(157 days)
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No
The description focuses on a nucleic acid probe test for detecting specific RNA sequences, which is a standard molecular diagnostic technique and does not mention or imply the use of AI or ML for analysis or interpretation.
No
This device is an in vitro diagnostic test used for qualitative detection and differentiation of specific RNAs to aid in the diagnosis of certain diseases. It does not provide therapy or treatment.
Yes
Explanation: The "Intended Use" section states that the assay is used "to aid in the diagnosis of gonococcal and/or chlamydial urogenital disease," which clearly indicates a diagnostic purpose.
No
The device description clearly states it is a "target amplification nucleic acid probe test" and mentions "ribosomal RNA (rRNA)" and "specimens," indicating it is a laboratory-based diagnostic assay involving biological samples and chemical reagents, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- The Intended Use/Indications for Use explicitly states "in vitro qualitative detection and differentiation". This is a key characteristic of IVDs, which are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
- The Device Description also mentions "in vitro qualitative detection and differentiation". This reinforces the IVD nature of the device.
- The assay is used to test specimens (swabs, urine, gynecological specimens) collected from individuals. This is another defining feature of IVDs – they analyze biological samples.
- The purpose is to "aid in the diagnosis of gonococcal and/or chlamydial urogenital disease". This directly relates to providing diagnostic information, which is the core function of an IVD.
N/A
Intended Use / Indications for Use
The APTIMA COMBO 2 Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis and/or Neisseria gonorrhoeae in clinician-collected endocervical, vaginal and male urethral swab specimens, patientcollected vaginal swab specimens', female and male urine specimens and gynecological specimens collected in the PreservCyt Solution and processed with the Cytyc ThinPrep 2000 System. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of gonococcal and/or chlamydial urogenital disease using the TIGRIS DTS Automated Analyzer or semi-automated instrumentation as specified.
1 Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The vaginal swab specimen collection kit is not for home use. 2 Gynecological specimens collected in the PreservCyt Solution and processed with the Cytyc ThinPrep 2000 System have only been reviewed and cleared for use with the APTIMA Combo 2 Assay in the United States by the Food and Drug Administration (FDA).
Product codes
LSL, MKZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
endocervical, vaginal, male urethral, urogenital
Indicated Patient Age Range
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Intended User / Care Setting
clinician-collected, patient-collected
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.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Brian J. Shea, RAC Regulatory Affairs Associate Gen-Probe Incorporated 10210 Genetic Center Drive San Diego, CA 92121-1589
AUG 1 7 2006
Re: K060652 Trade/Device Name: TIGRIS® DTS® GEN-PROBE® APTIMA COMOBO 2® Assay Regulation Number: 21 CFR 866.3390 Regulation Name: Neisseria spp. direct serological test reagents Regulatory Class: Class II Product Code: LSL, MKZ Dated: May 26, 2005 Received: May 30, 2005
Dear Mr. Shea:
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 Foond, Or to 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 not 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 Parts 20).
1
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 tolli-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, atton
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
2
Indications for Use
510(k) Number (if known):
Device Name: TIGRIS® DTS® GEN-PROBE® APTIMA COMBO 2® Assay
Indications For Use:
The APTIMA COMBO 2 Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis and/or Neisseria gonorrhoeae in clinician-collected endocervical, vaginal and male urethral swab specimens, patientcollected vaginal swab specimens', female and male urine specimens and gynecological specimens collected in the PreservCyt Solution and processed with the Cytyc ThinPrep 2000 System. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of gonococcal and/or chlamydial urogenital disease using the TIGRIS DTS Automated Analyzer or semi-automated instrumentation as specified.
1 Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The vaginal swab specimen collection kit is not for home use. 2 Gynecological specimens collected in the PreservCyt Solution and processed with the Cytyc ThinPrep 2000 System have only been reviewed and cleared for use with the APTIMA Combo 2 Assay in the United States by the Food and Drug Administration (FDA).
| Prescription Use | √ |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) |
|---|
| Division Sign-Off |
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K010652