(88 days)
Not Found
No
The description focuses on PCR amplification and hybridization capture, and the software scripts are described as directing an automated workstation for sample processing, not for data analysis or interpretation using AI/ML. There is no mention of AI, ML, or related concepts.
No
The device is described as a qualitative in vitro test for the detection of C. trachomatis DNA, indicating it's a diagnostic tool, not one intended for treatment or therapy.
Yes
Explanation: The device is a qualitative in vitro test for the detection of C. trachomatis DNA, which is used to provide evidence of infection, a key aspect of diagnosis. It detects "C. trachomatis DNA... as evidence infection with C. trachomatis."
No
The device described is a software accessory (Roche Scripts) that directs a hardware workstation (Tecan Genesis RSP 150) to perform sample preparation for an in vitro diagnostic test (AMPLICOR CT/NG test). While the scripts themselves are software, the overall system and its intended use involve hardware components and laboratory procedures, not just software functionality.
Yes, this device is 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 C. trachomatis DNA". The term "in vitro" is a key indicator of an IVD, meaning it is used to test samples outside of the living body.
- Device Description: The description reiterates that it is a "qualitative in vitro test".
- Function: The device detects the presence of C. trachomatis DNA in biological samples (urine and swab specimens) to diagnose infection. This is a typical function of an IVD.
- Sample Types: It analyzes biological samples (urine and swabs), which are common matrices for IVD testing.
N/A
Intended Use / Indications for 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 trachomatis
- AMPLICOR® CT/NG test for Neisseria gonorrhoeae
Product codes (comma separated list FDA assigned to the subject device)
MKZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urine, endocervical swab specimens, urethral swab specimens
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical specificity: Negative results from 133 bacteria, 6 fungal, 1 protozoan and 11 viral strains.
Analytical sensitivity: 1 IFU/test; equivalent to 20 IFU/mL for urine specimens and 80 IFU/mL for Culture Transport Medium (CTM) with swab specimen) (Manual preparation: Same, Automated preparation: 20 IFU/mL for CTM with swab specimen)
Precision: 100% correct results for panels of CTM and urine specimens. (Manual preparation: Same, Automated preparation: 99.6% correct results for panels of CTM specimens)
Clinical performance: Sensitivity vs. culture: • 94.1 % for females • 92.9 % for males Specificity vs. culture: • 98.4 % for females • 94.7 % for males (with internal control) (Manual preparation: Same, Automated preparation: 98.5% concordance with manual method)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
APR 1 6 2007
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: |
:
:
.
:
2
| Feature | Predicate Device: K973707
AMPLICOR CT/NG test
for Chlamydia trachomatis | Current Device:
AMPLICOR CT/NG test
for Chlamydia trachomatis
with optional Roche
Scripts accessory |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product features | | |
| 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 of 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. | 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 |
| Feature | Predicate Device: K973707
AMPLICOR CT/NG test
for Chlamydia trachomatis | Current Device:
AMPLICOR CT/NG test
for Chlamydia trachomatis
with optional Roche
Scripts accessory |
| Controls provided | Positive control: plasmid
DNA from C. trachomatis
Negative control: plasmid
DNA from N.
gonorrhoeae
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 133
bacteria, 6 fungal, 1
protozoan and 11 viral
strains. | Same |
| Analytical sensitivity | 1 IFU/test; equivalent to 20
IFU/mL for urine
specimens and 80
IFU/mL for Culture
Transport Medium
(CTM) with swab
specimen) | Manual preparation:
Same
Automated preparation:
20 IFU/mL for CTM with
swab specimen |
| Precision | 100% correct results for
panels of CTM and urine
specimens. | Manual preparation:
Same
Automated preparation:
99.6% correct results for
panels of CTM specimens |
| Clinical performance | Sensitivity vs. culture:
• 94.1 % for females
• 92.9 % for males
Specificity vs. culture:
• 98.4 % for females
• 94.7 % for males
(with internal control) | Manual preparation:
Same
Automated preparation:
98.5% concordance with
manual method |
| Feature | Predicate Device: K973707
AMPLICOR CT/NG test
for Chlamydia trachomatis | Current Device:
AMPLICOR CT/NG test
for Chlamydia trachomatis
with optional Roche
Scripts accessory |
| Specimen and control
preparation options | Manual | • Manual or
• 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) |
.
Confidential
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:
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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):
Device Name: AMPLICOR CT/NG test for Chlamydia trachomatis
Indications For 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.
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)
folleas
Vision Sign-Off
Page 1 of Office of in Vitro Diagnostic Device Evaluation and Safety
Confidential
8
510(k) Number (if known):
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
22
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:
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 of 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.
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:
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)
Wie Schif
Division Sign-Off
Page 1 of Office of In Vitro Diagnostic Device Evaluation and Safety
C13(k) K070174
Confidential