K140887 · Roche Molecular Systems, Inc. · LSL · May 5, 2014 · Microbiology
Device Facts
Record ID
K140887
Device Name
COBAS CT/NG V2.0 TEST
Applicant
Roche Molecular Systems, Inc.
Product Code
LSL · Microbiology
Decision Date
May 5, 2014
Decision
SESE
Submission Type
Special
Regulation
21 CFR 866.3390
Device Class
Class 2
Indications for Use
The cobas® CT/NG v2.0 Test is an automated, in vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in urogenital specimens. The Test utilizes the Polymerase Chain Reaction (PCR) for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in male and female urine, self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, and endocervical swab specimens, all collected in cobas® PCR Media (Roche Molecular Systems, Inc.), and cervical specimens collected in PreservCyt® solution. This test is intended as an aid in the diagnosis of chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals. Ancillary Collection Kits The cobas® PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. The cobas® PCR Media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens. Use this collection kit only with either the cobas® CT/NG Test or the cobas® CT/NG v2.0 Test. The cobas® PCR Urine Sample Kit is used to collect and transport urine specimens. The cobas® PCR Media serves as a nucleic acid stabilizing transport and storage medium for urine specimens. Use this collection kit only with either the cobas® CT/NG Test or the cobas® CT/NG v2.0 Test.
Device Story
System performs automated nucleic acid extraction and real-time PCR amplification/detection for CT/NG. Input: barcoded primary specimen containers (urine, swabs). Process: cobas x 480 instrument performs automated DNA extraction/purification and PCR plate setup; cobas z 480 analyzer performs real-time PCR using fluorescent-labeled probes. Output: qualitative test results displayed on control unit, printable, or exportable to LIS. Used in clinical laboratories; operated by technicians. Software (v2.1) manages workflow, instrument control, and data analysis via modular 'plug and play' architecture. System tracks specimens via barcodes, monitors transfer times, and validates runs. Benefits: automated, standardized diagnostic aid for chlamydial/gonococcal disease; improved workflow efficiency via integrated work order editor, tip tracking, and flexible run sizes.
Clinical Evidence
Bench testing only. Validation performed at unit, component, and system levels. Verification confirmed product requirements were met and risks mitigated. Anomaly reports (channel shift, core system) confirmed minimal risk. No clinical performance data required for this software-only modification.
Technological Characteristics
Real-time PCR amplification; semi-automated sample preparation. Hardware (cobas x 480, cobas z 480) unchanged. Software architecture modularized; OS updated to Windows 7. Connectivity via HL7 standard. System performs automated sample processing, tip tracking, and result calculation.
Indications for Use
Indicated for qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae DNA in urogenital specimens (urine, vaginal/endocervical swabs, cervical specimens). Patient population includes symptomatic and asymptomatic individuals. Contraindications: Female urine for cobas® CT/NG Test; alternative gynecological specimens for specific collection kits.
Regulatory Classification
Identification
Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identify Neisseria spp. from cultured isolates. Additionally, some of these reagents consist of Neisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence of Neisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, 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.
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SPECIAL 510(k): Device Modification OIR Review Memorandum
To: THE FILE
RE: DOCUMENT NUMBER K140887
This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):
1. The name and 510(k) number of the SUBMITTER'S previously cleared device: Roche cobas CT/NG v2.0 Test (K132270) and cobas CT/NG Test (K110923)
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
The labeling for this modification to the subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification.
3. A description of the device MODIFICATIONS:
This change was for new modularized software architecture. The changes to the software include consolidation of different platforms into one architecture, result view and report layout changes, and the method of implementation for the calculation of results (no changes to the results determination algorithm); update OS to Windows 7, remove redundancy in work order creation, automate sample processing parameters based on sample type, improve tip tracking and specimen removal function, expand allowable run size options, improve recovery from unexpected error (graceful recovery), and improvements to the LIS functions to support the HL7 communication standard.
4. The FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed
5. Comparison Information (similarities and differences):
Similarities
| | Predicate devices CT/NG v2.0 Test (K132270) | Modified device CT/NG v2.0 Test (K140887) |
| --- | --- | --- |
| Intended Use | The cobas® CT/NG v2.0 Test is an automated, in vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in urogenital specimens. The Test utilizes the Polymerase Chain Reaction (PCR) for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in male and female urine, self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, and endocervical swab specimens, all collected in cobas® PCR Media (Roche Molecular Systems, Inc.), and cervical specimens collected in PreservCyt® solution. This test is intended as an aid in the diagnosis of | Same |
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| | chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals.
Ancillary Collection Kits
The cobas® PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. The cobas® PCR Media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens. Use this collection kit only with either the cobas® CT/NG Test or the cobas® CT/NG v2.0 Test.
The cobas® PCR Urine Sample Kit is used to collect and transport urine specimens.
The cobas® PCR Media serves as a nucleic acid stabilizing transport and storage medium for urine specimens. Use this collection kit only with either the cobas® CT/NG Test or the cobas® CT/NG v2.0 Test. | |
| --- | --- | --- |
| Symptomatic Status | Asymptomatic and symptomatic | Same |
| Sample Preparation Procedure | Semi-automated | Same |
| CT Analyte Targets | CT cryptic plasmid DNA
CT ompA gene | Same |
| NG Analyte Targets | NG genomic DNA | Same |
| Amplification Technology | Real-time PCR | Same |
| Specimen Types | Male Urine
Female Urine
Endocervical swabs
Clinician-collected vaginal swabs
Patient-collected vaginal swabs
Cervical specimens in PreservCyt® Solution | Same |
| Specimen Collection Devices | cobas PCR Urine Sample Kit
cobas PCR Female Sample Kit
PreservCyt® Solution | Same |
| | Predicate devices
CT/NG Test (K110923) | Modified device
CT/NG Test (K140887) |
| --- | --- | --- |
| Intended Use | The cobas® CT/NG Test is an in vitro nucleic acid amplification test that utilizes the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA to aid in the diagnosis | Same |
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| | of chlamydial and gonococcal disease. The test may be used with vaginal swab specimens self-collected in a clinical setting and male urine from both symptomatic and asymptomatic individuals. Specimens to be tested should be collected in cobas® PCR Media.
Ancillary Collection Kits:
The cobas® PCR Female Swab Sample Kit is used to collect and transport self-collected vaginal swab specimens in a clinical setting.
The cobas® PCR Media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens. Use this collection kit only with the cobas® CT/NG Test. NOTE: This collection kit should not be used for collection of alternative gynecological specimens.
The cobas® PCR Urine Sample Kit is used to collect and transport male urine specimens.
The cobas® PCR Media serves as a nucleic acid stabilizing transport and storage medium for urine specimens. Use this collection kit only with the cobas® CT/NG Test. NOTE: This collection kit should not be used for collection of female urine specimens. | |
| --- | --- | --- |
| Symptomatic Status | Asymptomatic and symptomatic | Same |
| Sample Preparation Procedure | Semi-automated | Same |
| CT Analyte Targets | CT cryptic plasmid DNA
CT ompA gene | Same |
| NG Analyte Targets | NG genomic DNA | Same |
| Amplification Technology | Real-time PCR | Same |
| Specimen Types | Male urine
Patient-collected vaginal swabs | Same |
| Specimen Collection Devices | cobas PCR Urine Sample Kit
cobas PCR Female Sample Kit | Same |
## Differences
The changes to the software include consolidation of different platforms into one architecture, automate sample processing parameters based on sample type, and the method of implementation for the calculation of results (no changes to the results determination algorithm); update OS to Windows 7, remove redundancy in work order creation, improve tip tracking, improve specimen removal function, expand allowable run size options, result view and report layout changes, improve
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recovery from unexpected error (graceful recovery), and improvements to the LIS functions to support the HL7 communication standard.
## 6. Design Control Activities Summary:
a) The detailed risk management plans for the cobas 4800 system and the cobas CT/NG and cobas CT/NG v2.0 products are provided in the following documents in the attachments “cobas 4800 System Release 2.1: Risk Management Plan” (DH-309-009A) and “cobas 4800 System Release 2.1: CT/NG and CT/NG v2.0 Risk Management Plan” (DH-252-022A). Final risk assessments were performed for the cobas 4800 system and CT/NG tests after hazard analysis and risk mitigations were completed. Various causes were considered in the risk analysis including human factors, hardware/software failures, installation/integration failures, and environmental. All remaining risks were identified to be As Low As Reasonably Possible (ALARP) in the final risk assessments and the rationale for risk acceptance was documented in the Risk Management Report.
b) The validation plan stated that the hardware components of the cobas x 480 (sample prep), cobas z 480 (analyzer), and assay reagents have not changed and therefore no validation was recommended. The changes to the cobas 4800 software were validated at the unit, component, and system level. The scope of the system level testing encompassed verification that product requirements were successfully implemented and that observed anomalies were either corrected or accepted as known issues with no adverse impact on system performance. Product requirements were tested to demonstrate that risks had been mitigated. If a particular product requirement passed testing, then the risk was deemed successfully mitigated. System level risk mitigation testing was captured within the plans and reports completed for each testing campaign. All planned system level testing for the cobas 4800 System Core Software Release 2.1 and the cobas CT/NG and CT/NG v2.0 Analysis Packages was completed successfully.
c) Anomaly reports “cobas 4800 System Release 2.1: Core Anomaly Summary Report” and cobas 4800 System Release 2.1: CT/NG Anomaly Summary Report” identify that anomalies within each configuration of the cobas 4800 system were acceptable and presented minimal risk to user, process, or product function. A “Known Issues” list will be distributed to system Users to address minor anomalies relevant to the user operation of the system.
Rare instances of a channel shift anomaly are reported. This anomaly causes errors in the results generated by cobas z480 due to a camera anomaly which causes image data to be incorrectly assigned an optical channel. The mechanism of the channel shift was confirmed to be an extra image in the camera memory buffer. The cobas z480 Instrument Control (IC) software and the cobas z480 service software (zSSW) have been updated to detect and prevent creation and accumulation of extra images in the cobas z480 camera buffer. All test items for the system verification activities related to the channel shift anomaly are acceptable as presented in “cobas 4800 System Release 2.1: Channel Shift System Verification Report.”
d) Traceability between requirements, identified hazards, and verification and validation testing has been established using several trace matrices. Gap analysis was performed on each trace matrix to ensure that each higher-level requirement or specification traces to the next lower level requirement or specification, and that each requirement or specification also traces to a verification or validation activity. Identified hazards that are mitigated by implementation of requirements are traced from the identified risk to the mitigating requirement. The traceability matrices are updated and maintained throughout the development lifecycle of the cobas 4800 system.
e) The Firm has provided a design control activities summary including the risk management files for the identification of risk analysis methods used to assess the impact of the modification on the
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devices and their components, and the results of the analysis. The deviations and anomalies reported in the verification report for the core system were acceptable. The design verification and validation report (DVVR) for CT/NG v2.0 and CT/NG system verification summary report were acceptable.
A declaration of conformity with design controls was submitted including:
i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.
7. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure.
The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
