(258 days)
No
The document describes software scripts for directing an automated workstation, with no mention of AI or ML technologies.
No.
The device provides software scripts to direct a workstation for sample processing and analysis, not for treatment or therapy. It is an accessory to an in vitro diagnostic test.
No
The device, "Roche Scripts for COBAS AMPLICOR CT/NG Test," is described as software scripts that direct an automated workstation to process samples for analysis using existing 510(k)-cleared assay test systems. It does not perform the diagnostic analysis itself; rather, it facilitates the processing step for samples that will then be analyzed by other diagnostic tests.
Yes
The device is described as software scripts provided on a CD, intended to control an existing automated workstation. It does not include any hardware components of its own.
Based on the provided information, the Roche Scripts for COBAS AMPLICOR CT/NG Test is an IVD (In Vitro Diagnostic) accessory.
Here's why:
- Intended Use: The intended use explicitly states that the scripts are for processing swab samples or control material for analysis using 510(k)-cleared assay test systems (COBAS AMPLICOR CT/NG tests). This processing of biological samples for diagnostic purposes is a core function of IVDs.
- Device Description: The device is described as containing scripts to direct an automated workstation to process samples for analysis. This processing is a step in the overall diagnostic workflow.
- Predicate Device: The presence of a predicate device (K973718; COBAS AMPLICOR CT/NG test for Chlamydia trachomatis) which is a cleared IVD, further supports that this device is an accessory to an IVD system.
While the scripts themselves are software, their intended use is to facilitate the performance of an in vitro diagnostic test. Therefore, they are considered an accessory to an IVD system and fall under the definition of an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
MKZ
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. 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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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AUG 1 0 2006
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.
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.
Continued on next page
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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: |
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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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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
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