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

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.

Device Description

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. 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

This document focuses on the AMPLICOR CT/NG test for Chlamydia trachomatis with optional Roche Scripts for AMPLICOR CT/NG Test Accessory. The primary purpose of the Roche Scripts accessory is to automate the specimen preparation procedure for the existing AMPLICOR CT/NG test. The study therefore aims to demonstrate that the automated preparation method yields equivalent performance to the manual preparation method for the detection of C. trachomatis.

Here's the breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a quantitative format with specific thresholds to be met. Instead, it states that the performance characteristics were "evaluated" and "results were equivalent to those obtained with manual specimen preparation." The table below summarizes the listed performance characteristics from the "Comparison - similarities" section, indicating that these were similar or equivalent to the predicate device, which used manual preparation. For the "Current Device (automated preparation)" column, the provided values are the reported performance characteristics where they differ or are newly reported for the automated process.

Feature	Acceptance Criteria (Implied: Equivalent to Manual Preparation)	Reported Device Performance (Automated Preparation)
Analytical Sensitivity	1 IFU/test (manual)	20 IFU/mL for CTM with swab specimen
Precision	100% correct results (manual)	99.6% correct results for panels of CTM specimens
Clinical Performance	Sensitivity vs. culture: 94.1% (females), 92.9% (males) (manual)	98.5% concordance with manual method
	Specificity vs. culture: 98.4% (females), 94.7% (males) (manual)	(Not explicitly stated; implied to be covered by concordance)
Analytical Specificity	Negative results from a range of organisms (manual)	Same (implied)

Note: The phrase "Results were equivalent to those obtained with manual specimen preparation" in the "Performance Evaluation" section suggests the overarching acceptance criterion was non-inferiority or equivalence to the established manual method.

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

The document does not explicitly state the sample size used for the clinical evaluation test set where the automated preparation method was compared to the manual method. It only states "A clinical evaluation was performed".

Data Provenance: The document does not specify the country of origin. It is a premarket notification to the FDA, suggesting the studies were conducted to support US regulatory approval. The studies are retrospective, comparing the automated preparation method with the established manual preparation method.

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

This information is not provided in the document. For diagnostic tests like this, the 'ground truth' for clinical samples would typically be established by culture or a combination of clinical diagnosis and other accepted laboratory methods, not usually by a panel of experts reviewing images or results. The analytical studies would have ground truth established by known concentrations of organisms.

4. Adjudication Method for the Test Set

The document does not explicitly describe an "adjudication method" in the context of expert review. Clinical performance is assessed against a comparator (manual method and potentially culture), not through adjudicated expert consensus on each case.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically for image-based diagnostic aids where human readers interpret results. The AMPLICOR CT/NG test is an in vitro diagnostic test that provides a qualitative (positive/negative) result; therefore, an MRMC study is not applicable. The comparison here is between two sample preparation methods for the same assay.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is an in vitro diagnostic test for detecting DNA. The "Roche Scripts accessory" automates a part of the sample preparation process for an existing, already cleared assay. Therefore, the "algorithm" (scripts) performs an automated laboratory task, not an independent diagnostic interpretation that would involve a "human-in-the-loop" once the assay is run. The overall test is an "algorithm only" in the sense that the assay itself generates a direct result. The study effectively evaluated the standalone performance of the automated sample preparation system in generating results that are equivalent to manual preparation.

7. The Type of Ground Truth Used

For the analytical studies (analytical sensitivity, specificity, precision), the ground truth is established by known concentrations or presence/absence of C. trachomatis (or other organisms for specificity) in laboratory-prepared samples.

For the clinical evaluation, the ground truth for C. trachomatis infection status in patient samples is likely based on:

Comparison to the manual preparation method of the AMPLICOR CT/NG test itself (labeled as "98.5% concordance with manual method"). This serves as a reference for equivalence, assuming the manual method's clinical performance is validated.
The predicate device's clinical performance also references "Sensitivity vs. culture" and "Specificity vs. culture". This indicates that bacterial culture was a key ground truth method for validating the diagnostic accuracy of the PCR test itself.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. This is a premarket submission for an in vitro diagnostic (IVD) device, where the focus is on validation and verification of analytical and clinical performance through predefined studies, not typically on machine learning model training. The "Roche Scripts" are software for automation, not an AI/ML diagnostic algorithm that would require a distinct training phase.

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

As there is no distinct "training set" in the context of an AI/ML model for this IVD device (the scripts automate a lab process), the concept of ground truth for a training set does not directly apply here. The existing knowledge and performance characteristics of the manual AMPLICOR CT/NG test would have informed the development and optimization of the automated scripts to ensure equivalent performance.

Summary

{0}------------------------------------------------

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 (317) 521-3723 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.

Continued on next page

{1}------------------------------------------------

510(k) Summary, Continued

1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -

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. 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 trachomatisAMPLICOR® CT/NG test for Neisseria gonorrhoeae
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:

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. 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 trachomatisAMPLICOR® CT/NG test for Neisseria gonorrhoeae

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:

{2}------------------------------------------------

Feature	Predicate Device: K973707AMPLICOR CT/NG testfor Chlamydia trachomatis	Current Device:AMPLICOR CT/NG testfor Chlamydia trachomatiswith optional RocheScripts accessory
Product features
Intended use	The AMPLICOR CT/NGtest for Chlamydiatrachomatis is a qualitativein vitro test for the detectionof C. trachomatis DNA inurine from symptomatic orasymptomatic males, inendocervical swabspecimens fromsymptomatic orasymptomatic females, andin urethral swab specimensfrom symptomatic males asevidence of infection withC. trachomatis. C.trachomatis DNA is detectedby Polymerase ChainReaction (PCR)amplification of target DNAand by hybridization captureof amplified target.	Same intended use forAMPLICOR CT/NG test.Roche Scripts forAMPLICOR CT/NG Test:The Roche Scripts forAMPLICOR CT/NG Testare intended to providesoftware scripts to direct theautomated Tecan GenesisRSP 150 Workstation toprocess swab samples orcontrol material for analysisusing either of the following510(k)-cleared assay testsystems:• AMPLICOR ® CT/NGtest for Chlamydiatrachomatis• AMPLICOR ® CT/NGtest for Neisseriagonorrhoeae
Test principle	DNA detection via PCRamplification of target DNAfollowed by hybridizationcapture of amplified targetusing the AMPLICORAnalyzer	Same
Feature	Predicate Device: K973707AMPLICOR CT/NG testfor Chlamydia trachomatis	Current Device:AMPLICOR CT/NG testfor Chlamydia trachomatiswith optional RocheScripts accessory
Controls provided	Positive control: plasmidDNA from C. trachomatisNegative control: plasmidDNA from N.gonorrhoeaeOptional internal control:plasmid DNA with CTprimer binding regionsand a unique probebinding region	Same
Labeled test performance
Analytical specificity	Negative results from 133bacteria, 6 fungal, 1protozoan and 11 viralstrains.	Same
Analytical sensitivity	1 IFU/test; equivalent to 20IFU/mL for urinespecimens and 80IFU/mL for CultureTransport Medium(CTM) with swabspecimen)	Manual preparation:SameAutomated preparation:20 IFU/mL for CTM withswab specimen
Precision	100% correct results forpanels of CTM and urinespecimens.	Manual preparation:SameAutomated preparation:99.6% correct results forpanels of CTM specimens
Clinical performance	Sensitivity vs. culture:• 94.1 % for females• 92.9 % for malesSpecificity vs. culture:• 98.4 % for females• 94.7 % for males(with internal control)	Manual preparation:SameAutomated preparation:98.5% concordance withmanual method
Feature	Predicate Device: K973707AMPLICOR CT/NG testfor Chlamydia trachomatis	Current Device:AMPLICOR CT/NG testfor Chlamydia trachomatiswith optional RocheScripts accessory
Specimen and controlpreparation options	Manual	• Manual or• 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)

Confidential

{3}------------------------------------------------

.....

.. .

{4}------------------------------------------------

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

{5}------------------------------------------------

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).

{6}------------------------------------------------

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, 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

{7}------------------------------------------------

510(k) Number (if known):

K070174

Device Name: AMPLICOR CT/NG test for Chlamydia trachomatis

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)

folleas

Vision Sign-Off

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

Confidential

{8}------------------------------------------------

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

Office of In Vitro Diagnostic Device Evaluation and Safety

Confidential

{9}------------------------------------------------

6070174 510(k) Number (if known):

Device Name: AMPLICOR CT/NG test for Chlamydia trachomatis

Indications For Use:

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)_

{10}------------------------------------------------

470174 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)

Wie Schif
Division Sign-Off

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

C13(k) K070174

Confidential

Regulation Number and Section

§ 866.3120 Chlamydia serological reagents.

(a)
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 genusChlamydia 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).(b)
Classification. Class I (general controls).