SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE

K031545 · Trek Diagnostic Systems, Inc. · JWY · Jul 16, 2003 · Microbiology

Device Facts

• Record ID: K031545
• Device Name: SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE
• Applicant: Trek Diagnostic Systems, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Jul 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Indications for Use

The Sensititre ESBL confirmatory test plate is an in vitro diagnostic product for detection of ESBL’s in clinical isolates of Klebsiella pneumoniae, Klebsiella oxytoca and Escherichia coli. Test results can be read either manually or automatically on a Sensititre® ARIS or Autoreader.

Device Story

The ESBL Confirmatory Test Plate is an in vitro diagnostic tool used in clinical laboratories to identify ESBL-producing bacteria. The device utilizes specific antimicrobial concentrations—Ceftazidime and Cefotaxime, both alone and in combination with clavulanic acid—to detect resistance patterns in clinical isolates of K. pneumoniae, K. oxytoca, and E. coli. Testing follows NCCLS M7 reference standards. Results are obtained via manual visual inspection or automated reading using the Sensititre ARIS or Autoreader systems. The output assists clinicians in confirming the presence of ESBLs, which informs antibiotic therapy selection and infection control decisions.

Clinical Evidence

Performance evaluated across three sites using 513 clinical isolates of K. pneumoniae, K. oxytoca, and E. coli compared to NCCLS reference methods. Manual reading showed 97.3% sensitivity and 95.4% specificity. Automated reading showed 98.3% sensitivity and 96.4% specificity. An additional study of 30 molecularly characterized isolates demonstrated 100% agreement for both manual and automated methods.

Technological Characteristics

Microtiter plate format containing dehydrated antimicrobial agents (Ceftazidime, Cefotaxime, and clavulanic acid combinations). Operates via broth microdilution principle. Compatible with Sensititre ARIS or Autoreader for automated optical reading. Complies with NCCLS M7 standards.

Indications for Use

Indicated for the detection of Extended-Spectrum Beta-Lactamases (ESBLs) in clinical isolates of Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.

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.

Submission Summary (Full Text)

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

A. 510(k) Number:
k031545

B. Analyte:
ESBL detection and confirmation

C. Type of Test:
Qualitative broth based growth detection using Ceftazidime/clavulanic acid at 0.06/4-128/4 ug/ml and Cefotaxime/clavulanic acid at 0.06/4-64/4 ug/ml

D. Applicant:
Trek diagnostics Systems

E. Proprietary and Established Names:
Sensititre® 18-24 hour Susceptibility plate

F. Regulatory Information:
1. Regulation section:
CFR 866.1640 Antimicrobial Susceptibility Test
2. Classification:
II
3. Product Code:
JWY
4. Panel:
83

G. Intended Use:
1. Indication(s) for use:
The Sensititre ESBL confirmatory test plate is an in vitro diagnostic product for detection of ESBL’s in clinical isolates of Klebsiella pneumoniae, Klebsiella oxytoca and Escherichia coli. Test results can be read either manually or automatically on a Sensititre® ARIS or Autoreader.
2. Special condition for use statement(s):
3. Special instrument Requirements:

H. Device Description:
The 96 well panel contains precision dosed antimicrobial agents that are dried.

I. Substantial Equivalence Information:
1. Predicate device name(s):
Dade MicroScan
2. Predicate K number(s):
K020037
3. Comparison with predicate:

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| specimen | Suspect colonies of E. coli, K. pneumonia or K oxytoca | Suspect colonies of E. coli, K. pneumonia or K oxytoca |
| Incubation | >15 hours | >15 hours |
| panels | Dried antimicrobial agents | Dried antimicrobial agents |
| Differences | | |
| Item | Device | Predicate |
| Antibiotic concentrations | Ceftazidime/clavulanic acid at 0.06/4-128/4 ug/ml
Cefotaxime/clavulanic acid 0.06/4-64/4 ug/ml | Ceftazidime/clavulanic acid at 0.12/4-32/4 ug/ml
Cefotaxime/clavulanic acid 0.12/4-32/4 ug/ml |

J. Standard/Guidance Document Referenced (if applicable):
NCCLS standard reference method from M7 A6.

K. Test Principle:
Results are based on broth based turbidity detection of growth in wells containing antimicrobial agents. The wells also contain a fluorescence which is used in the auto reading with the instrumentation where fluorescence indicates the presence of microbial growth. A ≥ 3 twofold concentration decrease in an MIC for either Ceftazidime or Cefotaxime tested in combination with clavulanic acid versus its MIC when tested alone would define the organism as an ESBL producer.

L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Reproducibility was determined to be >95% when the individual antibiotics were cleared for use on the gram negative Sensititre® panels.
b. Linearity/assay reportable range:
Not applicable
c. Traceability (controls, calibrators, or method):
Quality control was performed on the NCCLS recommended organisms with acceptable results using both the manual and the Autoread methods. Each of the four sites tested the confirmatory test 20 times resulting in only one failure.
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:
NCCLS reference method used for comparison along with molecular characterization methods
b. Matrix comparison:

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Not applicable

3. Clinical studies:
a. Clinical sensitivity:
b. Clinical specificity:
c. Other clinical supportive data (when a and b are not applicable): A study was performed at three sites on 513 isolates of Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli and compared to the reference method. Percent agreement to the reference method was established with the following results:

| | Reference ESBL positive | Reference ESBL negative |
| --- | --- | --- |
| Manual read of Sensititre panel | 97.3% (392/403) | 95.4% (105/110) |
| Autoread of Sensititre panel | 98.3% (396/403) | 96.4% (106/110) |

An additional study was performed at one site on 30 molecular characterized isolates with a 100% agreement for both the manual method of reading and the fluorogenic autoread.

4. Clinical cut-off:

5. Expected values/Reference range:
A ≥ 3 twofold concentration decrease in an MIC for either Ceftazidime or Cefotaxime tested in combination with clavulanic acid versus its MIC when tested alone = ESBL.

M. Conclusion:
Acceptable performance was provided to demonstrate that the Sensititre 18-24 Susceptibility panel can detect and confirm the presence of ESBL producing Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli and is substantially equivalent to the predicate listed above.