The Roche Scripts for COBAS 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:

COBAS AMPLICOR™ CT/NG test for Chlamydia trachomatis
COBAS AMPLICOR™ CT/NG test for Neisseria gonorrhoeae

Device Description

The Roche Scripts for COBAS 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 provided text describes a 510(k) summary for the COBAS AMPLICOR CT/NG test for Chlamydia trachomatis with Roche Scripts Accessory. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document mainly focuses on:

Device description and intended use of the COBAS AMPLICOR CT/NG test.
Description of the Roche Scripts accessory (software) to automate sample processing.
Comparison to a predicate device.
The FDA's decision letter for 510(k) clearance, confirming substantial equivalence.
Indications for Use for the Roche Scripts accessory.

There is no mention of:

A table of acceptance criteria and reported device performance.
Sample sizes used for test sets, data provenance.
Number of experts or their qualifications for ground truthing.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

Therefore,Based on the provided text, I cannot describe the acceptance criteria or a study that proves the device meets the acceptance criteria, as this information is not present in the document. The document primarily focuses on the description and intended use of the device and its 510(k) clearance.

Summary

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AUG 1 0 2006

K053287

510(k) Summary -- COBAS AMPLICOR CT/NG test for Chlamydia trachomatis with Roche Scripts Accessory

Introduction

נייר בין ליי

According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence

Submitter name, address, contact

Roche Diagnostics 9115 Hague Rd Indianapolis IN 46250 (317) 521-3723

Contact person: Theresa M. Ambrose

Date prepared: November 23, 2005

Device Name

Proprietary Name: COBAS AMPLICOR CT/NG test for Chlamydia trachomatis; Roche Scripts for COBAS AMPLICOR CT/NG Test (Roche Scripts Accessory)

Common name: Chlamydia trachomatis test system; software accessory

Classification name: DNA probe, nucleic acid amplification, chlamydia

Device Description The COBAS 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 analvzer.

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510(k) Summary, Continued

Intended use	The COBAS AMPLICOR CT/NG test for Chlamydia trachomatis is a qualitative in vitro test for the detection of C. trachomatis plasmid DNA in urine from males and females, in endocervical swab specimens, and in male urethral swab specimens as evidence of symptomatic or asymptomatic 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 COBAS AMPLICOR analyzer.
	The Roche Scripts for COBAS 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: COBAS AMPLICOR™ CT/NG test for Chlamydia trachomatisCOBAS AMPLICOR™ CT/NG test for Neisseria gonorrhoeae
Predicate Device	We claim equivalence to the currently marketed COBAS AMPLICOR CT/NG test for Chlamydia trachomatis cleared under K973718.
Comparison - similarities	The table below shows the similarities between the COBAS AMPLICOR CT/NG test for Chlamydia trachomatis with optional Roche Scripts accessory and the predicate device:

Continued on next page:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Theresa Ambrose Bush, Ph.D., RAC Regulatory Affairs Principal Centralized Diagnostics Roche Diagnostics, Inc. 9115 Hague Road Indianapolis, IN 46250-0416

AUG 1 0 2006

Re: K053287

Trade/Device Name: Roche Scripts for COBAS AMPLICOR CT/NG Test Regulation Number: 21 CFR8866.3120 Regulation Name: Chlamydia serological reagents Regulatory Class: Class II Product Code: MKZ Dated: June 30, 2006 Received: July 3, 2006

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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Page 2 -

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)276-0484. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sale, a Hogg

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): K053287

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

Indications For Use:

The Roche Scripts for COBAS AMPLICOR CT/NG Test are intended to provide The Room Lorect 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:

COBAS AMPLICOR™ CT/NG test for Chlamydia trachomatis .
COBAS 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)

Fuderic tu. Locke

Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

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).