The GONOSTAT® Gonococcal Detection Kit is indicated for the presumptive detection of Neisseria gonorrhoeae based on the detection of gonococcal DNA in female endocervical and male urethral specimens. Because of some cross-reactivity with DNA from N. meningitidis and some other members of the genus Neisseria, the test cannot be used with rectal or throat specimens.

Device Description

The device is a modification of the predicate device which is also marketed by Sierra Diagnostics, Inc. The device labeling was changed to reflect the results of additional clinical studies that support claims for the use of the device in low prevalence female populations.

AI/ML Overview

Acceptance Criteria and Study for Sierra Diagnostics, Inc. GONOSTAT® Gonococcal Detection Kit

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve X% sensitivity"). However, the clinical study results are presented, and the FDA's clearance of the device implies that these results were deemed acceptable for the intended use and for demonstrating substantial equivalence to the predicate device. For the purpose of this analysis, the reported clinical study results for female endocervical specimens will be considered the target performance that was accepted by the FDA.

Metric	Reported Device Performance (Female Endocervical Specimens)	Implied Acceptance Criteria (Based on FDA Clearance)
Sensitivity	98.3%	98.3% or higher (implicitly accepted by FDA)
Specificity	99.3%	99.3% or higher (implicitly accepted by FDA)
Predictive Value Positive	94.4%	94.4% or higher (implicitly accepted by FDA)
Predictive Value Negative	99.8%	99.8% or higher (implicitly accepted by FDA)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: N = 3318 (female endocervical specimens)
Data Provenance:
- Country of Origin: Not explicitly stated in the provided text, but inferred to be within the United States given the FDA submission.
- Retrospective or Prospective: The study is described as an "additional clinical study" that was "performed using endocervical specimens at five study sites." This phrasing typically implies a prospective collection of new data for the purpose of the study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given text. The document refers to "clinical studies," but does not detail how the true positive or true negative cases were confirmed (i.e., the ground truth method and who established it).

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance

MRMC Study: This device is a diagnostic kit for the detection of Neisseria gonorrhoeae DNA, not an AI-assisted diagnostic tool for image interpretation. Therefore, a Multi-Reader Multi-Case (MRMC) study involving human readers and AI assistance is not applicable and was not done.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Yes, the reported performance metrics (Sensitivity, Specificity, PPV, NPV) are for the GONOSTAT® Gonococcal Detection Kit operating as a standalone diagnostic assay. This kit directly detects gonococcal DNA; it is not an algorithm that requires human-in-the-loop interaction for interpretation, beyond standard laboratory procedures for running the test and reading the results. The "device performance" refers to the output of the kit itself.

7. The Type of Ground Truth Used

This information is not explicitly stated in the provided text. For a diagnostic test like this, the ground truth would typically be established by a reference method, which could include:

Bacterial culture (gold standard for N. gonorrhoeae)
Another validated molecular test
Clinical diagnosis based on symptoms and other laboratory findings
However, the document does not specify which reference method was used to establish the true disease status of the 3318 specimens.

8. The Sample Size for the Training Set

This information is not applicable for this device submission as it is described. The GONOSTAT® Gonococcal Detection Kit is a DNA detection kit, not an AI/machine learning algorithm that requires a "training set" in the conventional sense of computational models. The "modification" mentioned refers to labeling changes based on additional clinical studies, not an update to a learned model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no mention of a training set for an AI/machine learning model.

Summary

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K991268

AUG 11 1999

510(k) Summary Sierra Diagnostics, Inc. GONOSTAT® Gonococcal Detection Kit

General Information on Submitter: I.

Name:	Sierra Diagnostics, Inc.
Address:	Suite C21109 Longeway RoadSonora, CA 95370
Telephone:	(209) 539-0886
Fax:	(209) 539-0853
Name of Contact Person:	Tony K. Baker
Date Summary Prepared:	April 13, 1999

General Information on Device II.

GONOSTAT® Gonococcal Detection Kit Name:

DNA Reagents, Neisseria Classification Name:

GONOSTAT® Gonococcal Detection Kit III. Predicate Device:

IV. Description of the Device:

V. Intended Use:

Presumptive detection of Neisseria gonorrhoeae based on the detection of gonococcal DNA in female endocervical and male urethral specimens. Because of some crossreactivity with DNA from N. meningitidis and some other members of the genus Neisseria, the test cannot be used with rectal or throat specimens.

Technological Characteristics of Device Compared to Predicate VI. Device:

The technological characteristics of the two devices are identical

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Summary of Clinical Data VII.

An additional clinical study was performed using endocervical specimens at five study sites. The results of this study support the following changes and additions to the product labeling:

A new table of female endocervical specimen results obtained from the a) new study has been added. A summary of the table contents is provided below (N=3318):

Sensitivity:	98.3%
Specificity:	99.3%
Predictive value positive:	94.4%
Predictive value negative:	99.8%

c) Deletion of statements concerning lack of data in low prevalence populations.
d) An analysis of prevalence by sample type and clinical site has been added.
e) A chart of hypothetical predictive values at different prevalence rates has been added.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wing segments.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 11 1999

Sierra Diagnostics Mr. Donald R. Stone c/o McKenna & Cuneo, L.L.P. 1900 K Street, N.W. Washington, D.C. 20006

K991268 Re:

Trade Name: GONOSTAT® Gonococcal Detection Kit Regulatory Class: II Product Code: LSL Dated: June 28, 1999 Received: June 29, 1999

Dear Mr. Stone:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number: K991268

Device Name:

GONOSTAT® Gonococcal Detection Kit

Indications For Use:

Woody Dubois

510(k) Numbe

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 C.F.R. § 801.109) Over-The-Counter Use

Regulation Number and Section

§ 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).