AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

K070172 · Roche Diagnostics Corporation · LSL · Apr 17, 2007 · Microbiology

Device Facts

• Record ID: K070172
• Device Name: AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
• Applicant: Roche Diagnostics Corporation
• Product Code: LSL · Microbiology
• Decision Date: Apr 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3390
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The AMPLICOR CT/NG test for Neisseria gonorrhoeae is a qualitative in vitro test for the detection of N. gonorrhoeae DNA in urine from symptomatic or asymptomatic males, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens from symptomatic males as evidence of infection with N. gonorrhoeae. N. gonorrhoeae DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target. Sample and control preparation can either be accomplished manually or automated using the optional Roche Scripts for AMPLICOR CT/NG Test Accessory to direct the Tecan Genesis RSP 150 Workstation. Urine specimens are not indicated for use with the automated sample preparation option. The Roche Scripts for AMPLICOR CT/NG Test are intended to provide software scripts to direct the automated Tecan Genesis RSP 150 workstation to process swab samples or control material for analysis using either of the following four 510(k)-cleared assay test systems: AMPLICOR ® CT/NG test for Chlamydia trachomatis AMPLICOR ® CT/NG test for Neisseria gonorrhoeae

Device Story

The AMPLICOR CT/NG test detects N. gonorrhoeae DNA via PCR amplification and hybridization capture using the AMPLICOR analyzer. The Roche Scripts accessory provides software to automate specimen/control preparation on the Tecan Genesis RSP 150 Workstation. The system is used in clinical laboratory settings by trained technicians. The automated workflow replaces manual preparation for swab samples, streamlining processing while maintaining equivalent analytical and clinical performance. Healthcare providers use the qualitative results to diagnose N. gonorrhoeae infections, facilitating timely clinical decision-making and patient management.

Clinical Evidence

Prospective method comparison study (n=288 valid datasets) compared automated vs. manual specimen preparation against culture. Overall concordance 99.0% (95% CI: 97.0%–99.8%). Positive agreement 98.5%, negative agreement 99.4%. Precision study (n=693 replicates) showed 99.4% overall precision for automated method. Cross-contamination study showed 0.3% false positive rate for automated vs 1.6% for manual (not statistically significant). Analytical sensitivity (LoD) for automated method is 100 CFU/mL.

Technological Characteristics

The device utilizes PCR amplification and hybridization capture. The Roche Scripts accessory is software (scripts) for the Tecan Genesis RSP 150 Workstation. The system is designed for in vitro diagnostic use in clinical laboratories. It supports manual or automated specimen preparation. The automated workflow is restricted to swab samples.

Indications for Use

Indicated for detection of N. gonorrhoeae DNA in symptomatic/asymptomatic males (urine, urethral swabs) and symptomatic/asymptomatic females (endocervical swabs). Automated preparation is restricted to swab samples only; urine is excluded from automated processing.

Regulatory Classification

Identification

Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identify Neisseria spp. from cultured isolates. Additionally, some of these reagents consist of Neisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence of Neisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, 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.

Predicate Devices

• AMPLICOR™ CT/NG test for Neisseria gonorrhoeae (k974503)

Submission Summary (Full Text)

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# 510(k) Summary – AMPLICOR CT/NG test for Neisseria gonorrhoeae with Roche Scripts for AMPLICOR CT/NG Test Accessory

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter<br>name, address,<br>contact | Roche Diagnostics<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone] |
| | Contact person: Theresa A Bush<br>Date prepared: Jan 17, 2007 |
| Device Name | Proprietary Name: AMPLICOR CT/NG test for Neisseria gonorrhoeae;<br>Roche Scripts for use on the Tecan Genesis RSP 150 Workstation (Roche<br>Scripts Accessory) |
| | Common name: Neisseria gonorrhoeae test system ; software accessory |
| | Classification name: DNA reagents, Neisseria |
| Device<br>Description | The AMPLICOR CT/NG test for Neisseria gonorrhoeae is a qualitative in<br>vitro test for the detection of N. gonorrhoeae DNA in urine from<br>symptomatic or asymptomatic males, in endocervical swab specimens from<br>symptomatic or asymptomatic females, and in urethral swab specimens from<br>sympotmatic males as evidence infection with N. gonorrhoeae. N.<br>gonorrhoeae DNA is detected by Polymerase Chain Reaction (PCR)<br>amplification of target DNA and by hybridization capture of amplified target<br>using the AMPLICOR analyzer. |
| | The Roche Scripts for AMPLICOR CT/NG Test accessory consists of a<br>compact disc (CDs) containing scripts to direct the automated Tecan Genesis<br>RSP 150 workstation to process swab samples or control material for<br>analysis. |

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# 510(k) Summary, Continued

:

| Intended use | The AMPLICOR CT/NG test for <i>Neisseria gonorrhoeae</i> is a qualitative <i>in vitro</i> test for the detection of <i>N. gonorrhoeae</i> DNA in urine from symptomatic or asymptomatic males, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens from sympotmatic males as evidence infection with <i>N. gonorrhoeae</i> . <i>N. gonorrhoeae</i> DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target using the AMPLICOR analyzer.<br><br>The Roche Scripts for AMPLICOR CT/NG Test are intended to provide software scripts to direct the automated Tecan Genesis RSP 150 Workstation to process swab samples or control material for analysis using either of the following 510(k)-cleared assay test systems:<br>• AMPLICOR ® CT/NG test for <i>Chlamydia trachomatis</i><br>• AMPLICOR ® CT/NG test for <i>Neisseria gonorrhoeae</i> | | |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Predicate Device | We claim equivalence to the currently marketed AMPLICOR CT/NG test for <i>Neisseria gonorrhoeae</i> cleared under K974503. | | |
| Comparison -<br>similarities | The table below shows the similarities between the AMPLICOR CT/NG test for <i>Neisseria gonorrhoeae</i> with optional Roche Scripts accessory and the predicate device: | | |
| | Feature | Predicate Device: K974503<br>AMPLICOR CT/NG test<br>for <i>Neisseria gonorrhoeae</i> | Current Device:<br>AMPLICOR CT/NG test<br>for <i>Neisseria gonorrhoeae</i><br>with optional Roche<br>Scripts accessory |
| | Product features | | |
| | | | |
| Intended use | The AMPLICOR CT/NG test<br>for Neisseria gonorrhoeae is a<br>qualitative <i>in vitro</i> test for the<br>detection of <i>N. gonorrhoeae</i><br>DNA in urine from<br>symptomatic or asymptomatic<br>males, in endocervical swab<br>specimens from symptomatic<br>or asymptomatic females, and<br>in urethral swab specimens<br>from symptomatic males as<br>evidence of infection with <i>N.<br/>gonorrhoeae</i> . <i>N. gonorrhoeae</i><br>DNA is detected by<br>Polymerase Chain Reaction<br>(PCR) amplification of target<br>DNA and by hybridization<br>capture of amplified target. | Same intended use for<br>AMPLICOR CT/NG test.<br><br>Roche Scripts for AMPLICOR<br>CT/NG Test: The Roche<br>Scripts for AMPLICOR<br>CT/NG Test are intended to<br>provide software scripts to<br>direct the automated Tecan<br>Genesis RSP 150 Workstation<br>to process swab samples or<br>control material for analysis<br>using either of the following<br>510(k)-cleared assay test<br>systems:<br>AMPLICOR ® CT/NG test<br>for Chlamydia trachomatis AMPLICOR ® CT/NG test<br>for Neisseria gonorrhoeae | |
| Test principle | DNA detection via PCR<br>amplification of target DNA<br>followed by hybridization<br>capture of amplified target<br>using the AMPLICOR<br>Analyzer | Same | |
| Controls provided | Positive control: plasmid<br>DNA from <i>N.<br/>gonorrhoeae</i><br>Negative control: plasmid<br>DNA from <i>C. trachomatis</i><br><br>Optional internal control:<br>plasmid DNA with CT<br>primer binding regions<br>and a unique probe<br>binding region | Same | |
| Labeled test performance | | | |
| Analytical specificity | Negative results from 130<br>bacteria, 6 fungal, 1<br>protozoan and 11 viral<br>strains. Some isolates<br>from <i>N. cinerea</i> and <i>N.<br/>subflava</i> may give false<br>positive results | Same | |
| Analytical sensitivity | 5 IFU/test; equivalent to 100 IFU/mL for urine specimens and 400 IFU/mL for Culture Transport Medium (CTM) with swab specimen) | Manual preparation:<br>Same<br>Automated preparation:<br>100 cfu/mL for CTM with swab specimen | |
| Precision | 100% correct results for panel of CTM specimens.<br>Three (out of 30) negative test results for one urine panel member. | Manual preparation:<br>Same<br>Automated preparation:<br>99.4% correct results for panels of CTM specimens | |
| Clinical performance | Sensitivity vs. culture:<br>• 95.9 % for females<br>• 96.5 % for males<br>Specificity vs. culture:<br>• 98.7 % for females<br>• 97.3 % for males<br>(with internal control) | Manual preparation:<br>Same<br>Automated preparation:<br>99.0% concordance with manual method | |

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## Premarket Notification 510(k), Continued

Comparison-The table below shows the differences between the AMPLICOR CT/NG test differences for Neisseria gonorrhoeae with optional Roche Scripts accessory and the predicate device:

| Feature | Predicate Device: K974503<br>AMPLICOR CT/NG test<br>for Neisseria gonorrhoeae | Current Device:<br>AMPLICOR CT/NG test<br>for Neisseria gonorrhoeae<br>with optional Roche<br>Scripts accessory |
|---------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Specimen and control<br>preparation options | Manual | • Manual<br>• Automated preparation<br>using the Roche Scripts to<br>direct the Tecan Genesis<br>RSP 150 Workstation |
| Specimen types | Male urine specimens;<br>endocervical and urethral<br>swabs | Manual: same<br>Automated preparation:<br>endocervical and urethral<br>swabs only (no urine<br>samples) |

#### Performance The Roche Scripts were developed and evaluated according to FDA Guidance evaluation documents.

The AMPLICOR CT/NG test for Neisseria gonorrhoeae with Roche Scripts accessory was evaluated for analytical performance characteristics including analytical sensitivity, cross-contamination, precision, and non-clinical specificity. Results were equivalent to those obtained with manual specimen preparation.

A clinical evaluation was performed where the results obtained using the AMPLICOR CT/NG test for Neisseria gonorrhoeae with automated specimen preparation using the Roche Scripts to direct the Tecan Genesis RSP 150 workstation were compared to results obtained with the manual specimen preparation method. Results were equivalent to those obtained with manual specimen preparation

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Tracy M. Ambrose Bush, PhD, RAC Regulatory Principal Regulatory Affairs Roche Diagnostics Corporation 9115 Hague Road Indianapolis, Indiana 46250

APR 1 7 2007

Re: k070172

Trade/Device Name: AMPLICOR™ CT/NG Test for Neisseria gonorrhoeae; Roche Scripts for AMPLICOR CT/NG Test (Roche Scripts Accessory) Regulation Number: 21 CFR 866.3390 Regulation Name: Neisseria species, Direct Serological Test Reagents Regulatory Class: Class II Product Code: LSL Dated: January 17, 2007 Received: January 18, 2007

Dear Dr. Bush:

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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Sally antone

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

Enclosure

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### Indications for Use

510(k) Number (if known): 〈〈○ フロイア 2

Device Name: AMPLICOR CT/NG test for Neisseria gonorrhoeae

Indications For Use:

The AMPLICOR CT/NG test for Neisseria gonorrhoeae is a qualitative in vitro test for the detection of N. gonorrhoeae DNA in urine from symptomatic or asymptomatic males, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens from symptomatic males as evidence of infection with N. gonorrhoeae. N. gonorrhoeae DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target.

Sample and control preparation can either be accomplished manually or automated using the optional Roche Scripts for AMPLICOR CT/NG Test Accessory to direct the Tecan Genesis RSP 150 Workstation Urine specimens are not indicated for use with the automated sample preparation option.

Prescription Use XXXX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sian-C

Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) kohd12

Page 1 of

Confidential

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### Indications for Use

12070172 510(k) Number (if known):

Device Name: Roche Scripts for AMPLICOR CT/NG Test Accessory

Indications For Use:

Roche Scripts for AMPLICOR CT/NG Test: The Roche Scripts for AMPLICOR CT/NG Test are intended to provide software scripts to direct the automated Tecan Genesis RSP 150 Workstation to process swab samples or control material for analysis using either of the following 510(k)-cleared assay test systems:

- AMPLICOR ® CT/NG test for Chlamydia trachomatis .
- AMPLICOR ® CT/NG test for Neisseria gonorrhoeae .

Prescription Use XXXX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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

Salh Umm
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of

510k) KO70172

Confidential

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