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.

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 .

Device Description

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 sympotmatic males as evidence 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 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.

AI/ML Overview

The document describes the AMPLICOR CT/NG test for Neisseria gonorrhoeae and the Roche Scripts for AMPLICOR CT/NG Test Accessory. The 'device' in question appears to be the Roche Scripts accessory which enables automated sample preparation for the existing AMPLICOR CT/NG test. The acceptance criteria and supporting studies focus on demonstrating that the automated sample preparation method (using the Roche Scripts) performs equivalently to the previously cleared manual sample preparation method.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated with numerical targets for the Roche Scripts accessory itself, but rather established through demonstrating equivalence to the performance of the predicate device (AMPLICOR CT/NG test for Neisseria gonorrhoeae with manual preparation). The acceptance is therefore implicitly based on demonstrating that the automated preparation method does not negatively impact the established performance characteristics.

Performance Characteristic	Predicate Device (Manual Preparation) Performance (Acceptance Criteria Based On)	Current Device (Automated Preparation with Roche Scripts) Performance
Analytical Sensitivity	5 IFU/test; equivalent to 100 IFU/mL for urine, 400 IFU/mL for CTM with swab	100 cfu/mL for CTM with swab specimen
Precision	100% correct results for CTM panel; 3/30 negative results for one urine panel member	99.4% correct results for panels of CTM specimens
Clinical Performance	Sensitivity vs. culture: 95.9% (females), 96.5% (males); Specificity vs. culture: 98.7% (females), 97.3% (males)	99.0% concordance with manual method
Analytical Specificity	Negative results from 130 bacteria, 6 fungal, 1 protozoan, 11 viral strains (some N. cinerea and N. subflava may give false positives)	Same (as expected since the assay chemistry is unchanged)
Cross-Contamination	Not explicitly quantified for predicate, but implied none.	Evaluation performed (results are stated as "equivalent to those obtained with manual specimen preparation")
Non-clinical Specificity	Not explicitly quantified for predicate, but implied no issues.	Evaluation performed (results are stated as "equivalent to those obtained with manual specimen preparation")

2. Sample Size Used for the Test Set and Data Provenance

Analytical Sensitivity (Automated preparation): The document states "100 cfu/mL for CTM with swab specimen" without specifying the number of samples used to determine this.
Precision (Automated preparation): "99.4% correct results for panels of CTM specimens" without specifying the number of CTM specimens or the total number of tests.
Clinical Evaluation (Automated vs. Manual): The sample size for the clinical evaluation comparing automated and manual methods is not explicitly stated. The data provenance (country of origin, retrospective/prospective) is not specified. However, the study involved comparing results from the automated method to the manual method, implying existing clinical samples or prospectively collected samples analyzed by both methods.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is an in vitro diagnostic device, and the ground truth for Neisseria gonorrhoeae infection is typically established via culture (a laboratory method), not by expert human interpretation of images or other subjective data. No experts for ground truth establishment are mentioned or implied.

4. Adjudication Method for the Test Set

Not applicable. As this is an in vitro diagnostic device, the results are quantitative/qualitative outputs from the assay, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is an in vitro diagnostic test system, not an AI-assisted diagnostic imaging or pathology tool involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device (Roche Scripts accessory) is essentially a standalone automation algorithm. Its performance is evaluated in a standalone manner by comparing its output (after automated sample prep) to the manual method's output. The "algorithm only" performance is represented by the "Automated preparation" columns in the table above and the clinical evaluation comparing automated vs. manual methods.

7. The Type of Ground Truth Used

For the original AMPLICOR CT/NG test (to which the new automated method is compared), the clinical performance ground truth was established "vs. culture." Culture is considered the gold standard for detecting viable Neisseria gonorrhoeae. For the evaluation of the Roche Scripts accessory, the "ground truth" for the clinical evaluation was implicitly the results obtained by the manual preparation method of the already cleared AMPLICOR CT/NG test, as the key objective was to show concordance.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model that undergoes a 'training phase' in the traditional sense. The "Roche Scripts" are software instructions for a liquid handling system; they were "developed" but not "trained" on a dataset like an AI algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. If "training set" refers to samples used during the development and optimization of the scripts, this information is not provided. The document states "The Roche Scripts were developed and evaluated according to FDA Guidance evaluation documents." This implies standard software development and verification procedures.

Summary

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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 informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence
Submittername, address,contact	Roche Diagnostics9115 Hague RdIndianapolis IN 46250(317) 521-3723
	Contact person: Theresa A BushDate prepared: Jan 17, 2007
Device Name	Proprietary Name: AMPLICOR CT/NG test for Neisseria gonorrhoeae;Roche Scripts for use on the Tecan Genesis RSP 150 Workstation (RocheScripts Accessory)
	Common name: Neisseria gonorrhoeae test system ; software accessory
	Classification name: DNA reagents, Neisseria
DeviceDescription	The AMPLICOR CT/NG test for Neisseria gonorrhoeae is a qualitative invitro test for the detection of N. gonorrhoeae DNA in urine fromsymptomatic or asymptomatic males, in endocervical swab specimens fromsymptomatic or asymptomatic females, and in urethral swab specimens fromsympotmatic males as evidence infection with N. gonorrhoeae. N.gonorrhoeae DNA is detected by Polymerase Chain Reaction (PCR)amplification of target DNA and by hybridization capture of amplified targetusing the AMPLICOR analyzer.
	The Roche Scripts for AMPLICOR CT/NG Test accessory consists of acompact disc (CDs) containing scripts to direct the automated Tecan GenesisRSP 150 workstation to process swab samples or control material foranalysis.

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510(k) Summary, Continued

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 sympotmatic males as evidence 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 using the AMPLICOR analyzer.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
Predicate Device	We claim equivalence to the currently marketed AMPLICOR CT/NG test for Neisseria gonorrhoeae cleared under K974503.
Comparison -similarities	The table below shows the similarities between the AMPLICOR CT/NG test for Neisseria gonorrhoeae with optional Roche Scripts accessory and the predicate device:
	Feature	Predicate Device: K974503AMPLICOR CT/NG testfor Neisseria gonorrhoeae	Current Device:AMPLICOR CT/NG testfor Neisseria gonorrhoeaewith optional RocheScripts accessory
	Product features

Intended use	The AMPLICOR CT/NG testfor Neisseria gonorrhoeae is aqualitative in vitro test for thedetection of N. gonorrhoeaeDNA in urine fromsymptomatic or asymptomaticmales, in endocervical swabspecimens from symptomaticor asymptomatic females, andin urethral swab specimensfrom symptomatic males asevidence of infection with N.gonorrhoeae . N. gonorrhoeaeDNA is detected byPolymerase Chain Reaction(PCR) amplification of targetDNA and by hybridizationcapture of amplified target.	Same intended use forAMPLICOR CT/NG test.Roche Scripts for AMPLICORCT/NG Test: The RocheScripts for AMPLICORCT/NG Test are intended toprovide software scripts todirect the automated TecanGenesis RSP 150 Workstationto process swab samples orcontrol material for analysisusing either of the following510(k)-cleared assay testsystems:AMPLICOR ® CT/NG testfor Chlamydia trachomatis AMPLICOR ® CT/NG testfor Neisseria gonorrhoeae
Test principle	DNA detection via PCRamplification of target DNAfollowed by hybridizationcapture of amplified targetusing the AMPLICORAnalyzer	Same
Controls provided	Positive control: plasmidDNA from N.gonorrhoeaeNegative control: plasmidDNA from C. trachomatisOptional internal control:plasmid DNA with CTprimer binding regionsand a unique probebinding region	Same
Labeled test performance
Analytical specificity	Negative results from 130bacteria, 6 fungal, 1protozoan and 11 viralstrains. Some isolatesfrom N. cinerea and N.subflava may give falsepositive 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:SameAutomated preparation:100 cfu/mL for CTM with swab specimen
Precision	100% correct results for panel of CTM specimens.Three (out of 30) negative test results for one urine panel member.	Manual preparation:SameAutomated preparation:99.4% correct results for panels of CTM specimens
Clinical performance	Sensitivity vs. culture:• 95.9 % for females• 96.5 % for malesSpecificity vs. culture:• 98.7 % for females• 97.3 % for males(with internal control)	Manual preparation:SameAutomated preparation: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: K974503AMPLICOR CT/NG testfor Neisseria gonorrhoeae	Current Device:AMPLICOR CT/NG testfor Neisseria gonorrhoeaewith optional RocheScripts accessory
Specimen and controlpreparation options	Manual	• Manual• Automated preparationusing the Roche Scripts todirect the Tecan GenesisRSP 150 Workstation
Specimen types	Male urine specimens;endocervical and urethralswabs	Manual: sameAutomated preparation:endocervical and urethralswabs only (no urinesamples)

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 (240)276-0450. 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 (800) 638-2041 or (301) 443-6597 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:

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:

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

Regulation Number and Section

§ 866.3390

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