← Product Code [JTN](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTN) · K070262

# ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K070262)

_Oxoid , Ltd. · JTN · Mar 14, 2007 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTN/K070262

## Device Facts

- **Applicant:** Oxoid , Ltd.
- **Product Code:** [JTN](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTN.md)
- **Decision Date:** Mar 14, 2007
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.1620
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

Oxoid Antimicrobial Susceptibility Test Discs are used in the agar diffusion test method for in vitro susceptibility testing. This semi-quantitative method is for use with rapidly growing organisms including Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes and some streptococci, and by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae, and Streptococcus pneumoniae.

## Device Story

Ertapenem Antimicrobial Susceptibility Test Discs consist of 6 mm absorbent paper discs impregnated with 10 µg/mL of Ertapenem. Used in clinical microbiology laboratories for in vitro susceptibility testing via the Kirby-Bauer agar diffusion method. Laboratory personnel inoculate Mueller-Hinton agar with bacterial colonies standardized to a 0.5 McFarland turbidity; place discs onto the agar surface; and incubate. Following incubation, the technician measures the diameter of the zone of inhibition around the disc. These measurements are compared against established interpretive criteria to categorize the organism as susceptible, intermediate, or resistant. This process assists clinicians in selecting appropriate antibiotic therapy for patients by identifying bacterial susceptibility to Ertapenem.

## Clinical Evidence

No clinical data. Performance characteristics were established based on interpretive criteria and quality control ranges provided by the FDA/CDER-approved pharmaceutical package insert for Ertapenem.

## Technological Characteristics

Paper-based antimicrobial susceptibility test discs impregnated with ertapenem. Operates via passive diffusion in agar medium. Standardized form factor for use in manual or automated agar diffusion systems. No electronic components, software, or energy sources.

## Regulatory Identification

An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

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

A. 510(k) Number:
k070262

B. Purpose for Submission:
Addition of Ertapenem Antimicrobial Susceptibility Test Disc

C. Measurand:
Ertapenem 10 µg/mL

D. Type of Test:
Semi-quantitative Antimicrobial Susceptibility Test Disc

E. Applicant:
Oxoid Limited

F. Proprietary and Established Names:
Ertapenem Antimicrobial Susceptibility Test Disc

G. Regulatory Information:

1. Regulation section:
21 CFR 866.1620 Antimicrobial Susceptibility Test Disc

2. Classification:
II

3. Product code:
JTN-Susceptibility Test Disc, Antimicrobial

4. Panel:
83 Microbiology

H. Intended Use:

1. Intended use(s):
Oxoid Antimicrobial Susceptibility Test Discs are used in the agar diffusion test method for in vitro susceptibility testing. This semi-quantitative method is for use with rapidly growing organisms including Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes and some streptococci, and by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae, and Streptococcus pneumoniae.

{1}

2. Indication(s) for use:

Ertapenem antimicrobial susceptibility test disc is indicated for Staphylococcus aureus (methicillin susceptible isolates only), Streptococcus agalactiae, Streptococcus pyogenes, Escherichia coli, Klebsiella pneumoniae, Moraxella catarrhalis, Proteus mirabilis, and by modified procedures Streptococcus pneumoniae (penicillin susceptible isolates only), and Haemophilus influenzae (Beta-lactamase negative isolates only).

3. Special conditions for use statement(s):

For prescription use only

The ability of Ertapenem to detect resistance with Haemophilus spp., Streptococcus pneumoniae, and Streptococcus spp. Other than S. pneumoniae is unknown because these strains have not yet been detected and should be retested. If a non-susceptible result is obtained, the strain should be sent to a reference laboratory for further testing.

4. Special instrument requirements:

Not Applicable

I. Device Description:

Ertapenem Antimicrobial Susceptibility Test Discs are 6 mm discs prepared by impregnating high quality absorbent paper with accurately determined amounts of Ertapenem. The Disc is clearly marked on both sides with the code ETP10, which designates the agent, Ertapenem, and the drug content. Discs are supplied in cartridges containing 50 discs each. Cartridges are individually sealed together with a desiccant capsule in a foil covered see-through blister pack.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Remel Antimicrobial Susceptibility Test Discs, Meropenem 10 µg/mL

2. Predicate 510(k) number(s):

K964421

3. Comparison with predicate:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  1. Intended Use | an in vitro diagnostic product for clinical susceptibility testing of most bacteria | same  |
|  2. Inoculum | prepared from colonies | same  |

{2}

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|   | using the direct inoculation method |   |
|  3. Inoculum Method | Direct equated to a 0.5 McFarland turbidity standard | same  |
|  4. Antibiotic concentration | 10 μg/mL | same  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  1. Antimicrobial | Ertapenem | Meropenem  |

**K. Standard/Guidance Document Referenced (if applicable):**

CLSI M7 (M100-S17) “Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard. The Center for Drug, Evaluation, and Review (CDER) pharmaceutical approved package insert, developed during clinical trial studies, was used for Interpretive Criteria and Quality Control (QC) expected ranges.

**L. Test Principle:**

The Ertapenem Antimicrobial Susceptibility Test Disc utilizes a dried filter paper disc impregnated with known concentrations of antimicrobial agents that are placed onto the test medium surface. The standard method of testing is the Kirby-Bauer method. Four to five colonies are transferred to 5ml of a suitable broth medium. The broth is either incubated at 35-37 °C for 2 to 8 hours until a light to moderate turbidity develops. Alternatively, a direct broth or saline suspension of colonies may be prepared from an 18-24 hour agar plate culture. The final inoculum density should be equivalent to a 0.5 McFarland standard. The inoculum density may also be standardized photometrically. Within 15 minutes of inoculum preparation, the Mueller-Hinton agar is streaked to obtain an even inoculation. Discs are aseptically placed onto the agar surface with an antibiotic dispenser or sterile forceps to ensure contact with the test surface. Plates are incubated in a regular air incubator at 35-37 °C and not incubated in a CO2 enriched atmosphere with the exception of *Haemophilus influenzae*, *Neisseria gonorrhoeae*, and some *Streptococcus pneumoniae*. After incubation, the media is examined and zones of inhibition around the discs are measured and compared against recognized zone size ranges for the antimicrobial agent being tested.

**M. Performance Characteristics (if/when applicable):** (Descriptive characteristics were sufficient for this disc, because the drug studies that CDER evaluated generated the Interpretive Criteria and Quality Control (QC) Expected Ranges used for review of this device.)

1. Analytical performance:

{3}

4

a. Precision/Reproducibility:
Not applicable

b. Linearity/assay reportable range:
Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Not applicable

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:
Not Applicable

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:

{4}

|  Susceptibility Interpretive Criteria for Ertapenem  |   |   |   |
| --- | --- | --- | --- |
|  Pathogen | Disk Diffusion
Zone Diameter (mm)  |   |   |
|   | S | I | R  |
|  Enterobacteriaceae and Staphylococcus spp. | >/=19 | 16–18 | </=15  |
|  Haemophilus spp. | >/=19 | * | *  |
|  Streptococcus pneumoniae | >/=19 | * | *  |
|  Streptococcus spp. other than Streptococcus pneumoniae | >/=19 | * | *  |

*The current absence of data in resistant isolates precludes defining any results other than "Susceptible". Isolates yielding MIC results suggestive of a "Nonsusceptible" category should be submitted to a reference laboratory for further testing.

**N. Proposed Labeling:**

The Interpretative criteria, QC isolates and expected ranges are the same as recommended by the FDA/CDER in the approved pharmaceutical package insert. All values will be included in the device package insert.

**O. Conclusion:**

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

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTN/K070262](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTN/K070262)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com