(89 days)
No
The device description and performance studies focus on PCR amplification, hybridization capture, and automated sample preparation using pre-defined software scripts. There is no mention of AI or ML algorithms for data analysis, interpretation, or decision-making.
No.
The device is an in vitro diagnostic test designed to detect Neisseria gonorrhoeae DNA, which is used for diagnostic purposes rather than for treating a disease or condition.
Yes
The device is an in vitro test designed to detect N. gonorrhoeae DNA in patient samples, providing evidence of infection. This information is used for diagnosis.
No
The device described is an in vitro diagnostic test system that includes reagents, an analyzer (AMPLICOR analyzer), and an optional software accessory (Roche Scripts) to automate a specific step (sample preparation) using a separate hardware workstation (Tecan Genesis RSP 150). While software is a component, the overall system is not software-only.
Based on the provided text, the device is indeed an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is a "qualitative in vitro test for the detection of N. gonorrhoeae DNA". The term "in vitro" is a key indicator of an IVD. It also describes the purpose of the test (detecting N. gonorrhoeae DNA) and the types of samples used (urine, endocervical swabs, urethral swabs), which are typical for IVD devices.
- Device Description: The description reiterates that it is a "qualitative in vitro test".
- Methodology: The test uses PCR amplification and hybridization capture, which are common techniques used in molecular diagnostic IVD tests.
- Clinical Evaluation: The text mentions a clinical evaluation where the results of the device were compared to a manual specimen preparation method, which is a standard practice for evaluating the performance of IVD devices.
- Key Metrics: The document provides performance metrics like sensitivity and specificity, which are crucial for evaluating the accuracy of an IVD test.
- Predicate Device: The mention of a predicate device (K974503; AMPLICOR CT/NG test for Neisseria gonorrhoeae) further confirms its classification as a medical device, and given the context, specifically an IVD.
The Roche Scripts for AMPLICOR CT/NG Test accessory is also related to the IVD, as it automates a step in the sample preparation process for the IVD test.
N/A
Intended Use / Indications for 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 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 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
Product codes
LSL
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical sensitivity:
Predicate: 5 IFU/test; equivalent to 100 IFU/mL for urine specimens and 400 IFU/mL for Culture Transport Medium (CTM) with swab specimen)
Current device (Manual preparation): Same
Current device (Automated preparation): 100 cfu/mL for CTM with swab specimen
Precision:
Predicate: 100% correct results for panel of CTM specimens. Three (out of 30) negative test results for one urine panel member.
Current device (Manual preparation): Same
Current device (Automated preparation): 99.4% correct results for panels of CTM specimens
Clinical performance:
Sensitivity vs. culture:
• 95.9 % for females
• 96.5 % for males
Specificity vs. culture:
• 98.7 % for females
• 97.3 % for males
(with internal control)
Current device (Manual preparation): Same
Current device (Automated preparation): 99.0% concordance with manual method
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
Image /page/0/Picture/0 description: The image shows the text "K070172" in a handwritten style. Below this, the text "APR 17 2007" is printed in a sans-serif font. The date indicates that the image was taken on April 17, 2007.
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 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 A Bush
Date 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 (Roche
Scripts Accessory) |
| | Common name: Neisseria gonorrhoeae test system ; software accessory |
| | Classification name: DNA reagents, Neisseria |
| 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. |
Continued on next page
1
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: K974503
AMPLICOR CT/NG test
for Neisseria gonorrhoeae | Current Device:
AMPLICOR CT/NG test
for Neisseria gonorrhoeae
with optional Roche
Scripts accessory |
| | Product features | | |
| | | | |
| 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 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. | Same intended use for
AMPLICOR CT/NG test.
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 | |
| Test principle | DNA detection via PCR
amplification of target DNA
followed by hybridization
capture of amplified target
using the AMPLICOR
Analyzer | Same | |
| Controls provided | Positive control: plasmid
DNA from N.
gonorrhoeae
Negative control: plasmid
DNA from C. trachomatis
Optional internal control:
plasmid DNA with CT
primer binding regions
and a unique probe
binding region | Same | |
| Labeled test performance | | | |
| Analytical specificity | Negative results from 130
bacteria, 6 fungal, 1
protozoan and 11 viral
strains. Some isolates
from N. cinerea and N.
subflava may give false
positive 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:
Same
Automated 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:
Same
Automated preparation:
99.4% correct results for panels of CTM specimens | |
| Clinical performance | Sensitivity vs. culture:
• 95.9 % for females
• 96.5 % for males
Specificity vs. culture:
• 98.7 % for females
• 97.3 % for males
(with internal control) | Manual preparation:
Same
Automated preparation:
99.0% concordance with manual method | |
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2
. . .
.
:
:
3
:
:
Continued on next page
.
.
:
4
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: K974503
AMPLICOR CT/NG test
for Neisseria gonorrhoeae | Current Device:
AMPLICOR CT/NG test
for Neisseria gonorrhoeae
with optional Roche
Scripts accessory |
|---------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Specimen and control
preparation options | Manual | • Manual
• Automated preparation
using the Roche Scripts to
direct the Tecan Genesis
RSP 150 Workstation |
| Specimen types | Male urine specimens;
endocervical and urethral
swabs | Manual: same
Automated preparation:
endocervical and urethral
swabs only (no urine
samples) |
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
5
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).
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 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
7
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:
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.
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
8
Indications for Use
12070172 510(k) Number (if known):
Device Name: Roche Scripts for AMPLICOR CT/NG Test Accessory
Indications For Use:
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 .
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
23