(302 days)
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No
The summary describes a latex agglutination test, which is a traditional laboratory method and does not mention any AI or ML components.
No.
The device is an in vitro diagnostic test used to identify MRSA, not to treat a condition.
Yes
The device is described as aiding in the identification of MRSA, which is a diagnostic purpose to determine the presence of a specific bacterial strain.
No
The device description explicitly states "PBP21 Latex Agglutination Test," which is a laboratory assay involving physical reagents and materials, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the kit "detects penicillin binding protein 2' in isolates of Staphylococcus as an aid in identifying Methicillin Resistant Staphylococcus aureus (MRSA) and methicillin resistant coagulase-negative staphylococci." This describes a test performed on biological samples (isolates of Staphylococcus) outside of the body to provide information for diagnosis or identification of a condition (MRSA and methicillin resistance).
- Device Description: The description "PBP21 Latex Agglutination Test" further confirms it's a laboratory test performed on samples.
These characteristics align directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This Kit detects penicillin binding protein 2' in isolates of Staphylococcus as an aid in identifying Methicillin Resistant Staphylococcus aureus (MRSA) and methicillin resistant coagulase-negative staphylococci.
Product codes
MYI
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.
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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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§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).
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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 wing segments, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Andy Hollingsworth Regulatory Affairs Manager Oxoid Limited Wade Road Basingstoke, Hants RG24 8PW England
APR 0 2 2002
Re: K011710
Trade/Device Name: PBP21 Latex Agglutination Test Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: MYI Dated: January 29, 2002 Received: January 30, 2002
Dear Mr. Hollingsworth:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/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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Image /page/2/Picture/0 description: The image shows the word "OXOID" in white letters against a black oval background. The letters are bold and sans-serif. The oval is oriented horizontally.
510(K) Submission for Oxoid PBP21 Latex Agglutination Test
Oxoid Ltd
이 위 해 이어 에 대해 대해 이 대 (이 역) 이 역 에 대해 대 대
Unknown (510K) Number :
PBP21 Latex Agglutination Test Device Name :
Indications for Use :
This Kit detects penicillin binding protein 2' in isolates of Staphylococcus as an aid in identifying Methicillin Resistant Staphylococcus aureus (MRSA) and methicillin resistant coagulase-negative staphylococci.
(PLEASE DO NOT WRITE BELOW THIS LINE --CONTINUE ON ANOTHER PAGE IF NEEDED).
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | OR | Over the Counter |
| ✓ | ||
| (Division Sign Off) | ||
| Division of Clinical Devices | (Division Sign-Off) | |
| 510(K) Number | Division of Clinical Laboratory Devices | |
| 510(k) Number K011710 |
Oxoid Limited Wade Road Basingstoke Hants RG24 8PW England Telephone (01256) 841144 Facsimile (01256) 463388 Telex 858793 Oxoid G ... .. ... ...