AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY

K070174 · Roche Diagnostics Corporation · MKZ · Apr 16, 2007 · Microbiology

Device Facts

• Record ID: K070174
• Device Name: AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY
• Applicant: Roche Diagnostics Corporation
• Product Code: MKZ · Microbiology
• Decision Date: Apr 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3120
• Device Class: Class 1

Intended Use

The AMPLICOR CT/NG test for Chlamydia trachomatis is a qualitative in vitro test for the detection of C. trachomatis 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 C. trachomatis. C. trachomatis 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 device is an accessory consisting of software scripts for the Tecan Genesis RSP 150 workstation, used to automate the preparation of swab samples for the AMPLICOR CT/NG test. The system processes swab samples or control material by directing the workstation's liquid handling. The output is a prepared sample ready for PCR amplification and hybridization capture on the AMPLICOR analyzer. Used in clinical laboratory settings by trained technicians. The automation replaces manual sample preparation, improving workflow efficiency while maintaining equivalent analytical performance. Healthcare providers use the resulting qualitative test results to diagnose C. trachomatis infections, facilitating timely clinical decision-making and patient treatment.

Clinical Evidence

Prospective method comparison study (n=727, 682 valid sets) compared automated vs. manual preparation against culture. Overall concordance 98.5% (95% CI: 97.2-99.2%). Precision study (n=693 replicates) showed 99.6% overall precision for automated method vs 99.4% for manual. LoD determined as 20 IFU/mL for both methods. Cross-contamination study showed 0.5% false positive rate for automated vs 0.3% for manual (not statistically significant).

Technological Characteristics

System comprises Tecan Genesis RSP 150 workstation with Gemini v4.2 software and Roche Scripts accessory. Uses disposable pipet tips with aerosol barrier filters. Liquid handling controlled by microprocessor-based liquid class settings (aspiration/dispense rates, mixing). Connectivity: standalone workstation. Sterilization: N/A (reagents/consumables).

Indications for Use

Indicated for qualitative detection of C. trachomatis DNA in endocervical swabs (females) and urethral swabs (males), symptomatic or asymptomatic. Urine specimens are contraindicated for automated preparation. Prescription use only.

Regulatory Classification

Identification

Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Chlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).

Predicate Devices

• AMPLICOR™ CT/NG test for Chlamydia trachomatis (K973707)

Submission Summary (Full Text)

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## APR 1 6 2007

K070174

# 510(k) Summary - AMPLICOR CT/NG test for Chlamydia trachomatis with Roche Scripts for AMPLICOR CT/NG Test Accessorv

According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence Submitter Roche Diagnostics name, address, 9115 Hague Rd contact Indianapolis IN 46250 [phone] Contact person: Theresa A. Bush Date prepared: January 17, 2007 Device Name Proprietary Name: AMPLICOR CT/NG test for Chlamydia trachomatis: Roche Scripts for AMPLICOR CT/NG Test (Roche Scripts Accessory) Common name: Chlamydia trachomatis test system; software accessory Classification name: DNA probe, nucleic acid amplification, chlamydia The AMPLICOR CT/NG test for Chlamydia trachomatis is a qualitative in Device Description vitro test for the detection of C. trachomatis 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 infection with C. trachomatis. C. trachomatis DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target using the AMPLICOR analyzer. The Roche Scripts for AMPLICOR CT/NG Test accessory consists of a compact disc (CDs) containing scripts to direct the automated Tecan Genesis RSP 150 workstation to process swab samples or control material for analysis.

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# 510(k) Summary, Continued

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| Intended use | The AMPLICOR CT/NG test for Chlamydia trachomatis is a qualitative in vitro test for the detection of C. trachomatis 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 infection with C. trachomatis. C. trachomatis DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target using the AMPLICOR analyzer. <p> 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: </p> <ul><li>AMPLICOR® CT/NG test for Chlamydia trachomatis</li><li>AMPLICOR® CT/NG test for Neisseria gonorrhoeae</li></ul> |
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| Predicate Device | We claim equivalence to the currently marketed AMPLICOR CT/NG test for Chlamydia trachomatis cleared under K973707. |
| Comparison - similarities | The table below shows the similarities between the AMPLICOR CT/NG test for Chlamydia trachomatis with optional Roche Scripts accessory and the predicate device: |

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| Feature | Predicate Device: K973707<br>AMPLICOR CT/NG test<br>for Chlamydia trachomatis | Current Device:<br>AMPLICOR CT/NG test<br>for Chlamydia trachomatis<br>with optional Roche<br>Scripts accessory |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product features | | |
| Intended use | The AMPLICOR CT/NG<br>test for Chlamydia<br>trachomatis is a qualitative<br>in vitro test for the detection<br>of C. trachomatis DNA in<br>urine from symptomatic or<br>asymptomatic males, in<br>endocervical swab<br>specimens from<br>symptomatic or<br>asymptomatic females, and<br>in urethral swab specimens<br>from symptomatic males as<br>evidence of infection with<br>C. trachomatis. C.<br>trachomatis DNA is detected<br>by Polymerase Chain<br>Reaction (PCR)<br>amplification of target DNA<br>and by hybridization capture<br>of amplified target. | Same intended use for<br>AMPLICOR CT/NG test.<br><br>Roche Scripts for<br>AMPLICOR CT/NG Test:<br>The Roche Scripts for<br>AMPLICOR CT/NG Test<br>are intended to provide<br>software scripts to direct the<br>automated Tecan Genesis<br>RSP 150 Workstation to<br>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<br>test for Chlamydia<br>trachomatis<br>• AMPLICOR ® CT/NG<br>test for Neisseria<br>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 |
| Feature | Predicate Device: K973707<br>AMPLICOR CT/NG test<br>for Chlamydia trachomatis | Current Device:<br>AMPLICOR CT/NG test<br>for Chlamydia trachomatis<br>with optional Roche<br>Scripts accessory |
| Controls provided | Positive control: plasmid<br>DNA from C. trachomatis<br><br>Negative control: plasmid<br>DNA from N.<br>gonorrhoeae<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 133<br>bacteria, 6 fungal, 1<br>protozoan and 11 viral<br>strains. | Same |
| Analytical sensitivity | 1 IFU/test; equivalent to 20<br>IFU/mL for urine<br>specimens and 80<br>IFU/mL for Culture<br>Transport Medium<br>(CTM) with swab<br>specimen) | Manual preparation:<br>Same<br><br>Automated preparation:<br>20 IFU/mL for CTM with<br>swab specimen |
| Precision | 100% correct results for<br>panels of CTM and urine<br>specimens. | Manual preparation:<br>Same<br><br>Automated preparation:<br>99.6% correct results for<br>panels of CTM specimens |
| Clinical performance | Sensitivity vs. culture:<br>• 94.1 % for females<br>• 92.9 % for males<br>Specificity vs. culture:<br>• 98.4 % for females<br>• 94.7 % for males<br>(with internal control) | Manual preparation:<br>Same<br><br>Automated preparation:<br>98.5% concordance with<br>manual method |
| Feature | Predicate Device: K973707<br>AMPLICOR CT/NG test<br>for Chlamydia trachomatis | Current Device:<br>AMPLICOR CT/NG test<br>for Chlamydia trachomatis<br>with optional Roche<br>Scripts accessory |
| Specimen and control<br>preparation options | Manual | • Manual or<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) |

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# Premarket Notification 510(k), Continued

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

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

> The AMPLICOR CT/NG test for Chlamydia trachomatis 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 Chlamydia trachomatis 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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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Theresa Ambrose Bush, Ph.D., RAC Regulatory Affairs Principal Roche Diagnostics 9115 Hague Road P.O. Box 50416 Indianapolis, IN 452650-0416

APR 1 6 2007

Re: k070174

> Trade/Device Name: AMPLICOR CT/NG test for Chlamydia trachomatic Roche Scripts for AMPLICOR CT/NG Test Accessory Regulation Number: 21 CFR 866.3120 Regulation Name: Chlamydia Serological Reagents Regulatory Class: Class II Product Code: MKZ 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, author

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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510(k) Number (if known):

K070174

Device Name: AMPLICOR CT/NG test for Chlamydia trachomatis

Indications For Use:

The AMPLICOR CT/NG test for Chlamydia trachomatis is a qualitative in vitro test for the detection of C. trachomatis 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 infection with C. trachomatis. C. trachomatis 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)

folleas

Vision Sign-Off

Page 1 of Office of in Vitro Diagnostic Device Evaluation and Safety

Confidential

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510(k) Number (if known):

K070174

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

Indications For Use:

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

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)

Sally Hrynas
Division Sign-Off

Page I of

22

Office of In Vitro Diagnostic Device Evaluation and Safety

Confidential

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6070174 510(k) Number (if known):

Device Name: AMPLICOR CT/NG test for Chlamydia trachomatis

Indications For Use:

The AMPLICOR CT/NG test for Chlamydia trachomatis is a qualitative in vitro test for the detection of C. trachomatis 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 C. trachomatis. C. trachomatis 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)

Livision Si

Office of In Vitro Diagnostic Device Page 1 of | Evaluation and Safety

2070174 Confidential 3(k)_

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470174 510(k) Number (if known):

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

Indications For Use:

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 .

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)

Wie Schif
Division Sign-Off

Page 1 of Office of In Vitro Diagnostic Device Evaluation and Safety

C13(k) k070174

Confidential