← Product Code [LRG](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LRG) · K050585

# MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE (K050585)

_Dade Behring, Inc. · LRG · Mar 18, 2005 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LRG/K050585

## Device Facts

- **Applicant:** Dade Behring, Inc.
- **Product Code:** [LRG](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LRG.md)
- **Decision Date:** Mar 18, 2005
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 866.1640
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

The MicroScan® Dried Gram-Negative MIC/Combo Panel is used to determine the quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. The panels are incubated for 16 - 20 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This particular submission is to evaluate the performance for the reformulated antimicrobial agent Amoxicillin/K. Clavulanate on the MicroScan® Dried Gram-Negative MIC/Combo Panels while being read on a MicroScan® AutoScan-4 Instrument utilizing the current DMS or LabPro 1.1 Software platforms.

## Device Story

MicroScan® Dried Gram-Negative MIC/Combo Panels are in vitro diagnostic devices used to determine antimicrobial susceptibility of gram-negative bacteria. The device consists of dried antimicrobial agents in microdilution wells. Clinical laboratory technicians inoculate the panels with bacterial colonies grown on solid media. Panels are incubated for 16-20 hours at 35°C in a non-CO2 incubator. Results are determined either visually or via the MicroScan® AutoScan-4 Instrument. The instrument uses DMS or LabPro 1.1 software to process the data. The output provides quantitative (MIC) or qualitative susceptibility results, which assist healthcare providers in selecting appropriate antibiotic therapy for patients with bacterial infections.

## Clinical Evidence

No clinical data provided; submission focuses on performance evaluation of a reformulated antimicrobial agent (Amoxicillin/K. Clavulanate) on existing panel technology.

## Technological Characteristics

Growth-based antimicrobial susceptibility testing system. Instrument: MicroScan® AutoScan-4. Test format: Dried Gram-Negative MIC/Combo panels. Incubation time: 16 hours. Software platforms: DMS and LabPro. Connectivity: Integrated with laboratory information systems.

## Regulatory 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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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K050585

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k003940 Dried Gram-Negative MIC/Combo panels with Amoxicillin/K. Clavulanate at 0.25/0.12-128/64ug/mL

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

The manufacturer stated on Page 2 that the changes would not affect the product labeling and therefore new labeling was not included

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for the MicroScan® AutoScan-4 instrument which had slight modifications for reading the reformulated Amoxicillin/K. Clavulanate using the current DMS and LabPro Software Platforms and the cleared Amoxicillin/K. Clavulanate at the same ranges and formulation already cleared in K003940.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics,

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Intended Use | For use with MicroScan® Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan® panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
The MicroScan® Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli | Same  |
|  Test Panel | Dried | Same  |
|  Technology | Growth based after 16 hours incubation | Same  |
|  Results | Report results as minimum inhibitory concentration (MIC) and categorical interpretation (SIR). | Same  |
|  antibiotic | Amoxicillin/K. Clavulanate | Same  |
|  Differences  |   |   |
|  Item | Device | Predicate  |
|  Instrument | Slight Modifications to instrument for reading of antibiotic | unmodified  |

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5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis:

Failure Mode and Effect Analysis (FMEA) was used

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and

ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has not been reviewed because the manufacturer stated that no changes to the labeling would be necessary to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, it is recommended that the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LRG/K050585](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LRG/K050585)

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