← Product Code [JWY](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JWY) · K163298

# Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL (K163298)

_Liofilchem s.r.l. · JWY · Feb 22, 2017 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JWY/K163298

## Device Facts

- **Applicant:** Liofilchem s.r.l.
- **Product Code:** [JWY](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JWY.md)
- **Decision Date:** Feb 22, 2017
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.1640
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

The Liofilchem® MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example, Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococus species) and fastidious bacteria (for example, anaerobes, Haemophilus and Streptococcus species and N. gonorrhoeae ). MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ye/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The indications for use of this 510(k) is specifically for the Ceftazidime MTS at concentrations of 0.016 - 256.0 ug/mL interpreted after 16-20 hours of incubation. The non-fastidious bacteria that have been shown to be active both clinically and in vitro against Ceftazidime according to the FDA label are: Citrobacter species Enterobacter species Escherichia coli Klebsiella species Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa

## Device Story

Liofilchem MIC Test Strip (MTS) is a quantitative in vitro diagnostic tool for determining antimicrobial susceptibility. Device consists of specialized paper strips impregnated with a predefined concentration gradient of Ceftazidime. Laboratory technicians place strips onto inoculated agar media; plates undergo overnight incubation (16-20 hours). Following incubation, the minimum inhibitory concentration (MIC) is determined via manual visual reading of the inhibition ellipse intersection with the strip. Results assist clinicians in selecting appropriate antibiotic therapy for bacterial infections. Used in clinical microbiology laboratories.

## Clinical Evidence

No clinical data provided. Performance is established via in vitro testing of antimicrobial susceptibility against specified bacterial species compared to reference methods.

## Technological Characteristics

Specialized paper strip impregnated with ceftazidime gradient (15 two-fold dilutions). Manual reading of inhibition ellipse on agar media. No electronic components or software. Sterilization not specified. Standardized to CLSI M07-A10 and M100-S26.

## 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)

> 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/).

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
K163298

B. Purpose for Submission:
To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing ceftazidime at concentrations of 0.016 -256.0 µg/mL for susceptibility testing of *Citrobacter* spp., *Enterobacter* species, *E. coli*, *Klebsiella* spp., *Proteus mirabilis*, *Proteus vulgaris*, and *Pseudomonas aeruginosa*

C. Measurand:
Ceftazidime 0.016-256.0 µg/mL

D. Type of Test:
Quantitative AST growth based detection

E. Applicant:
Liofilchem s.r.l.

F. Proprietary and Established Names:
Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016-256.0 µg/mL

G. Regulatory Information:

1. Regulation section:
866.1640 Antimicrobial Susceptibility Test Powder

2. Classification:
II

3. Product code:
JWY - Manual Antimicrobial Test Systems

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4. Panel:
83 – Microbiology

H. Intended Use:

1. Intended use(s):

The Liofilchem MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example, Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococcus species) and fastidious bacteria (for example, anaerobes, Haemophilus and Streptococcus species and N. gonorrhoeae). MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in $\mu \mathrm{g} / \mathrm{mL}$ of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

2. Indication(s) for use:

The Liofilchem MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example, Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococcus species) and fastidious bacteria (for example, anaerobes, Haemophilus and Streptococcus species and N. gonorrhoeae). MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in $\mu \mathrm{g} / \mathrm{mL}$ of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The indications for use of this $510(\mathrm{k})$ is specifically for the Ceftazidime MTS at concentrations of $0.016 - 256.0~\mu \mathrm{g / mL}$ interpreted after 16-20 hours of incubation.

Ceftazidime has been shown to be active against the following bacteria, both clinically and in vitro according to the FDA label:

Citrobacter spp.
Enterobacter spp.
Escherichia coli
Klebsiella spp.
Proteus mirabilis
Proteus vulgaris
Pseudomonas aeruginosa

3. Special conditions for use statement(s):

For prescription use

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4. Special instrument requirements:

Manual reading only

I. Device Description:

The ceftazidime MIC Test Strip (MTS) consists of specialized paper impregnated with a predefined concentration gradient of ceftazidime across 15 two-fold dilutions like those of a conventional MIC method. One side of the strip is labelled with the ceftazidime code (CAZ) and the MIC reading scale in $\mu \mathrm{g} / \mathrm{mL}$. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 16-20 hours incubation, a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of $\mu \mathrm{g} / \mathrm{mL}$ at the point where the edge of the inhibition ellipse intersects the MIC Test Strip.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Liofilchem MTS, ceftolozane/tazobactam

2. Predicate $510(\mathbf{k})$ number(s):

K161175

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3. Comparison with predicate:

Table 1: Comparison with the Predicate Device

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate
Liofilchem MTS,
ceftolozane/tazobactam
K161175  |
|  Intended Use | Quantitative susceptibility to antimicrobial agents | Same  |
|  Media | Mueller Hinton agar | Same  |
|  Inoculation | Isolated colonies from culture in suspension equivalent to 0.5 McFarland. Inoculum is applied manually using the manual plate inoculation method or plate rotator for even distribution of inoculum | Same  |
|  Reading | Manual; the point where the edge of inhibition ellipse intersects the MIC Test Strip | Same  |
|  Result | MIC | Same  |
|  Incubation | 35 ± 2°C for 16-20hrs | Same  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Antibiotic | Ceftazidime | Ceftolozane/tazobactam  |

K. Standard/Guidance Document Referenced:

"Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA"

CLSI M07-A10 "Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard, Tenth Edition January 2015"

CLSI M100-S26 "Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement, January 2016"

L. Test Principle:

MTS are made of specialized paper impregnated with a predefined concentration gradient of antibiotic, across 15 two-fold dilutions like those of a conventional MIC method. When the MIC Test Strip is applied onto an inoculated agar surface, the preformed exponential gradient of antimicrobial agent is immediately transferred to the agar matrix. After 16-20 hours incubation, a symmetrical inhibition ellipse centered along the strip is formed. The MIC is

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read directly from the scale in terms of $\mu \mathrm{g} / \mathrm{mL}$ at the point where the edge of the inhibition ellipse intersects the strip MIC Test Strip.

Growth along the entire gradient (i.e. no inhibition ellipse) indicates that the MIC value is greater than or equal to $(\geq)$ the highest value on the scale. An inhibition ellipse that intersects below the lower end of the scale is read as less than $(<)$ the lowest value. An MIC of $0.125\mu \mathrm{g / mL}$ is considered to be the same as $0.12\mu \mathrm{g / mL}$ for reporting purposes.

An MTS MIC value which falls between standard two-fold dilutions must be rounded up to the next standard upper two fold value before categorization.

## M. Performance Characteristics (if/when applicable):

a. Precision/Reproducibility:

Reproducibility testing was performed using six *Pseudomonas aeruginosa* isolates and four *Enterobacteriaceae* isolates (two *E. coli*, one *K. pneumoniae*, and one *Enterobacter cloacae*). These ten organisms were tested at three sites in triplicates on three days. The mode of MIC value was determined and the reproducibility was calculated based on the number of MIC values that fell within $\pm 1$ doubling dilution of the mode. The testing resulted in overall reproducibility of greater than $95\%$. The results were acceptable.

b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The recommended QC isolates were tested a sufficient number of times at all three sites with acceptable results in comparison to the reference method. All results were within the expected range greater than $95\%$ of the time. The results are summarized in Table 2 below.

5

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Table 2: Ceftazidime MTS QC results

|  Organism^{a} | Concentration (μg/mL) | Reference | MTS  |
| --- | --- | --- | --- |
|  E. coli
ATCC 25922
Expected Result
0.06 – 0.5μg/mL | 0.03 |  |   |
|   |  0.06 |  |   |
|   |  0.12 | 4 | 2  |
|   |  0.25 | 43 | 48  |
|   |  0.5 | 13 | 10  |
|   |  1 |  |   |
|  |   |   |   |
|  P. aeruginosa
ATCC 27853
Expected Result
1 – 4 μg/mL | 0.5 |  |   |
|   |  1 | 4 | 18  |
|   |  2 | 48 | 41  |
|   |  4 | 8 | 1  |
|   |  8 |  |   |
|  |   |   |   |
|  K. pneumoniae
ATCC 700603
Expected Result
16 - 64 μg/mL | 8 |  |   |
|   |  16 | 5 | 6  |
|   |  32 | 32 | 28  |
|   |  64 | 23 | 26  |
|   |  128 |  |   |

a E. coli ATCC 25922 and P. aeruginosa ATCC 27853 recommended by FDA and CLSI; K. pneumoniae ATCC 700603 recommended by CLSI only.

The inoculum was prepared to achieve a 0.5 McFarland standard turbidity. Colony counts were performed periodically at each site. Inoculum density checks were performed and the average colony counts of each QC strain were within the recommended range of approximately $1 \times 10^{8}$ CFU/mL.

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:

Clinical testing was conducted at three sites (two U.S. sites and one outside the U.S.). A total of 509 organisms were tested and all organisms grew in the studies. There

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were 358 (82.5%) isolates that were tested within seven days of collection and 76 (17.5%) isolates that were tested within one year of collection. The study included 327 Enterobacteriaceae and 182 Pseudomonas aeruginosa. The Enterobacteriaceae tested were Citrobacter spp., Enterobacter species, E. coli, Klebsiella spp., Proteus mirabilis, and Proteus vulgaris. All organisms grew in the clinical study. The performance is listed in Table 3 below:

Table 3: Performance of Enterobacteriaceae and Pseudomonas aeruginosa isolates*

|  Ceftazidime | EA Tot | EA % | EA % | Eval. EA Tot | Eval. EA % | Eval. EA % | CA N | CA % | #R | min | maj | vmj  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | Enterobacteriaceae ≤4 (Susceptible), 8 (Intermediate), ≥16 (Resistant)  |   |   |   |   |   |   |   |   |   |   |   |
|  E. coli |  |  |  |  |  |  |  |  |  |  |  |   |
|  Clinical | 94 | 88 | 93.6 | 81 | 75 | 92.6 | 92 | 97.9 | 24 | 2 | 0 | 0  |
|  Challenge | 13 | 13 | 100 | 8 | 8 | 100 | 12 | 92.3 | 11 | 1 | 0 | 0  |
|  Combined | 107 | 101 | 94.4 | 89 | 83 | 93.3 | 104 | 97.2 | 35 | 3 | 0 | 0  |
|  K. pneumoniae |  |  |  |  |  |  |  |  |  |  |  |   |
|  Clinical | 59 | 58 | 98.3 | 49 | 48 | 98.0 | 57 | 96.6 | 15 | 2 | 0 | 0  |
|  Challenge | 14 | 14 | 100 | 6 | 6 | 100 | 14 | 100 | 11 | 0 | 0 | 0  |
|  Combined | 73 | 72 | 98.6 | 55 | 54 | 98.2 | 71 | 97.3 | 26 | 2 | 0 | 0  |
|  K. oxytoca |  |  |  |  |  |  |  |  |  |  |  |   |
|  Clinical | 28 | 26 | 92.9 | 27 | 25 | 92.6 | 27 | 96.4 | 3 | 1 | 0 | 0  |
|  Challenge | 3 | 3 | 100 | 3 | 3 | 100 | 3 | 100 | 3 | 0 | 0 | 0  |
|  Combined | 31 | 29 | 93.5 | 30 | 28 | 93.3 | 30 | 96.8 | 6 | 1 | 0 | 0  |
|  Proteus mirabilis |  |  |  |  |  |  |  |  |  |  |  |   |
|  Clinical | 31 | 29 | 93.5 | 28 | 26 | 92.9 | 31 | 100 | 4 | 0 | 0 | 0  |
|  Challenge | 2 | 2 | 100 | 2 | 2 | 100 | 0 | 0 | 0 | 2 | 0 | 0  |
|  Combined | 33 | 31 | 93.9 | 30 | 28 | 93.3 | 31 | 93.9 | 4 | 2 | 0 | 0  |
|  Ent. cloacae |  |  |  |  |  |  |  |  |  |  |  |   |
|  Clinical | 30 | 26 | 86.7 | 22 | 18 | 81.8 | 30 | 100 | 15 | 0 | 0 | 0  |
|  Challenge | 9 | 9 | 100 | 1 | 1 | 100 | 9 | 100 | 9 | 0 | 0 | 0  |
|  Combined | 39 | 35 | 89.7 | 23 | 19 | 82.6 | 39 | 100 | 24 | 0 | 0 | 0  |
|  C. freundii |  |  |  |  |  |  |  |  |  |  |  |   |
|  Clinical | 12 | 11 | 91.7 | 10 | 9 | 90.0 | 12 | 100 | 8 | 0 | 0 | 0  |
|  C. koseri |  |  |  |  |  |  |  |  |  |  |  |   |
|  Clinical | 10 | 10 | 100 | 9 | 9 | 100 | 10 | 100 | 2 | 0 | 0 | 0  |
|  Ent. aerogenes |  |  |  |  |  |  |  |  |  |  |  |   |
|  Clinical | 12 | 10 | 83.3 | 8 | 6 | 75.0 | 12 | 100 | 6 | 0 | 0 | 0  |
|  Proteus vulgaris |  |  |  |  |  |  |  |  |  |  |  |   |
|  Clinical | 10 | 10 | 100 | 10 | 10 | 100 | 10 | 100 | 0 | 0 | 0 | 0  |
|  Enterobacteriaceae Total | 327 | 309 | 94.5 | 264 | 246 | 93.2 | 319 | 97.6 | 111 | 8 | 0 | 0  |
|  Pseudomonas aeruginosa ≤8 (Susceptible), -, ≥16 (Resistant)  |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 148 | 135 | 91.2 | 136 | 123 | 90.4 | 146 | 98.6 | 57 | 0 | 2 | 0  |
|  Challenge | 34 | 34 | 100 | 14 | 14 | 100 | 34 | 100 | 30 | 0 | 0 | 0  |
|  Combined | 182 | 169 | 92.9 | 150 | 137 | 91.3 | 180 | 98.9 | 87 | 0 | 2 | 0  |
|  All Isolates | 509 | 478 | 93.9 | 414 | 383 | 92.5 | 499 | 98.0 | 198 | 8 | 2 | 0  |

*EA - Essential Agreement
CA - Category Agreement
R- resistant isolates

maj - major discrepancies

vmj- very major discrepancies

min- minor discrepancies

Essential Agreement (EA) is when the Liofilchem MIC Test Strip (MST) results agree exactly or within one

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doubling dilution of the reference broth microdilution results. Category Agreement (CA) is when the Liofilchem MIC Test Strip (MST) result interpretation agrees exactly with the reference broth microdilution result interpretation.

**Enterobacteriaceae**: The overall performance of *Enterobacteriaceae* was acceptable with EA 94.5% EA and 97.6% CA. There were no major or very major discrepancies. When stratified, the EA for *E. aerogenes* was low at 83.3% due to two resistant strains (both gave reference MIC values of 128 µg/mL and device MIC values of >256 µg/mL). The low EA did not affect the CA, which was 100%. The EA for *Enterobacter* species (*E. cloacae* and *E. aerogenes* combined) was 88.2% with 100% CA.

**Pseudomonas aeruginosa**: The performance of *P. aeruginosa* was 91.3% EA, 98.9% CA and major discrepancy rate 2.1% (2/95) with no vary major discrepancies. The performance met the acceptance criteria.

## Trending

The claimed *Enterobacteriaceae* organisms were also evaluated for trending. This trending calculation takes into account MIC values that are determined to be ≤1 and ≥1 doubling dilutions compared to the reference method irrespective whether the device MIC values are on-scale or not. The analysis showed that within EA, trending was observed for *E. coli*, *K. oxytoca*, *P. mirabilis* and *E. cloacae*. The trending analysis was shown in Tables 4.1 and 4.2:

Table 4.1: Trending Analysis of Evaluable Clinical and Challenge Results for *E. coli* and *K. pneumoniae*

|  Ceftazidime
0.016- 256
µg/mL | Total^{a} | Difference in MIC as Compared to the CLSI Reference Method  |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   |   |  ≤2 dil. lower | 1 dil. lower | Exact | 1 dil. higher | ≥2 dil. higher  |
|  E. coli | 91 | 2 | 43 | 35
(38.5%) | 7 | 4  |
|   |   |  45 (49.5%)^{b}
95% CI (39.41% to 59.54%) |   |   | 11 (12.09%)^{b}
95% CI (6.88% to 20.36%)  |   |
|  |   |   |   |   |   |   |
|  K. oxytoca | 31 | 0 | 15 | 12
(38.71%) | 3 | 1  |
|   |   |  15 (48.39%)^{c}
95% CI (31.97% to 65.16%) |   |   | 4 (12.90%)^{c}
95% CI (5.13% to 28.85%)  |   |

a Total number of evaluable results for trending analysis
b Difference: 37.36%; 95% CI (24.35% to 48.71%)
c Difference: 35.48%; 95% CI (12.60% to 53.97%)

A lower MIC reading trend was observed in the overall performance of *E. coli* and *Klebsiella oxytoca* compared to the CLSI broth microdilution reference method, which raises concerns for potential very major discrepancies. This trending and the potential for occurrence of very major discrepancies for ceftazidime when testing

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clinical and challenge isolate results with the Ceftazidime MTS was addressed by adding the following footnote in the Performance Characteristics section of the labeling, "Drug Specific Supplement for Ceftazidime MIC Test Strip (MTS)":

"The Liofilchem MIC Test Strip (MTS) ceftazidime values tended to be in exact agreement or at least one doubling dilution lower when testing E. coli and K. oxytoca compared to the CLSI reference broth microdilution."

Table 4.2: Trending Analysis of Evaluable Clinical and Challenge Results for E. cloacae and P. mirabilis

|  Ceftazidime 0.016- 256 μg/mL | Totala | Difference in MIC as Compared to the CLSI Reference Method  |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   |   |  ≤2 dil. lower | 1 dil. lower | Exact | 1 dil. higher | ≥2 dil. higher  |
|  E. cloacae | 35 | 0 | 5 | 13 (37.14%) | 13 | 4  |
|   |   |  5 (14.29%)b 95% CI (6.26% to 39.37%) |   |   | 17 (48.57%)b 955CI (32.99% to 64.43%)  |   |
|  |   |   |   |   |   |   |
|  P. mirabilis | 30 | 0 | 1 | 16 (53.33%) | 11 | 2  |
|   |   |  1 (3.33%)c 95% CI (0.59% to 16.67%) |   |   | 13 (43.33%)c 95% CI 27.38% to 60.80%)  |   |

a Total number of evaluable results for trending analysis
b Difference: -34%; 95% CI (-52.06% to -12.60%)
c Difference: -40%; 95% CI (-57.68% to -19.20%)

A higher MIC reading trend was observed in the overall performance of Enterobacter cloacae and Proteus mirabilis compared to the CLSI broth microdilution reference method, which raises concerns for potential major discrepancy. This trending and the potential for occurrence of major discrepancies for ceftazidime when testing clinical and challenge isolate results with the Ceftazidime MTS was addressed by adding the following footnote in the Performance Characteristics section of the labeling, "Drug Specific Supplement for Ceftazidime MIC Test Strip (MTS)".

"The Liofilchem MIC Test Strip (MTS) ceftazidime values tended to be in exact agreement or at least one doubling dilution higher when testing E. cloacae and P. mirabilis compared to the CLSI reference broth microdilution."

The analysis of the Pseudomonas aeruginosa MIC data demonstrated no notable trending.

b. Matrix comparison:

Not Applicable

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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:

Table 5: FDA Interpretive Criteria for Ceftazidime (μg/mL)

|  Organisms | S | I | R  |
| --- | --- | --- | --- |
|  Enterobacteriaceae | ≤4 | 8 | ≥16  |
|  Pseudomonas aeruginosa | ≤8 | -- | ≥16  |

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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/JWY/K163298](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JWY/K163298)

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