(63 days)
The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in rific Schollae Fracmopillian Susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae. This 510(k) is for the addition of Vancomycin in the dilution range of 0.06 - 4 ug/ml to the I mis Stortifits for the addition of cass pneumoniae MIC panel for testing Streptococcus Delistine Fracthophilus influenzae isolates. The "Indications for Use" and clinical pheumomac and Traomycin is for: Streptococcus pneumoniae (including penicillin-resistant strains )
Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Vancomycin
This FDA 510(k) clearance letter dated November 2, 2001, for the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Vancomycin, does not contain the detailed information required to answer your request about acceptance criteria and a study proving the device meets those criteria.
This document is a formal communication from the FDA stating that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed. It outlines regulatory classifications, general controls, and points of contact for further inquiries.
The information typically requested in your prompt (e.g., specific acceptance criteria for performance metrics, details of clinical studies, sample sizes, ground truth establishment, expert qualifications, MRMC studies) is usually found within the 510(k) submission itself or in a summary of the data submitted, not in the clearance letter.
Therefore, most of the sections below cannot be populated using the provided text.
Based on the provided document, here's what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Not available in this document. This document is the clearance letter, not the performance study report itself.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not available in this document. Given the nature of an antimicrobial susceptibility test (AST) device, ground truth is typically established by reference laboratory methods (e.g., broth microdilution or agar dilution performed by trained microbiologists), not generally by "experts" in the sense of clinicians or radiologists reviewing images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is an in vitro diagnostic (IVD) for antimicrobial susceptibility testing, not an imaging device or an AI-assisted diagnostic tool that would involve human "readers" in that context. Its performance is evaluated on its ability to accurately determine minimum inhibitory concentrations (MICs) or categorize susceptibility (susceptible, intermediate, resistant) compared to a reference method.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable in the AI sense. However, the device itself (the Sensititre plate and its reading system) is designed to provide results without human interpretation of raw data beyond reading the wells and interpreting the results based on established breakpoints. Its "standalone" performance would refer to its accuracy against a gold standard method. Details of this are not in the document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implied: For antimicrobial susceptibility testing, the ground truth is typically established by a recognized reference method, such as broth microdilution or agar dilution, often following CLSI (Clinical and Laboratory Standards Institute) guidelines. This document doesn't explicitly state it but it is the standard for such devices.
8. The sample size for the training set
- Not available in this document. This document does not pertain to an AI/ML device that would typically have a "training set" in the computational sense. For an IVD like this, studies involve testing a sufficient number of clinical isolates.
9. How the ground truth for the training set was established
- Not available in this document. (See point 7 for the implied method if it were an IVD study).
In summary, this document is a regulatory approval letter and does not contain the detailed study information you are seeking. To obtain that information, one would typically need access to the actual 510(k) submission data, which is usually summarized in a 510(k) Summary or Decision Memorandum available on the FDA website for successful clearances.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The eagle is facing to the right. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Cynthia C. Knapp NOV 0 2 2001 Director of Lab Services Trek Diagnostic Systems, Inc. 29299 Clemens Road, Suite 1-K Westlake, OH 44145
K012921 Re:
Trade/Device Name: Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Vancomycin Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: II Product Code: JWY Dated: August 29, 2001 Received: August 31, 2001
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 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 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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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/cdrh/dsma/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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NOV 0 2 2001
510 (k) Number (If known):
Device Name: Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.
Indications For Use:
The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in rific Schollae Fracmopillian Susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae.
This 510(k) is for the addition of Vancomycin in the dilution range of 0.06 - 4 ug/ml to the I mis Stortifits for the addition of cass pneumoniae MIC panel for testing Streptococcus Delistine Fracthophilus influenzae isolates. The "Indications for Use" and clinical pheumomac and Traomycin is for: Streptococcus pneumoniae (including penicillin-resistant strains )
(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 | |
| 510(k) Number | K012921 |
| Prescription Use(Per 21 CFR 801.109 | |
| OR | |
| Over-The-Counter Use |
§ 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).