(258 days)
Not Found
No
The summary describes software scripts for directing an automated workstation, with no mention of AI, ML, or related concepts.
No.
The device is a software script that processes swab samples for diagnostic analysis, not a device used for therapy.
Yes
The device processes swab samples for analysis using 510(k)-cleared assay test systems that detect Chlamydia trachomatis and Neisseria gonorrhoeae, which are used for diagnosis of infections.
No
The device is described as software scripts on a CD that direct an automated workstation. While the core component is software, it is an accessory to and controls a hardware device (Tecan Genesis RSP 150 Workstation) that performs physical processing of samples. It is not a standalone software application performing a medical function independently of hardware manipulation.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software scripts are designed to direct an automated workstation to process samples for analysis using 510(k)-cleared assay test systems for detecting Chlamydia trachomatis and Neisseria gonorrhoeae. These are diagnostic tests performed in vitro (outside the body) on biological samples.
- Device Description: The device is described as software scripts that direct an automated workstation to process swab samples or control material for analysis. This aligns with the processing of biological samples for diagnostic purposes.
- Anatomical Site: The mention of "endocervical swab specimens; urethral swab specimens" further confirms that the device is involved in the processing of biological samples for diagnostic testing.
- Predicate Device: The mention of a predicate device (K974342; COBAS AMPLICOR CT/NG test for Neisseria gonorrhoeae) which is itself an IVD, strongly suggests that this device, which is an accessory to that system, is also considered an IVD.
While the document doesn't explicitly state "In Vitro Diagnostic Device," the intended use, device description, and context within the regulatory framework (mentioning 510(k)-cleared assays and a predicate device) all point to it being an IVD. It's an accessory that enables the automated processing of samples for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The COBAS 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 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 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 trachomatis
- COBAS AMPLICOR™ CT/NG test for Neisseria gonorrhoeae
Product codes
LSL
Device Description
The COBAS 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 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 COBAS AMPLICOR analyzer.
The Roche Scripts for COBAS AMPLICOR CT/NG Test accessory consists of a compact disc (CD) containing software scripts which direct the automated Tecan Genesis RSP 150 Workstation to process swab samples or control material for analysis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
§ 866.3390
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).
0
K053289
AUG 10 2006
510(k) Summary – COBAS AMPLICOR CT/NG test for Neisseria gonorrhoeae with Roche Scripts Accessory
| Introduction | 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 22, 2005 |
| Device Name | Proprietary Name: COBAS AMPLICOR CT/NG test for Neisseria
gonorrhoeae; Roche Scripts for COBAS AMPLICOR CT/NG Test (Roche
Scripts Accessory) |
| | Common name: Neisseria gonorrhoeae test system ; software accessory |
| | Classification name: DNA reagents, Neisseria |
| Device
Description | The COBAS 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 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 COBAS AMPLICOR analyzer. |
| | The Roche Scripts for COBAS AMPLICOR CT/NG Test accessory consists
of a compact disc (CD) containing software scripts which 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
.
| Intended use | The COBAS 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 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 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 trachomatis
● COBAS AMPLICOR™ CT/NG test for Neisseria gonorrhoeae |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate
Device | We claim equivalence to the currently marketed COBAS AMPLICOR
CT/NG test for Neisseria gonorrhoeae cleared under K974342. |
| Comparison -
similarities | The table below shows the similarities between the COBAS AMPLICOR
CT/NG test for Neisseria gonorrhoeae with optional Roche Scripts accessory
and the predicate device: |
2
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 stripes forming its wing and body. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Public Health Service
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
Theresa M. Ambrose Bush, Ph.D., RAC Regulatory Affairs Principal Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50416 Indianapolis, Indiana 46256-0416
AUG 1 0 2006
Re: K053289
Trade/Device Name: Roche Scripts for COBAS AMPLICOR CT/NG Test Regulation Number: 21 CFR § 866.3390 Regulation Name: Direct Serological Test Reagents Regulatory Class: II Product Code: LSL Dated: June 30, 2006 Received: July 3, 2006
Dear Dr. Ambrose 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). 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.
3
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, artman
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
4
Indications for Use
510(k) Number (if known):
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 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 �
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 Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of
KO 23289 510(k)_
Confidential