(98 days)
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Not Found
No
The device description and intended use clearly describe a latex agglutination test, which is a traditional laboratory technique and does not involve AI or ML. The "Not Found" entries for AI/ML mentions and performance study details further support this conclusion.
No
The device is described as a diagnostic tool (latex agglutination test) for differentiating types of Staphylococci, not for treating a condition.
Yes
The device is described as "latex agglutination tests for the differentiation of Staphylococci," which indicates it is used to identify or distinguish between different types of staphylococci, a process integral to diagnosing infections.
No
The device description clearly states it is a "latex agglutination test," which is a physical laboratory test involving reagents and samples, not a software-only device.
Based on the provided information, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "latex agglutination test for the differentiation of Staphylococci". This indicates that it is used to perform a test on a biological sample (likely a bacterial culture) in vitro (outside of the living body) to provide diagnostic information.
- Device Description: The description confirms it is a "latex agglutination test," which is a common type of IVD used for detecting the presence of specific substances or organisms in a sample.
The core function of the device is to analyze a biological sample in vitro to aid in the diagnosis or identification of a specific type of bacteria (Staphylococci with certain characteristics). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Staphytect Plus, and Dryspot Staphytect Plus are latex agglutination tests for the differentiation of Staphylococci which possess clumping factor, Protein A, and certain capsular polysaccharides found in MRSA strains, from those which do not.
Product codes
JWX
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): 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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human figures, each represented by a head and torso, connected in a row.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Andy Hollingsworth QS Manaqer Oxoid Limited Wade Road Basingstoke Hants RG24 8PW ENGLAND
SEP - 8 1997
Re : K972030/S1 Staphytect Plus/Dryspot Staphytect Plus Trade Name: Requlatory Class: I Product Code: JWX Dated: Auqust 22, 1997 Received: August 22, 1997
Dear Mr. Hollingsworth:
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 requirement, 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 Failure to comply with the GMP regulation may result in assumptions. 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 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
2
510(k) Submission for Oxoid
Staphytect Plus and Dryspot Staphytect Plus
510(K) Number : Unknown
Staphytect Plus Device Name : Dryspot Staphytect Plus
Indications for Use :
Staphytect Plus, and Dryspot Staphytect Plus are latex agglutination tests for the differentiation of Staphylococci which possess clumping factor, Protein A, and certain capsular polysaccharides found in MRSA strains, from those which do not.
Ade P
510(k) Num
✓ For Prescription Use