(255 days)
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Not Found
No
The summary describes an enzyme activity test and makes no mention of AI or ML.
No.
The device is an enzyme activity test for detection, not treatment, of a condition.
Yes
The device is an enzyme activity test used for the "detection of Gardnerella vaginalis Proline IminoPeptidase (PIP) activity in vaginal fluid specimens from patients suspected of having vaginosis," which is an activity for diagnosis of vaginosis.
No
The device description explicitly states it is an "enzyme activity test," which implies a physical test kit or reagent, not a software-only solution.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used to detect a specific enzyme activity (Gardnerella vaginalis Proline IminoPeptidase) in a biological specimen (vaginal fluid) from a patient to aid in the diagnosis of a condition (vaginosis). This aligns directly with the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnostic purposes.
- Device Description: It is explicitly described as an "enzyme activity test," which is a type of test performed on biological samples outside of the body.
- Anatomical Site: The test is performed on "vaginal fluid specimens," which are collected from the human body.
The other sections (image processing, AI/ML, training/test sets, performance studies, etc.) are not relevant to determining if a device is an IVD. The core function of testing a biological sample in vitro for diagnostic information is the key indicator.
N/A
Intended Use / 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.
Product codes
MJM
Device Description
The Indicard™ test is an enzyme activity test for use in the detection of Gardnerella vaginalis Proline IminoPeptidase (PIP) activity in vaginal fluid specimens.
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
Vaginal fluid specimens
Indicated Patient Age Range
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Intended User / Care Setting
Professional use only, may be used at point of care.
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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§ 866.2660 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.
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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 representation of a human figure, with three profiles overlapping to create a sense of depth and community. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the figure, with "DEPARTMENT OF HEALTH & HUMAN" on the left side and "SERVICES • USA" on the right side.
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 C
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| D | of |
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| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
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| 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)