(196 days)
Not Found
Not Found
No
The summary describes a biochemical identification panel and mentions fluorescent reagents, but there is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as an "in vitro diagnostic product" intended for identifying organisms, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product is "an in vitro diagnostic product intended to be used in conjunction with the Sensititre system for the automated identification of clinically significant gram positive organisms."
No
The device description explicitly states it is an "in vitro diagnostic product" and describes a physical panel with reagents, indicating it is a hardware component used in conjunction with a system.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in both the "Intended Use / Indications for Use" and "Device Description" sections that the Sensititre AP90 panel is an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The Sensititre AP90 panel is an in vitro diagnostic product intended to be used in conjunction with the Sensititre system for the automated identification of clinically significant gram positive organisms. This 510(k) is for gram positive identification.
Product codes
LQL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 2 1998
Cynthia C. Knapp Director of Lab Services AccuMed International, Inc. 29299 Clemens Road, Suite 1-K Westlake, OH 44145
Re: K972576
Trade Name: Gram Positive Autoidentification Plates, Sensititre AP90 Regulatory Class: I Product Code: LQL Dated: January 7, 1998 Received: January 12, 1998
Dear Ms. Knapp:
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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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 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
2
ト -
:
Device Name: Gram Positive AutoIdentification Panel, Sensititre® AP90
dications For Use:
The Sensititie AP90 panel is an in vitro diagnostic product intended to be used in conjunction with the Sensititre system for the automated identification of clinically significant gram positive organisms.
This 510(k) is for gram positive identification. Reagents are listed as follows:
REAGENTS & PLATE TEST LAYOUT
| 1 | 2 | 3 | 4 | |
|---|---|---|---|---|
| A | UREA | ESCULIN | ARGININE | FR13 |
| B | FR16 | RHAMNOSE | FR15 | MANNITOL |
| C | FR14 | TREHALOSE | FR17 | MALTOSE |
| D | FR18 | FR19 | FR20 | FR21 |
| E | FR22 | FR23 | GLYCEROL | FR24 |
| F | FR25 | GLUCOSE | SUCROSE | FR26 |
| G | FR27 | B-METHYL | ||
| GLUCOSIDE | FR28 | FR29 |
H SORBITOL FR30 The above 4 by 8 layout is repeated 3 times across the plate. FR-Fluorescent reagent. The Urease test requires an oil overlay.
The Grease test requires an Oil Overlay.
Organisms with indications for testing include:
Enterococcus avium Enterococcus durans Enteracoccus taacalis Enterposcous faecium Eryslpelothrix rhusiopathiae Listeria species Micrococcus species Rhodococcus equit Staphylococcus aureus Staphylococcus capits Staphylococcus epidemidis Staphylococcus haemolyticus
Staphylococcus hominis
Staphylococcus saprophyticus
Staphylococcus warneri
Streptococcus agalactiae
Streptococcus milleri group
Streptococcus Group G
Streptococcus mitis
Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus uberis
FR32
FR31
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED),
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lashy T. Ashcroft for J. Tychicus
(Division Sign-Off) Division of Clinical Laboratory Devices KG 510(k) Number.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
c:\windows\temp\indfuse.doc
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