The Xpert® CT/NG Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro real-time PCR test for the automated detection and differentiation of genomic DNA from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) to aid in the diagnosis of chlamydial and gonorrheal urogenital disease. The assay may be used to test the following specimens from asymptomatic and symptomatic individuals: female and male urine, endocervical swab, and patient-collected vaginal swab (collected in a clinical setting).

Ancillary Collection Kits Indications for Use:

The Cepheid® Xpert® CT/NG Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve and transport patient Chiamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical and vaginal specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.

The Cepheid® Xpert® CT/NG Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis and Neisseria gonorrhoeae DNA in first-catch male and female urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.

Device Description

The Xpert CT/NG Assay is an automated in vitro diagnostic test for qualitative detection and differentiation of DNA from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoege (NG). The assay is performed on the Cepheid GeneXpert Instrument Systems. The GeneXpert Instrument Systems automate and integrate sample purification, nucleic acid amplification, and detection of the target sequences in simple or complex samples using real-time PCR and RT-PCR assays. The systems consist of an instrument, personal computer, and preloaded software for running the tests on collected samples and viewing the results. The system requires the use of single-use disposable cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are selfcontained, cross-contamination between cartridges during the testing process is minimized.

The Xpert CT/NG Assay includes reagents for the 5' exonuclease real-time PCR detection and differentiation of CT and NG. Reagents for the detection of a Sample Processing Control (SPC), a Sample Adequacy Control (SAC), and a Probe Check Control (PCC) are also included in the cartridge. The SPC is present to control for adequate processing of the target bacteria and to monitor the presence of inhibitors in the PCR reaction. The SAC reagents detect the presence of a single copy human gene and monitor whether the specimen contains human DNA. The PCC verifies reagent rehydration. PCR tube filling in the cartridge, probe integrity, and dye stability. The primers and probes in the Xpert CT/NG Assay detect chromosomal sequences in the bacteria. One target is detected for CT (CT1) and two different targets are detected for NG (NG2 and NG4). Both NG targets need to be positive for the Xpert CT/NG Assay to return a positive NG result.

The GeneXpert Instrument Systems, comprised of the GeneXpert Dx Systems, the GeneXpert Infinity-48 System and the GeneXpert Infinity-80 System, have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample preparation and real-time PCR tests. Each module contains a svringe drive for dispensing fluids (i.e., the syringe drive activates the plunger that works in concert with the rotary valve in the cartridge to move fluids between chambers), an ultrasonic horn for lysing cells or spores, and a proprietary I-CORE® thermocycler for performing real-time PCR and detection.

The ancillary specimen collection kits for use with the Xpert CT/NG Assay are the Cepheid® Xpert® CT/NG Vaginal/Endocervical Specimen Collection Kit and the Cepheid® Xpert® CTNG Urine Specimen Collection Kit.

AI/ML Overview

This response describes the acceptance criteria and the study that proves the device meets the acceptance criteria, as extracted from the provided text.

Acceptance Criteria and Device Performance

The acceptance criteria for the Xpert CT/NG Assay are primarily demonstrated through its analytical sensitivity (Limit of Detection - LoD), analytical specificity (cross-reactivity), and clinical performance (sensitivity and specificity compared to a Patient Infected Status algorithm).

Table of Acceptance Criteria and Reported Device Performance (Clinical Performance - Overall "All" Category):

Test	Specimen Type	Acceptance Criteria (Implied by achieved performance, generally high sensitivity/specificity)	Reported Sensitivity % (95% CI)	Reported Specificity % (95% CI)
Chlamydia trachomatis (CT)	Patient-collected Vaginal Swab	High performance necessary for diagnostic aid	99.5 (97.3-100)	99.1 (98.8-99.4)
	Endocervical Swab	High performance necessary for diagnostic aid	96.0 (92.3-98.3)	99.6 (99.3-99.7)
	Female Urine	High performance necessary for diagnostic aid	98.1 (95.2-99.5)	99.8 (99.6-99.9)
	Male Urine	High performance necessary for diagnostic aid	98.5 (95.6-99.7)	99.8 (99.6-99.9)
Neisseria gonorrhoeae (NG)	Patient-collected Vaginal Swab	High performance necessary for diagnostic aid	100 (93.2-100)	99.9 (99.8-100)
	Endocervical Swab	High performance necessary for diagnostic aid	100 (93.2-100)	>99.9 (99.8-100)
	Female Urine	High performance necessary for diagnostic aid	94.4 (84.6-98.8)	>99.9 (99.9-100)
	Male Urine	High performance necessary for diagnostic aid	98.3 (94.1-99.8)	99.9 (99.7-100)

Note: The document does not explicitly state pre-defined numerical "acceptance criteria" thresholds for clinical performance. Instead, it presents the achieved performance metrics, which are then assessed for substantial equivalence to predicate devices.

Study Information

1. Sample sizes used for the test set and data provenance:

Clinical Study:
- Female Subjects: A total of 3767 female subjects were included in the overall clinical performance analysis across various specimen types.
  - Patient-Collected Vaginal Swabs (PC-VS) analyzed for CT: 3766 subjects
  - Endocervical Swabs (ES) analyzed for CT: 3757 subjects
  - Female Urine analyzed for CT: 3767 subjects
  - PC-VS analyzed for NG: 3766 subjects
  - ES analyzed for NG: 3757 subjects
  - Female Urine analyzed for NG: 3767 subjects
- Male Subjects: A total of 3436 male subjects were included in the overall clinical performance analysis.
  - Male Urine analyzed for CT: 3436 subjects
  - Male Urine analyzed for NG: 3436 subjects
- Data Provenance: The study was a "multi-site prospective investigational study at 36 US and UK institutions". This indicates the data is prospective and collected from multiple countries (United States and United Kingdom).
Reproducibility Study (Test Set):
- Panel of 22 specimens (11 in urine matrix, 11 in swab matrix), tested 4 times per day, by 2 operators, for 5 days, across 3 sites.
- Total replicates per panel member: 22 specimens x (4 runs/day * 5 days * 2 operators * 3 sites) = 120 replicates per panel member.
Instrument System Precision Study (Test Set):
- Panel of 20 specimens (10 in urine matrix, 10 in swab matrix), tested on 12 different days by 2 operators, with each operator conducting 4 runs of each panel specimen per day on each of two instrument systems.
- Total replicates per panel member: 20 specimens x (4 runs/day * 12 days * 2 operators * 2 instrument systems) = Approximately 191-192 total agreement results reported per panel member depending on specific run outcomes (ERROR, INVALID, NO RESULT).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The ground truth for the clinical study (Patient Infected Status - PIS) was established using an algorithm based on the results from two currently marketed NAAT tests (predicate devices). The document does not specify the number or qualifications of human experts involved in establishing the PIS, as it relies on a composite reference standard from established molecular diagnostic tests (GEN-PROBE® APTIMA® Combo 2 Assay and Becton Dickenson ProbeTec™ ET Chlamydia trachomatis /Neisseria gonorrhoeae Amplified DNA Assay).

3. Adjudication method for the test set:

For the clinical study, the PIS algorithm was defined as:
- Infected (I) for CT or NG: If at least one positive result was reported from each of the two reference NAAT tests.
- Equivocal (EQ): If both NAAT tests resulted in equivocal results for both sample types (swab and urine). (No study participants fell into this category).
- Not Infected (NI): Any other combination of results.
- Specific rules were applied for cases where reference urine was positive and swab negative, or vice versa (e.g., for females, positive on both reference urine and negative on both reference swab would be 'infected' for urine and 'not infected' for swab).
This approach constitutes a composite reference standard using two predicate devices. It's not a typical human expert adjudication method (e.g., 2+1), but rather an algorithmic adjudication based on existing cleared tests.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was performed or described. This device is an automated, qualitative in vitro real-time PCR test, meaning it directly detects and differentiates genomic DNA. It does not involve human readers interpreting results, nor does it incorporate AI for diagnostic assistance in the manner typically described in MRMC studies.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, the clinical performance study evaluated the Xpert CT/NG Assay as a standalone algorithm (device only) against the Patient Infected Status (PIS) algorithm. The device is designed to be fully automated and provides qualitative results (DETECTED, NOT DETECTED), thus it inherently operates without human interpretation of the primary result.

6. The type of ground truth used:

The ground truth for the clinical performance study was a Patient Infected Status (PIS) algorithm, which served as a composite reference standard. This PIS was derived from the combined results of two predicate (legally marketed) Nucleic Acid Amplification Tests (NAATs): GEN-PROBE® APTIMA® Combo 2 Assay and Becton Dickenson ProbeTec™ ET Chlamydia trachomatis /Neisseria gonorrhoeae Amplified DNA Assay.

7. The sample size for the training set:

The document describes pre-market non-clinical (analytical) and clinical validation studies. There is no mention of a separate "training set" in the context of machine learning model development. This device is a real-time PCR assay, not a machine learning or AI-based diagnostic that typically undergoes an explicit training phase with a distinct training dataset. The development of such an assay involves analytical optimization and robust validation rather than AI model training.

8. How the ground truth for the training set was established:

As the device is a real-time PCR assay and not an AI/ML-based system, an explicit "training set" with ground truth in the AI sense is not applicable. The development cycle would involve designing primers and probes, optimizing reaction conditions, and verifying analytical performance against known standards and cultured organisms to establish the assay's ability to detect target DNA. For the non-clinical analytical studies (e.g., LoD, specificity), the ground truth was established by using purified elementary bodies or cells of known organisms at specified concentrations (e.g., ATCC reference strains) or well-characterized human biological samples confirmed negative for the targets.

Summary

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K121710

510(k) Summary

DEC 2 7 2012

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As required by 21 CFR Section 807.92(c).

Cepheid® .

904 Caribbean Drive

Submitted by:

904 Caribbean DriveSunnyvale, CA 90489Phone number: (408) 400-8460Fax number: (408) 541-6439
Contact:	Kerry J. Flom, Ph.D.
Date of Preparation:	December 26, 2012
Device:
Trade name:	Xpert® CT/NG
Common name:	Xpert CT/NG Assay
Type of Test:	Automated, multiplex real-time polymerase chain reaction(PCR) assay intended for the in vitro qualitative detection anddifferentiation of DNA from Chlamydia trachomatis (CT)and/or Neisseria gonorrhoeae (NG).
Regulation number/Classification name:	866.3120/ Chlamydia serological reagents.866.3390/ Neisseria spp. direct serological test reagents
Product code:	MKZLSL
ClassificationAdvisory Panel	Microbiology (83)
Predicate Devices -Assay:	GEN-PROBE® APTIMA® Combo 2 Assay [510(k)#K043224]Becton Dickenson ProbeTec™ ET Chlamydia trachomatis/Neisseria gonorrhoeae Amplified DNA Assay [510(k)#K012351]
Predicate Devices –Ancillary SpecimenCollection Kits:	GEN-PROBE® APTIMA® Combo 2 Assay [510(k)#K043244] for use with:GEN-PROBE® APTIMA® Unisex Swab Specimen CollectionKit for Endocervical and Urethral Swab SpecimensGEN-PROBE® APTIMA® Urine Specimen Collection Kit forMale and Female UrineGEN-PROBE® APTIMA® Vaginal Swab SpecimenCollection Kit for Male and Female Urine

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Device Description:

. The Xpert CT/NG Assay is an automated in vitro diagnostic test for qualitative detection 心: and differentiation of DNA from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoege (NG). The assay is performed on the Cepheid GeneXpert Instrument Systems. The GeneXpert Instrument Systems automate and integrate sample purification, nucleic acid amplification, and detection of the target sequences in simple or complex samples using real-time PCR and RT-PCR assays. The systems consist of an instrument, personal computer, and preloaded software for running the tests on collected samples and viewing the results. The system requires the use of single-use disposable cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are selfcontained, cross-contamination between cartridges during the testing process is minimized.

Device Intended Use:

Xpert CT/NG Assay:

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aid in the diagnosis of chlamydial and gonorrheal urogenital disease. The assay may be used to test the following specimens from asymptomatic and symptomatic individuals: female and male urine, endocervical swab, and patient-collected vaginal swab (collected in a clinical setting).

Ancillary Collection Kits:

The Cepheid® Xpert® CT/NG Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical and vaginal specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.

The Cepheid Xpert CT/NG Vaginal/Endocervical Specimen Collection Kit has only been cleared for use with the Cepheid Xpert® CT/NG Assay.

Substantial Equivalence:

The Xpert CT/NG Assay is substantially equivalent to the following predicate assays:

K043224: GEN-PROBE® APTIMA® Combo 2 Assay, Gen-Probe Inc. .
K012351: Becton Dickenson ProbeTec™ ET Chlamydia trachomatis /Neisseria . gonorrhoeae Amplified DNA Assay, Becton Dickenson & Co.

Similarities and differences between the Cepheid Xpert CT/NG Assay and the predicate devices are shown in Table 1.

A clinical study at thirty-six collection sites was conducted to compare Xpert CT/NG Assay performance relative to a patient infection status algorithm, based on results from the GEN-PROBE APTIMA Combo 2 Assay and Becton Dickenson ProbeTec ET Chlamydia trachomatis /Neisseria gonorrhoeae Amplified DNA Assay tests.

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	Device	Predicates
Item	Cepheid Xpert CT/NGAssay	GEN-PROBE®APTIMA® Combo 2Assay	Becton DickensonProbeTec™ ETChlamydia trachomatis/Neisseria gonorrhoeaeAmplified DNA Assay
510(k) No.	To be assigned	K043224	K012351
Regulation	866.3120, 866.3390	866.3120, 866.3390	866.3120, 866.3390
Product Code	MKZ, LSL	MKZ, LSL	MKZ, LSL
Device Class	I, II	I, II	I, II
Technology/Detection	Multiplex real-timepolymerase chainreaction (PCR)	Multiplex transcription-mediated amplification(TMA)	Multiplex stranddisplacementamplification (SDA)
Intended Use	An automated, multiplexreal-time RT-PCR assay,performed on theGeneXpert InstrumentSystems, intended for thein vitro qualitative anddifferentiation ofgenomic DNA fromChlamydia trachomatis(CT) and/or Neisseriagonorrhoeae (NG) to aidin the diagnosis ofchlamydial gonorrhealurogenital disease. Theassay may be used to testthe following specimensfrom asymptomatic andsymptomatic individuals:female and male urine,endocervical swab, andpatient-collected vaginalswab (collected in aclinical setting).	A target amplificationnucleic acid probe testthat utilizes targetcapture for the in vitroqualitative detectionand differentiation ofribosomal RNA(rRNA) fromChlamydia trachomatis(CT) and/or Neisseriagonorrhoeae (GC) inclinician-collectedendocervical, vaginal,and male urethral swabspecimens, patient-collected vaginal swabspecimens*, and femaleand maleurine specimens. Theassay is also intendedfor use with testing ofgynecologicalspecimens collected inthe PreservCyt Solutionand processed with theCytyc ThinPrep 2000System. The assay maybe used to testspecimens from	Strand DisplacementAmplification (SDA)technology for thedirect, qualitativedetection ofChlamydia trachomatisand Neisseriagonorrhoeae DNA inendocervical swabs,male urethral swabs,and in female and maleurine specimens asevidence ofinfection with C.trachomatis, N.gonorrhoeae, or of co-infection with bothC. trachomatis and N.gonorrhoeae.Specimens may befrom symptomatic orasymptomatic femalesand males. A separateAmplification Controlis an option forinhibition testing(BDProbeTec™ ETCT/GC/AC ReagentPack).
	Device	Predicates
Item	Cepheid Xpert CT/NGAssay	GEN-PROBE®APTIMA® Combo 2Assay	Becton DickensonProbeTec™ ETChlamydia trachomatis/Neisseria gonorrhoeaeAmplified DNA Assay
Indication forUse	Asymptomatic andsymptomatic patients	symptomatic andasymptomaticindividuals to aid in thediagnosis ofgonococcal and/orchlamydial urogenitaldisease.*Patient-collectedvaginal swabspecimens are anoption for screeningwomen when a pelvicexam is not otherwiseindicated. The vaginalswab specimencollection kit is not forhome use.
Assay Targets	DNA from Chlamydiatrachomatis (CT) and/orNeisseria gonorrhoeae(NG)	Same	Same
SpecimenTypes	Urine, endocervicalswab, and patient-collected vaginal swab	ribosomal RNA(rRNA) fromChlamydia trachomatis(CT) and/or Neisseriagonorrhoeae (GC)	DNA from Chlamydiatrachomatis (CT) andNeisseria gonorrhoeae(NG)
CT AnalyteTargets	CT genomic DNA	Clinician-collectedendocervical, vaginal,and male urethralswab specimens,patient-collectedvaginal swabspecimens, and femaleand maleurine specimens	Endocervical swabs,male urethral swabs,and urine specimens forfemales and males
NG AnalyteTargets	NG genomic DNA	CT ribosomal RNA	CT cryptic plasmid DNA
	Device		Predicates
Item	Cepheid Xpert CT/NGAssay	GEN-PROBE®APTIMA® Combo 2Assay	Becton DickensonProbeTec™ ETChlamydia trachomatis/Neisseria gonorrhoeaeAmplified DNA Assay
Collection Kit	Urine collection kitSwab collection kit	Urine collection kitSwab collection kit	Urine collection kitSwab collection kit
TechnologicalPrinciples	RT/PCR	TMA	SDA
Nucleic AcidExtraction	Yes	Yes	Yes
SampleExtraction	Self-contained andautomated after specimensample elution and twosingle-dose reagentadditions.	Manual	Manual
Assay Results	Qualitative	Qualitative	Qualitative
InstrumentSystem	Cepheid GeneXpertInstrument Systems	Gen-Probe Leader HC+luminometer and Gen-Probe Target CaptureSystem	ProbeTec™ ET System
AssayControls	Internal sampleprocessing control (SPC),sample adequacy control(SAC), and probe checkcontrol (PCC).External controlsavailable.	The Positive Control,CT / Negative Control,GC and the PositiveControl, GC / NegativeControl, CT act ascontrols for the targetcapture, amplification,and detection steps ofthe assay.	Amplification Control(AC)
Rapid testresults	Approximately 90minutes (1.5 hours) toresults.	Approximately 4.5hours to results.	Approximately 3.5hours to results.
Item	Device :Cepheid Xpert CT/NGVaginal/EndocervicalSpecimen Collection Kit	Predicate:GEN-PROBE®APTIMA® UnisexSwab SpecimenCollection kit forEndocervical andMale Urethral SwabSpecimen	Predicate:GEN-PROBE®APTIMA® VaginalSwab SpecimenCollection kit
Description	Contains an individuallypackaged sterile largecleaning swab (forendocervical samples) anda package containing anindividually packagedsterile collection swab (forvaginal and endocervicalsampling) and a XpertCT/NG Swab TransportReagent tube. Thecollection swab is placedinto the Transport ReagentTube after swab samplingto stabilize the nucleic aciduntil sample preparation.	Contains anindividually packagedsterile Endocervicalcleaning swab and anindividually-packagedsterile specimencollection swab that isplaced into theTransport Tube afterswab sampling and isused to stabilize thenucleic acid untilsample preparation.	Contains anindividuallypackaged sterilespecimen collectionswab that is placedinto the TransportTube after swabsampling and is usedto stabilize thenucleic acid untilsample preparation.

Table 1: Comparison of Similarities and Differences of the Xpert CT/NG Assay with the Predicate Devices

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The Ancillary Specimen Collection Kits are substantially equivalent to the following predicate assays:

GEN-PROBE® APTIMA® Unisex Swab Specimen Collection Kit for o Endocervical and Urethral Swab Specimens [in 510(k) #K043144]
GEN-PROBE® APTIMA® Urine Specimen Collection Kit for Male and o Female Urine [in 510(k) #K043144]

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GEN-PROBE® APTIMA® Vaginal Swab Specimen Collection Kit for o Male and Female Urine [in 510(k) #K043144] .
Similarities and differences between the Cepheid Collection Kits and the predicate Collection devices are shown in Table 2.

Table 2: Comparison of Similarities and Differences of the Xpert CT/NG Collection
Kits with the Predicate Device Collection Kits

Item	Cepheid Xpert CT/NGUrine Specimen Collection Kit	GEN-PROBE® APTIMA® UrineSpecimen Collection kit
Description	Contains one individually packagedsterile disposable transfer pipette andone Xpert CT/NG Urine TransportReagent tube. Approximately 7 mL ofa first-catch urine specimen istransferred to the Urine TransportReagent tube to preserve and transportthe specimen prior to analysis with theCepheid Xpert CT/NG Assay.	Contains a disposable transferpipette for adding approximately 2mL of urine to a Specimen TransportTube containing 2.0 mL ofTransport Buffer.

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Non-Clinical Studies:

Analytical Sensitivity (Limit of Detection)

Studies were performed to determine the analytical limit of detection (LoD) of the Xpert CT/NG Assay with purified CT elementary bodies seeded into negative natural human pooled vaginal swab and pooled male urine matrices, and NG cells seeded into negative pooled simulated swab and pooled male urine matrices.

Pooled Vaginal Swab Matrix

Elementary bodies from two CT serovars, ATCC vr885 serovar D and ATCC vr879 serovar H. were purified by centrifugation through a 30% sucrose cushion and titered by enumeration of elementary bodies by transmission electron microscopy. Each serovar was diluted into pooled negative vaginal swab matrix and tested with the Xpert CTNG Assay. Replicates of 20 were evaluated at eight concentrations for CT serovar D and at seven concentrations for CT serovar H and LoDs were estimated by probit analysis. The claimed LoDs were confirmed by analyzing at least 20 replicate samples with elementary bodies diluted to the estimated LoD concentrations. For this study, the claimed LoD is defined as the lowest concentration at which 95% of at least 20 replicates are positive.

The claimed LoD for purified CT serovar D elementary bodies in vaginal swab matrix is 84 EB/mL. The claimed LoD for purified CT serovar H elementary bodies in vaginal swab matrix is 161 EB/mL (Table 3). In this study, LoDs for the remaining purified CT serovars (in EB/mL) are A (600), B (6), Ba (1900), C (34), E (6), F (202), G (96), I (21), J (150), K (117), LGV I (31), LGV II (20) and LGV III (210) EB/mL.

Organism	LoD
CT ATCC vr885 serovar D (EB/mL)	84
CT ATCC vr879 serovar H (EB/mL)	161

CT Serovar		LoD (GC/mL)
CT Serovar D		$1.0 x 10^3$
CT Serovar E		$1.0 x 10^3$

Two NG strains (ATCC 19424 and ATCC 49226) were tested. Replicates of 20 were evaluated at six concentrations. The LoD was estimated by probit analysis.

The LoD for NG, estimated by probit analysis, is 1.6 CFU/mL in a simulated swab matrix background (Table 4). An additional 30 NG strains were tested in a simulated matrix and the LoD was confirmed by testing replicates of three at or near the LoD.

Table 4: LoD of Two NG Strains in Pooled Vaginal Swab Matrix

Organism	LoD
NG ATCC19424 (CFU/mL)	1.5
NG ATCC49226 (CFU/mL)	1.6

Pooled Male Urine Matrix

Xpert CT/NG Assay 510(k) Summary

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Purified and titered elementary bodies from two CT serovars, ATCC vr885 serovar D and ATCC vr879 serovar H, were each tested in a sample matrix of negative pooled male urine. Replicates of 20 were evaluated at eight concentrations for CT serovar D and at seven concentrations for CT serovar H and LoDs were estimated by probit analysis. The claimed LoDs were confirmed by analyzing at least 20 replicate samples with elementary bodies diluted to the estimated LoD concentrations. For this study, the claimed LoD is defined as the lowest concentration at which 95% of at least 20 replicates are positive.

The claimed LoD for purified CT serovar D elementary bodies in male urine matrix is 75 EB/mL. The claimed LoD for purified CT serovar H elementary bodies in male urine matrix is 134 EB/mL (Table 5). In this study, LoDs for the remaining purified CT serovars (in EB/mL) are A (900), B (11), Ba (3037), C (34), E (12), F (151), G (48), I (43), J (112), K (88), LGV I (31), LGV II (40) and LGV III (157).

Table 5: LoD of Two CT Serovars in Pooled Male Urine Matrix

Organism	LoD
CT ATCC vr885 serovar D (EB/mL)	75
CT ATCC vr879 serovar H (EB/mL)	134

Two NG strains, ATCC 19424 and ATCC 49226, were tested in a sample matrix of negative pooled male urine. Replicates of 20 were evaluated at six concentrations. The LoD was estimated by probit analysis.

The LoD for NG, estimated by probit analysis, is 1.2 - 2. 7 CFU/mL in a male urine matrix background (Table 6). LoD for 30 additional NG strains was confirmed by testing replicates of three at or near the LoD.

Organism	LoD
NG ATCC19424 (CFU/mL)	2.7
NG ATCC49226 (CFU/mL)	1.2

Table 6: LoD of Two NG Strains in Pooled Male Urine Matrix

Analytical Specificity (Cross-reactivity)

One hundred and one (101) different microorganisms were tested at a concentration of at least 106 CFU/mL or 10 genome copies/mL in replicates of three (Table 7). All isolates were reported CT NOT DETECTED:NG NOT DETECTED; none of the organisms were detected by the Xpert CT/NG Assay. Positive and negative controls were included in the study. The analytical specificity was 100%.

Table 7: Analytical Specificity Determination for Xpert CT/NG Assay
---------------------------------------------------------------------	--	--	--	--	--

Acinetobacter calcoaceticus	Herpes simplex virus I'	Neisseria sicca (3)
Acinetobacter Iwoffi	Herpes simplex virus II'	Neisseria subflava (2)

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Aerococcus viridans	Human papilloma virus1	Paracoccus denitrificans
Aeromonas hydrophila	Kingella denitrificans	Peptostreptococcus anaerobius
Alcaligenes faecalis	Kingella kingae	Plesiomonas shigelloides
Arcanobacterium pyogenes	Klebsiella oxytoca	Propionibacterium acnes
Bacteriodes fragilis	Klebsiella pneumoniae	Proteus mirabilis
Bifidobacterium adolescentis	Lactobacillus acidophilus	Proteus vulgaris
Branhamella catarrhalis	Lactobacillus brevis	Providencia stuartii
Brevibacterium linens	Lactobacillus jensonii	Pseudomonas aeruginosa
Candida albicans	Lactobacillus lactis	Pseudomonas fluorescens
Candida glabrata	Legionella pneumophila	Pseudomonas putida
Candida parapsilosis	Leuconostoc paramensenteroides	Rahnella aquatilis
Candida tropicalis	Listeria monocytogenes	Saccharomyces cerevisiae
Chlamydia pneumoniae	Micrococcus luteus	Salmonella minnesota
Chromobacterium violaceum	Moraxella lacunata	Salmonella typhimurium
Citrobacter freundii	Moraxella osloensis	Serratia marcescens
Clostridium perfringens	Morganella morganii	Staphylococcus aureus
Corynebacterium genitalium	Mycobacterium smegmatis	Staphylococcus epidermidis
Corynebacterium xerosis	N. meningiditis	Staphylococcus saprophyticus
Cryptococcus neoformans	N. meningitidis Serogroup A	Streptococcus agalactiae
Cytomegalovirus1	N. meningitidis Serogroup B	Streptococcus bovis
Eikenella corrodens	N. meningitidis Serogroup C	Streptococcus mitis
Enterococcus avium	N. meningitidis Serogroup D	Streptococcus mutans
Enterococcus faecalis	N. meningitidis Serogroup W135	Streptococcus pneumoniae
Enterococcus faecium	N. meningitidis Serogroup Y	Streptococcus pyogenes
Enterobacter aerogenes	Neisseria cinerea	Streptococcus salivarius
Enterobacter cloacae	Neisseria denitrificans	Streptococcus sanguis
Erysipelothrix rhusiopathiae	Neisseria elongata (3)	Streptococcus griseinus
Escherichia coli	Neisseria flava	Vibrio parahaemolyticus
Elizabethkingia meningoseptica2	Neisseria flavescens (2)	Yersinia enterocolitica
Fusobacterium nucleatum	Neisseria lactamica (5)
Gardnerella vaginalis	Neisseria mucosa (3)
Gemella haemolysans	Neisseria perflava
Haemophilus influenzae	Neisseria polysaccharea

Xpert CT/NG Assay 510(k) Summary

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(n) number of strains tested

Tested at 1 x 105 genome copies/mL

2 Previously known as Flavobacterium meningosepticum

Interfering Substances

Performance of the Xpert CT/NG Assay was evaluated in the presence of potentially interfering substances. The evaluated substances were diluted into vaginal/endocervical swab simulated matrix and urine matrix containing either 5x LoD CT serovar D and NG strain ATCC 49226 or x LoD CT serovar H and NG strain ATCC 19424.

There was no assay interference in the presence of the substances at the concentrations for vaginal/endocervical matrix (Table 8) and urine matrix (Table 9).

Substance	Concentration
Blood	1.0% v/v
Mucin	0.8% w/v
Seminal Fluid	5.0% v/v
Hormones	7 mg/mL Progesterone + 0.07mg/mL Beta Estradiol
LGV II (CT EB)	106 EB/mL
Vagisil Anti Itch Cream	0.25% w/v
Clotrimazole Vaginal cream	0.25% w/v
Preparation H Hemorroidal cream	0.25% w/v
Miconazole 3	0.25% w/v
Monistat 1	0.25% w/v
Zovirax Cold Sore Cream	0.25% w/v
Vagisil Moisturizer	0.25% w/v
Vagi Gard Moisturizing Gel	0.25% w/v
KY Jelly Personal Lubricant	0.25% w/v

Table 8: Potentially Interfering Substances in Swab Matrix

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Substance	Concentration
Yeast Gard Douche	0.25% w/v
Delfen Vaginal Contraceptive Foam	0.25% w/v
VH Essentials Povidone-IodineMedicated Douche	0.25% v/v
Leukocytes	106 cells/mL

Table 9: Potentially Interfering Substances in Urine Matrix

Substance	Concentration
Blood	0.3% v/v
Mucin	0.2% v/v
Seminal Fluid	5.0% v/v
Hormones	7 mg/mL Progesterone + 0.07mg/mL Beta Estradiol
LGV II (CT EB)	106 EB/mL
Leukocytes	106 cells/mL
Norforms Deodorant Suppositories	0.25% w/v
BSA	10 mg/mL
Glucose	10 mg/mL
Bilirubin	0.2 mg/mL
Aspirin	40 mg/mL
Azithromycin	1.8 mg/mL
Doxycycline	3.6 mg/mL
Organisms - UTI Candida albicans/Staphylococcus aureus/Escherichia coli	2.9 x 104 CFU/mL
Acetaminophen	3.2 mg/mL
Vagisil Feminine Powder	0.25% w/v
Acidic Urine	pH 4.0
Alkaline Urine	pH 9.0

Carry-Over Contamination Study

A study was conducted to demonstrate that single-use, self-contained GeneXpert cartridges prevent carry-over contamination in negative samples run following very high

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positive samples in the same GeneXpert module. The study consisted of a negative sample processed in the same GeneXpert module immediately following a sample with high CT spike (1.9 x 104 EB/mL) and a high NG spike (5.2 x 105 CFU/mL). Two sample types were used for this testing: a) known pooled negative urine samples; and b) known pooled negative swab sample type was tested in each of four GeneXpert modules for a total of 44 runs for both swab and urine samples resulting in 20 positives and 24 negatives. All 40 positive samples were correctly reported as CT DETECTED:NG DETECTED. All 48 negative samples were correctly reported as CT NOT DETECTED;NG NOT DETECTED.

Clinical Performance Characteristics:

Reproducibility

Reproducibility of the Xpert CT/NG Assay was evaluated at three sites using specimens comprised of CT and NG organisms seeded into pooled, negative male urine (urine matrix) or in pooled, negative female vaginal swab samples (swab matrix). The specimens were prepared at concentration levels representing low positive (1X LoD), moderate positive (2-3X LoD), and high positive (>20X LoD) for each organism. Negative panel members were also included, and were comprised of pooled, negative male urine and pooled, negative vaginal swab samples. A panel of 22 specimens (11 in urine matrix and 11 in swab matrix) was tested on five different days by two different operators four times per day at three sites (22 specimens x 2 operators/day x 5 days x 4 replicates per day x 3 sites). Three lots of Xpert CT/NG reagents were included in the study, with two lots being tested at each site. Xpert CT/NG Assays were performed according to the Xpert CT/NG Assay procedure. The rate of agreement with expected results of CT and NG for each panel member is presented in Tables 10 and 11.

Xpert CT/NG Assay 510(k) Summary

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Sample		Site 1(GeneXpert Dx)	Site 2(Infinity-80)	Site 3(Infinity-48)	% TotalAgreement bySample
CT >20X LoD;	CT	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)
NG >20X LoD	NG	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)
CT >20X LoD;	CT	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)
NG 1X LoD	NG	87.5% (35/40)	97.5% (39/40)	95.0% (38/40)	93.3% (112/120)
CT >20X LoD;	CT	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)
NG neg	NG	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)
CT 1X LoD:	CT	90.0% (36/40)	97.5% (39/40)	95.0% (38/40)	94.2% (113/120)
NG >20X LoD	NG	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)
CT 1X LoD;	CT.	97.5% (39/40)	100% (40/40)	100% (40/40)	99.2% (119/120)
NG 1X LoD	NG	92.5% (37/40)	90.0% (36/40)	90.0% (36/40)	90.8% (109/120)
CT 1X LoD;	CT	97.5% (39/40)	90.0% (36/40)	90.0% (36/40)	92.5% (111/120)
NG neg	NG	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)
CT 2-3X LoD;	CT	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)
NG neg	NG	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)
CT neg;	CT	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)
NG >20X LoD	NG	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)
CT neg;	CT	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)
NG IX LoD	NG	100.0% (40/40)	97.5% (39/40)	97.5% (39/40)	98.3% (118/120)
CT neg;	СТ	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)
NG 2-3X LoD	NG	97.5% (39/40)	100% (40/40)	100% (40/40)	99.2% (119/120)
CT neg;	CT	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)
NG neg	NG	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)

Table 10: Summary of Reproducibility Results by Study Site; Percent Agreement Swab Samples

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Sample		Site 1(GeneXpert Dx)	Site 2(Infinity-80)	Site 3(Infinity-48)	% TotalAgreement bySample						Between-Site		Between-Lot		Between-Day		Between-Run¹		Within-Run		Total
CT >20X LoD;NG>20X LoD	CT	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)	Type	CT(LoD)	NG(LoD)	Agree/N	Agrmt(%)	MeanCt	SD	CV(%)	SD	CV(%)	SD	CV(%)	SD	CV(%)	SD	CV(%)	SD	CV(%)
	NG	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)	Swab	>20X	>20X	120/120	100	20.67	0.21	1.0	0.11	0.5	0.11	0.5	0.00	0.0	0.29	1.4	0.39	1.9
CT >20X LoD;NG 1X LoD	CT	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)		>20X	1X	112/120	93.3	20.73	0.29	1.4	0.37	1.8	0.00	0.0	0.00	0.0	1.59	7.7	1.66	8.0
	NG	87.5% (35/40)	97.5% (39/40)	95.0% (38/40)	93.3% (112/120)		>20X	NEG	120/120	100	20.59	0.00	0.0	0.21	1.0	0.06	0.3	0.08	0.4	0.26	1.3	0.35	1.7
CT >20X LoD;NG neg	CT	100% (40/40)	100% (40/40)	100% (40/40)	.100% (120/120)		1X	>20X	113/120	94.2	37.20	0.10	0.3	0.21	0.6	0.00	0.0	0.00	0.0	1.15	3.1	1.18	3.2
	NG	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)		1X	1X	106/120	88.3	37.04	0.17	0.5	0.00	0.0	0.00	0.0	0.12	0.3	1.08	2.9	1.10	3.0
CT 1X LoD;NG >20X LoD	CT	90.0% (36/40)	97.5% (39/40)	95.0% (38/40)	94.2% (113/120)		1X	NEG	111/120	92.5	37.04	0.06	0.2	0.00	0.0	0.00	0.0	0.00	0.0	1.12	3.0	1.12	3.0
	NG	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)		2-3X	NEG	120/120	100	35.63	0.13	0.4	0.00	0.0	0.15	0.4	0.10	0.3	0.77	2.2	0.80	2.3
CT 1X LoD;NG 1X LoD	CT	97.5% (39/40)	100% (40/40)	100% (40/40)	99.2% (119/120)		NEG	>20X	120/120	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	NG	92.5% (37/40)	90.0% (36/40)	90.0% (36/40)	90.8% (109/120)		NEG	1X	118/120	98.3	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
CT 1X LoD;NG neg	CT	97.5% (39/40)	90.0% (36/40)	90.0% (36/40)	92.5% (111/120)		NEG	2-3X	119/120	99.2	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	NG	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)		NEG	NEG	120/120	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
CT 2-3X LoD;NG neg	CT	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)	Urine	>20X	>20X	120/120	100	21.46	0.23	1.0	0.00	0.0	0.12	0.5	0.02	0.1	0.31	1.4	0.40	1.9
	NG	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)		>20X	1X	115/120	95.8	21.33	0.13	0.6	0.05	0.2	0.13	0.6	0.00	0.0	0.43	2.0	0.47	2.2
CT neg;NG>20X LoD	CT	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)		>20X	NEG	120/120	100	21.36	0.19	0.9	0.00	0.0	0.12	0.6	0.02	0.1	0.47	2.2	0.52	2.4
	NG	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)		1X	>20X	111/120	92.5	37.24	0.36	1.0	0.00	0.0	0.00	0.0	0.00	0.0	1.33	3.6	1.38	3.7
CT neg;NG 1X LoD	CT	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)		1X	1X	97/120	80.8	37.15	0.40	1.1	0.18	0.5	0.17	0.4	0.00	0.0	1.02	2.8	1.13	3.0
	NG	100.0% (40/40)	97.5% (39/40)	97.5% (39/40)	98.3% (118/120)		1X	NEG	113/120	94.2	37.39	0.10	0.3	0.32	0.9	0.00	0.0	0.00	0.0	1.38	3.7	1.42	3.8
CT neg;NG 2-3X LoD	CT	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)		2-3X	NEG	120/120	100	35.26	0.24	0.7	0.00	0.0	0.30	0.9	0.00	0.0	0.80	2.3	0.89	2.5
	NG	97.5% (39/40)	100% (40/40)	100% (40/40)	99.2% (119/120)		NEG	>20X	119/120	99.2	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
CT neg;NG neg	CT	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)		NEG	1X	118/120	98.3	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	NG	100% (40/40)	100% (40/40)	100% (40/40)	100% (120/120)		NEG	2-3X	120/120	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	NEG	NEG	119/120	99.2	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A

Table 11: Summary of Reproducibility Results by Study Site; Percent Agreement Urine Samples

The reproducibility of the Xpert CT/NG Assay was also evaluated in terms of the fluorescence signal expressed in Ct values for each target detected. The mean, standard deviation (SD), and coefficient of variation (CV) between-sites, between-lots, between-days, and between-runs for each panel member are presented in Tables 12 through 14.

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Table 12: Summary of Reproducibility data for Swab and Urine Specimens – CT1 Target

ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ Note: Vanability from some factors may be numerically negative, which can occur it the variability
measured with SD and CV is set to 0.
'A run is defined as the four samples

Xpert CT/NG Assay 510(k) Summary

. :

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Table 13: Summary of Reproducibility data for Swab and Urine Specimens – NG2 Targe

Type	Target Conc.		Agree/N	Agrmt(%)	MeanCt	Between-Site		Between-Lot		Between-Run1		Within-Run		Total
	CT(LoD)	NG(LoD)				SD	CV(%)	SD	CV(%)	SD	CV(%)	SD	CV(%)	SD	CV(%)
Swab	>20X	>20X	120/120	100	19.65	0.03	0.1	0.09	0.4	0.07	0.3	0.24	1.2	0.26	1.3
	>20X	1X	112/120	93.3	35.38	0.22	0.6	0.00	0.0	0.00	0.0	1.98	5.6	1.99	5.6
	>20X	NEG	120/120	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	1X	>20X	113/120	94.2	19.69	0.12	0.6	0.00	0.0	0.19	1.0	0.43	2.2	0.49	2.5
	1X	1X	106/120	88.3	35.61	0.00	0.0	0.53	1.5	0.00	0.0	1.37	3.9	1.67	4.7
	1X	NEG	111/120	92.5	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Swab	2-3X	NEG	120/120	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	NEG	>20X	120/120	100	19.60	0.10	0.5	0.07	0.4	0.00	0.0	0.20	1.0	0.25	1.3
	NEG	1X	118/120	98.3	35.43	0.39	1.1	0.00	0.0	0.04	0.1	0.94	2.6	1.04	2.9
	NEG	2-3X	119/120	99.2	33.97	0.00	0.0	0.15	0.4	0.00	0.0	0.71	2.1	0.74	2.2
	NEG	NEG	120/120	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	>20X	>20X	120/120	100	20.34	0.06	0.3	0.09	0.4	0.00	0.0	0.23	1.1	0.26	1.3
Urine	>20X'	1X	115/120	95.8	35.41	0.00	0.0	0.00	0.0	0.19	0.5	1.15	3.3	1.20	3.4
	>20X	NEG	120/120	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	1X	>20X	111/120	92.5	20.40	0.06	0.3	0.07	0.3	0.00	0.0	0.39	1.9	0.40	2.0
	1X	1X	97/120	80.8	35.57	0.20	0.6	0.00	0.0	0.13	0.4	1.28	3.6	1.31	3.7
	1X	NEG	113/120	94.2	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	2-3X	NEG	120/120	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Urine	NEG	>20X	119/120	99.2	20.39	0.00	0.0	0.07	0.4	0.14	0.7	0.26	1.3	0.31	1.5
	NEG	1X	118/120	98.3	35.35	0.00	0.0	0.11	0.3	0.00	0.0	0.92	2.6	0.99	2.8
	NEG	2-3X	120/120	100	33.80	0.00	0.0	0.18	0.5	0.00	0.0	0.54	1.6	0.57	1.7
	NEG	NEG	119/120	99.2	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
1Agrmt=Agreement, Conc=concentration, CV=coefficient of variation, N/A=Not Applicable for negative samples, SD=standard deviation

region of the come the country of council of the can occur it in ear occur if the variability due to those factors is very small. When this occurs, the variability as
measur

A run is defined as the four samples per panel member run by one operator at one site on one day

(pert CT/NG Assay 510(k) Summar

Page 17

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Table 14: Summary of Reproducibility data for Swab and Urine Specimens – NG4 Targe

		Target Conc.					Between-Site		Between-Lot		Between-Day		Between-Run¹		Within-Run		Total
Type	CT(LoD)	NG(LoD)	Agree/N	Agrmt(%)	MeanCt	SD	CV(%)	SD	CV(%)	SD	CV(%)	SD	CV(%)	SD	CV(%)	SD	CV(%)
Swab	>20X	>20X	120/120	100	19.34	0.00	0.0	0.12	0.6	0.11	0.6	0.00	0.0	0.39	2.0	0.42	2.2
	>20X	1X	112/120	93.3	35.00	0.41	1.2	0.00	0.0	0.00	0.0	0.32	0.9	1.89	5.4	1.96	5.6
	>20X	NEG	120/120	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	1X	>20X	113/120	94.2	19.41	0.07	0.4	0.00	0.0	0.14	0.7	0.03	0.2	0.49	2.5	0.52	2.7
	1X	1X	106/120	88.3	35.47	0.32	0.9	0.00	0.0	0.00	0.0	0.70	2.0	0.90	2.5	1.19	3.3
	1X	NEG	111/120	92.5	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	2-3X	NEG	120/120	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	NEG	>20X	120/120	100	19.35	0.02	0.1	0.04	0.2	0.00	0.0	0.07	0.4	0.28	1.5	0.29	1.5
	NEG	1X	118/120	98.3	35.05	0.00	0.0	0.16	0.5	0.00	0.0	0.00	0.0	1.00	2.9	1.01	2.9
	NEG	2-3X	119/120	99.2	33.57	0.14	0.4	0.17	0.5	0.00	0.0	0.00	0.0	0.78	2.3	0.81	2.4
	NEG	NEG	120/120	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	>20X	>20X	120/120	100	20.06	0.12	0.6	0.12	0.6	0.09	0.4	0.00	0.0	0.39	1.9	0.43	2.1
	>20X	1X	115/120	95.8	35.27	0.17	0.5	0.13	0.4	0.00	0.0	0.00	0.0	1.04	2.9	1.06	3.0
	>20X	NEG	120/120	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Urine	1X	>20X	111/120	92.5	20.16	0.00	0.0	0.08	0.4	0.00	0.0	0.12	0.6	0.56	2.8	0.58	2.9
	1X	1X	97/120	80.8	35.25	0.00	0.0	0.00	0.0	0.41	1.2	0.00	0.0	1.17	3.3	1.24	3.5
	1X	NEG	113/120	94.2	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	2-3X	NEG	120/120	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	NEG	>20X	119/120	99.2	20.12	0.09	0.5	0.10	0.5	0.06	0.3	0.00	0.0	0.41	2.0	0.43	2.2
	NEG	1X	118/120	98.3	35.05	0.24	0.7	0.00	0.0	0.15	0.4	0.12	0.4	1.09	3.1	1.13	3.2
	NEG	2-3X	120/120	100	33.67	0.00	0.0	0.33	1.0	0.00	0.0	0.16	0.5	0.83	2.5	0.91	2.7
	NEG	NEG	119/120	99.2	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Agrmt=Agreement, Conc=concentration, CV=coefficient of variation. N/A=Not Applicable for negative samples, SD=standard deviation

right Vigating Conce laction, or viction of the versear internationing de comes for samel in this occurs sers mail. When this occurs, the variability as and the variability o

Kpert CT/NG Assay 510(k) Summary

Page 18

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Instrument System Precision

An in-house precision study was conducted to compare the performance of the GeneXpert Dx and the Infinity-80 Instrument Systems using specimens comprised of CT and NG organisms seeded into negative urine (urine matrix) or diluent for the Xpert CT/NG Assay (swab matrix). The specimens were prepared at concentration levels representing low positive (0.25-0.5X LoD), moderate positive (2-3X LoD), and high positive (>20X LoD) for each organism. Negative panel members were also included and were comprised of negative urine and negative diluent. A panel of 20 specimens (10 in urine matrix and 10 in swab matrix) was tested on 12 different days by two operators. Each operator conducted four runs of each panel specimen per day on each of the two instrument systems (20 specimens x 4 times/ day x 12 days x 2 operators x 2 instrument systems). One lot of Xpert CT/NG Assay was used for the study. Xpert CT/NG assays were performed according to the Xpert CT/NG Assay procedure. The rate of agreement with expected results of CT and NG for each panel member is presented by instrument in Tables 15 and 16.

Sample		GeneXpert Dx	Infinity-80	% Total Agreementby Sample
CT>20X LoD; NG>20X LoD	CT	100% (96/96)	100% (95/95)a	100% (191/191)
	NG	100% (96/96)	100% (95/95)a	100% (191/191)
CT >20X LoD; NG0.25-0.5X LoD	CT	100% (96/96)	100% (96/96)	100% (192/192)
	NG	62.5% (60/96)	52.1% (50/96)	57.3% (110/192)
CT >20X LoD; NGneg	CT	100% (96/96)	100% (95/95)b	100% (191/191)
	NG	100% (96/96)	100% (95/95)b	100% (191/191)
CT 0.25-0.5X LoD;NG>20X LoD	CT	46.9% (45/96)	42.7% (41/96)	44.8% (86/192)
	NG	100% (96/96)	100% (96/96)	100% (192/192)
CT 0.25-0.5X LoD;NG 0.25-0.5X LoD	CT	55.2% (53/96)	60.4% (58/96)	57.8% (111/192)
	NG	50.0% (48/96)	66.7% (64/96)	58.3% (112/192)
CT 0.25-0.5X LoD;NG neg	CT	61.5% (59/96)	62.1% (59/95)c	61.8% (118/191)
	NG	100% (96/96)	100% (95/95)c	100% (191/191)
CT 2-3X LoD; NG2-3X LoD	CT	100% (96/96)	100% (96/96)	100% (192/192)
	NG	100% (96/96)	100% (96/96)	100% (192/192)
CT neg;NG>20X LoD	CT	100% (96/96)	100% (96/96)	100% (192/192)
	NG	100% (96/96)	100% (96/96)	100% (192/192)
CT neg;NG 0.25-0.5X LoD	CT	100% (95/95)b	100% (96/96)	100% (191/191)
	NG	58.9% (56/95)b	62.5% (60/96)	60.7% (116/191)
CT neg;NG neg	CT	100% (96/96)	100% (96/96)	100% (192/192)
	NG	100% (96/96)	100% (96/96)	100% (192/192)

Table 15: Summary of Instrument System Precision Results;
Percent Agreement Swab Matrix

4 One sample was indeterminate after initial and retest.

*One sample each of CT >20X LoD; NG neg sample and CT neg; NG 0.25-0.5.Y LoD resulted in ERROR on initial test and were not retested.

One sample mistakenly not tested.

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Sample		GeneXpert Dx	Infinity-80	% Total Agreementby Sample
CT >20X LoD; NG	CT	100% (96/96)	100% (96/96)	100% (192/192)
>20X LoD	NG	100% (96/96)	100% (96/96)	100% (192/192)
CT >20X LoD; NG	CT	100% (96/96)	100% (96/96)	100% (192/192)
0.25-0.5X LoD	NG	46.9% (45/96)	49.0% (47/96)	47.9% (92/192)
CT >20X LoD; NG	CT	100% (96/96)	100% (96/96)	100% (192/192)
neg	NG	100% (96/96)	100% (96/96)	100% (192/192)
CT 0.25-0.5X LoD;	CT	50.0% (48/96)	52.1% (50/96)	51.0% (98/192)
NG >20X LoD	NG	100% (96/96)	100% (96/96)	100% (192/192)
CT 0.25-0.5X LoD;	CT	44.8% (43/96)	39.6% (38/96)	42.2% (81/192)
NG 0.25-0.5X LoD	NG	62.5% (60/96)	58.3% (56/96)	60.4% (116/192)
CT 0.25-0.5X LoD;	CT	46.9% (45/96)	46.9% (45/96)	46.9% (90/192)
NG neg	NG	100% (96/96)	100% (96/96)	100% (192/192)
CT 2-3X LoD; NG	CT	100% (96/96)	100% (96/96)	100% (192/192)
2-3X LoD	NG	100% (96/96)	100% (96/96)	100% (192/192)
CT neg;	CT	100% (96/96)	100% (96/96)	100% (192/192)
NG >20X LoD	NG	100% (96/96)	100% (96/96)	100% (192/192)
CT neg;	CT	100% (96/96)	100% (96/96)	100% (192/192)
NG 0.25-0.5X LoD	NG	36.5% (35/96)	33.3% (32/96)	34.9% (67/192)
CT neg;	CT	100% (96/96)	100% (96/96)	100% (192/192)
NG neg	NG	100% (96/96)	100% (96/96)	100% (192/192)

Table 16: Summary of Instrument System Precision Results; Percent Agreement Urine Matrix

The reproducibility of the Xpert CT/NG Assay was also evaluated in terms of the fluorescence signal expressed in Ct values for each target detected. The mean, standard deviation (SD), and coefficient of variation (CV) between-instruments, between-days, and between-runs for each panel member are presented in Tables 17 through 19.

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Table 17: Summary of Reproducibility data for Swab and Urine Specimens – CT1 Targer

Type	CT	NG	Agree/N	Agrmt (%)	Mean Ct	SD	Between-Instrument CV (%)	SD	Between-Day CV (%)	SD	Between-Run' CV (%)	SD	Within-Run CV (%)	SD	Total CV (%)
Swab	>20X	>20X	191/191	100	23.52	0.05	0.2	0.02	0.1	0.00	0.0	0.25	1.1	0.26	1.1
	>20X	0.25-0.5X	110/192	57.3	23.52	0.00	0.0	0.00	0.0	0.08	0.3	0.18	0.7	0.19	0.8
	>20X	NEG	191/191	100	23.55	0.03	0.1	0.00	0.0	0.00	0.0	0.22	0.9	0.22	0.9
	0.25-0.5X	>20X	86/192	44.8	38.77	0.00	0.0	0.00	0.0	0.32	0.8	1.38	3.6	1.42	3.7
	0.25-0.5X	0.25-0.5X	59/192	30.7	38.46	0.00	0.0	0.30	0.8	0.00	0.0	1.35	3.5	1.39	3.6
	0.25-0.5X	NEG	118/191	61.8	38.05	0.08	0.2	0.00	0.0	0.00	0.0	1.26	3.3	1.26	3.3
	2-3X	2-3X	192/192	100	31.49	0.04	0.1	0.00	0.0	0.06	0.2	0.24	0.8	0.25	0.8
	NEG	>20X	192/192	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	NEG	0.25-0.5X	116/191	60.7	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	NEG	NEG	192/192	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Urine	>20X	>20X	192/192	100	24.35	0.05	0.2	0.20	0.8	0.10	0.4	0.30	1.2	0.38	1.6
	>20X	0.25-0.5X	92/192	47.9	24.25	0.00	0.0	0.06	0.3	0.00	0.0	0.62	2.6	0.62	2.6
	>20X	NEG	192/192	100	24.12	0.00	0.0	0.15	0.6	0.19	0.8	0.34	1.4	0.41	1.7
	0.25-0.5X	>20X	98/192	51.0	38.33	0.12	0.3	0.00	0.0	0.84	2.2	1.03	2.7	1.33	3.5
	0.25-0.5X	0.25-0.5X	48/192	25.0	38.26	0.00	0.0	0.00	0.0	0.56	1.5	1.05	2.7	1.19	3.1
	0.25-0.5X	NEG	90/192	46.9	38.39	0.00	0.0	0.00	0.0	0.00	0.0	1.09	2.8	1.09	2.8
	2-3X	2-3X	192/192	100	31.85	0.00	0.0	0.11	0.4	0.18	0.6	0.32	1.0	0.39	1.2
	NEG	>20X	192/192	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	NEG	0.25-0.5X	67/192	34.9	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	NEG	NEG	192/192	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A

n "s ﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ੰਡਿਕ ﺔ ofe. Variability from some ractors is

・

Xperi CT/NG Assay 510(k) Summary

Pagc 2 I

. .

{21}------------------------------------------------

Table 18: Summary of Reproducibility data forSwab and Urine Specimens – NG2 Target
Between-
Between-
Between-

Type	CT	NG	Agree/N	Agrmt (%)	Mean Ct	Between-Instrument SD	Between-Instrument CV (%)	Between-Day SD	Between-Day CV (%)	Between-Run' SD	Between-Run' CV (%)	Within-Run SD	Within-Run CV (%)	Total SD	Total CV (%)
Swab	>20X	>20X	191/191	100	19.03	0.01	0.0	0.02	0.1	0.00	0.0	0.21	1.1	0.21	1.1
	>20X	0.25-0.5X	110/192	57.3	37.63	0.07	0.2	0.46	1.2	0.00	0.0	1.55	4.1	1.62	4.3
	>20X	NEG	191/191	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	0.25-0.5X	>20X	86/192	44.8	19.08	0.00	0.0	0.00	0.0	0.10	0.5	0.31	1.6	0.32	1.7
	0.25-0.5X	0.25-0.5X	59/192	30.7	36.78	0.00	0.0	0.24	0.6	0.00	0.0	1.47	4.0	1.49	4.0
	0.25-0.5X	NEG	118/191	61.8	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	2-3X	2-3X	192/192	100	31.35	0.00	0.0	0.00	0.0	0.00	0.0	0.33	1.1	0.33	1.1
	NEG	>20X	192/192	100	19.02	0.00	0.0	0.00	0.0	0.07	0.4	0.22	1.2	0.23	1.2
Urine	NEG	0.25-0.5X	116/191	60.7	36.77	0.00	0.0	0.46	1.2	0.00	0.0	1.65	4.5	1.71	4.7
	NEG	NEG	192/192	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	>20X	>20X	192/192	100	19.85	0.00	0.0	0.15	0.7	0.00	0.0	0.34	1.7	0.37	1.8
	>20X	0.25-0.5X	92/192	47.9	36.72	0.15	0.4	0.00	0	0.00	0.0	1.36	3.7	1.37	3.7
	>20X	NEG	192/192	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	0.25-0.5X	>20X	98/192	51.0	19.51	0.00	0.0	0.00	0.0	0.00	0.0	1.20	6.1	1.20	6.1
	0.25-0.5X	0.25-0.5X	48/192	25.0	36.38	0.26	0.7	0.00	0.0	1.98	5.5	1.13	3.1	2.30	6.3
	0.25-0.5X	NEG	90/192	46.9	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	2-3X	2-3X	192/192	100	31.53	0.00	0.0	0.09	0.3	0.16	0.5	0.42	1.3	0.46	1.4
	NEG	>20X	192/192	100	19.26	0.14	0.7	0.00	0.0	0.17	0.9	0.43	2.3	0.49	2.4
	NEG	0.25-0.5X	67/192	34.9	36.88	0.00	0.0	0.31	0.8	0.00	0	1.45	3.9	1.48	7.5
	NEG	NEG	192/192	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A

Note: Variability from some factors may be numcically negative, which can occur if the variability due to those factors is very small. When this ocurs, the
variability as me

Xpert CT/NG Assay 510(k) Summary

Page 22

{22}------------------------------------------------

Table 19: Summary of Reproducibility data for Swab and Urine Specimens – NG4 Targe

Type	Target Conc.		Between-Instrument	Between-Day	Between-Run'	Within-Run	Total
	CT	NG	Agree/N	Agrmt (%)	Mean Ct	SD	CV (%)	SD	CV (%)	SD	CV (%)	SD	CV (%)	SD	CV (%)
Swab	>20X	>20X	191/191	100	18.67	0.00	0.0	0.00	0.0	0.19	1.0	0.34	1.8	0.39	2.1
	>20X	0.25-0.5X	110/192	57.3	36.94	0.49	1.3	0.00	0.0	0.10	0.3	1.63	4.4	1.71	4.6
	>20X	NEG	191/191	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	0.25-0.5X	>20X	86/192	44.8	18.72	0.06	0.3	0.00	0.0	0.21	1.1	0.41	2.2	0.46	2.5
	0.25-0.5X	0.25-0.5X	59/192	30.7	36.57	0.00	0.0	0.50	1.4	0.00	0.0	1.55	4.3	1.63	4.5
	0.25-0.5X	NEG	118/191	61.8	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	2-3X	2-3X	192/192	100	31.06	0.00	0.0	0.05	0.2	0.00	0.0	0.42	1.4	0.43	1.4
	NEG	>20X	192/192	100	18.69	0.00	0.0	0.00	0.0	0.22	1.2	0.38	2.0	0.44	2.3
Urine	NEG	0.25-0.5X	116/191	60.7	36.31	0.08	0.2	0.13	0.4	0.00	0.0	1.24	3.4	1.25	3.4
	NEG	NEG	192/192	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	>20X	>20X	192/192	100	19.44	0.01	0.1	0.10	0.5	0	0	0.45	2.3	0.46	2.4
	>20X	0.25-0.5X	92/192	47.9	36.31	0	0	0.04	0.1	0.17	0.5	1.18	3.2	1.19	6.1
	>20X	NEG	192/192	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	0.25-0.5X	>20X	98/192	51.0	19.08	0	0	0	0	0	0	1.35	7.1	1.35	6.9
	0.25-0.5X	0.25-0.5X	48/192	25.0	36.16	0	0	0	0	0.24	0.7	0	0	1.98	5.5	2.00
	0.25-0.5X	NEG	90/192	46.9	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	2-3X	2-3X	192/192	100	31.09	0	0	0.16	0.5	0.11	0.4	0.49	1.6	0.53	2.7
	NEG	>20X	192/192	100	18.80	0.04	0.2	0	0	0.14	0.7	0.47	2.5	0.50	2.6
	NEG	0.25-0.5X	67/192	34.9	36.58	0.18	0.5	0	0	0.74	2.0	1.40	3.8	1.60	8.2
	NEG	NEG	192/192	100	0	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A

Agrime agentent. Concection, C. (2) schient of variable for regarive sampes sommers and artition and other one of the variability as
Note: Variability form one lactors not

(pert CT/NG Assay 510(k) Summary

{23}------------------------------------------------

Clinical Performance Study

Performance characteristics of the Xpert CT/NG Assay were determined in a multi-site prospective investigational study at 36 US and UK institutions by comparing the Xpert CT/NG Assay to a patient infected status (PIS) algorithm based on combined results from two currently marketed NAAT tests.

Study participants included consenting asymptomatic and symptomatic, sexually active males and females seen at locations including, but not limited to: OB/GYN, sexually transmitted disease (STD), teen, public health, and family planning clinics. The average age among female study participants was 30.3 years (range = 14 to 83 years); the average age among male study participants was 37.7 years (range = 17 to 74 years).

The study specimens consisted of prospectively collected male urine, female urine, endocervical swabs, urethral swabs and patient-collected vaginal swabs (collected in a clinical setting).

A female study participant was categorized as infected (I) by PIS for CT or NG if at least one positive result was reported from each reference NAAT test. If both NAAT tests resulted in equivocal results for both sample types (swab and urine) the PIS status was defined as equivocal (EQ). This is the only scenario for an overall PIS of EQ; no study participants fell into this category for this study. Female study participants with positive results on both reference urine specimens and negative results on both reference swab specimens were categorized as infected (1) for urine and not infected (NI) for the swab specimen. Any other combination of results was categorized as not infected (NI).

A male study participant was categorized as infected (1) by PIS for CT or NG if at least one positive result was reported from each reference NAAT test. If both NAAT tests resulted in equivocal results for both sample types (swab and urine) the PIS status was defined as equivocal (EQ). This is the only scenario for an overall PIS of EQ; no study participants fell into this category for this study. Any other combination of results was categorized as not infected (NI).

Performance of the Xpert CT/NG Assay was calculated relative to the PIS for each of the three female sample types (endocervical swabs, self-collected vaginal swabs and urine), and male urine.

During the clinical evaluation of the Xpert CT/NG Assay, a total of 212 female subjects were infected with CT. Symptoms were reported in 41.0% (87/212) of infected and 34.1% (1221/3579) non-infected female subjects. A total of 54 female subjects were infected with NG. Symptoms were reported in 53.7% (29/54) of infected and 34.1% (1273/3729) non-infected female subjects. A total of 196 male subjects were infected with CT. Symptoms were reported in 62.8% (123/196) of infected and 18.0% (584/3248) non-infected male subjects. A total of 119 male subjects were infected with NG. Symptoms were reported in 89.1% (106/119) of infected and 18.1% (601/3325) noninfected male subjects.

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

Among the 14,790 tests performed, 416 had to be retested due to ERROR, INVALID or NO RESULT outcomes (2.81%, 95% CI 2.56-3.09). Of those, 355 specimens yielded valid results upon repeat assay (18 specimens were not retested). The overall valid reporting rate of the assay was 99.6% (14,729/14,790).

Chlamydia trachomatis Performance Results

Results from the Xpert CT/NG Assay were compared to the patient infected status (PIS) algorithm for determination of sensitivity, specificity, and predictive values. Sensitivity and specificity for CT by gender, specimen type, and symptom status are presented in Table 20.

Specimen		SxStatus	n	TP	FP	TN	FN	Prev%	Sensitivity %(95 CI)	Specificity %(95 CI)	PPV %(95 CI)	NPV %(95 CI)
	PC-VS	Sym	1294	79	20	1195	0	6.1	100(95.4-100)	98.4(97.5-99.0)	79.8(70.5-87.2)	100(99.7-100)
		Asym	2472	121	11	2339	1	4.9	99.2(95.5-100)	99.5(99.2-99.8)	91.7(85.6-95.8)	>99.9(99.8-100)
		All	3766	200	31	3534	1	5.3	99.5(97.3-100)	99.1(98.8-99.4)	86.6(81.5-90.7)	>99.9(99.8-100)
Female	ES	Sym	1293	76	5	1209	3	6.1	96.2(89.3-99.2)	99.6(99.0-99.9)	93.8(86.2-98.0)	99.8(99.3-99.9)
		Asym	2464	117	11	2331	5	5.0	95.9(90.7-98.7)	99.5(99.2-99.8)	91.4(85.1-95.6)	99.8(99.5-99.9)
		All	3757	193	16	3540	8	5.4	96.0(92.3-98.3)	99.6(99.3-99.7)	92.3(87.9-95.6)	99.8(99.6-99.9)
	Urine	Sym	1292	84	4	1203	1	6.6	98.8(93.6-100)	99.7(99.2-99.9)	95.5(88.8-98.7)	99.9(99.5-100)
		Asym	2475	123	2	2347	3	5.1	97.6(93.2-99.5)	99.9(99.7-100)	98.4(94.3-99.8)	99.9(99.6-100)
		All	3767	207	6	3550	4	5.6	98.1(95.2-99.5)	99.8(99.6-99.9)	97.2(94.0-99.0)	99.9(99.7-100)
Male	Urine	Sym	706	120	2	581	3	17.4	97.6(93.0-99.5)	99.7(98.8-100)	98.4(94.2-99.8)	99.5(98.5-99.9)
		Asym	2730	73	5	2652	0	2.7	100.0(95.1-100)	99.8(99.6-99.9)	93.6(85.7-97.9)	100(99.9-100)
		All	3436	193	7	3233	3	5.7	98.5(95.6-99.7)	99.8(99.6-99.9)	96.5(92.9-98.6)	99.9(99.7-100)

Table 20: Xpert CT/NG Assay vs. Patient Infected Status for CT Detection

TP=true positive. FP=false positive, TN=true negative, ES=endocervical swah, PC-VS=patient-collected vaginal swab

{25}------------------------------------------------

Neisseria gonorrhoeae Performance Results

Results from the Xpert CT/NG Assay were compared to the patient infected status (PIS) algorithm for determination of sensitivity, specificity, and predictive values. Sensitivity and specificity for NG by gender, specimen type, and symptom status are presented in Table 21.

Specimen	Sx Status	n	TP	FP	TN	FN	Prev %	Sensitivity % (95 CI)	Specificity % (95 CI)	PPV % (95 CI)	NPV % (95 CI)
PC-VS	Sym	1294	27	2	1265	0	2.1	100 (87.2-100)	99.8 (99.4-100)	93.1 (77.2-99.2)	100 (99.7-100)
	Asym	2472	25	1	2446	0	1.0	100 (86.3-100)	>99.9 (99.8-100)	96.2 (80.4-99.9)	100 (99.8-100)
	All	3766	52	3	3711	0	1.4	100 (93.2-100)	99.9 (99.8-100)	94.5 (84.9-98.9)	100 (99.9-100)
Female	ES	Sym	1293	27	1	1265	0	2.1	100 (87.2-100)	99.9 (99.6-100)	96.4 (81.7-99.9)	100 (99.7-100)	Asym	2464	25	0	2439	0	1.0	100 (86.3-100)	100 (99.8-100)	100 (86.3-100)	100 (99.8-100)	All	3757	52	1	3704	0	1.4	100 (93.2-100)	>99.9 (99.8-100)	98.1 (89.9-100)	100 (99.9-100)	Urine	Sym	1292	28	0	1263	1	2.2	96.6 (82.2-99.9)	100 (99.7-100)	100 (87.7-100)	99.9 (99.6-100)
		Female	ES	Sym	1293	27	1	1265	0	2.1	100 (87.2-100)	99.9 (99.6-100)	96.4 (81.7-99.9)	100 (99.7-100)	Asym	2464	25	0	2439	0	1.0	100 (86.3-100)	100 (99.8-100)	100 (86.3-100)	100 (99.8-100)
				Female	ES	Sym	1293	27	1	1265	0	2.1	100 (87.2-100)	99.9 (99.6-100)	96.4 (81.7-99.9)	100 (99.7-100)
Asym	2464					25	0	2439	0	1.0	100 (86.3-100)	100 (99.8-100)	100 (86.3-100)	100 (99.8-100)
All	3757	52	1			3704	0	1.4	100 (93.2-100)	>99.9 (99.8-100)	98.1 (89.9-100)	100 (99.9-100)
Urine	Sym	1292	28	0	1263	1	2.2	96.6 (82.2-99.9)	100 (99.7-100)	100 (87.7-100)	99.9 (99.6-100)
	Asym	2475	23	1	2449	2	1.0	92.0 (74.0-99.0)	>99.9 (99.8-100)	95.8 (78.9-99.9)	99.9 (99.7-100)
	All	3767	51	1	3712	3	1.4	94.4 (84.6-98.8)	>99.9 (99.9-100)	98.1 (89.7-100)	99.9 (99.8-100)
Male	Urine	Sym	706	105	0	600	1	15.0	99.1 (94.9-100)	100 (99.4-100)	100 (96.5-100)	99.8 (99.1-100)
		Asym	2730	12	3	2714	1	0.5	92.3 (64.0-99.8)	99.9 (99.7-100)	80.0 (51.9-95.7)	>99.9 (99.8-100)
		All	3436	117	3	3314	2	3.5	98.3 (94.1-99.8)	99.9 (99.7-100)	97.5 (92.9-99.5)	99.9 (99.8-100)

Table 21: Xpert CT/NG Assay vs. Patient Infected Status for NG Detection

TP=true positive, FP=false positive, TN=talse negalive, ES=endocervical swab, PC VS=patient-collected vaginal swab

Table 22 shows the number of results from symptomatic and asymptomatic females designated as infected or not infected with CT based on the PIS algorithm.

{26}------------------------------------------------

	NAAT1		NAAT2		Xpert			Symptom Status		Total
PISa	SWa	URa	SW	UR	PC-VSa	ESa	UR	Symp	Asymp
NIb	-	-	-	-	-	-	-	1160	2269	3429
NI	-	-	-	-	IND	-	-	6	8	14
NI	-	-	-	-	-	INDc	-	6	16	22
NI	-	-	-	-	-	-	IND	5	6	11
NI	-	-	-	-	+	+	-	0	1	1
NI	-	-	-	-	+	-	-	6	4	10
NI	-	-	-	-	-	+	-	3	5	8
NI	-	-	-	-	-	-	+	1	0	1
NI	-	-	-	EQd	-	-	-	6	20	26
NI	-	-	-	EQ	IND	IND	-	1	0	1
NI	-	-	EQ	EQ	-	-	-	3	4	7
NI	-	-	EQ	EQ	-	-	IND	1	0	1
NI	-	-	-	+	-	-	-	0	7	7
NI	-	-	+	-	-	-	-	3	0	3
NI	-	-	+	-	-	+	-	0	1	1
NIf	-	+	-	+	+	+	+	7	1	8
NIf	-	+	-	+	+	+	-	0	1	1
NIf	-	+	+	+	-	-	+	0	1	1
NI	-	+	-	-	-	-	-	1	0	1
NI	-	+	-	-	+	-	+	1	0	1
NI	+	-	-	-	-	-	-	4	8	12
NI	+	-	-	-	+	-	-	2	1	3
NI	+	-	-	-	+	+	-	1	2	3
NI	+	+	-	-	-	+	-	0	1	1
NI	+	+	-	-	-	-	-	1	0	1
NI	+	+	-	-	-	-	+	0	1	1
NI	+	+	-	-	+	+	+	1	1	2
NI	+	+	-	-	+	-	+	1	0	1
NI	+	+	-	-	+	-	-	1	0	1
Total Non-Infected								1221	2358	3579
Ie	+	+	+	+	+	+	+	65	104	169
I	+	+	+	+	IND	+	+	0	1	1
I	+	+	+	+	+	IND	+	0	1	1
I	+	+	+	+	+	+	IND	1	0	1
I	+	+	+	+	+	+	+	0	1	1
I	+	+	+	+	+	-	+	0	1	1
If	-	+	-	+	+	-	+	7	1	8
If	-	+	-	+	+	-	-	0	1	1
I	-	+	-	+	+	-	+	0	1	1
I	-	+	+	-	-	+	+	0	2	2
I	+	-	+	+	+	+	+	1	0	1
I	+	-	+	+	+	-	+	0	1	1
I	+	-	+	+	+	+	+	1	0	1
I	+	+	-	+	+	+	+	3	2	5

Table 22: Patient Infected Status – Female CT

・

, "

{27}------------------------------------------------

PISa	SWa	URa	SW	UR	PC-VSa	ESa	UR	Symp	Asymp	Total
I	+	+	+	-	+	+	+	3	4	7
I	+	+	+	-	+	+	-	1	1	2
I	+	+	+	-	+	-	+	0	1	1
I	+	-	+	-	+	+	+	1	0	1
I	+	-	EQ	+	+	+	+	0	1	1
Total Infected								87	125	212

| Total Infected

"PIS = Patient Infected Status; SW = Swab; UR = urine: PC-VS = Patient-collected Vaginal Swab; ES = Indocervical Swab °Ni = Non-infected

fIND = Indeceminate = ERROR, INVALID or NO RESULT by Xpert CT/NG Assay: specimens with IND results by Xpert are not included in the 2x2 tables for that specimen type.

"EQ = Equivocal result for this individual specimen type only; PIS status determined based on remaining specimens. °] = Infected

These samples are infected for urine and non-infected for swabs. In this table they appear twice.

Table 23 shows the number of results from symptomatic and asymptomatic females designated as infected or not infected with NG based on the PIS algorithm.

	NAAT1		NAAT2		Xpert			Symptom Status
PISa	SWa	URa	SW	UR	PC-VSa	ESa	UR	Symp	Asymp	Total
NIb	-	-	-	-	-	-	-	1229	2390	3619
NI	-	-	-	-	INDc	-	-	6	9	15
NI	-	-	-	-	-	IND	-	6	17	23
NI	-	-	-	-	-	-	IND	6	6	12
NI	-	-	-	-	+	-	+	0	1	1
NI	-	-	-	-	+	-	-	1	0	1
NI	-	-	EQd	-	-	-	-	2	5	7
NI	-	-	-	EQ	-	-	-	9	20	29
NI	-	-	-	+	-	-	-	1	3	4
NI	-	-	+	-	-	-	-	7	4	11
NIf	-	+	-	+	+	+	+	1	0	1
NIf	-	+	-	+	+	-	+	1	0	1
NI	-	+	+	-	-	-	-	1	0	1
NI	+	-	-	-	-	-	-	1	1	2
NI	-	-	EQ	-	-	-	IND	1	0	1
NI	-	-	-	EQ	-	IND	IND	1	0	1
Total Non-Infected
Ie	+	+	+	+	+	+	+	19	19	38
I	+	+	+	+	+	+	+	2	2	4
I	+	+	+	+	+	+	+	1	1	2
If	-	+	-	+	+	+	+	1	0	1
If	-	+	-	+	+	-	+	1	0	1
I	+	+	+	-	+	+	+	1	2	3
I	+	+	+	+	+	+	+	1	0	1
I	+	+	-	+	+	+	+	1	0	1
I	+	+	+	EQ	+	+	+	0	1	1
I	+	+	EQ	+	+	+	+	0	1	1

Table 23: Patient Infected Status - Female NG

{28}------------------------------------------------

PISa	NAAT1		NAAT2		Xpert		Symptom Status		Total
	SWa	URa	SW	UR	PC-VSa	ESa	UR	Symp	Asymp
1	+	EQ	+	-	+	+	+	1	0	1
Total Infected								29	25	54

4PIS = Patient Infected Status; SW = Swab; UR = urine; PC-VS = Patient-collected Vaginal Swab; ES = Endocervical Swab °NI = Non-infected

^IND = Indeterminate = ERROR, INVALID or NO RESULT by Xpert CT/NG Assay: specimens with INID results by Xpert are not included in the 2x2 tables for that specimen type.

4EQ = Equivocal result for this individual specimen type only: PIS status determined based on remaining specimens. ೪ = Infected

These samples are infected for urine and non-infected for swabs. In this table they appear twice.

Table 24 shows the number of results from symptomatic and asymptomatic males designated as infected or not infected with CT based on the PIS algorithm.

PISa	NAAT1		NAAT2		GX	Symptom Status		Total
	SWa	URa	SW	UR	UR	Symp	Asymp
NIb	-	-	-	-	-	568	2621	3189
NI	-	-	-	EQc	-	0	19	19
NI	-	-	+	-	-	2	1	3
NI	+	-	-	-	-	6	1	7
NI	+	+	-	-	-	1	1	2
NI	-	-	-	+	-	2	7	9
NI	-	+	-	-	-	2	1	3
NI	-	-	EQ	-	-	0	1	1
NI	+	+	-	-	+	2	4	6
NI	-	-	-	-	+	0	1	1
NI	-	-	-	-	INDd	1	6	7
NI	-	-	EQ	IND	IND	0	1	1
Total Non-Infected
						584	2664	3248
Ie	+	+	+	+	+	104	50	154
I	+	+	-	+	+	8	10	18
I	+	+	-	+	+	4	7	11
I	+	+	+	-	+	2	2	4
I	+	-	+	-	+	1	0	1
I	+	-	-	+	+	1	0	1
I	-	+	+	+	+	0	1	1
I	+	+	+	EQ	+	0	2	2
I	EQ	+	-	+	+	0	1	1
I	+	-	+	-	-	2	0	2
I	+	+	+	-	-	1	0	1
Total Infected						123	73	196

Table 24: Patient Infected Status - Male CT

aPIS = Patient Infected Status; SW = Swab; UR = urine.

°NI = Non-infected

"EQ = Equivocal result for this individual specimen type only; PIS status determined based on remaining specimens. 4!ND = Indeterninate = ERROR, INVALID or NO RESULT by Xpert CT/NG Assay; specimens with IND results by Xpert are not included in the 2x2 tables for that specimen type.

೪ = Infected

{29}------------------------------------------------

Table 25 shows the number of results from symptomatic and asymptomatic males designated as infected or not infected with NG based on the PIS algorithm

	NAAT1		NAAT2		GX	Symptom Status	Total
bla"	SW"	UR*	SW	UR	UR	Symp	Asymp
NIb	t	-	-	-	-	રતે રહ્યું રહ્યું રહ્યું રહ્યું રહ્યું રહ્યું રહ્યું રહ્યું રહ્યું રહ્માન સાય સાય સાય સાય સાય તેમને સાથે સાથે સાથે સાથે સાથે સાથે સાથે સાથે સાથે છે. આ ગામના પાસની તેમની સાથે	2680	3277
NI	-		-	EO°	-	0	21	2 I
NI		-	EQ	-		0	1	1
NI	EQ	EQ	-	-	ﺖ	l	0	1
NI	-	:	+	-	ﮯ	0	3	3
NI	-	-	-	+-	-	0	3	3
NI	ﮯ	+	-	-	=	0	1	1
NI	+			-	-	2	5	7
NI	-	EQ		-	+	0	1	1
NI	EO	ﮯ	+	-	-f-	0	1
NI	-	•		ー	+	0	. 1
NI	-	ﺳ		-	INDa	l	6	7
NI			-	EQ	IND	0	1	l
	Total Non-Infected					60 I	2724	3325
le	+	-+-	+	-+-	-+-	। ()રે	1 1	।। ୧
I	+	+-	್ಕೆ	-	+	0	1.	1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	+	-	+	ー	-	0	1	1
	+		제	-f-		l	0	1
	Total Infected			1 06	13	। 19

Table 25: Patient Infected Status - Male NG

*PIS = Patient Infected Status; SW = Swab; UR = urine.

"N1 = Non-infected

EQ = Equivocal result for this individual specimen type only: PIS status determined based on remaining specimens. 41ND = Indeterminate = ERROR, INVALID or.NO RESULT by Xpert CT/NG Assay, specimens with IND results by Xpert are not included in the 2x2 tables for that specimen type.

°I = Infected

Hypothetical estimated positive and negative predictive values (PPV and NPV) for different prevalence rates using Xpert CT/NG Assay are shown in Tables 26 through 29 below. These calculations are based on a hypothetical prevalence and the overall sensitivity and specificity (compared to the patient infected status) observed during the Xpert CT/NG for a multi-center clinical study (Tables 20 and 21).

In patient-collected vaginal swab specimens, the overall sensitivity and specificity for CT were 99.5% and 99.1%, respectively (Table 20). The overall sensitivity and specificity for NG were 100% and 99.9%, respectively (Table 21). The following table shows PPV and NPV for patient-collected vaginal swab specimens using hypothetical prevalence rates.

{30}------------------------------------------------

PrevalenceRate (%)	CT				NG
	Sensitivity(%)	Specificity(%)	PPV(%)	NPV(%)	Sensitivity(%)	Specificity(%)	PPV(%)	NPV(%)
1	99.5	99.1	53.6	100	100	99.9	92.6	100
2	99.5	99.1	70.0	100	100	99.9	96.2	100
5	99.5	99.1	85.8	100	100	99.9	98.5	100
10	99.5	99.1	92.7	99.9	100	99.9	99.3	100
15	99.5	99.1	95.3	99.9	100	99.9	99.5	100
20	99.5	99.1	96.6	99.9	100	99.9	99.7	100
25	99.5	99.1	97.4	99.8	100	99.9	99.8	100
30	99.5	99.1	98.0	99.8	100	99.9	99.8	100
50	99.5	99.1	99.1	99.5	100	99.9	99.9	100

Table 26: Hypothetical PPV and NPV- Patient-collected Vaginal Swabs

In endocervical swab specimens, the overall sensitivity and specificity for CT were 96.0% and 99.6%, respectively (Table 20). The overall sensitivity and specificity for NG were 100% and >99.9%, respectively (Table 21). The following table shows PPV and NPV for endocervical swab specimens using hypothetical prevalence rates.

CT					NG
Prevalence Rate (%)	Sensitivity (%)	Specificity (%)	PPV (%)	NPV (%)	Sensitivity (%)	Specificity (%)	PPV (%)	NPV (%)
1	96.0	99.6	68.3	100	100	>99.9	97.4	100
2	96.0	99.6	81.3	99.9	100	>99.9	98.7	100
5	96.0	99.6	91.8	99.8	100	>99.9	99.5	100
10	96.0	99.6	96.0	99.6	100	>99.9	99.8	100
15	96.0	99.6	97.4	99.3	100	>99.9	99.8	100
20	96.0	99.6	98.2	99.0	100	>99.9	99.9	100
25	96.0	99.6	98.6	98.7	100	>99.9	99.9	100
30	96.0	99.6	98.9	98.3	100	>99.9	99.9	100
50	96.0	99.6	99.5	96.2	100	>99.9	100	100

Table 27: Hypothetical PPV and NPV- Endocervical Swabs

In female urine specimens, the overall sensitivity and specificity for CT were 98.1% and 99.8%, respectively (Table 20). The overall sensitivity and specificity for NG were 94.4% and >99.9%, respectively (Table 21). The following table shows PPV and NPV for female urine specimens using hypothetical prevalence rates.

Table 28: Hypothetical PPV and NPV- Female Urine

	CT				NG
PrevalenceRate (%)	Sensitivity(%)	Specificity(%)	PPV(%)	NPV(%)	Sensitivity(%)	Specificity(%)	PPV(%)	NPV(%)
1	98.1	99.8	85.5	100	94.4	>99.9	97.3	99.9
2	98.1	99.8	92.2	100	94.4	>99.9	98.6	99.9
5	98.1	99.8	96.8	99.9	94.4	>99.9	99.5	99.7
10	98.1	99.8	98.5	99.8	94.4	>99.9	99.7	99.4
15	98.1	99.8	99.0	99.7	94.4	>99.9	99.8	99.0
20	98.1	99.8	99.3	99.5	94.4	>99.9	99.9	98.6
25	98.1	99.8	99.5	99.4	94.4	>99.9	99.9	98.2
30	98.1	99.8	99.6	99.2	94.4	>99.9	99.9	97.7
50	98.1	99.8	99.8	98.1	94.4	>99.9	100	94.7

Xpert CT/NG Assay 510(k) Summary

{31}------------------------------------------------

In male urine specimens, the overall sensitivity and specificity for CT were 98.5% and 99.8%, respectively (Table 20). The overall sensitivity and specificity for NG were 98.3% and 99.9%, respectively (Table 21). The following table shows PPV and NPV for male urine specimens using hypothetical prevalence rates.

	CT				NG
PrevalenceRate (%)	Sensitivity(%)	Specificity(%)	PPV(%)	NPV(%)	Sensitivity(%)	Specificity(%)	PPV(%)	NPV(%)
1	98.5	99.8	82.2	100	98.3	99.9	91.7	100
2	98.5	99.8	90.3	100	98.3	99.9	95.7	100
5	98.5	99.8	96.0	99.9	98.3	99.9	98.3	99.9
10	98.5	99.8	98.1	99.8	98.3	99.9	99.2	99.8
15	98.5	99.8	98.8	99.7	98.3	99.9	99.5	99.7
20	98.5	99.8	99.1	99.6	98.3	99.9	99.6	99.6
25	98.5	99.8	99.3	99.5	98.3	99.9	99.7	99.4
30	98.5	99.8	99.5	99.3	98.3	99.9	99.8	99.3
50	98.5	99.8	99.8	98.5	98.3	99.9	99.9	98.3

Table 29: Hypothetical PPV and NPV- Male Urine

Conclusions

The results of the nonclinical analytical and clinical performance studies summarized above demonstrate that the Xpert CT/NG Assay is substantially equivalent to the predicate devices.

{32}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

DEC 2 7 2012

Cepheid® c/o Kerry Flom, Ph.D. Senior Vice President. Clinical Affairs and Regulatory Submissions 904 Caribbean Drive Sunnyvale, CA 90489

Re: K121710

Xpert® CT/NG Regulation Number: 21 CFR 866.3390 Regulation Name: Neisseria spp. direct serological test reagents Regulatory Class: Class II Product Code: LSL, MKZ, OOI Dated: December 10, 2012 Received: December 11, 2012

Dear Dr. Flom:

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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health 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,

Sally A. Hojvat

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

Enclosure

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4.0 Indications for Use Statement

Indications for Use Form

510(k) Number (if known): _ K12|710

Device Name: Xpert® CT/NG

Indications for Use:

Ancillary Collection Kits Indications for Use:

Prescription Use(Part 21 CFR 801 Subpart D)X	AND/OR Over-The-Counter Use(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Sak am
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

从121710 510(k)_

Regulation Number and Section

§ 866.3390

Neisseria spp. direct serological test reagents.(a)
Identification. Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identifyNeisseria spp. from cultured isolates. Additionally, some of these reagents consist ofNeisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence ofNeisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.(b)
Classification. Class II (performance standards).