APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER

• K Number: K122062
• Device Name: APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER
• Manufacturer: GEN-PROBE, INC.
• Date Cleared: 2013-01-09 ( 180 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 PANTHER System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician-collected vaginal swabs, and specimens collected in PreservCyt Solution.

Device Description

The ATV Assay with the modified TCR, referred to as ATV Assay (Version 2) in this submission is the subject of this premarket notification. The ATV Assay (Version 2) is similar to the ATV Assay originally cleared (ref: K102911), except for the formulation of the TCR. The TCR is a HEPES-buffered solution containing lithium salts and derivatized magnetic beads. A second target capture oligo was added to the TCR formulation in order to accommodate future specimen types. The TCR modification did not result in the change of assay technology. The ATV Assay (Version 2) uses Target Capture (TC), Transcription Mediated Amplification (TMA), and Hybridization Protection Assay (HPA) technologies to qualitatively detect ribosomal RNA (rRNA) from Trichomonas vaginalis. The overall assay design as well as the assay procedural steps remain unchanged from that previously described in the original 510(k) for the ATV Assay (K102911). The ATV Assay (Version 2) kit is comprised of 3 boxes: 1. Refrigerated Box Contains the Amplification Reagent, Enzyme Reagent, Probe Reagent and Target Capture Reagent-B 2. Room Temperature Box Contains Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Probe Reconstitution Solution, Selection Reagent and Target Capture Reagent 3. Controls Box Contains the Negative and Positive Controls The ATV Assay (Version 2) on PANTHER would utilize three specimen collection kits. These collection kits were cleared for use with the originally cleared ATV Assay and other commercialized APTIMA Assays. 1. APTIMA Unisex Swab Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens 2. APTIMA Vaginal Swab Specimen Collection Kit 3. APTIMA Specimen Transfer Kit Instrumentation The ATV Assay (Version 2) was validated using the PANTHER System, which was previously cleared in May 2012 (Ref: K111409).

Predicate Devices

K102911

Reference Devices

K111409

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on nucleic acid amplification and detection technologies (TC, TMA, HPA) and does not mention any AI/ML components or algorithms. The performance studies are based on standard clinical metrics like sensitivity and specificity, not AI/ML specific metrics.

Therapeutic

No.
Explanation: The device is an in vitro diagnostic test for the detection of Trichomonas vaginalis to aid in the diagnosis of trichomoniasis. It does not provide therapy or treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the assay is "to aid in the diagnosis of trichomoniasis."

SaMD (Software as a Medical Device)

No

The device is an in vitro diagnostic (IVD) assay kit that includes reagents and is used with a specific hardware system (PANTHER System). It is not solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device 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". The term "in vitro" means "in glass" or "in the lab," indicating that the test is performed outside of the living body using biological specimens.
• Device Description: The description details a kit containing reagents and controls used to perform a test on collected specimens (endocervical swabs, vaginal swabs, and specimens collected in PreservCyt Solution). This aligns with the nature of an in vitro diagnostic device.
• Specimen Types: The assay is designed to test specific biological specimens collected from patients.
• Performance Studies: The document describes clinical performance studies conducted using collected specimens to evaluate the device's ability to detect the target analyte (Trichomonas vaginalis rRNA) and aid in diagnosis.

All of these points are characteristic of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 PANTHER System.

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

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

OUY

Device Description

The ATV Assay with the modified TCR, referred to as ATV Assay (Version 2) in this submission is the subject of this premarket notification. The ATV Assay (Version 2) is similar to the ATV Assay originally cleared (ref: K102911), except for the formulation of the TCR. The TCR is a HEPES-buffered solution containing lithium salts and derivatized magnetic beads. A second target capture oligo was added to the TCR formulation in order to accommodate future specimen types.

The TCR modification did not result in the change of assay technology. The ATV Assay (Version 2) uses Target Capture (TC), Transcription Mediated Amplification (TMA), and Hybridization Protection Assay (HPA) technologies to qualitatively detect ribosomal RNA (rRNA) from Trichomonas vaginalis. The overall assay design as well as the assay procedural steps remain unchanged from that previously described in the original 510(k) for the ATV Assay (K102911).

The ATV Assay (Version 2) kit is comprised of 3 boxes:

• 1. Refrigerated Box Contains the Amplification Reagent, Enzyme Reagent, Probe Reagent and Target Capture Reagent-B
• 2. Room Temperature Box Contains Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Probe Reconstitution Solution, Selection Reagent and Target Capture Reagent
• 3. Controls Box Contains the Negative and Positive Controls

The ATV Assay (Version 2) on PANTHER would utilize three specimen collection kits. These collection kits were cleared for use with the originally cleared ATV Assay and other commercialized APTIMA Assays.

• 1. APTIMA Unisex Swab Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens
• 2. APTIMA Vaginal Swab Specimen Collection Kit
• 3. APTIMA Specimen Transfer Kit

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

endocervical, vaginal

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

Clinical performance of the ATV Assay on the PANTHER System was evaluated using leftover specimens collected from consenting subjects during a previous, prospective, multicenter clinical study of the ATV Assay on the TIGRIS DTS System. Symptomatic and asymptomatic women were enrolled from 9 US clinical sites, including obstetrics and gynecology, family planning, and STD clinics. Three (3) vaginal swabs, 1 endocervical swab, and 1 PreservCyt Solution liquid Pap specimen were collected from each subject. All specimens were clinician-collected.

PreservCyt liquid Pap specimens were collected with a broom-type device or a spatula and cytobrush. Two of the vaginal swab specimens were tested with a commercially available culture system and wet mount microscopic examination to establish infected status. The remaining specimens were prepared for APTIMA Trichomonas vaginalis Assay testing in accordance with the appropriate APTIMA specimen collection kit package insert instructions.

PANTHER System testing with the APTIMA Trichomonas vaginalis Assay was conducted at 3 sites (2 external laboratories and Gen-Probe) in accordance with package insert instructions.

Performance characteristics of the APTIMA Trichomonas vaginalis Assay were estimated by comparing results to a patient infected status algorithm. In the algorithm, the designation of a subject as being infected or non-infected with 7. vaginalis was based on results from vaginal swab specimens tested by culture and/or wet mount microscopic examination. At least one of the reference test results was required to be positive to establish an infected patient status. Both reference tests were required to be negative to establish a non-infected patient status.

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

Test Principle: The ATV 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).

1. Analytical Performance

• Precision/Reproducibility: A 4-member reproducibility panel was prepared in PreservCyt (ThinPrep) liquid cytology specimen-STM matrix (1:2.9). PreservCyt sample pools were screened with the ATV Assay to confirm that T. vaginalis was not present. The pools were then spiked with T. vaginalis lysate to produce high negative (expected positivity: >0% and /= 2400 (x 1000) Total RLU).
• Traceability, Stability, Expected Values: Data supported recommended shipping and storage conditions for vaginal swab and PreservCyt liquid Pap, with >98% positivity observed in both matrices at all times and temperatures tested.
• Quality Control: APTIMA Negative Control for Trichomonas and APTIMA Positive Control for Trichomonas act as controls. Negative Control must be 0* and =500 and =95% sensitivity) except for Astroglide personal lubricant, porcine gastric mucus, and glacial acetic acid, which did not interfere at higher T. vaginalis concentrations (0.3 TV/mL or 1 TV/mL).
• Detection Limit: Sensitivity panels prepared with two strains of T. vaginalis (Metronidazole-susceptible and Metronidazole-resistant). >95% positivity for panels containing 0.01 TV/mL in PreservCyt liquid Pap and 0.003 TV/mL in swab specimen matrix.
• Assay Cut-Off: Same as "Assay reportable range" above.

2. Comparison Studies

• Matrix comparison: N/A

3. Clinical Studies

• Clinical Performance (Clinical Sensitivity and Specificity):
  • Evaluated using leftover specimens from a previous clinical study of the ATV Assay on the TIGRIS DTS System. Symptomatic and asymptomatic women from 9 US clinical sites. Vaginal swabs, endocervical swabs, and PreservCyt Solution liquid Pap specimens collected.
  • Infected status established by culture and/or wet mount microscopic examination of vaginal swab specimens; non-infected status by both reference tests negative.
  • 22 valid runs on PANTHER System. Total of 689 vaginal swab, 737 endocervical swab, and 791 PreservCyt Solution liquid Pap specimens tested. Specimens with initial/final invalid results were retested or excluded from analysis.
  • Results (Overall, All Symptom Statuses):
    • CVS: Sensitivity 100%, Specificity 98.2%, PPV 88.3%, NPV 100%. Prevalence 10.3%.
    • ES: Sensitivity 100%, Specificity 98.1%, PPV 84.8%, NPV 100%. Prevalence 9.6%.
    • PCyt: Sensitivity 100%, Specificity 98.6%, PPV 89.2%, NPV 100%. Prevalence 10.7%.
  • Performance was comparable across specimen types, symptom statuses, collection sites, and cervical collection device types for PreservCyt specimens.
• Agreement of APTIMA Trichomonas vaginalis Assay Results on the PANTHER System and the TIGRIS DTS System:
  • Assessed using prospectively collected specimens from asymptomatic subjects (women from 6 US clinical sites). Vaginal swab, endocervical swab, and PreservCyt Solution liquid Pap specimens collected. All clinician-collected.
  • Total of 227 vaginal swab, 227 endocervical swab, and 227 PreservCyt Solution liquid Pap specimens tested. One vaginal swab specimen retested due to initial invalid result.
  • Results for asymptomatic subjects:
    • CVS: % Positive Agreement 93.5%, % Negative Agreement 97.4%. TIGRIS Positivity 13.7%.
    • ES: % Positive Agreement 100%, % Negative Agreement 99.5%. TIGRIS Positivity 12.3%.
    • PCyt: % Positive Agreement 100%, % Negative Agreement 99.5%. TIGRIS Positivity 11.5%.
• Clinical Reproducibility:
  • ATV Assay (Version 2) testing conducted at 3 sites (in-house and 2 external) on the PANTHER System by 6 operators using 2 reagent lots over at least 6 days.
  • Four reproducibility panel members (negative, high negative, moderate positive, and high positive) were prepared in PreservCyt solution. Tested in 3 replicates per run.
  • Results (Agreement %):
    • Negative: 99.1%
    • High Negative: 90.7%
    • Moderate Positive: 97.2%
    • High Positive: 100%

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

Overall Clinical Performance (All Symptom Statuses):
CVS: Sensitivity 100% (94.7-100), Specificity 98.2% (96.7-99.0), PPV 88.3% (77.9-92.8), NPV 100% (99.4-100)
ES: Sensitivity 100% (94.6-100), Specificity 98.1% (96.7-98.9), PPV 84.8% (76.3-91.5), NPV 100% (99.4-100)
PCyt: Sensitivity 100% (95.6-100), Specificity 98.6% (97.4-99.2), PPV 89.2% (82.0-94.5), NPV 100% (99.5-100)

Agreement between PANTHER System and TIGRIS DTS System in Asymptomatic Subjects:
CVS: % Positive Agreement 93.5% (79.3-98.2), % Negative Agreement 97.4% (94.2-98.9)
ES: % Positive Agreement 100% (87.9-100), % Negative Agreement 99.5% (97.2-99.9)
PCyt: % Positive Agreement 100% (87.1-100), % Negative Agreement 99.5% (97.2-99.9)

Clinical Reproducibility (Agreement %):
Negative: 99.1%
High Negative: 90.7%
Moderate Positive: 97.2%
High Positive: 100%

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.

K102911

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.

K111409

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

0

SECTION 2 510(k) SUMMARY

JAN 0 9 2013

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. The information provided is consistent with FDA recommendations cited in Appendix B – The 510(k) Summary Document Requirements from the draft guidance document entitled, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" (Dec. 27, 2011).

A. 510(k) Number:

K122062

B. Purpose of Submission:

Device Modification to K102911: Change in formulation of the Target Capture Reagent (TCR) used in APTIMA Trichomonas vaginalis (ATV) Assay, and use of the PANTHER System as a platform.

C. Measurand:

Ribosomal RNA from Trichomonas vaginalis

D. Type of Test:

Nucleic acid amplification test

E. Applicant:

Gen-Probe Incorporated 10210 Genetic Center Drive San Diego, CA 92121 [phone]

| Company Contact: | Ma. Carmelita S. Baluyot
Regulatory Affairs Specialist |
|------------------|-----------------------------------------------------------|
| Phone: | 858-410-8309 |
| Fax: | 858-410-9028 |
| Email: | [e-mail] |
| Date Prepared: | December 18, 2012 |

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F. Proprietary and Established Names:

APTIMA Trichomonas vaginalis Assay

G. Regulatory Information

• 1. Regulation Section
• 21 CFR 866.3860
• 2. Classification Class II
• 3. Product Code OUY - Trichomonas vaginalis nucleic acid amplification test system
• 4. Panel 83 - Microbiology

H. Intended Use

• l. 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 PANTHER System.

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

2. 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 PANTHER System.

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

• 3. Special conditions for use statement
     For prescription use

2

4. Special instrument requirements

The automated PANTHER System

I. Device Description

The ATV Assay with the modified TCR, referred to as ATV Assay (Version 2) in this submission is the subject of this premarket notification. The ATV Assay (Version 2) is similar to the ATV Assay originally cleared (ref: K102911), except for the formulation of the TCR. The TCR is a HEPES-buffered solution containing lithium salts and derivatized magnetic beads. A second target capture oligo was added to the TCR formulation in order to accommodate future specimen types.

The TCR modification did not result in the change of assay technology. The ATV Assay (Version 2) uses Target Capture (TC), Transcription Mediated Amplification (TMA), and Hybridization Protection Assay (HPA) technologies to qualitatively detect ribosomal RNA (rRNA) from Trichomonas vaginalis. The overall assay design as well as the assay procedural steps remain unchanged from that previously described in the original 510(k) for the ATV Assay (K102911).

The ATV Assay (Version 2) kit is comprised of 3 boxes:

• 1. Refrigerated Box Contains the Amplification Reagent, Enzyme Reagent, Probe Reagent and Target Capture Reagent-B
• 2. Room Temperature Box Contains Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Probe Reconstitution Solution, Selection Reagent and Target Capture Reagent
• 3. Controls Box Contains the Negative and Positive Controls

The ATV Assay (Version 2) on PANTHER would utilize three specimen collection kits. These collection kits were cleared for use with the originally cleared ATV Assay and other commercialized APTIMA Assays.

• 1. APTIMA Unisex Swab Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens
• 2. APTIMA Vaginal Swab Specimen Collection Kit
• 3. APTIMA Specimen Transfer Kit

Instrumentation

The ATV Assay (Version 2) was validated using the PANTHER System, which was previously cleared in May 2012 (Ref: K111409).

3

J. Substantial Equivalence Information:

• A. Predicate Device Name:
  • APTIMA Trichomonas vaginalis Assay on TIGRIS
• B. Predicate 510(k) Number:

K102911

• C. Comparison with Predicate:

Similarities
Item	ATV Assay (Version 2)
Device	ATV Assay (K102911)
Predicate
Device Class	2	same
Qualitative
/Quantitative Assay	Qualitative	same
Intended Use	NAAT test for detection of
Trichomonas vaginalis
ribosomal RNA (rRNA)	same
Technology	Target Capture(TC)
Transcription Mediated
Amplification(TMA)
Hybridization Protection
Assay (HPA)	same

Differences
Item	ATV Assay (Version 2) Device	ATV Assay (K102911) Predicate
Formulation	Original Formulation plus additional oligo in TCR	Original Formulation
Platform	PANTHER	TIGRIS
Specimen Types	Three (3) Female specimen types:
• Vaginal swab
• Endocervical swab
• ThinPrep in PreservCyt solution	Four (4) Female specimen types:
• Urine
• Vaginal swab
• Endocervical swab
• ThinPrep in PreservCyt solution

4

K. Standard/ Guidance Document Referenced

EN 13640:2002 - Stability Testing of In-Vitro Diagnostic Medical Devices

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

EP15-A2, 2006 - User Verification of Performance for Precision and Trueness, CLSI Approved Guideline

EP07-A2, 2005 - Interference Testing in Clinical Chemistry, Approved Guideline

Format for Traditional and Abbreviated 510(k)s - Guidance for Industry and FDA Staff, August 2005

General Principles of Software Validation, Final Guidance for Industry and FDA Staff, January 2002

The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], Draft Guidance for Industry and FDA Staff, Dec. 27, 2011.

L. Test Principle

The ATV 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

1. Analytical Performance

Precision/Reproducibility a.

The precision of the ATV Assay (Version.2) on PANTHER was evaluated in-house by multiple operators who performed multiple runs over multiple days with three different reagent lots on three different PANTHER Systems.

5

A 4-member reproducibility panel was prepared in PreservCyt (ThinPrep) liquid cytology specimen-STM matrix (1:2.9). PreservCyt sample pools were screened with the ATV Assay to confirm that 7. vaginalis was not present. The pools were then spiked with T. vaginalis lysate to produce high negative (expected positivity: >0% and /= 2400 |

*If the RLU measured on the PANTHER System is 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.

6

ﻥ ﺍ Traceability, Stability, Expected Values (controls, calibrators or methods)

Data to support the recommended shipping and storage conditions for the vaginal swab and PreservCyt liquid Pap were generated with negative clinical specimens spiked with T. vaginalis. Greater than 98% positivity was observed in both matrices 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 rRNA.

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

*If the RLU measured on the PANTHER System is 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.

2. Comparison Studies

• Performance characterization relative to an established patient-infected status a. algorithm.
  See 3 (a) below

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• b. Matrix comparison
  N/A

3. Clinical Studies

a. Clinical Performance (Clinical Sensitivity and Specificity)

Clinical performance of the ATV Assay on the PANTHER System was evaluated using leftover specimens collected from consenting subjects during a previous, prospective, multicenter clinical study of the ATV Assay on the TIGRIS DTS System. Symptomatic and asymptomatic women were enrolled from 9 US clinical sites, including obstetrics and gynecology, family planning, and STD clinics. Three (3) vaginal swabs, 1 endocervical swab, and 1 PreservCyt Solution liquid Pap specimen were collected from each subject. All specimens were clinician-collected.

PreservCyt liquid Pap specimens were collected with a broom-type device or a spatula and cytobrush. Two of the vaginal swab specimens were tested with a commercially available culture system and wet mount microscopic examination to establish infected status. The remaining specimens were prepared for APTIMA Trichomonas vaginalis Assay testing in accordance with the appropriate APTIMA specimen collection kit package insert instructions.

PANTHER System testing with the APTIMA Trichomonas vaginalis Assay was conducted at 3 sites (2 external laboratories and Gen-Probe) in accordance with package insert instructions.

Performance characteristics of the APTIMA Trichomonas vaginalis Assay were estimated by comparing results to a patient infected status algorithm. In the algorithm, the designation of a subject as being infected or non-infected with 7. vaginalis was based on results from vaginal swab specimens tested by culture and/or wet mount microscopic examination. At least one of the reference test results was required to be positive to establish an infected patient status. Both reference tests were required to be negative to establish a non-infected patient status.

Twenty-three (23) APTIMA Trichomonas vaginalis Assay runs were initiated on the PANTHER System. Of these 23 runs, 1 (4.3%, 1/23) was aborted due to a fatal hardware error that led to a software failure. Specimens tested in the aborted run were retested. A total of 689 vaginal swab, 737 endocervical swab, and 791 PreservCyt Solution liquid Pap specimens were tested in the 22 valid runs. Of these specimens, 12 vaginal swab (1.7%, 12/689), 24 endocervical swab (3.3%, 24/737), and 29 PreservCyt Solution liquid Pap (3.7%, 29/791) specimens had initial invalid results due to hardware or software errors. Specimens with initial invalid results were retested. Eleven (11) vaginal swab (1.6%, 11/689), 24 endocervical swab (3.3%, 24/737), and 1 PreservCyt Solution liquid Pap (0.1%, 1/791) specimens had final invalid results due to hardware or software errors; these specimens were excluded from the analyses.

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Results below show the sensitivity, specificity, positive value (PPV), and negative predictive value (NPV) of the ATV Assay and the prevalence of T. vaginalis in each specimen type. Performance was comparable across specimen types.

Table 2 below shows the sensitivity, specificity, PPV, and NPV of the APTIMA Trichomonas vaginalis Assay on the PANTHER System and the prevalence of T. vaginalis (based on the infected status) in each specimen type by symptom status and overall. Subjects were classified as symptomatic if symptoms were reported by the subjects were classified as asymptomatic if the subject did not report symptoms. Prevalence was higher in symptomatic women.

| Specimen
Type | Symptom
Status | n | TP | FP1 | TN | FN | Prev % | Sensitivity %
(95% CI)2 | Specificity %
(95% CI)2 | PPV %
(95% CI)3 | NPV %
(95% CI)3 |
|------------------|-------------------|-----|----|-----|-----|----|--------|----------------------------|----------------------------|---------------------|--------------------|
| CVS | Asymptomatic | 274 | 12 | 7a | 255 | 0 | 4.4 | 100
(75.8-100) | 97.3
(94.6-98.7) | 63.2
(45.8-80.9) | 100
(98.9-100) |
| | Symptomatic | 393 | 57 | 4b | 332 | 0 | 14.5 | 100
(93.7-100) | 98.8
(97.0-99.5) | 93.4
(84.9-98.1) | 100
(98.9-100) |
| | All | 667 | 69 | 11c | 587 | 0 | 10.3 | 100
(94.7-100) | 98.2
(96.7-99.0) | 88.3
(77.9-92.8) | 100
(99.4-100) |
| ES | Asymptomatic | 309 | 16 | 5d | 288 | 0 | 5.2 | 100
(80.6-100) | 98.3
(96.1-99.3) | 76.2
(58.1-90.8) | 100
(98.9-100) |
| | Symptomatic | 391 | 51 | 7e | 333 | 0 | 13.0 | 100
(93.0-100) | 97.9
(95.8-99.0) | 87.9
(78.1-94.7) | 100
(99.0-100) |
| | All | 700 | 67 | 12f | 621 | 0 | 9.6 | 100
(94.6-100) | 98.1
(96.7-98.9) | 84.8
(76.3-91.5) | 100
(99.4-100) |
| PCyt | Asymptomatic | 333 | 19 | 2g | 312 | 0 | 5.7 | 100
(83.2-100) | 99.4
(97.7-99.8) | 90.5
(72.6-98.7) | 100
(98.9-100) |
| | Symptomatic | 441 | 64 | 8h | 369 | 0 | 14.5 | 100
(94.3-100) | 97.9
(95.9-98.9) | 88.9
(80.4-94.9) | 100
(99.1-100) |
| | All | 774 | 83 | 10i | 681 | 0 | 10.7 | 100
(95.6-100) | 98.6
(97.4-99.2) | 89.2
(82.0-94.5) | 100
(99.5-100) |

Table 2 - PANTHER System: Performance Characteristics of the APTIMA Trichomonas
vaginalis Assay by Symptom Status

Cl = confidence interval, CVS = dinician-collected vagin.al swab, FN = false negative, FP = false positive, PCyt = PreservCyt Solution liquid Pap, Prev = prevalence, TN = true negative, TP = true positive,

17. vaginalis NAAT results from a previous study (# positive results / # samples tested): a: 47. b: 34. c: 7/11. d 1/5, e: 2/7, f. 3/12 g: 0/2, h: 3/8, i: 3/10.

Score confidence interval

IPPV 95% confidence interval computed from the exact for the positive likelinod rato, NPV 95% confidence interval computed from the exact 95% confidence interval from the negative likelihood ratio

11

APTIMA Trichomonas vaginalis Assay

Table 3 below shows the sensitivity, specificity, PPV, and NPV of the APTIMA Trichomonas vaginalis Assay on the PANTHER System and the prevalence of T. vaginalis (based on the infected status) in each specimen type by collection site. For each specimen type, performance was similar across collection sites. Prevalence varied across collection sites, as expected.

Table 3: Performance Characteristics of the APTIMA Trichomonas vaginalis Assay by Collection Site

| Site | Specimen
Type | n | TP | FP | TN | FN | Prev % | Sensitivity
(95% CI)¹ | Specificity
(95% CI)¹ | PPV %
(95% CI)² | NPV %
(95% CI)² |
|------|------------------|-----|----|----|-----|----|--------|--------------------------|--------------------------|--------------------|--------------------|
| 1 | CVS | 52 | 8 | 1 | 43 | 0 | 15.4 | 100 (67.6-100) | 97.7 (88.2-99.6) | 88.9 (60.2-99.7) | 100 (93.7-100) |
| 1 | ES | 53 | 9 | 2 | 42 | 0 | 17.0 | 100 (70.1-100) | 95.5 (84.9-98.7) | 81.8 (56.9-97.4) | 100 (93.5-100) |
| 1 | PCyt | 59 | 11 | 0 | 48 | 0 | 18.6 | 100 (74.1-100) | 100 (92.6-100) | 100 (75.6-100) | 100 (93.9-100) |
| 2 | CVS | 52 | 3 | 1 | 48 | 0 | 5.8 | 100 (43.9-100) | 98.0 (89.3-99.6) | 75.0 (28.5-99.2) | 100 (95.8-100) |
| 2 | ES | 56 | 4 | 1 | 51 | 0 | 7.1 | 100 (51.0-100) | 98.1 (89.0-99.7) | 80.0 (40.5-99.4) | 100 (95.6-100) |
| 2 | PCyt | 68 | 5 | 0 | 63 | 0 | 7.4 | 100 (58.6-100) | 100 (94.3-100) | 100 (58.3-100) | 100 (96.0-100) |
| 3 | CVS | 12 | 2 | 0 | 10 | 0 | 16.7 | 100 (34.2-100) | 100 (72.2-100) | 100 (32.1-100) | 100 (85.6-100) |
| 3 | ES | 16 | 2 | 0 | 14 | 0 | 12.5 | 100 (34.2-100) | 100 (78.5-100) | 100 (31.5-100) | 100 (89.3-100) |
| 3 | PCyt | 17 | 2 | 1 | 14 | 0 | 11.8 | 100 (34.2-100) | 93.3 (70.2-98.8) | 66.7 (19.9-98.8) | 100 (89.5-100) |
| 4 | CVS | 41 | 7 | 1 | 33 | 0 | 17.1 | 100 (64.6-100) | 97.1 (85.1-99.5) | 87.5 (57.3-99.6) | 100 (92.2-100) |
| 4 | ES | 41 | 7 | 0 | 34 | 0 | 17.1 | 100 (64.6-100) | 100 (89.8-100) | 100 (66.7-100) | 100 (92.2-100) |
| 4 | PCyt | 43 | 7 | 1 | 35 | 0 | 16.3 | 100 (64.6-100) | 97.2 (85.8-99.5) | 87.5 (57.2-99.6) | 100 (92.6-100) |
| 5 | CVS | 145 | 1 | 0 | 144 | 0 | 0.7 | 100 (20.7-100) | 100 (97.4-100) | 100 (6.4-100) | 100 (99.3-100) |
| 5 | ES | 162 | 1 | 0 | 161 | 0 | 0.6 | 100 (20.7-100) | 100 (97.7-100) | 100 (6.4-100) | 100 (99.4-100) |
| 5 | PCyt | 167 | 1 | 0 | 166 | 0 | 0.6 | 100 (20.7-100) | 100 (97.7-100) | 100 (6.4-100) | 100 (99.4-100) |
| 6 | CVS | 67 | 10 | 2 | 55 | 0 | 14.9 | 100 (72.2-100) | 96.5 (89.1-99.0) | 83.3 (59.2-98.2) | 100 (94.8-100) |
| 6 | ES | 80 | 13 | 4 | 63 | 0 | 18.3 | 100 (77.2-100) | 94.0 (85.6-97.7) | 76.5 (57.1-92.2) | 100 (95.3-100) |
| 6 | PCyt | 92 | 20 | 3 | 69 | 0 | 21.7 | 100 (83.9-100) | 95.8 (88.5-98.6) | 87.0 (70.4-97.0) | 100 (95.5-100) |
| 7 | CVS | 173 | 18 | 3 | 152 | 0 | 10.4 | 100 (82.4-100) | 98.1 (94.5-99.3) | 85.7 (67.7-96.7) | 100 (97.9-100) |
| 7 | ES | 161 | 12 | 3 | 146 | 0 | 7.5 | 100 (75.8-100) | 98.0 (94.2-99.3) | 80.0 (58.3-95.4) | 100 (97.9-100) |
| 7 | PCyt | 194 | 18 | 4 | 172 | 0 | 9.3 | 100 (82.4-100) | 97.7 (94.3-99.1) | 81.8 (64.1-94.3) | 100 (98.1-100) |
| 8 | CVS | 80 | 10 | 2 | 68 | 0 | 12.5 | 100 (72.2-100) | 97.1 (90.2-99.2) | 83.3 (59.0-98.2) | 100 (95.8-100) |
| 8 | ES | 83 | 9 | 2 | 72 | 0 | 10.8 | 100 (70.1-100) | 97.3 (90.7-99.3) | 81.8 (56.3-97.4) | 100 (96.1-100) |
| 8 | PCyt | 88 | 9 | 0 | 77 | 0 | 10.5 | 100 (70.1-100) | 100 (95.2-100) | 100 (71.4-100) | 100 (96.2-100) |
| 9 | CVS | 45 | 10 | 1 | 34 | 0 | 22.2 | 100 (72.2-100) | 97.1 (85.5-99.5) | 90.9 (65.7-99.7) | 100 (91.9-100) |
| 9 | ES | 48 | 10 | 0 | 38 | 0 | 20.8 | 100 (72.2-100) | 100 (90.8-100) | 100 (74.0-100) | 100 (92.5-100) |
| 9 | PCyt | 48 | 10 | 1 | 37 | 0 | 20.8 | 100 (72.2-100) | 97.4 (86.5-99.5) | 90.9 (65.6-99.7) | 100 (92.5-100) |

Cl = confidence interval, CVS = cirician-collected vaginal swab, ES = endocervical swab, FN = false positive, PCyt = PreservCyt Solution liquid Pap. Prev = prevalence. TN = true negative, TP = true positive.

'Score confidence interval.

PPV 95% confidence interval computed from the exact 85% confidence interval for the positive likelihood ratio. NPV 95% confidence interval computed from the exact 95% confidence interval from the negative likelihood ratio

12

Table 4 shows the sensitivity, specificity, PPV, and NPV of the APTIMA Trichomonas vaginalis Assay on the PANTHER System and the prevalence of 7. vaginalis (based on the infected status) in PreservCyt Solution liquid Pap specimens by cervical collection device. For PreservCyt Solution liquid Pap specimens, performance was similar across collection devices.

Table 4: Performance Characteristics of the APTIMA Trichomonas vaginalis Assay in PreservCyt Solution Liquid Pap Specimens by Collection Device Type

| Collection Device | n | TP | FP | TN | FN | Prev % | Sensitivity
(95% CI)1 | Specificity
(95% CI)1 | PPV %
(95% CI)2 | NPV %
(95% CI)2 |
|-------------------|-----|----|----|-----|----|--------|--------------------------|--------------------------|--------------------|--------------------|
| Broom-type Device | 414 | 54 | 5 | 355 | 0 | 13.0 | 100 (93.4-100) | 98.6 (96.8-99.4) | 91.5 (82.4-97.1) | 100 (99.0-100) |
| Spatula/Cytobrush | 360 | 29 | 5 | 326 | 0 | 8.1 | 100 (88.3-100) | 98.5 (96.5-99.4) | 85.3 (71.5-94.7) | 100 (99.0-100) |

Cl = confidence interval, FN = false positive, Prev = prevalence, TN = true negative, TP = true positive, Score confidence interval.

f PPV 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.

Agreement of APTIMA Trichomas vaginalis Assay Results on the PANTHER System and the TIGRIS DTS System

It is recognized that device performance in an asymptomatic population is essential since the majority of individuals infected with Trichomonas vaginalis do not have symptoms. To further characterize performance of the assay in asymptomatic subjects, agreement between APTIMA Trichomonas vaginalis Assay results on the PANTHER System and the TIGRIS DTS System was assessed using prospectively collected specimens from asymptomatic subjects. Women were enrolled from 6 US clinical sites, including obstetrics and gynecology, family planning, and STD clinics. One (1) vaginal swab, 1 endocervical swab, and 1 PreservCyt Solution liquid Pap specimen were collected from each subject. All specimens were clinician-collected. PreservCyt liquid Pap specimens were collected with a broom-type device or a spatula and cytobrush.

APTIMA Trichomonas vaginalis Assay testing was conducted in accordance with the package insert instructions. PANTHER System testing was conducted at 3 sites (2 external laboratories and Gen-Probe). TIGRIS DTS System testing was conducted at Gen-Probe.

Eighteen (18) APTIMA Trichomonas vaginalis Assay runs were initiated on the PANTHER System; all were valid. A total of 227 vaginal swab, 227 endocervical swab, and 227 PreservCyt Solution liquid Pap specimens were tested. Of these specimens, 1 vaginal swab specimen (0.4%, 1/227) had an initial invalid result due to hardware error. The specimen with an initial invalid result was retested and had a valid result.

Of the samples with final valid APTIMA Trichomonas vaginalis Assay results on the PANTHER System, 227 vaginal swab, 227 endocervical swab, and 226 PreservCyt Solution liquid Pap o specimens had valid, paired results on the TIGRIS DTS System.

13

Table 5 shows positive and negative percent agreements of APTIMA Trichomonas vaginalis Assay results on the PANTHER System and the TIGRIS DTS System in each specimen type for asymptomatic subjects.

| Specimen
Type | n | TIGRIS +
PANTHER + | TIGRIS -
PANTHER + | TIGRIS -
PANTHER - | TIGRIS +
PANTHER - | TIGRIS
Positivity | % Positive
Agreement
(95% CI)2 | % Negative
Agreement
(95% CI)2 |
|------------------|-----|-----------------------|-----------------------|-----------------------|-----------------------|----------------------|--------------------------------------|--------------------------------------|
| CVS1 | 227 | 29 | 5 | 191 | 2 | 13.7 | 93.5 (79.3-98.2) | 97.4 (94.2-98.9) |
| ES | 227 | 28 | 1 | 198 | 0 | 12.3 | 100 (87.9-100) | 99.5 (97.2-99.9) |
| PCyt | 228 | 26 | 1 | 199 | 0 | 11.5 | 100 (87.1-100) | 99.5 (97.2-99.9) |

Table 5: Agreement between APTIMA Trichomonas vaginalis Assay Results on the
PANTHER System and the TIGRIS DTS System in Asymptomatic Subjects

positive, - = negative, Cl = comfidence interval, CVS = clinician-collected vaginal swab, ES = PreservCyt Solution liquid Pap.

The 2 vaginal swab samples with positive APTIMA Trichomonas vaginalis Assay results on the TIGRIS DTS System and negative results on the PANTHER System were from subjects whose other samples had negative results on both the PANTHER System and the TIGRIS DTS System.

2 Score confidence interval.

b.) Clinical Reproducibility:

The ATV Assay (Version 2) testing was conducted at 3 sites (in-house and 2 external) on the PANTHER System. Six operators, 2 at each site, performed reproducibility testing using 2 reagent lots over a period of at least 6 days. Four reproducibility panel members were prepared using a representative specimen matrix. The panels consisted of Trichomonas vaginalis negative and positive specimens prepared in PreservCyt solution. The panels included negative, high negative, moderate positive, and high positive samples. Identical panels were tested on 1 PANTHER System at each test site. Each run contained 3 replicates of each reproducibility panel member (12 PreservCyt samples total). Results are shown in the chart below (Table 6).

14

| Conc | Target
Conc
(TV/mL) | N | Agmt
(%) | Mean
RLU | Between Sites | | Between
Operators | | Between Lots | | Between Runs | | Within Runs | | Totals | |
|------|---------------------------|-----|-------------|-------------|---------------|--------|----------------------|--------|--------------|--------|--------------|--------|-------------|--------|--------|--------|
| | | | | | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) |
| Neg | N/A | 108 | 99.1 | 23.5 | 0.0 | 0.0 | 2.7 | 11.6 | 0.0 | 0.0 | 0.0 | 0.0 | 37.5 | 159.7 | 37.6 | 160.1 |
| HNeg | 0.003 | 108 | 90.7 | 69.3 | 5.0 | 7.3 | 4.5 | 6.5 | 6.1 | 8.8 | 14.8 | 21.4 | 16.0 | 23.1 | 23.6 | 34.1 |
| MPos | 0.02 | 108 | 97.2 | 348.1 | 30.3 | 8.7 | 33.1 | 9.5 | 33.1 | 9.5 | 77.0 | 22.1 | 62.9 | 18.1 | 114.0 | 32.8 |
| HPos | 1.00 | 108 | 100 | 1185.5 | 0.0 | 0.0 | 17.0 | 1.4 | 0.0 | 0.0 | 28.0 | 2.4 | 34.2 | 2.9 | 47.4 | 4.0 |

Table 6 - APTIMA Trichomas vaginalis Assay Reproducibility Study

Agmt = agreement, Conc = concentration, CV = coefficient of variation, HNeg = high negative, HPos = high positive,

MPos = moderate positive, Neg = negative, RLU = relative light units, SD = standard deviation.

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 have been numerically negative. This occurred if the variability due to those factors was very small. In these cases, SD and CV are shown as 0.

c. Expected Values and 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.

The positivity rate for the ATV Assay (Version 2) by specimen type, collection site and overall was 11.8% (80/678) for vaginal swabs, 11.2% (80/713) for endocervical swabs and 11.8% (93/790) for PreservCyt specimens.

N. Instrument Name

The PANTHER System

15

O. System Descriptions:

• Modes of Operation a. Batch, random access
• b. Specimen Identification

By handheld barcode reader and positional checks

• Specimen Sampling and Handling C.
  Fully Automated

• d. Calibration
  Gen-Probe Field Service Engineers perform a luminometer calibration on the PANTHER System every 12 months as part of the Preventive Maintenance. Also. there are process controls and calibration checks on all of the dispenses, thermal devices, and the vacuum system.

• e. Quality Control
  In addition to the assay controls that are specific to each assay, the PANTHER System contains process controls that employ both hardware and software components. The process controls include, but are not limited to:

• Verification that the sequence of assay processing steps is correct for each . reaction.

• . Verification that the reaction incubation times and temperatures are correct.

• . Verification that reagents and fluids were appropriately dispensed.

P. Conclusion

The submitted information in this premarket notification demonstrates that the APTIMA Trichomonas vaginalis Assay on the PANTHER System is substantially equivalent to the predicate device.

16

Image /page/16/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

JAN 0-9 2013

Gen-Probe Incorporated C/O Maria Carmelita S. Baluyot 10210 Genetic Center Drive San Diego, CA 92121-4362

Re: K122062

Trade/Device Name: APTIMA® Trichomonas vaginalis Assay (PANTHER® System) Regulation Number: 21 CFR 866.3860 Regulation Name: Trichomonas vaginalis Nucleic Acid Amplification Test System Regulatory Class: Class II Product Code: OUY Dated: December 27, 2012 Received: December 28, 2012

Dear Ms. Baluyot:

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), 2 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

17

Page 2 - Maria Carmelita S. Baluyot

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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sally A. Hojvat

Sally A. Hojvat, MSc., PhD. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

18

Indications for Use Form

510(k) Number (if known): K122062

Device Name: APTIMA® Trichomonas vaginalis Assay (PANTHER® System) 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 PANTHER System.

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

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

Tamara Veldblbly

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K122062

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