	0	2	2
NA	-	-	-	NA	-	-	NA	-	…	0	l	1
NA	-	-	ー	NA	-	NA	=	-	-	0	1	1
ー	-	NA	ー	-	-	।	ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ	-	-	0	-	-
--	l	NA	-	--	-	NA	-	NA	ー	0	-	-
NA	-	NA	ー	-	ﺖ	-	-	-	-	0	1	1
ー	NA	-	-	-	-	-	NA	1	-	0	-	-
NA	ー	-	-	-	-	—	ー	-	-	l	0	l
NA	=	-	-	-	-	-	-	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
	-	. I	-	--	-	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}------------------------------------------------

< : + 4-1 .............................................................................................................................................................................. ( 1. 1. Table 3.23
nd/or N. go 5

Sitea	Clinician-Collected Vaginal Swab% Prevalence (Number Positive/Number Tested)			Self-Collected Vaginal Swab% Prevalence (Number Positive/Number Tested)
	CT+/NG+	CT+/NG-b	CT-/NG+b	CT+/NG+	CT+/NG-b	CT-/NG+b
1	0.0(0/40)	0.0(0/40)	0.0(0/40)	0.0(0/41)	0.0(0/41)	0.0(0/41)
3	1.5(2/134)	4.5(6/134)	0.7(1/134)	2.3(3/130)	3.8(5/130)	0.8(1/130)
4	0.0(0/26)	7.7(2/26)	0.0(0/26)	0.0(0/26)	15.4(4/26)	0.0(0/26)
5	0.0(0/16)	0.0(0/16)	0.0(0/16)	0.0(0/17)	0.0(0/17)	0.0(0/17)
6	0.0(0/9)	11.1(1/9)	0.0(0/9)	0.0(0/8)	12.5(1/8)	0.0(0/8)
7	3.8(9/238)	9.2(22/238)	3.8(9/238)	3.9(9/230)	10.0(23/230)	3.9(9/230)
8	0.0(0/46)	8.7(4/46)	4.3(2/46)	0.0(0/47)	10.6(5/47)	4.3(2/47)
9	5.6(3/54)	14.8(8/54)	3.7(2/54)	4.3(2/47)	12.8(6/47)	6.4(3/47)
10	1.9(3/162)	11.1(18/162)	1.9(3/162)	2.6(4/152)	13.8(21/152)	2.0(3/152)
11	1.1(3/261)	7.3(19/261)	1.5(4/261)	1.2(3/258)	7.4(19/258)	1.6(4/258)
12	0.0(0/11)	0.0(0/11)	0.0(0/11)	0.0(0/11)	0.0(0/11)	0.0(0/11)
13	0.0(0/61)	0.0(0/61)	0.0(0/61)	0.0(0/59)	0.0(0/59)	0.0(0/59)
14	0.0(0/75)	1.3(1/75)	1.3(1/75)	0.0(0/72)	2.8(2/72)	0.0(0/72)
15	1.9(1/53)	0.0(0/53)	0.0(0/53)	1.9(1/52)	0.0(0/52)	0.0(0/52)
16	0.0(0/22)	0.0(0/22)	4.5(1/22)	0.0(0/23)	4.3(1/23)	4.3(1/23)
All	1.7(21/1208)	6.7(81/1208)	1.9(23/1208)	1.9(22/1173)	7.4(87/1173)	2.0(23/1173)

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

Admin. Sec. 3
510(k) Summary

{37}------------------------------------------------

3.24
ರಿ
œ
q
g
C
1

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

Site	CT+/NG+	CT+/NG-a	CT-/NG+b
1	0.0(0/60)	0.0(0/60)	0.0(0/60)
3	1.8(3/165)	3.6(6/165)	1.8(3/165)
4	0.0(0/49)	8.2(4/49)	2.0(1/49)
5	0.0(0/21)	0.0(0/21)	0.0(0/21)
6	0.0(0/15)	6.7(1/15)	6.7(1/15)
7	3.1(9/293)	8.5(25/293)	3.8(11/293)
8	0.0(0/57)	7.0(4/57)	3.5(2/57)
9	4.6(3/65)	15.4(10/65)	4.6(3/65)
10	2.4(4/168)	11.3(19/168)	1.8(3/168)
11	1.4(4/284)	8.8(25/284)	2.1(6/284)
12	0.0(0/11)	0.0(0/11)	0.0(0/11)
13	0.0(0/70)	0.0(0/70)	0.0(0/70)
14	0.0(0/79)	2.5(2/79)	0.0(0/79)
15	1.7(1/59)	0.0(0/59)	0.0(0/59)
16	0.0(0/26)	0.0(0/26)	3.8(1/26)
All	1.7(24/1422)	6.8(96/1422)	2.2(31/1422)

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3.25
ble
ਦੇ
L

revalence of C. trachomatis and/or N. gonorrhoeae by Collection Site
Symptomatic Male Urethral Swab

Sitea,b	CT+/NG+	CT+/NG-	CT-/NG+c
3	12.0(10/83)	12.0(10/83)	16.9(14/83)
4	5.6(2/36)	2.8(1/36)	8.3(3/36)
5	0.0(0/22)	9.1(2/22)	4.5(1/22)
6	0.0(0/6)	16.7(1/6)	16.7(1/6)
7	11.1(9/81)	17.3(14/81)	17.3(14/81)
8	7.5(11/147)	15.6(23/147)	21.1(31/147)
9	11.4(17/149)	13.4(20/149)	38.3(57/149)
10	5.5(4/73)	17.8(13/73)	13.7(10/73)
12	0.0(0/3)	0.0(0/3)	0.0(0/3)
13	0.0(0/24)	0.0(0/24)	0.0(0/24)
14	0.0(0/14)	0.0(0/14)	14.3(2/14)
15	0.0(0/6)	0.0(0/6)	0.0(0/6)
16	3.7(1/27)	0.0(0/27)	14.8(4/27)
All	8.0(54/671)	12.5(84/671)	20.4(137/671)

No symptomatic male urethral swab specimens were available from Site 2 or
Does not include specimens that were positive for both CT and NG.

SOURCE: https://www.mdpi.com/2076-2607/11/1/155/htm

DISCUSSION

In this study, we investigated the effects of both pre- and post-slaughter factors on the meat quality of Boer goats. The results showed that pre-slaughter factors, especially transportation time, significantly affected meat quality traits such as pH, color, and tenderness. Specifically, longer transportation times were associated with higher pH values, darker meat color, and lower tenderness scores. These findings suggest that reducing transportation time could improve the meat quality of Boer goats.

Post-slaughter factors, including chilling rate and aging time, also had a significant impact on meat quality. Rapid chilling rates were associated with improved tenderness and reduced drip loss, while longer aging times resulted in increased tenderness and improved flavor. These results indicate that optimizing chilling rate and aging time can enhance the meat quality of Boer goats.

Furthermore, we found that the interaction between pre- and post-slaughter factors also played a crucial role in determining meat quality. For example, the effect of transportation time on tenderness was more pronounced in carcasses that were chilled slowly compared to those that were chilled rapidly. This suggests that the impact of pre-slaughter stress can be mitigated by optimizing post-slaughter handling practices.

Overall, our findings highlight the importance of considering both pre- and post-slaughter factors when aiming to improve the meat quality of Boer goats. By minimizing pre-slaughter stress and optimizing post-slaughter handling practices, producers can enhance the quality and value of their products.

CONCLUSIONS

In conclusion, this study provides valuable insights into the effects of pre- and post-slaughter factors on the meat quality of Boer goats. The results showed that transportation time, chilling rate, and aging time all had a significant impact on meat quality traits such as pH, color, tenderness, and drip loss. Furthermore, the interaction between pre- and post-slaughter factors also played a crucial role in determining meat quality. These findings suggest that optimizing both pre- and post-slaughter handling practices can improve the meat quality of Boer goats and enhance the value of their products. Future research should focus on identifying specific strategies for minimizing pre-slaughter stress and optimizing post-slaughter handling practices to further improve the meat quality of Boer goats.

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3.26
ble
Ta

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

Sitea	Urine% Prevalence (Number Positive/Number Tested)
	CT+/NG+	CT+/NGb	CT-/NG+b
2	0.0(0/6)	0.0(0/6)	0.0(0/6)
3	15.1(26/172)	8.7(15/172)	9.9(17/172)
4	4.2(4/96)	6.3(6/96)	7.3(7/96)
5	0.0(0/35)	5.7(2/35)	2.9(1/35)
6	0.0(0/41)	22.0(9/41)	2.4(1/41)
7	6.7(12/179)	16.8(30/179)	10.1(18/179)
8	5.2(15/290)	15.2(44/290)	12.4(36/290)
9	10.1(21/208)	20.7(43/208)	30.8(64/208)
10	1.4(2/145)	20.7(30/145)	8.3(12/145)
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(0/76)	1.3(1/76)	2.6(2/76)
15	0.0(0/53)	3.8(2/53)	0.0(0/53)
16	0.0(0/101)	1.0(1/101)	5.9(6/101)
All	5.5(80/1467)	12.7(186/1467)	11.2(164/1467)

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Admin. Sec. 3
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	I	"able	t13.2
--	---	-------	---------------	--

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

PrevalenceRate(%)	Sensitivity(%)	Specificity(%)	PositivePredictiveValue (%)	NegativePredictiveValue (%)
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

Table 3.28
----------------	--

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

PrevalenceRate(%)	Sensitivity(%)	Specificity(%)	PositivePredictiveValue (%)	NegativePredictiveValue (%)
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

.

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Page 41 of 44

:

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Conclusion Drawn from Clinical Studies 3.16

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

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References 3.17

• 1. Schachter J. Chlamydial infections. West J Med 1990;153(5):523-34.
• 2. Cates W Jr. Wasserheit JN. Genital chlamydial infections: epidemiology and reproductive sequelae. Am J Obstet Gynecol 1991;164(6 Pt 2):1771-81.
• 3. 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.
• 4. 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.
• 5. 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.
• 6. Alexander ER, Harrison HR. Role of Chlamydia trachomatis in perinatal infection. Rev Infect Dis 1983:5(4):713-9.
• 7. 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.
• 8. 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.
• 9. 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.
• 10. 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.
• 11. 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.
• 12. 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.
• 13. 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.

.

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• 14. 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.
• 15. Palmer L, Falkow S. A common plasmid of Chlamydia trachomatis. Plasmid 1986;16(1):52-62.

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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 Chlamydiatrachomatis and Neisserua gonorrhoeae and MicrobiologicalSpecimen 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 [phone]. 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 [phone] or [phone] 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

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Office of In Vitro Diagnostic Device
Evaluation and Safety

c092704

Abbott RealTime CT/NG // multi-Collect Specimen Collection Kit
May 2010	510(k)
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Page Last Updated: 04/30/2009

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

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).