PASCO MIC AND MIC/ID PANELS

K041214 · Pasco Laboratories, Inc. · JWY · Jun 7, 2004 · Microbiology

Device Facts

• Record ID: K041214
• Device Name: PASCO MIC AND MIC/ID PANELS
• Applicant: Pasco Laboratories, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Jun 7, 2004
• 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 non-fastidious organisms which use routine inoculation procedure.

Device Story

Microdilution panels containing two-fold dilutions of daptomycin; used for antimicrobial susceptibility testing (AST). Panels are frozen, thawed, inoculated with bacterial samples, and incubated for 16-24 hours at 35°C. Growth is detected via turbidity; manual reading performed using indirect lighted background viewer. Minimum inhibitory concentration (MIC) defined as lowest concentration with no visible growth. Used in clinical microbiology laboratories by technicians. Results inform clinicians of bacterial susceptibility to daptomycin, guiding antibiotic therapy selection.

Clinical Evidence

Bench testing performed at three sites using 348 challenge and clinical Streptococcus spp. (excluding S. pneumoniae) isolates. Daptomycin concentrations tested ranged from 0.06-8 mcg/ml. Results showed 99.7% Essential Agreement (EA) and 99.6% evaluable EA compared to reference methodology. Reproducibility testing of 13 organisms across three sites over three days showed 100% intra-site reproducibility. QC performance met NCCLS recommendations.

Technological Characteristics

Microdilution panels containing antimicrobial agents in two-fold dilutions. Principle: broth microdilution for MIC determination and biochemical substrate analysis for organism identification. Form factor: frozen multi-well panels. Energy source: none (manual/visual interpretation).

Indications for Use

Indicated for testing Streptococcus spp. (excluding S. pneumoniae) for susceptibility to Daptomycin (0.06–8 ug/ml). For use with Beta Hemolytic Streptococci only. Prescription use only.

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- gatifloxacin (K032259)

Submission Summary (Full Text)

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

A. 510(k) Number:
k041214

B. Purpose of Submission:
Addition of daptomycin to the Pasco MIC and MIC/ID Panels

C. Analyte:
Daptomycin at 0.06 - 8 ug/ml

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

E. Applicant:
BD Diagnostic Systems – Pasco Laboratories

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

G. 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

H. 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 non-fastidious organisms which use routine inoculation procedure.

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2. **Indication(s) for use:**
The indication is for the addition of the antimicrobial Daptomycin at concentrations of 0.06 – 8 ug/ml to Pasco Panels for use in testing *Streptococcus spp.* other than *S. pneumoniae*.

3. **Special condition for use statement(s):**
Routine turbidity method of inoculation.
Beta Hemolytic Streptococci only

Prescription use only

4. **Special instrument Requirements:**
Not Applicable

I. **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 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.

J. **Substantial Equivalence Information:**

1. **Predicate device name(s):**
Pasco MIC Panels- gatifloxacin

2. **Predicate K number(s):**
K032259

3. **Comparison with predicate:**

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| 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 | Daptomycin at predefined 2-fold dilutions | Gatifloxacin at predefined 2-fold dilutions |

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K. 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.

L. Test Principle:
The test panels are dependent on the growth of the organisms in the presence of antibiotics. These antibiotics are diluted to appropriate test concentrations in cation adjusted Mueller Hinton Broth adjusted to ionized physiologic levels with calcium and magnesium. The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC).

M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Thirteen on-scale Streptococcus spp. were tested at three sites on three separate days in triplicate. The reproducibility was acceptable at >95%.
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 demonstrated that the system can produce QC results in the recommended range.

| ORGANISM | Conc ug/ml | Reference | Pasco turbidity |
| --- | --- | --- | --- |
| | | | |
| S. pneumoniae ATCC 49619 Expected Range 0.06-0.5 ug/ml | 0.06 | | |
| | 0.12 | 53 | 46 |
| | 0.25 | 21 | 28 |
| | 0.5 | | |
| | | | |

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

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and a subset of the clinical isolates and demonstrated the appropriate inoculum was used.

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 supplemented with 2-5% lysed horse blood prepared according to the recommendations of the NCCLS were used to compare with the Pasco results. The concentration of calcium on the Mueller Hinton Broth was also adjusted to 50 ug/mL as recommended by the NCCLS and FDA. Testing was performed at 3 sites and included fresh and stock clinical isolates and a set of challenge organisms. Although the number of challenge isolates tested was not that many, there were sufficient number tested in clinicals with a very good EA%. Category agreement is not determined since there is only a susceptible interpretative category. The comparison resulted in the following performance evaluations.

| | total | EA | %EA | Total evaluable | EA of evaluable | %EA of evaluable | #R | min | maj | vmj |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Clinical | 181 | 181 | 100.0 | 97 | 97 | 100.0 | 2 | 0 | 0 | 0 |
| Challenge | 25 | 25 | 100.0 | 9 | 9 | 100.0 | 0 | 0 | 0 | 0 |
| Combined | 206 | 206 | 100.0 | 106 | 106 | 100.0 | 2 | 0 | 0 | 0 |

EA-essential agreement
R-resistant isolates

maj-major discrepancies
vmj-very major discrepancies
min- minor discrepancies

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. The %EA is 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".

There are no vmj, maj or minor errors encountered in the overall submission. The %EA and %EA of evaluable are both very good.

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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:
Streptococcus spp. ≤ 1 (S)
These interpretative criteria are the same as those in the FDA approved daptomycin pharmaceutical package insert. The recommended QC is also the same and appears in the package insert.

The current absence of data on resistant strains precludes defining any results other than "Susceptible". Strains yielding MIC results suggestive of a "non-susceptible" category should be submitted to a reference laboratory for further testing.

N. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.