(144 days)
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No
The summary describes a nucleic acid probe test for detecting Chlamydia trachomatis, which is a standard laboratory diagnostic technique and does not mention any AI or ML components.
No
The device is described as an "in vitro qualitative detection of ribosomal RNA (rRNA) from Chlamydia trachomatis" which is used "to aid in the diagnosis of chlamydial urogenital disease." This indicates it is a diagnostic device, not a therapeutic one.
Yes
The device is described as "a target amplification nucleic acid probe test...for the in vitro qualitative detection of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT)...to aid in the diagnosis of chlamydial urogenital disease." This explicitly states its purpose is to assist in diagnosis.
No
The device is a laboratory assay that detects ribosomal RNA from Chlamydia trachomatis in biological specimens using target amplification and nucleic acid probes. This involves physical reagents and laboratory instrumentation, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- "in vitro qualitative detection": The intended use explicitly states that the assay is for "in vitro qualitative detection". "In vitro" means "in glass" or "outside of the body," which is a key characteristic of IVDs.
- "ribosomal RNA (rRNA) from Chlamydia trachomatis (CT)": The assay is detecting a specific biological marker (rRNA from CT) in a specimen taken from the body.
- "in clinician-collected endocervical, vaginal and male urethral swab specimens, patient-collected vaginal swab specimens, and female and male urine specimens": The assay is performed on specimens collected from the patient, not directly on the patient's body.
- "to aid in the diagnosis of chlamydial urogenital disease": The purpose of the test is to provide information that helps in the diagnosis of a disease.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The APTIMA Assay for Chlamydia trachomatis is a target amplification nucleix acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) in clinician-collected endocervical, vaginal and male urethral swab specimens, patient-collected vaginal swab specimens1, and female and male urine specimens. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of 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.
Product codes
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
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
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 features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Brian J. Shea, RAC Regulatory Affairs Associate Gen-Probe Incorporated 10210 Genetic Center Drive San Diego, CA 92121-1589
OCT 13 2006
Re: K061413
Trade/Device Name: TIGRIS® DTS® Automated Analyzer APTIMA® Assay for Chlamydia trachomatis Regulation Number: 21 CFR 866.3120 Regulation Name: Chlamydia Serological Reagents Regulatory Class: Class I Product Code: MKZ Dated: October 12, 2006 Received: October 13, 2006
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 indice includio is for use stated in the enclosure) to legally marketed prodicate 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 areemig southerner your device 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).
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 Iv(L) marketed predicate device results in a classification for your device and thus, verse to volu 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 frem mor (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sally, autry
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
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GEN-PROBE INCORPORATED
APTIMA Assay® for Chlamydia trachomatis – Special 510(k) TIGRIS DTS
INDICATIONS FOR USE STATEMENT
| 510(k) Number:
| (if known) | K061413 |
|---|---|
| Device Name: | TIGRIS® DTS® GEN-PROBE APTIMA Assay® for Chlamydia trachomatis |
| Indications for Use: | The APTIMA Assay for Chlamydia trachomatis is a target amplification nucleix acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) in clinician-collected endocervical, vaginal and male urethral swab specimens, patient-collected vaginal swab specimens1, and female and male urine specimens. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of 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. |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-the-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) |
Division Sign Off
Office of In Vitro Diagnostic Device
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Ko�1413