(64 days)
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No
The document describes a laboratory culture medium for isolating bacteria, with no mention of AI or ML technology.
No
The device is a laboratory medium for isolating bacteria, not for treating a condition or disease.
Yes
The agar medium is used for the "primary isolation of vancomycin resistant enterococci from surveillance cultures," which is a diagnostic procedure to identify specific microorganisms.
No
The 510(k) summary describes a plated medium (agar) for laboratory use, which is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "selective and differential medium for the primary isolation of vancomycin resistant enterococci from surveillance cultures." This involves testing biological samples (surveillance cultures) outside of the body to obtain information about a person's health status (presence of vancomycin resistant enterococci).
- Qualitative Procedure: It's used in "qualitative procedures," which is a common characteristic of IVDs that determine the presence or absence of a substance or organism.
The description fits the definition of an IVD, which is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions.
N/A
Intended Use / Indications for Use
REMEL's Bile Esculin Azide Agar w/ 6 μg/ml Vancomycin is a plated medium recommended for use in qualitative procedures as a selective and differential medium for the primary isolation of vancomycin resistant enterococci from surveillance cultures. This product is not intended for use as method of antimicrobial susceptibility testing. Confirmation of vancomycin resistance by an approved method is recommended as some organisms on initial isolation may overoome the inhibitory effects of the medium.
Product codes
JSO
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
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.1700 Culture medium for antimicrobial susceptibility tests.
(a)
Identification. A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 28 1997
Mary Ann Silvius Manager, Research & Development * Remel 12076 Santa Fe Drive Lenexa, KS 66215-3594
Re: K972359
Trade Name: Remel Bile Esculin Azide Agar w/6 µg/ml Vancomycin Regulatory Class: II Product Code: JSO Dated: June 24, 1997 Received: June 25, 1997
Dear Ms. Silvius:
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 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 (QS) 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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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 Sutman
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
510(k) Number (if known): ______________________
Device Name: Bile Esculin Azide Agar w/ 6 ug/ml Vancomycin
Indications For Use: REMEL's Bile Esculin Azide Agar w/ 6 μg/ml Vancomycin is a plated medium recommended for use in qualitative procedures as a selective and differential medium for the primary isolation of vancomycin resistant enterococci from surveillance cultures. This product is not intended for use as method of antimicrobial susceptibility testing. Confirmation of vancomycin resistance by an approved method is recommended as some organisms on initial isolation may overoome the inhibitory effects of the medium.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Clinical Laboratory Devices |
| 510(k) Number | K972359 |
|---|---|
| --------------- | --------- |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |