(125 days)
The APTIMA® Assay for Neisseria gonorrhoeae is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Neisseria gonorrhoeae (GC) to aid in the diagnosis of gonococcal urogenital disease using the TIGRIS® DTS® Automated Analyzer or semi-automated instrumentation as specified. The assay may be used to test the following specimens from symptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens; and patient-collected female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected endocervical and vaginal swab specimens; and patient-collected vaginal swab specimens¹ and female and male urine specimens. ¹Patient-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.
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This document is a 510(k) clearance letter for the TIGRIS® DTS® GEN-PROBE® APTIMA Assay® for Neisseria gonorrhoeae. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this letter does not contain the detailed study results, acceptance criteria, or performance data that would typically be found in the actual 510(k) submission or a clinical study report.
Therefore, I cannot fulfill most of your request directly from this document. The information provided is primarily an FDA clearance letter and an "Indications for Use Statement."
Here's what I can extract and what is explicitly missing from the provided text:
Information Extracted from the Document:
- Device Name: TIGRIS® DTS® GEN-PROBE® APTIMA Assay® for Neisseria gonorrhoeae
- Intended Use: In vitro qualitative detection of ribosomal RNA (rRNA) from Neisseria gonorrhoeae (GC) to aid in the diagnosis of gonococcal urogenital disease, using specified specimens from symptomatic and asymptomatic individuals.
- Sample Types: Clinician-collected endocervical, vaginal, and male urethral swab specimens; patient-collected female and male urine specimens; patient-collected vaginal swab specimens.
Missing Information (Not provided in the document):
- A table of acceptance criteria and the reported device performance: This document does not include a table of acceptance criteria or performance metrics (e.g., sensitivity, specificity, PPV, NPV). These would be in the original 510(k) submission.
- Sample sizes used for the test set and the data provenance: No information on sample sizes or data provenance (country, retrospective/prospective) is present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. For an in vitro diagnostic (IVD) like this, the "ground truth" is typically established by well-characterized reference tests (e.g., culture, another FDA-approved NAAT), not by human experts adjudicating images.
- Adjudication method for the test set: Not applicable in the traditional sense for an IVD diagnostic assay primarily detecting genetic material. The ground truth is usually determined by reference methods.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable. This is an IVD assay, not an imaging device requiring human reader interpretation or assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is a standalone assay. Its performance is measured directly against a reference standard.
- The type of ground truth used: While not explicitly stated, for Neisseria gonorrhoeae detection, the ground truth for such an assay is typically established through culture or a comparator FDA-approved nucleic acid amplification test (NAAT). The document refers to "in vitro qualitative detection of ribosomal RNA," strongly suggesting laboratory-based reference methods.
- The sample size for the training set: The concept of a "training set" as understood in machine learning (which this question implies) is generally not applicable to a traditional IVD chemical/molecular assay like this one. These assays are developed and validated using a series of laboratory experiments and clinical studies, but not typically "trained" in the AI sense.
- How the ground truth for the training set was established: See point 8.
In summary, this document is an FDA clearance letter and does not contain the detailed technical and clinical study information required to answer most of your questions. That data would be found in the actual 510(k) submission that was reviewed by the FDA, but is not included in this publicly available letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows a stylized, abstract symbol in black against a white background. It consists of three parallel, curved lines that appear to be connected at the left side. The lines have varying thicknesses and end in a flourish at the bottom, resembling a calligraphic design or a stylized representation of a bird in flight.
Public Heaith Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. E. Joseph McMullen Associate Director, Regulatory Affairs Gen-Probe Incorporated 10210 Genetic Center Drive San Diego. CA 92121-4362
OCT - 4 2006
K061509 Re: K001509
Trade/Device Name: TIGRIS® DTS® GEN-PROBE® APTIMA Assay for Neisseria gonorrhoeae Regulation Number: 21 CFR 866.3390 Regulation Name: Neisseria spp. direct serological test reagents Regulatory Class: Class II Product Code: LSL Dated: September 25, 2006 Received: September 26. 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 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 r head be actived and itermination 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).
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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 prarketed 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, n you stions 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, attorn
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 Neisseria gonorrhoeae – Special 510(k) TIGRIS DTS
INDICATIONS FOR USE STATEMENT
| 510(k) Number:(if known) | K061509 |
|---|---|
| Device Name: | TIGRIS® DTS® GEN-PROBE APTIMA Assay® for Neisseriagonorrhoeae |
| Indications forUse: | The APTIMA® Assay for Neisseria gonorrhoeae is a targetamplification nucleic acid probe test that utilizes target capture forthe in vitro qualitative detection of ribosomal RNA (rRNA) fromNeisseria gonorrhoeae (GC) to aid in the diagnosis of gonococcalurogenital disease using the TIGRIS® DTS® Automated Analyzeror semi-automated instrumentation as specified. The assay may beused to test the following specimens from symptomaticindividuals: clinician-collected endocervical, vaginal and maleurethral swab specimens; and patient-collected female and maleurine specimens. The assay may be used to test the followingspecimens from asymptomatic individuals: clinician-collectedendocervical and vaginal swab specimens; and patient-collectedvaginal swab specimens¹ and female and male urine specimens.¹Patient-collected vaginal swab specimens are an option for screening womenwhen a pelvic exam is not otherwise indicated. The vaginal swab specimencollection kit is not for home use. |
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR
sion Sign Off
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k 061509
§ 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).