(38 days)
K041776, K041214, K032518, K032259, K033119, K031727, K031205, K031103, K030933, K030620, K011116, K010508, K020331, K001953, K001887, K001721, K001612, K001516, K992853, K992726, K992717, K992646, K992647, K992593, K992562, K992568, K992507, K992546, K992420, K992296, K992297, K992143, K992108, K992076, K992059, K992077, K991925, K946126
Not Found
No
The device description and performance studies focus on traditional microbiological methods (visual observation of growth and color changes) and do not mention any computational analysis or algorithms that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
This device is for in vitro diagnostic use, specifically for measuring the susceptibility of bacterial pathogens to antimicrobial agents and identifying these organisms. It does not directly treat or diagnose a disease, therefore it is not a therapeutic device.
Yes
The device is explicitly stated to be used for "quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms." This process involves identifying microorganisms and determining their susceptibility to various treatments, which are key functions of a diagnostic device.
No
The device description explicitly states that the device involves physical panels containing antimicrobial agents and requires visual observation of growth or color changes, indicating a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the panels are used for "quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms." This is a classic description of an in vitro diagnostic test used to aid in the diagnosis and treatment of infectious diseases.
- Device Description: The description details a laboratory procedure involving the inoculation of bacterial organisms into panels containing antimicrobial agents and biochemical substrates. The results are interpreted based on visible growth or color changes, which are standard methods for in vitro diagnostic testing in microbiology.
- Performance Studies: The performance studies describe testing conducted in a laboratory setting using challenge strains, clinical isolates, and QC strains to evaluate the device's performance against a reference methodology. This type of testing is characteristic of the validation process for IVD devices.
- Predicate Devices: The list of predicate devices includes numerous other Pasco MIC and MIC/ID panels, all of which are also IVD devices used for antimicrobial susceptibility testing and identification of microorganisms.
The device is designed to be used outside of the body (in vitro) to provide information about a patient's condition (the susceptibility of a bacterial infection to specific antibiotics and the identification of the causative organism), which directly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PASCO MIC AND MIC/ID PANELS are used for quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.
This 510(k) notification is for the addition of the antimicrobial Telithromycin at concentrations of 0.015 - 4 mcg/ml to Pasco Panels. Telithromycin has been shown to be active in vitro against the following microorganisms, pursuant to each of the FDA-approved package insert for this antimicrobic:
Aerobic Gram-positive microorganisms
Staphylococcus aureus (methicillin-susceptible and erythromycin susceptible isolates only)
Product codes (comma separated list FDA assigned to the subject device)
JWY
Device Description
Quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco microdilution panels and the panels are then frozen. Panels are thawed prior to inoculation with the test organisms, incubated the traditional 16-24 hours and panels are then observed for visible growth or color changes as described in the package insert.
The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC). Changes in and production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.
Mentions image processing
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Challenge strains, fresh clinical isolates, stock clinical isolates and QC strains were tested concurrently using both Pasco methodology and reference methodology in panels that contained Telithromycin at concentrations ranging from 0.015 -- 4 mcg/ml. Testing was conducted at three test sites.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test results of 207 challenge and clinical Staphylococcus aureus demonstrated an Essential Agreement (EA) of 100%.
QC endpoints for the NCCLS recommended QC organisms (S. aureus ATCC 29213 and P. aeruginosa ATCC 27853) with the Pasco MIC and MIC/ID panel and test methodology were acceptable.
Reproducibility testing of 10 organisms at each site on three separate days in triplicate demonstrated reproducibility of MIC results of 100% for all three sites.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA) of 100%
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.
K041776, K041214, K032518, K032259, K033119, K031727, K031205, K031103, K030933, K030620, K011116, K010508, K020331, K001953, K001887, K001721, K001612, K001516, K992853, K992726, K992717, K992646, K992647, K992593, K992562, K992568, K992507, K992546, K992420, K992296, K992297, K992143, K992108, K992076, K992059, K992077, K991925, K946126
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).
Not Found
§ 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).
0
1(09233/
510(k) SUMMARY (page 1 of 3)
| DATE: | September 30, 2004 |
|---|---|
| CONTACT PERSON: | Linda K. Dillon |
| Chuck Lakel | |
| Pasco Laboratories | |
| 12750 West 42nd Avenue | |
| Wheat Ridge, Co 80033 | |
| 303-390-3240 | |
| TRADE NAME OF DEVICE: | Pasco MIC and MIC/ID Panels |
| COMMON NAME: | Antimicrobial Susceptibility Test |
| CLASSIFICATION NAME: | Class II Antimicrobial Susceptibility Test |
| Microbiology Panel #83 |
SUBSTANTIAL EQUIVALENCE:
In review of previous 510(k) notifications for the Pasco MIC and MIC/ID panels: K041776, August 3, 2004 RE: Telithromycin (Streptococcus); K041214, June 7, 2004 RE: Daptomycin (Streptococcus); K032518, September 15, 2003 RE: Gemifloxacin (Strep), K032259, August 19, 2003 RE: Gatifloxacin (Strep); K033119, November 18, 2003 RE: Daptomycin; K031727, July 30, 2003 RE: Gemifloxacin; K031205, June 13, 2003 RE: Linezolid; K031103, June 12, 2003 RE: Ertapenem; K030933, May 1, 2003 RE: Moxifloxacin; K030620, April 14, 2003 RE: Gatifloxacin; K011116, April 24, 2001 RE: ESBL Confirmatory Test; K010508, April 23, 2001 RE: ESBL Screen Test; K020331, March 20, 2002 RE: Ertapenem; K001953, August 10, 2000 RE: Amoxicillin; K001887, August 9, 2000 RE: Ampicillin; K001721, August 4, 2000 RE: Clarithromycin; K001612, July 18, 2000 RE: Linezolid; K001516, July 12, 2000 RE: Moxifloxacin; K992853, November 4, 1999 RE: Cefdinir; K992726, November 3, 1999 RE: Synercid (non-fastidious); K992717, November 2, 1999 RE: Synercid; K992646, October 19, 1999 RE: Penicillin; K992647, October 19, 1999 RE: Erythromycin; K992593, October 14, 1999 RE: Chloramphenicol; K992562, October 13, 1999 RE: Ceftriaxone; K992568, October 14, 1999 RE: Cefotaxime; K992507, October 18, 1999 RE: Trovafloxacin; K992546, October 12, 1999 RE: Meropenem; K992420, September 27, 1999 RE: Sparfloxacin; K992296, September 21, 1999 RE: Vancomycin; K992297, September 3, 1999 RE: Levofloxacin; K992143, September 16, 1999 RE: Clindamycin; K992108, September 3, 1999 RE: Cefepime; K992076, August 30, 1999 RE: Cefuroxime; K992059, August 30, 1999 RE: Imipenem; K992077, September 3, 1999 RE: Ofloxacin; K991925, August 20, 1999 RE: Amoxicillin/Clavulanic Acid; and K946126, January 17, 1995 RE: Detection of resistant pneumococci), the FDA has determined the Pasco panels to be substantially equivalent to devices marketed in
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510(k) SUMMARY
(page 2 of 3)
interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments.
The term "substantial equivalence" as used in this 510(k) notification is limited to the I he term - substantial equivalence as found in the Federal Food, Drug, and Cosmetic demintion of substantial equilted and a comments of CFR 807, Subpart E under which a device can Act, as amended and as approval or reclassification. A determination of oc marketed without pro mail this notification is not intended to have any bearing substantial equivalency and entre ent infringement suits or any other patent matters. No whatsocver on the rootation of prof, substantial equivalence herein shall be construed statements reluted to, or in beppen cer the US Patent Laws or their application by the courts.
DESCRIPTION OF THE DEVICE:
DESCRIPTION OF Corporatitatively measuring the susceptibility of rapidly growing I aso I and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. Varying and determining and antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco microdilution panels and the panels are then frozen. Panels are thawed prior to the Faso International with the test organisms, incubated the traditional 16-24 hours and panels are then observed for visible growth or color changes as described in the package insert.
The lowest concentration of each antimicrobial agent with no apparent visible growth of The test organism is recorded as the minimum inhibitory concentration (MIC). Changes in tHand production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.
INTENDED USE FOR THE PASCO MIC AND MIC/ID PANELS:
PASCO MIC AND MIC/ID PANELS are used for quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.
SUMMARY/CONCLUSION OF SUBSTANTIAL EQUIVALENCE TESTING:
Challenge strains, fresh clinical isolates, stock clinical isolates and QC strains were tested concurrently using both Pasco methodology and reference methodology in panels that contained Telithromycin at concentrations ranging from 0.015 -- 4 mcg/ml. Testing was conducted at three test sites.
Test results of 207 challenge and clinical Staphylococcus aureus demonstrated an Essential Agreement (EA) of 100%.
2
510(k) SUMMARY
(page 3 of 3)
QC endpoints for the NCCLS recommended QC organisms (S. aureus ATCC 29213 and QC enaponiis for the NCCLS recommentate Q o organize and test methodology were acceptable.
Reproducibility testing of 10 organisms at each site on three separate days in triplicate Reproductionity testing of 10 organisms areast illity of MIC results of 100% for all three sites.
The results of the clinical testing, reproducibility testing and QC performance testing The results of the childed tosting, reproductions) comment "Class II Special supports Substantial Equiraler as Simonorolal Susceptibility Test (AST) Systems; Guidance for Industry and FDA.
3
Image /page/3/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 lines representing its wings or feathers. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", which is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 7 - 2004
Ms. Linda K. Dillon R&D Manager BD Diagnostic Systems Pasco Laboratories 12750 W. 42nd Avenue Wheat Ridge, CO 80033-2440
Re: K042331
Trade/Device Name: PASCO MIC and MIC/ID Panels for Telithromycin at 0.015-4 mcg/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: August 23, 2004 Received: August 30, 2004
Dear Ms. Dillon:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 31 xxx, presidentially equivalent (for the indications felerenced above and nave decembined by marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manat date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have tech recuire approval of a premarket approval application (PMA). and Cosmetic Act (Fee) that do not require subject to the general controls provisions of the Act. The 1 ou may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of tactice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (600 a00 - 5) irols. Existing major regulations affecting your device it may be subject to such additional controllar controller.
can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA can be lound in This 21, Occareents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised hat I Dri 3 issualite or a cevice complies with other requirements of the Act that FDA has made a decommanding administered by other Federal agencies. You must of any I cutures and regarants and regarants ancluding, but not limited to: registration and listing (21 comply with an the Het brequire.nems 801 and 809); and good manufacturing practice CI K Part 807), laboring in the quality systems (QS) regulation (21 CFR Part 820).
4
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maketing your aven equivalence of your device to a legally premarket nothleation. The PDA intellig of backanda vour 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, If you destic specific information and advertising of your device, please contact the Office of or questions on the promotion and Safety at (301) 594-3084. Also, please note the In Viro Diagliostic Device Development and store to premarket notification" (21 CFR Part 807.97). regulation entitied, "Misoranums of responsibilities under the Act from the You may outdil other general mormational 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,
Salartys
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
5
Page 1 of 1
510(k) Number (if known): K042331
Device Name: PASCO MIC and MIC/ID Panels – Telithromycin 0.015 – 4 mcg/ml
Indications For Use: Inclusion of Telithromycin
Pasco MIC and MIC/ID panels are used for quantitatively measuring the susceptibility of rapidly Pasco MIC and MICHD pareis are used to qualitian. Or head in 3 a battery of antimicrobial agents growing aerobic and tabalicative andertification of those organisms.
This 510(k) notification is for the addition of the antimicrobial Telithromycin at concentrations of This 510(K) notification is for the addition of the antiness and white be active in vitro against 0.015 - 4 mcgmi to Pasco Panels. Telithonyon has been enom to Beach of the FDA-approved package insert for this antimicrobic.
Active In Vitro and in Clinical Infectious Against:
Aerobic Gram-positive microorganisms
Aerobic Grain-positive imetoorganisms and erythromycin susceptible isolates only)
Prescription Use X (Per 21 CRF 801 Subpart D) AND/OR
Over-The-Counter Use_ (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)
Liddie Lu- Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K04233