(255 days)
The Indicard™ test is an enzyme activity test for use in the detection of Gardnerella vaginalis Proline IminoPeptidase (PIP) activity in vaginal fluid specimens from patients suspected of having vaginosis.
The Indicard™ test is indicated for professional use only and may be used at point of care. It is not intended for home use.
The Indicard™ test is an enzyme activity test.
This document is a 510(k) clearance letter from the FDA for the "INDICARD Test." It primarily focuses on the regulatory approval and indications for use, rather than detailed study results. Therefore, much of the requested information about acceptance criteria and study particulars cannot be fully extracted from this document.
Here's what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) from a clinical study. The FDA clearance is based on "substantial equivalence" to a predicate device, meaning it performs similarly, but the actual performance values are not detailed here.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not an AI device. The INDICARD Test is described as an "enzyme activity test" for detecting bacterial vaginosis. Therefore, an MRMC study and AI-related performance improvements are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI algorithm. The device is a "test" and is indicated for "professional use," implying human involvement in performing and interpreting the test.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The document states the device is for "detection of Gardnerella vaginalis Proline IminoPeptidase (PIP) activity in vaginal fluid specimens from patients suspected of having vaginosis." The ground truth for such a device would typically involve a definitive diagnostic method for Gardnerella vaginalis or bacterial vaginosis, such as Gram stain (Nugent score), culture, or PCR, but this is not specified in the document.
8. The sample size for the training set
This information is not available in the provided document.
9. How the ground truth for the training set was established
This information is not available in the provided document.
In summary, this FDA clearance letter is a regulatory document confirming that the INDICARD Test is substantially equivalent to a pre-existing device and outlining its indications for use. It does not contain the detailed technical or clinical study data that would address most of your questions. To obtain such information, one would typically need to review the full 510(k) submission or supporting technical documentation for K964015.
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Marian B. Buccafurni Office of the President Litmus Concepts, Inc. 2981 Copper Road Santa Clara, California 95051
144 1007
- Re: K964015 Indicard Test Requlatory Class: I Product Code: MJM Dated: May 16, 1997 Received: May 19, 1997
Dear Ms. Buccafurni:
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 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 The general controls provisions of the Act 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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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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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Butman
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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| DAND CﮐD | of |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| 510(k) Number (if known): | K964015 |
|---|---|
| Device Name: | INDICARD Test |
Indications For Use:
The Indicard™ test is an enzyme activity test for use in the detection of Gardnerella vaginalis Proline IminoPeptidase (PIP) activity in vaginal fluid specimens from patients suspected of having vaginosis.
The Indicard™ test is indicated for professional use only and may be used at point of care. It is not intended for home use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Q. Halbert
Division Sign-Off) Division of Clinical Laboratory Devices 1914015 510(k) Number.
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.