← Product Code [JWY](/productcode/JWY) · K202423

# MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL) (K202423)

_Beckman Coulter, Inc. · JWY · May 18, 2021 · Microbiology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K202423

## Device Facts

- **Applicant:** Beckman Coulter, Inc.
- **Product Code:** [JWY](/productcode/JWY.md)
- **Decision Date:** May 18, 2021
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 866.1640
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

The MicroScan MICroSTREP plus Panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative anaerobic bacteria. The panels are for use with the MicroScan WalkAway System or for manual reading of results. The MicroScan MICroSTREP plus Panels are indicated for use with Streptococcus species, Enterococcus species, and other fastidious gram-positive cocci. The panels are intended for use in clinical settings by trained laboratory personnel.

## Device Story

MicroScan MICroSTREP plus Panels are miniaturized broth dilution susceptibility tests. Panels contain antimicrobial agents diluted in water/buffer/broth. Clinical laboratory workflow: inoculation of panels with standardized organism suspension in saline; rehydration with Mueller-Hinton broth supplemented with 2-5% lysed horse blood and 50mM HEPES; incubation for 20-24 hours at 35°C in non-CO2 incubator. Output: Minimum Inhibitory Concentration (MIC) determined by observing lowest antimicrobial concentration inhibiting growth. Readout: manual visual inspection or automated reading via MicroScan WalkAway instrument. Healthcare providers use MIC results to guide antibiotic therapy selection for Streptococcus pneumoniae infections. Benefits include standardized, quantitative susceptibility data to inform clinical decision-making.

## Clinical Evidence

Bench testing only. Performance was evaluated by re-analyzing existing data for 296 isolates (manual read) and 53 isolates (WalkAway system) of S. pneumoniae against tetracycline. Essential Agreement (EA) for manual read was 90.2% and Category Agreement (CA) was 99.7%. For the WalkAway system, EA was 98.1% and CA was 100.0%. Trending analysis was performed, noting a bias in manual read results. Quality control was verified using S. pneumoniae ATCC 49619 within the updated 0.06-0.5 µg/mL range.

## Technological Characteristics

Miniaturized broth microdilution panels. Reagents: Mueller-Hinton broth, 2-5% lysed horse blood, 50mM HEPES. Incubation: 35°C +/- 1°C, 20-24 hours, non-CO2. Readout: Manual visual or automated via MicroScan WalkAway instrument. Connectivity: Standalone or integrated with WalkAway system.

## 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.

## Predicate Devices

- MicroScan MICroSTREP plus Tetracycline ([K020939](/device/K020939.md))
- MicroScan MICroSTREP plus Tetracycline ([K062923](/device/K062923.md))

## 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}

FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K202423

B Applicant

Beckman Coulter, Inc.

C Proprietary and Established Names

MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  LTT, JWY, LRG, JTZ, LTW | Class II | 21 CFR 866.1640 - Antimicrobial Susceptibility Test Powder | MI - Microbiology  |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use.
3. A description of the device MODIFICATION(S), in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for reanalysis of MIC results for Streptococcus pneumoniae with tetracycline using currently recognized interpretive criteria.
4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

{1}

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.
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.

Table 1. Performance. Re-analysis of Results Obtained with S. pneumoniae/ Tetracycline with Currently-Recognized Interpretive Criteria

|   | Tot | EA Nb | EA %b | CA Tot | CA % | No. R | No. S | min | maj | vmj  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Manual Reada | 296 | 267 | 90.2 | 295 | 99.7 | 72 | 223 | 1 | 0 | 0  |
|  WalkAway | 53 | 52 | 98.1 | 53 | 100.0 | 25 | 28 | 0 | 0 | 0  |

a Primary method
b Not evaluated in re-analysis but provided for context

Table 2. Quality Control. Re-analysis of QC Results Using Currently Recommended Range, Turbidity Inoculation Method  ${}^{a}$

|  Organism | Concentration (μg/mL) | Reference | Manual Read | WalkAway  |
| --- | --- | --- | --- | --- |
|  S. pneumoniae ATCC 49619 | 0.06 |  |  |   |
|   |  0.12 | 68 |  |   |
|   |  0.25 | 28 | 58 | 12  |
|   |  0.5 | 8 | 46 | 8  |
|  Expected Range: 0.06-0.5 μg/mL | 1 |  |  |   |
|   |  2 |  |  |   |
|   |  4 |  |  |   |
|   |  8 |  |  |   |
|   |  16 |  |  |   |

a Note CLSI QC range for S. pneumoniae ATCC 49619 was modified from  $0.12 - 0.5\mu \mathrm{g / mL}$  to  $0.06 - 0.5\mu \mathrm{g / mL}$  after clearance of the original  $510(\mathrm{k})\mathrm{s}$  (K020939 and K062923).

Table 3. Trending. Evaluation of Trending of S. pneumoniae Isolates

|  Read Method | Total Evaluable for Trending | ≥1 Dilution lower No. (%) | Exact No. (%) | ≥1 Dilution Higher No. (%) | Percent Difference (CI) | Trending Noted  |
| --- | --- | --- | --- | --- | --- | --- |
|  Manual | 233 | 4 (1.7) | 65 (27.9) | 164 (70.4) | 68.7% (62.0 to 74.3) | Yesa  |
|  WalkAway | 34 | 2 (5.9) | 27 (79.4) | 5 (14.7) | 8.9% (-6.7 to 24.8) | No  |

a Trending is addressed in a footnote to the performance table in the device labeling.

To support the implementation of changes to FDA-recognized susceptibility test interpretive criteria (i.e., breakpoints), this submission included a breakpoint change protocol that was reviewed and accepted by FDA. This protocol addresses future revisions to device labeling in

K202423 - Page 2 of 3

{2}

response to breakpoint changes that are recognized on the FDA STIC webpage (https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm410971.htm). The protocol outlined the specific procedures and acceptance criteria that Beckman Coulter intends to use to evaluate the MicroScan MICroSTREP plus Panels with tetracycline (0.06 to 16  $\mu$ g/mL) when revised breakpoints for tetracycline are published on the FDA STIC webpage. The breakpoint change protocol included with the submission indicated that if specific criteria are met, Beckman Coulter will update the tetracycline device label to include (1) the new breakpoints, (2) an updated performance section after re-evaluation of data in this premarket notification with the new breakpoints, and (3) any new limitations as determined by their evaluation.

The labeling for this modified subject device has been reviewed 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, I recommend the device be determined substantially equivalent to the previously cleared device.

K202423 - Page 3 of 3

---

**Source:** [https://fda-staging.innolitics.com/device/K202423](https://fda-staging.innolitics.com/device/K202423)

**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