(46 days)
PASCO MIC AND MIC/ID PANELS are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement or category results) 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 Gatifloxacin at concentrations of 0.03 - 8 mcg/ml to Pasco Panels. Gatifloxacin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic.
Active In Vitro and in Clinical Infectious Against:
Aerobic Gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only) Aerobic Gram-negative microorganisms Escherichia coli Klebsiella pneumoniae Proteus mirabilis
Active In Vitro but their clinical significance is unknown
Aerobic Gram-positive microorganisms Staphylococcus saprophyticus
Aerobic Gram-negative microorganisms Acinetobacter lwoffii Citrobacter koseri Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Klebsiella oxytoca Morganella morganii Proteus vulgaris
Pasco 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. 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 use, inoculated 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 pH and production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.
This document describes the regulatory submission for the Pasco MIC and MIC/ID Panels, specifically for the inclusion of the antimicrobial Gatifloxacin. The study's purpose is to demonstrate substantial equivalence to previously cleared devices.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Nonfastidious Gram-Positive Organisms (410 tested) | Essential Agreement (EA): 100% |
| - Major (M) errors | None observed |
| - Very Major (VM) errors | None observed |
| - Minor errors | 10 minor errors observed (all within EA) |
| Category Agreement (CA) | 98.3% |
| Gram-Negative Organisms (615 tested) | Essential Agreement (EA): 99.6% |
| - Major (M) errors | None observed |
| - Very Major (VM) errors | None observed |
| - Minor errors | 17 minor errors observed (all within EA except one) |
| Category Agreement (CA) | 98.1% |
| OC Endpoints for NCCSL Recommended OC Organisms (S. aureus ATCC 29213, E. faecalis ATCC 29212, E. coli ATCC 25922, P. aeruginosa ATCC 27853) | Acceptable for both reference and test methodology |
| Inter-site Reproducibility (10 organisms, 3 days, triplicate) | 99.6% |
| Intra-site Reproducibility | 100% for 2 sites, 98.9% for 1 site |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size:
- Nonfastidious gram-positive organisms: 410
- Gram-negative organisms: 615
- Reproducibility testing: 10 organisms (tested in triplicate over 3 days at each of 3 sites, total 90 tests per site for reproducibility and 270 total tests across all sites)
- Data Provenance: The document does not specify the country of origin. It indicates that "Challenge strains, fresh clinical isolates, stock clinical isolates and QC strains were tested concurrently." The testing was conducted at "three test sites." The type of study is prospective, as it involves concurrent testing of "fresh clinical isolates" and "challenge strains."
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)
The document does not provide information on the number or qualifications of experts used to establish the ground truth. The "reference methodology" is used as the comparator, which typically implies established laboratory practices and expert interpretation but specific details are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe an explicit adjudication method. The comparison is made against "reference methodology," and errors (major, very major, minor) are reported based on this comparison. It does not mention multiple readers or an adjudication process for discrepancies.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on a standalone device's performance (antimicrobial susceptibility test panel) against a reference method, not on human reader performance with or without AI assistance. This device is not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone study was done. The "Pasco MIC and MIC/ID Panels" are a device for quantitatively measuring antimicrobial susceptibility. The performance metrics (Essential Agreement, Category Agreement, reproducibility) are reported for the device itself against a "reference methodology." While human observation is involved in reading the panels (visible growth or color changes), the evaluation is of the device's accuracy in determining MIC values compared to the reference, not human performance using the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth was established by "reference methodology" for antimicrobial susceptibility testing. This typically refers to established and validated laboratory methods for determining Minimum Inhibitory Concentrations (MICs), often following guidelines from organizations like the Clinical and Laboratory Standards Institute (CLSI) or its predecessors (like NCCLS, mentioned in the document). The specific nature of this "reference methodology" is not detailed but is implied to be a standard, accepted laboratory procedure.
8. The sample size for the training set
This document does not describe a "training set" as it would for a machine learning or AI model. The study is a traditional device validation comparing the Pasco panels to a reference method, not a development of an algorithm that requires a separate training phase.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this device validation study.
{0}------------------------------------------------
②
K030620
510(k) SUMMARY (page 1 of 3)
APR 1 4 2003
| DATE: | February 26, 2003 |
|---|---|
| CONTACT PERSON: | Linda K. DillonChuck LakelPasco Laboratories12750 West 42nd AvenueWheat Ridge, Co 80033303-423-9504 |
| TRADE NAME OF DEVICE: | Pasco MIC and MIC/ID Panels |
| COMMON NAME: | Antimicrobial Susceptibility Test |
| CLASSIFICATION NAME: | Class II Antimicrobial Susceptibility TestMicrobiology Panel #83 |
SUBSTANTIAL EQUIVALENCE:
In review of previous 510(k) notifications for the Pasco MIC and MIC/ID panel: 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: Ervthromycin: 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 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 definition of substantial equivalence as found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification. A determination of
{1}------------------------------------------------
substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of, substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.
DESCRIPTION OF THE DEVICE:
Pasco 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. 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 use, inoculated 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 pH and 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 (with the exception of the Breakpoint/ID panel which provides qualitative measurement or category results) 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 OC strains were tested concurrently using both Pasco methodology and reference methodology in panels contained Gatifloxacin at concentrations ranging from 0.03 - 8 mcg/ml. Testing was conducted at three test sites.
Test results of 410 nonfastidious gram-positive organisms (included in the Microbiology Indications and Usage section of the FDA approved pharmaceutical package insert) demonstrated an Essential Agreement (EA) of 100%. No major (M) or very major (VM) errors were observed. Ten random minor errors, all of which were within EA. were observed. Category agreement (CA) was 98.3% .
Test results of 615 gram-negative organisms (included in the Microbiology Indications and Usage section of the pharmaceutical package insert) demonstrated an Essential Agreement (EA) of 99.6%. No major (M) or very major (VM) errors were observed.
{2}------------------------------------------------
510(k) SUMMARY (page 3 of 3)
Seventeen random minor errors were observed, all of which were within EA with the exception of one. Category agreement (CA) was 98.1%.
OC endpoints for the NCCLS recommended OC organisms (S. aureus ATCC 29213. E. faecalis ATCC 29212, E. coli ATCC 25922 and P. aeruginosa ATCC 27853) from panels using both the reference and test methodology were acceptable.
Reproducibility testing of 10 organisms at each site on three separate days in triplicate demonstrated inter-site reproducibility of MIC results of 99.6%. Intra-site reproducibility of MIC results was 100% for 2 sites and 98.9% for one site.
The results of the clinical testing, reproducibility testing and QC performance testing supports Substantial Equivalence as outlined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial 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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 4 2003
Ms. Linda K. Dillon Pasco R&D Manager BD Diagnostics Systems Pasco Laboratories 12750 W. 42nd Avenue Wheat Ridge, CO 80033-2440
K030620 Re:
Trade/Device Name: PASCO MIC and MIC/ID Panels Gatifloxacin Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: LTT Dated: February 26, 2003 Received: February 27, 2003
Dear Ms. Dillon:
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
{4}------------------------------------------------
Page 2 –
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 (301) 594-3084. 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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
510(k) Number (if known): K 030600 PASCO MIC and MIC/ID Panels Device Name: _ Indications for Use: Inclusion of Gatifloxacin
Pasco MIC and MIC/ID panels are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement of category results) 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 Gatifloxacin at concentrations of 0.03 - 8 mcg/ml to Pasco Panels. Gatifloxacin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic.
Active In Vitro and in Clinical Infectious Against:
Aerobic Gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only) Aerobic Gram-negative microorganisms Escherichia coli Klebsiella pneumoniae Proteus mirabilis
Active In Vitro but their clinical significance is unknown
Aerobic Gram-positive microorganisms Staphylococcus saprophyticus
Aerobic Gram-negative microorganisms Acinetobacter lwoffii Citrobacter koseri Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Klebsiella oxytoca Morganella morganii Proteus vulgaris
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted July 1, 1998)
(Optional Format 3-10-98)
Freddie Padole
(Division Sign-Off) Division of Clinical Laboratory Devices 10(k) Number _K D
Prescription Use Only
§ 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).