PASCO MIC AND MIC/ID PANELS

K032259 · Bd Diagnostic Systems · JWY · Aug 19, 2003 · Microbiology

Device Facts

• Record ID: K032259
• Device Name: PASCO MIC AND MIC/ID PANELS
• Applicant: Bd Diagnostic Systems
• Product Code: JWY · Microbiology
• Decision Date: Aug 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

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 these organisms. The MIC Supplemental III panel contains antimicrobial agents fully diluted to concentrations appropriate for testing S. pneumoniae and other Streptococcus spp. which require the use of SP Blood Supplement for inoculation. This panel also contains antimicrobial agents at concentrations appropriate for testing various nonfastidious organisms which use routine inoculation procedure.

Device Story

Pasco MIC and MIC/ID panels are microdilution plates containing two-fold dilutions of antimicrobial agents. Panels are frozen, thawed, and inoculated with bacterial samples in a clinical laboratory setting. After 16-24 hours of incubation, the device is observed for visible growth or color changes. The minimum inhibitory concentration (MIC) is determined by identifying the lowest concentration of antimicrobial agent with no visible growth. Biochemical identification is performed via pH changes and metabolite production. Results are interpreted by laboratory personnel to guide antimicrobial therapy decisions for patients with bacterial infections. The device provides standardized susceptibility data to assist clinicians in selecting effective antibiotic treatments.

Clinical Evidence

Bench testing only. Study compared Pasco methodology to reference methodology using 570 challenge and clinical isolates of Streptococcus pneumoniae and Streptococcus spp. Essential Agreement (EA) was 100%. Category Agreement (CA) was 99.7% with 2 minor discrepancies. Reproducibility testing (17 organisms, 3 sites, 3 days, triplicate) showed 100% inter-site and intra-site reproducibility. QC performance using S. pneumoniae ATCC 49619 was acceptable.

Technological Characteristics

Microdilution panel containing two-fold dilutions of antimicrobial agents. Frozen format, thawed prior to use. Manual or visual interpretation of growth/color change based on pH and metabolite production. No electronic sensing or automated software algorithm described; relies on conventional microbiological observation.

Indications for Use

Indicated for testing Streptococcus pneumoniae and Streptococcus spp. other than S. pneumoniae using Gatifloxacin at concentrations of 0.03 – 8 ug/ml.

Regulatory Classification

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.

Predicate Devices

• Pasco MIC Panels with moxifloxacin (K030620)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
k032259

B. Analyte:
Gatifloxacin at 0.03-8 ug/ml

C. Type of Test:
Quantitative – broth based growth detected by turbidity

D. Applicant:
Pasco Laboratories-BD Diagnostics Systems

E. Proprietary and Established Names:
Pasco MIC and MIC/ID Panels

F. Regulatory Information:
1. Regulation section:
866.1640 - Antimicrobial Susceptibility Test Powder
2. Classification:
II
3. Product Code:
JWY - Manual Antimicrobial Test Systems
4. Panel:
83 - Microbiology

G. Intended Use:
1. Intended use(s):
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 these organisms.

The MIC Supplemental III panel contains antimicrobial agents fully diluted to concentrations appropriate for testing S. pneumoniae and other Streptococcus spp. which require the use of SP Blood Supplement for inoculation. This panel also contains antimicrobial agents at concentrations appropriate for testing various nonfastidious organisms which use routine inoculation procedure.

2. Indication(s) for use:
The indication is for the addition of the antimicrobial Gatifloxacin at concentrations of 0.03 – 8 ug/ml to Pasco Panels for use in testing Streptococcus pneumoniae and Streptococcus spp. other than S. pneumoniae.

3. Special condition for use statement(s):
Direct turbidity method of inoculation

4. Special instrument Requirements:
Not applicable

H. Device Description:
Various concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco microdilution panels and the panels are then frozen. Panels

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are thawed prior to use, inoculated with the test organisms, incubated the traditional 16-24 hours at 35° in a non-CO₂ incubator and panels are then observed for visible growth or color changes (ID portion). The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC). Only manual readings are performed using an indirect lighted background viewer.

Inoculation procedures include the Direct Turbidity Standard method, which uses a spectrophotometer.

I. Substantial Equivalence Information:

1. Predicate device name(s):
Pasco MIC Panels with moxifloxacin
2. Predicate K number(s):
K030620
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | Same | Same |
| Type panel | 100 μl/well frozen | 100 μl/well frozen |
| Inoculum | 5 μl | 5 μl |
| Inoculation method | Direct equated to a 0.5 McFarland | Direct equated to a 0.5 McFarland |
| Incubation | 16-24 hours | 16-24 hours |
| Reading method | Visual growth | Visual growth |
| Differences | | |
| Item | Device | Predicate |
| Antibiotic | serial dilutions of gatifloxacin | serial dilutions of moxifloxacin |

J. Standard/Guidance Document Referenced (if applicable):

"Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA"; NCCLS Standard M7 Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard; M100 Performance Standards for Antimicrobial Susceptibility Testing

K. Test Principle:

The test panels are dependent on the growth of the organisms in the presence of the antibiotics. The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC).

L. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Ten isolates with on-scale results were tested at three sites. These were evaluated for site to site reproducibility and inter site reproducibility using the ten isolate study described in the guidance document (10 organisms tested 3 times on 3 days

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at 3 sites). The testing included 17 on scale organisms with very good reproducibility.

b. Linearity/assay reportable range:

Not applicable

c. Traceability (controls, calibrators, or method):

The recommended QC isolate was tested a sufficient number of times with acceptable results with the reference method. The Pasco results demonstrate that the system can produce QC results in the recommended range.

| ORGANISM | Conc ug/ml | Reference | Pasco turbidity |
| --- | --- | --- | --- |
| | | | |
| S. pneumoniae ATCC 49619 Expected Range 0.12-0.5 | 0.06 | | |
| | 0.12 | 1 | 1 |
| | 0.25 | 73 | 73 |
| | 0.5 | | |
| | 1.0 | | |

Inoculum Density Check- An internal study was performed to verify the colony counts (CC) that would be obtained with each method of inoculation. Clinical site inoculum density checks were also performed on QC isolates, reproducibility isolates and a subset of the clinical isolates.

d. Detection limit:

Not applicable

e. Analytical specificity:

Not applicable

f. Assay cut-off:

Not applicable

2. Comparison studies:

a. Method comparison with predicate device:

Broth reference panels prepared according to the recommendations of the NCCLS were used to compare the Pasco results to. Testing was performed at 3 sites and included fresh and stock clinical isolates and a set of challenge organisms. The comparison resulted in the following performance evaluations.

| | total | EA | %EA | Total evaluable | EA of evaluable | %EA | CA | %CA | #R | min | maj | vmj |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Clinical | 470 | 470 | 100 | 463 | 463 | 100 | 468 | 99.6 | 17 | 2 | 0 | 0 |
| Challenge | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 5 | 0 | 0 | 0 |
| Combined | 570 | 570 | 100 | 563 | 563 | 100 | 568 | 99.7 | 22 | 2 | 0 | 0 |

EA-Essential Agreement

CA-Category Agreement

R-resistant isolates

maj-major discrepancies

vmj-very major discrepancies

min-minor discrepancies

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EA is when there is agreement between the reference method and the Pasco panel within plus or minus one serial two-fold dilution of antibiotic. CA is when the interpretation of the reference method agrees exactly with the interpretation of the Pasco result. The %EA and CA are acceptable with acceptable discrepancy rates when compared to the reference method as described in the FDA guidance document, “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA”.

b. Matrix comparison: Not applicable

3. Clinical studies:
a. Clinical sensitivity: Not applicable
b. Clinical specificity: Not applicable
c. Other clinical supportive data (when a and b are not applicable): Not applicable

4. Clinical cut-off: Not applicable

5. Expected values/Reference range: ≤ 1 (S), 2 (I), ≥ 4 (R)

These are the same interpretative ranges for both the FDA approved antibiotic and the NCCLS listings in Table 2G.

M. Conclusion:

Data analysis when analyzed as recommended in the “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA” demonstrates that the Pasco MIC and MIC/ID Panels with Gatifloxacin is substantially equivalent to the Pasco MIC and MIC/ID Panels with moxifloxacin.