K Number

Device Name

APTIMA TRICHOMONAS VAGINALIS ASSAY

Manufacturer

GEN-PROBE INCORPORATED

Date Cleared

2011-04-19

(6 days)

Product Code

OUY

Regulation Number

866.3860

Intended Use

The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the TIGRIS DTS System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician-collected vaginal swabs, female urine specimens, and specimens collected in PreservCyt solution.

Device Description

The ATV assay is a nucleic acid amplification test intended for the in vitro qualitative detection of ribosomal RNA from T. vaginalis in patient-collected first catch urine and clinician collected vaginal swabs, endocervical swab and ThinPrep Pap Test specimens collected in Cytyc Preservcyt solution. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of trichomoniasis using the TIGRIS DTS System automated analyzer. There are 4 kits (1 master and 3 ancillary) that are required to perform the ATV assay on the TIGRIS DTS System. The Master Kit contains 9 reagents and 2 controls and is made up of 3 boxes. Box 1 - the Refrigerated box contains ATV amplification reagent, ATV enzyme reagent, ATV probe reagent and ATV Target Capture reagent-B. Box 2 - the Room Temperature box contains ATV amplification reconstitution solution, ATV enzyme reconstitution reagent, ATV probe reconstitution reagent, ATV selection reagent and ATV target capture reagent. Box 3-the Controls kit box contains ATV positive and negative controls. The three ancillary kits consist of the APTIMA Assay Fluids kit, the APTIMA Auto Detect Reagents kit and APTIMA System Fluids Preservative kit. In addition to the reagents provided in the kit, the assay utilizes four specimen collection kits - the APTIMA unisex swab specimen collection kit for endocervical and male urethral swab specimens, APTIMA vaginal swab specimen collection kit, APTIMA urine specimen collection kit for male and female urine specimens and the APTIMA specimen transfer kit.

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Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K896296

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on a nucleic acid amplification test (NAAT) and its analytical and clinical performance metrics (sensitivity, specificity, etc.). There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The analysis is based on detecting ribosomal RNA, a standard molecular diagnostic technique.

Therapeutic

No.
The device is an in vitro diagnostic (IVD) test designed to detect the presence of ribosomal RNA from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis. It does not provide treatment or directly influence the body's structure or function for therapeutic purposes.

Diagnostic

Yes

The device is explicitly stated as being used "to aid in the diagnosis of trichomoniasis."

SaMD (Software as a Medical Device)

The device is an in vitro diagnostic (IVD) assay that involves physical reagents, controls, and specimen collection kits, which are hardware components. It also utilizes an automated analyzer (TIGRIS DTS System), which is a hardware system.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states: "The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the TIGRIS DTS System."

The term "in vitro" is a key indicator that the device is intended for use outside of a living organism, which is the definition of an in vitro diagnostic device. The description further clarifies that it is a test performed on patient specimens (swabs, urine, PreservCyt solution) to detect a specific biological marker (rRNA from Trichomonas vaginalis) to aid in diagnosis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician-collected vaginal swabs, female urine specimens, and specimens collected in PreservCyt solution.

For prescription use

Product codes (comma separated list FDA assigned to the subject device)

OUY

Device Description

There are 4 kits (1 master and 3 ancillary) that are required to perform the ATV assay on the TIGRIS DTS System. The Master Kit contains 9 reagents and 2 controls and is made up of 3 boxes. Box 1 - the Refrigerated box contains ATV amplification reagent, ATV enzyme reagent, ATV probe reagent and ATV Target Capture reagent-B. Box 2 - the Room Temperature box contains ATV amplification reconstitution solution, ATV enzyme reconstitution reagent, ATV probe reconstitution reagent, ATV selection reagent and ATV target capture reagent. Box 3-the Controls kit box contains ATV positive and negative controls. The three ancillary kits consist of the APTIMA Assay Fluids kit, the APTIMA Auto Detect Reagents kit and APTIMA System Fluids Preservative kit. In addition to the reagents provided in the kit, the assay utilizes four specimen collection kits - the APTIMA unisex swab specimen collection kit for endocervical and male urethral swab specimens, APTIMA vaginal swab specimen collection kit, APTIMA urine specimen collection kit for male and female urine specimens and the APTIMA specimen transfer kit.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Clinician-collected endocervical swabs, clinician-collected vaginal swabs, female urine specimens

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

A pivotal prospective multicenter clinical trial was conducted with 1025 symptomatic and asymptomatic women enrolled from 9 US clinical sites, including obstetric and gynecology, family planning and STD clinics. Up to 6 specimens were collected from each subject (1 first catch urine, 3 vaginal swabs, 1 endocervical swab and 1 PreservCyt solution liquid Pap specimen). All specimens were clinician-collected except urine specimens. 2 of the vaginal swab specimens were tested with a commercially available culture system and wet mount microscopic exam to establish infected status. The remaining 4 specimens were tested with the ATV assay at 3 external labs. Performance characteristics of the ATV assay were determined by comparing results to a patient infected status algorithm. Each subject was designated as infected or non-infected based on vaginal swab specimen results tested by culture and/or wet mount microscopic exam. At least one positive reference result established an infected patient status. Both reference tests were required to be negative to establish a non-infected patient status. Of the evaluable specimens, a total of 738 urines, 877 vaginal swabs, 922 endocervical swabs and 813 PreservCyt solution liquid Pap specimens were tested with the assay. There were 3 urines, 2 vaginal and 2 endocervical swabs with final invalid results due to hardware errors or specimen issues.

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

Clinical trial:
Urine: N=735, Sensitivity=95.2% (95% CI: 88.4-98.1), Specificity=98.9% (95% CI: 97.8-99.5), PPV=92.0% (95% CI: 1-96.4), NPV=99.4% (95% CI: 98.5-99.8)
Clinician-collected vaginal swab: N=875, Sensitivity=100% (95% CI: 96.7-100), Specificity=99.0% (95% CI: 97.9-99.5), PPV=93.3% (95% CI: 87.6-97.0), NPV=100% (95% CI: 99.5-100)
Endocervical swab: N=920, Sensitivity=100% (95% CI: 96.7-100), Specificity=99.4% (95% CI: 98.6-99.7), PPV=95.8% (95% CI: 90.7-98.6), NPV=100% (95% CI: 99.6-100)
PreservCyt: N=813, Sensitivity=100% (95% CI: 96.0-100), Specificity=99.6% (95% CI: 98.8-99.9), PPV=96.9% (95% CI: 91.4-99.3), NPV=100% (95% CI: 99.5-100)

Performance was similar across specimen types and in symptomatic and asymptomatic women. Prevalence was higher in symptomatic women.

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

Sensitivity, Specificity, PPV (Positive Predictive Value), NPV (Negative Predictive Value)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

In Pouch Trichomonas vaginalis, K896296

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 866.3860

Trichomonas vaginalis nucleic acid assay.(a)
Identification. ATrichomonas vaginalis nucleic acid assay is a device that consists of primers, probes, enzymes, and controls for the amplification and detection of trichomonas nucleic acids in endocervical swabs, vaginal swabs, and female urine specimens, from women symptomatic for vaginitis, cervicitis, or urethritis and/or to aid in the diagnosis of trichomoniasis in asymptomatic women. The detection of trichomonas nucleic acids, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of trichomoniasis caused byTrichomonas vaginalis .(b)
Classification. Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection ofTrichomonas vaginalis; Guideline for Industry and Food and Drug Administration Staff.” See § 866.1(e) for information on obtaining this document.

Summary

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:

K102911

B. Purpose for Submission:

Evaluation of automatic Class III designation for the Aptima Trichomonas vaginalis (ATV) assay

C. Measurand:

Ribosomal RNA from T. vaginalis

D. Type of Test:

Nucleic acid amplification test

E. Applicant:

Gen Probe Inc.

F. Proprietary and Established Names:

Aptima Trichomonas vaginalis assay

G. Regulatory Information:

1. Regulation section:
- 21 CFR 866.3860
1. Classification:

Class II

1. Product code:
  OUY - Trichomonas vaginalis nucleic acid amplification test system
1. Panel:
- 83 Microbiology

H. Intended Use:

1. Intended use:
  The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the TIGRIS DTS System.

1. Indications for use:
  The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the TIGRIS DTS System.

1. Special conditions for use statement:
  For prescription use
1. Special instrument requirements:
  The automated TIGRIS DTS System

I. Device Description:

vaginal swab specimen collection kit, APTIMA urine specimen collection kit for male and female urine specimens and the APTIMA specimen transfer kit.

J. Substantial Equivalence Information:

1. Predicate device name: In Pouch Trichomonas vaginalis
1. Predicate 510(k) number: K896296
1. Comparison with predicate:

Similarities
Item	Device	Predicate
Intended Use	NAAT test for detection of
T. vaginalis ribosomal RNA
(rRNA)	Accurate system for early
microscopic identification
and culture confirmation of
T. vaginalis from female
and male urogenital sites

Differences
Item	Device	Predicate
Specimen types	Urine, vaginal swab,
endocervical swab, Thin
Prep in PreservCyt solution	Vaginal swab ,seminal
fluid, urine
Assay type	Target capture, transcription
mediated amplification
assay	Culture media
Detection	Direct microscopic
observation, then
inoculation for culture	Hybridization protection
assay, providing relative
light units (RLUs)

K. Standard/Guidance Document Referenced (if applicable):

EP5-A2, 2004: Evaluation of Precision Performance of Quantitative Measurement Methods, CLSI Approved Guideline

EP 15-A2, 2006: User Verification of Performance For Precision and Trueness, CLSI approved Guideline

Format for Traditional and Abbreviated 510(k)s; Guidance for Industry and Staff, Aug.2005

General Principles of Software Validation; final guidance for Industry and FDA Staff, Jan. 2002

Guidance for the Content of Premarket Submissions for Software contained in Medical Devices, May 2005

L. Test Principle:

The Aptima TV assay involves 3 main steps which take place in a single tube: target capture (TC), target amplification by Transcription Mediated Amplification (TMA) and detection of the amplification products (amplicon) by Hybridization Protection Assay (HPA). Specimens to be tested are collected and transferred into their respective specimen transport tubes. The transport solutions in the specimen transport tubes release the rRNA targets and protect them from degradation. When the TV assay is performed, the target rRNA is isolated from the specimen by use of capture oligomers via target capture that utilizes magnetic particles. When target capture is complete, the TV rRNA is amplified via TMA. Detection of the amplicon is achieved by HPA using single stranded nucleic acid probes with chemiluminescent labels that are complimentary to the amplicon. During the detection step, light emitted from the labeled RNA: DNA hybrids is measured as photon signals in a luminometer and are reported as Relative Light Units (RLU).

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
- a. Precision/Reproducibility:

Reproducibility was evaluated at 3 external US labs using the TIGRIS DTS System. Six operators, 2 at each site, performed reproducibility testing using 3 reagent kit lots. At each site, testing was performed over 6 days. Each site performed 2 runs per day. Each run contained 3 replicates of an 8 member reproducibility panel. The panels consisted of Trichomonas vaginalis negative and positive specimens prepared in either a urine or PreservCyt solution. For each sample matrix, there was a high negative, moderate positive, high positive and negative sample. Results are shown in the chart below.

						Between Sites			Between Operators			Between Lots			Between Worklists			Within Worklists
			Conc	Target		Mean		CV		CV		CV		CV		CV		CV
	PM	Matrix	Level	Conc¹	N	RLU	SD	(%)	SD	(%)	SD	(%)	SD	(%)	SD	(%)	SD	(%)
A	P	Neg	N/A	106	2.0	1.1	56.8	0.0	0.0	0.0	0.0	0.4	21.3	0.8	42.5	1.5	74.1
B	P	HNeg	0.01	106	58.3	17.2	29.4	0.0	0.0	11.1	19.1	0.0	0.0	22.2	38.0	30.2	51.7
C	P	MPos	0.1	108	367.0	32.8	8.9	0.0	0.0	57.5	15.7	51.0	13.9	140.6	38.3	163.6	44.6
D	P	HPos	1	107	1110.4	53.9	4.9	0.0	0.0	109.6	9.9	60.9	5.5	77.1	6.9	156.8	14.1
E	U	Neg	N/A	108	2.1	1.0	45.7	0.0	0.0	0.0	0.0	0.0	0.0	1.3	62.4	1.7	77.3
F	U	HNeg	0.006	107	60.2	11.2	18.7	0.0	0.0	9.6	15.9	9.8	16.2	12.0	19.9	21.4	35.6
G	U	MPos	0.1	107	781.6	53.2	6.8	0.0	0.0	66.6	8.5	56.0	7.2	83.7	10.7	131.9	16.9
H	U	HPos	1	108	1122.8	49.5	4.4	15.0	1.3	119.3	10.6	109.2	9.7	106.9	9.5	200.7	17.9

Reproducibility Study: Signal Variability of the ATV Assay by Panel Member, Including Samples With Discordant Test Results

Conc=concentration, HNeg=high positive, MPos=moderate positive, Neg=negative, P=PreservCyt, PM=panel member, U=Urine

1 Concentration units = trichomonads/mL

Note: The RLU value reported by the software is the total measured RLU divided by 1000 with the decimal point truncated. Variability from some factors may be numerically negative. This can occur if the variability due to those factors is very small. In these cases, SD and CV are shown as 0.

b. Linearity/assay reportable range:

The ATV Assay is designed for and validated on the TIGRIS DTS System. The assay test results are automatically interpreted by the TIGRIS DTS System APTIMA Trichomonas vaginalis Software. A test result may be negative, positive or invalid as determined by the total RLU in the detection step. A test result may be invalid due to RLU values outside the normal expected ranges. Initial invalid results should be retested.

Test Interpretation	Total RLU (x 1000)
Negative	0* to /= 2400

*If the RLU measured on the TIGRIS DTS System in between 0 and 999, a result of "O" is reported in the "Total RLU (000s)" column in the run report. Measured RLU values less than 690 are reported as invalid. RLU values between 690 and 999 are reported as valid.

Traceability, Stability, Expected values (controls, calibrators, or methods): C.
Data to support the recommended shipping and storage conditions for the vaginal swab, PreservCyt liquid Pap and urine specimens were generated with negative clinical specimens spiked with T. vaginalis to a final concentration of 250 TV/mL. Greater than 95% positivity was observed in all matrices (vaginal swab, PreservCyt liquid Pap, and urine) at all times and temperatures tested confirming the validity of the claimed maximum storage times and temperatures.

Quality Control Results and Acceptability

The APTIMA Negative Control for Trichomonas and APTIMA Positive Control for Trichomonas act as controls for the target capture, amplification and detection steps of the assay. The Positive Control contains non-infectious Trichomonas vaginalis trichomonads rRNA.

| Control | Total RLU (x1000) | Trichomonas
vaginalis Result |
|------------------|-------------------|---------------------------------|
| Negative Control | 0* and /=500 and /= 2400 |

*If the RLU measured on the TIGRIS DTS System in between 0 and 999, a result of "0" is reported in the "Total RLU (000s)" column in the run report. Measured RLU values less than 690 are reported as invalid. RLU values between 690 and 999 are reported as valid.

1. Comparison studies:
- a. Method comparison with predicate device:

See 3 (a) below

b. Matrix comparison:

N/A

3. Clinical studies:

a. Clinical Sensitivity:
A pivotal prospective multicenter clinical trial was conducted with 1025 symptomatic and asymptomatic women enrolled from 9 US clinical sites, including obstetric and gynecology, family planning and STD clinics. Up to 6 specimens were collected from each subject (1 first catch urine, 3 vaginal swabs, 1 endocervical swab and 1 PreservCyt solution liquid Pap specimen). All specimens were clinician-collected except urine specimens. 2 of the vaginal swab specimens were tested with a commercially available culture system and wet mount microscopic exam to establish infected status. The remaining 4 specimens were tested with the ATV assay at 3 external labs. Performance characteristics of the ATV assay were determined by comparing results to a patient infected status algorithm. Each subject was designated as infected or non-infected based on vaginal swab specimen results tested by culture and/or wet mount microscopic exam. At least one positive reference result established an infected patient status. Both reference tests were required to be negative to establish a non-infected patient status. Of the evaluable specimens, a total of 738 urines, 877 vaginal swabs, 922 endocervical swabs and 813 PreservCyt solution liquid Pap specimens were tested with the assay. There were 3 urines, 2 vaginal and 2 endocervical swabs with final invalid results due to hardware errors or specimen issues. Results below show the sensitivity, specificity, positive value (PPV), and negative predictive value (NPV) of the APTIMA Trichomonas vaginalis Assay and the prevalence of T. vaginalis (based on the infected status) in each specimen type. Performance was similar across specimen types.

| Specimen
Type | N | TP | FP | TN | FN | Prev
% | Sensitivity%
(95% CI) | Specificity%
(95%CI) | PPV%
(95%CI) | NPV%
(95%CI) |
|----------------------------------------|-----|-----|----|-----|----|-----------|--------------------------|-------------------------|---------------------|---------------------|
| Urine | 735 | 80 | 7 | 644 | 4 | 11.4 | 95.2 (88.4-
98.1) | 98.9 (97.8-
99.5) | 92.0 (1-
96.4) | 99.4(98.5-
99.8) |
| Clinician
collected
vaginal swab | 875 | 111 | 8 | 756 | 0 | 12.7 | 100 (96.7-
100) | 99.0(97.9-
99.5) | 93.3(87.6-
97.0) | 100(99.5-
100) |
| Endocervical
swab | 920 | 114 | 5 | 801 | 0 | 12.4 | 100 (96.7-
100) | 99.4(98.6-
99.7) | 95.8(90.7-
98.6) | 100(99.6-
100) |

Performance characteristics of the APTIMA Trichomonas vaginalis Assay

| PreservCyt | 813 | 93 | 3 | 717 | 0 | 11.4 | 100 (96.0-
100) | 99.6 (98.8-
99.9) | 96.9(91.4-
99.3) | 100(99.5-
100) |

------------	-----	----	---	-----	---	------	--------------------	----------------------	---------------------	-------------------

The sensitivity, specificity, PPV, and NPV of the APTIMA Trichomonas vaginalis Assay and the prevalence of T. vaginalis (based on the infected status) in each specimen type were also evaluated by symptom status. Subjects were classified as symptomatic if symptoms were reported by the subject. Subjects were classified as asymptomatic if the subject did not report symptoms. For each specimen type, performance was similar in symptomatic and asymptomatic women. Prevalence was higher in symptomatic women.

| Specimen
Type | Symptom
Status | n | TP | FP | TN | FN | Prev % | Sensitivity %
(95% CI)¹ | Specificity %
(95% CI)¹ | PPV %
(95% CI)² | NPV %
(95% CI)² |
|------------------|-------------------|-----|----|----|-----|----|--------|----------------------------|----------------------------|---------------------|---------------------|
| Urine | Asymptomatic | 324 | 21 | 3 | 299 | 1 | 6.8 | 95.5
(78.2-99.2) | 99.0
(97.1-99.7) | 87.5
(71.4-96.9) | 99.7
(98.4-100) |
| | Symptomatic | 411 | 59 | 4 | 345 | 3 | 15.1 | 95.2
(86.7-98.3) | 98.9
(97.1-99.6) | 93.7
(85.7-98.1) | 99.1
(97.7-99.8) |
| CVS | Asymptomatic | 345 | 24 | 4 | 317 | 0 | 7.0 | 100
(86.2-100) | 98.8
(96.8-99.5) | 85.7
(70.3-95.6) | 100
(98.9-100) |
| | Symptomatic | 530 | 87 | 4 | 439 | 0 | 16.4 | 100
(95.8-100) | 99.1
(97.7-99.6) | 95.6
(89.5-98.8) | 100
(99.2-100) |
| ES | Asymptomatic | 372 | 26 | 1 | 345 | 0 | 7.0 | 100
(87.1-100) | 99.7
(98.4-99.9) | 96.3
(82.4-99.9) | 100
(99.0-100) |
| | Symptomatic | 548 | 88 | 4 | 456 | 0 | 16.1 | 100
(95.8-100) | 99.1
(97.8-99.7) | 95.7
(89.6-98.8) | 100
(99.2-100) |
| PCyt | Asymptomatic | 353 | 23 | 0 | 330 | 0 | 6.5 | 100
(85.7-100) | 100
(98.8-100) | 100
(86.2-NC) | 100
(99.0-100) |
| | Symptomatic | 460 | 70 | 3 | 387 | 0 | 15.2 | 100
(94.8-100) | 99.2
(97.8-99.7) | 95.9
(88.9-99.1) | 100
(99.1-100) |

Table 3: Performance Characteristics of the APTIMA Trichomonas vaginalis Assay by Symptom Status

CI = confidence interval, CVS = clinician-collected vaginal swab, ES = endocervical swab, FN = false negative, FP = false positive, NC = not calculable, PCyt = PreservCyt Solution liquid Pap, Prev = prevalence, TN = true negative, TP = true positive.

4Score confidence interval.

2PPV 95% confidence interval computed from the exact 95% confidence interval for the positive likelihood ratio, NPV 95% confidence interval computed from the exact 95% confidence interval from the negative likelihood ratio. Some confidence limits could not be calculated due to undefined results in the formulas.

Clinical specificity: b.
See 3(a) above
Other clinical supportive data (when a. and b. are not applicable): C.
N/A
1. Clinical cut-off:
  N/A
1. Expected values/Reference range:
  The prevalence of T. vaginalis in different populations depends on patient risk factors such as age, lifestyle, the presence or absence of symptoms, and the sensitivity of the test in detecting the infection. A summary of the prevalence of T. vaginalis, by specimen type, as determined by the APTIMA Trichomonas vaginalis Assay in the clinical trial is described below.

The positivity rate for the Aptima TV assay by specimen type, collection site and overall was 11.8% (87/735) for urines, 11.8% (96/813) for PreservCyt solution Pap specimens, 12.9% (119/920) for endocervical swab specimens and 13.6% (119/875) for vaginal swab specimens.

N. Instrument Name:

The TIGRIS DTS System

O. System Descriptions:

1. Modes of Operation:
  The TIGRIS DTS System is an integrated hardware and software system that fully automates all steps of nucleic acid testing necessary to perform Gen-Probe assays. The system automates the following steps: sample processing/ target capture, amplification, detection and results processing. The 2 main components of the system are the computer work station and the analyzer. The assay software in the computer work station directs the analyzer modules to perform each sequential assay step. The analyzer holds all of the fluids, reagents and consumables needed to perform the assay.
1. Software:
  FDA has reviewed applicant's Hazard Analysis and software development processes for this line of product types:

Yes _X _________ or No _______________________________________________________________________________________________________________________________________________________

1. Specimen Identification:
  See Section L, Test Principle. A complete description is included in theTIGRIS DTS System Operator's Manual for system procedural information
1. Specimen Sampling and Handling:
  See #3 above
1. Calibration:
  N/A
1. Quality Control:
  See #3 above

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:

N/A

Q. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

R. Conclusion:

The submitted information in this premarket notification is complete and supports reclassification into Class II