(89 days)
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No
The summary describes an in vitro diagnostic product for susceptibility testing and mentions manual or automatic reading on specific instruments, but there is no mention of AI or ML in the provided text.
No.
The device is an in vitro diagnostic product used for susceptibility testing of bacterial isolates, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as an "in vitro diagnostic product for quantitatively and or qualitative susceptibility testing of isolated colonies." It is used to test clinical specimens, which indicates a diagnostic purpose to determine the susceptibility of certain microorganisms to Daptomycin.
No
The device description is not available, but the intended use clearly describes in vitro diagnostic plates (physical products) used for susceptibility testing. It also mentions hardware like the Sensititre Autoreader and ARIS. This indicates it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Sensititre® Haemophilus influenzae/Streptococcus species plates are in vitro diagnostic products for quantitatively and or qualitative susceptibility testing of isolated colonies of Haemophilus influenzae and Streptococcus species from clinical specimens."
This statement directly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The Sensititre® Haemophilus influenzae/Streptococcus species plates are in vitro diagnostic products for quantitatively and or qualitative susceptibility testing of isolated colonies of Haemophilus influenzae and Streptococcus species from clinical specimens. Plates can either be read manually or automatically on the Sensititre Autoreader and/or ARIS with Streptococcus species and manually with H.influenzae.
This 510(k) is for the addition of Streptococcus spps. to Daptomycin (0.03-32pg/mL) for use with the Sensitire® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. The approved primary "indications for use" and clinical significance of Daptomycin is for:
Aerobic facultative Gram-positive microorganisms Streptococcus agalactiae Streptococcus pyogenes Streptococcus dysgalactiae subsp. equisimilis
Product codes
JWY, LRG
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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and science. The department's name is inscribed in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Cynthia C. Knapp Director Lab Services TREK Diagnostic Systems Inc. Magellan Biosciences 982 Keynote Circle, Suite 6 Cleveland, OH 44131
DEC 2 0 2006
Re: K062841
Trade/Device Name: Sensititre® Haemophilus influenzae/Streptococcus species MIC Susceptibility Plates Daptomycin (0.03 - 32 ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY. LRG Dated: December 14, 2006 Received: December 18, 2006
Dear Ms. Knapp:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally
1
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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,
Sally, artopm
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KO 6 2 84 |
Device Name: Sensititre® Haemophilus influenzae / Streptococcus species MIC Susceptibility plates, Daptomycin (0.03-32ug/mL)
Indications For Use:
The Sensititre® Haemophilus influenzae/Streptococcus species plates are in vitro diagnostic products for quantitatively and or qualitative susceptibility testing of isolated colonies of Haemophilus influenzae and Streptococcus species from clinical specimens. Plates can either be read manually or automatically on the Sensititre Autoreader and/or ARIS with Streptococcus species and manually with H.influenzae.
This 510(k) is for the addition of Streptococcus spps. to Daptomycin (0.03-32pg/mL) for use with the Sensitire® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. The approved primary "indications for use" and clinical significance of Daptomycin is for:
Aerobic facultative Gram-positive microorganisms Streptococcus agalactiae Streptococcus pyogenes Streptococcus dysgalactiae subsp. equisimilis
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Page 1 of
Lueddi W. Poole
Division
ce of In Viro Diagnostic Device
210(K) K062841