(28 days)
K033119, K032518, K032259, 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, and K946126
Not Found
No
The device description and performance studies detail a traditional microbiology method involving visual observation of growth and color changes, with no mention of AI or ML technologies.
No.
The device is used to measure the susceptibility of bacteria to antimicrobial agents and determine their biochemical identification, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as "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," which directly relates to diagnosing and guiding treatment for bacterial infections.
No
The device description explicitly states that the device is a physical panel with varying concentrations of antimicrobial agents dispensed into it. It is a hardware component used for laboratory testing.
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 involves testing biological samples (bacterial pathogens) outside of the body to provide information for diagnosis or treatment.
- Device Description: The description details a laboratory method involving dispensing antimicrobial agents into panels, adding organisms, incubating, and observing for growth or color changes. This is a typical in vitro diagnostic process.
- Performance Studies: The performance studies involve testing "challenge strains, fresh clinical isolates, stock clinical isolates and QC strains" using the device and comparing the results to a "reference methodology." This demonstrates the evaluation of the device's performance in a laboratory setting using biological samples.
The core function of the device is to analyze biological samples (bacterial pathogens) in a laboratory setting to provide information about their susceptibility to antimicrobial agents and their identification. This aligns directly 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 Daptomycin at concentrations of 0.06 - 8 mcg/ml to Pasco Panels for use in testing Streptococcus spp. other than S. pneumoniae. Daptomycin 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 Streptococcus agalactiae Streptococcus dysgalactiae subsp. equisimilis Streptococcus pyogenes
Product codes (comma separated list FDA assigned to the subject device)
JWY
Device Description
DESCRIPTON of ITAL of the quantitatively measuring the susceptibility of rapidly growing I asso i and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. Varying and detentining are ere erobial 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 raseo have a read 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.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Daptomycin at concentrations ranging from 0.06 - 8 mcg/ml. Testing was conducted at three test sites. Test results of the 348 challenge and clinical Streptococcus spp. other than S. pneumoniae demonstrate an Essential Agreement (EA) 99.7% and an evaluable EA of 99.6%. QC endpoints for the NCCLS recommended QC organisms (S. pneumoniae ATCC QC chapoints for the reference and test methodology were acceptable. Reproducibility testing of 13 organisms at each site on three separate days in triplicate Reproductions' testing of 15 organilize of 100%. Intra-site reproducibility of MIC results was 100% for all three sites. The results of the clinical testing, reproducibility testing and QC performance testing The results of the ennout verance as outlined in the FDA document "Class II Special Supports Bacsument: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA) 99.7% and an evaluable EA of 99.6%. Intra-site reproducibility of MIC results was 100% for all three sites.
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.
K033119, K032518, K032259, 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, and 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).
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JUN - 7 2004
510(k) SUMMARY
(page 1 of 3)
DATE:
May 7. 2004
| CONTACT PERSON: | Linda K. Dillon
Chuck Lakel
Pasco Laboratories
12750 West 42nd Avenue
Wheat Ridge, Co 80033
303-423-9504 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------|
| 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 panel: K033119, November 18, 2003 RE: Daptomycin (nonfastidious); K032518, September 15, 2003 RE: Gemifloxacin (Streptococcus); K032259, August 19, 2003 RE: Gatifloxacin (Streptococcus); 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: Trovatloxacin: 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.
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The term "substantial equivalence" as used in this 510(k) notification is limited to the The term -substantial equivalence as found in the Federal Food. Drug, and Cosmetic demirron of Substantall equival under 21 CFR 807. Subpart E under which a device can I tot as antellawithout pre-market approval or reclassification. A determination of oc manteted withis notification is notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No whatsocver on the resortinen of parefits substantial equivalence herein shall be construce Statements relainst interest under the US Patent Laws or their application by the courts.
DESCRIPTION OF THE DEVICE:
DESCRIPTON of ITAL of the quantitatively measuring the susceptibility of rapidly growing I asso i and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. Varying and detentining are ere erobial 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 raseo have a read 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 QC strains were tested concurrently using both Pasco methodology and reference methodology in panels that contained Daptomycin at concentrations ranging from 0.06 - 8 mcg/ml. Testing was conducted at three test sites.
Test results of the 348 challenge and clinical Streptococcus spp. other than S. pneumoniae demonstrate an Essential Agreement (EA) 99.7% and an evaluable EA of 99.6%.
2
510(k) SUMMARY
(page 3 of 3)
QC endpoints for the NCCLS recommended QC organisms (S. pneumoniae ATCC QC chapoints for the reference and test methodology were acceptable.
Reproducibility testing of 13 organisms at each site on three separate days in triplicate Reproductions' testing of 15 organilize of 100%. Intra-site reproducibility of MIC results was 100% for all three sites.
The results of the clinical testing, reproducibility testing and QC performance testing The results of the ennout verance as outlined in the FDA document "Class II Special Supports Bacsument: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined strands and a stylized wing-like element above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the caduceus symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 7 2004
Ms. Linda K. Dillon R&D Manager BD Diagnostic Systems Pasco Laboratories 12750 W. 42nd Avenue Wheat Ridge, CO 80033-2440
Re: K041214
Trade/Device Name: PASCO MIC and MIC/ID Panels for Daptomycin at 0.06-8 mcg/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: May 7, 2004 Received: May 10, 2004
Dear Ms. Dillon:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assossion in the encrease, 1976, the enactment date of the Medical Device Amendments, or to conninered processified 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). and Cosmeter For (110) that be device, subject to the general controls provisions of the Act. The r ou may, mercretere, mains of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 your device to such additional controls. Existing major regulations affecting your device it may be subject to Justic address 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 I least be advised that I DTT vissance over device complies with other requirements of the Act that I DA has Inade a actor regulations administered by other Federal agencies. You must of any I ederal stututed and registments, 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).
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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). You may obtain other general information on your responsibilities under the Act 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,
Salazar
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
Indications for Use
510(k) Number (if known): K041214
Device Name: Pasco MIC and MIC/ID Panels for Daptomycin at 0.06 - 8 mcg/ml
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 Daptomycin at concentrations of 0.06 - 8 mcg/ml to Pasco Panels for use in testing Streptococcus spp. other than S. pneumoniae. Daptomycin 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 Streptococcus agalactiae Streptococcus dysgalactiae subsp. equisimilis Streptococcus pyogenes
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)
Fuddli. Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
210(k) Rochisla