Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions "Classification software" and a "Classification algorithm" that analyzes optical signals and periodic measurements to determine presumptive positive or negative results. While this involves algorithmic processing of data, the description does not use terms like AI, ML, deep learning, or neural networks, nor does it describe a system that learns or adapts from data in a way characteristic of AI/ML. The process described appears to be based on predefined thresholds and kinetic analysis of turbidity, which is standard signal processing and algorithmic classification, not necessarily AI/ML.

Therapeutic

No

This device is an in vitro diagnostic system used to aid in the diagnosis of UTIs by detecting bacteriuria, not to treat a condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that "The BacterioScan 216Dx System is a semi-automated, in vitro diagnostic system" and its results are "intended for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of Urinary Tract Infections (UTIs)."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the BacterioScan 216Dx System consists of an instrument, software, and disposable Multicuvettes, indicating it is a system with both hardware and software components, not software-only.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicitly Stated: The "Intended Use / Indications for Use" and "Device Description" sections both clearly state that the BacterioScan 216Dx System is an "in vitro diagnostic system".
Analyzes Samples from the Human Body: The device analyzes urine samples, which are specimens taken from the human body.
Provides Information for Diagnosis: The results are intended "to aid in the diagnosis of Urinary Tract Infections (UTIs)". This is a key characteristic of an IVD.
Qualitative Determination: It provides a qualitative determination (presumptive positive or presumptive negative) of bacteriuria, which is a diagnostic result.
Used in a Laboratory Setting: The description of the method comparison study indicates it was conducted in a laboratory setting, which is typical for IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The BacterioScan 216Dx System is a semi-automated, in vitro diagnostic system (consisting of an instrument, software, and disposable Multicuvettes) that analyzes light scattering to measure any bacterial growth directly from urine sample incubated in trypticase soy broth. The BacterioScan 216Dx is for qualitative determination (presumptive positive or presumptive negative) of bacteriuria at a density of ≥5x10 CFU/mL. The BacterioScan 216Dx results are intended for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of Urinary Tract Infections (UTIs).

The 216Dx System is not intended to provide bacteriuria levels, bacterial identification, or differentiation. The system does not distinguish between growth of infecting, colonizing or contaminating bacteria, or if mixed urogenital flora are present. Presumptive positive urine samples must be cultured. Presumptive negative urine samples must be cultured if a low level of bacteriuria is suspected and is clinically relevant. The system also does not detect anaerobic bacteria, fungi/yeasts, fastidious organisms or those associated with sterile pyuria.

Product codes (comma separated list FDA assigned to the subject device)

OBQ

Device Description

The BacterioScan 216Dx System is a semi-automated, in vitro diagnostic system (consisting of an instrument, software, and disposable Multicuvettes) that analyzes light scattering to measure any bacterial growth directly from urine sample incubated in trypticase soy broth. The BacterioScan 216Dx is for qualitative determination (presumptive positive or presumptive negative) of bacteriuria at a density of ≥5x104 CFU/mL.

The BacterioScan 216Dx System uses laser light scattering to measure turbidity (particle density) of a prepared urine-broth sample during a period of incubation. The system is designed to kinetically capture digital measurements of sample turbidity at very low particle densities. Classification software analyzes these optical signal measurements, and interprets increasing turbidity as bacterial growth. Samples with robust growth during the second half of the test cycle, and/or high turbidity, are reported as "Presumptive Positive" for bacteriuria and/or UTI. Low turbidity samples that do not exhibit growth are classified as "Presumptive Negative".

The user logs into the 216Dx interface and is prompted to associate a patient sample ID with a Multicuvette serial number and well location. The user will then pipette the prepared liquid samples into a Multicuvette. Once the Multicuvette is filled, it is loaded into a 216Dx Instrument. The Multicuvette is then incubated for approximately three (3) hours. During the instrument run, the 216Dx appliance will analyze optical measurements to provide a qualitative determination of the presence or absence of viable bacteria in urine specimens at a cut-off of >5x10 CFU/ml. The Classification algorithm qualitatively assesses a result by analyzing periodic measurements taken throughout this incubation period.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Urinary Tract

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Method Comparison Study:
Sample Size: 3,153 urine samples enrolled, 3,052 evaluable specimens for primary analysis of bacteriuria, 3,010 evaluable for secondary analysis at ≥5x104 CFU/mL, 3,020 for ≥1x105 CFU/mL.
Data Source: Urine samples received in the laboratory for routine urine culture at three (3) geographically diverse sites.
Annotation Protocol: Reference testing was performed using 1- and 10μL loops. Colony count plates were performed in triplicate, and a median result was generated for each loop size. Median colony count was determined to be the reference result and compared to the 216Dx result. Any colony counts at or above 5x104 CFU/mL were considered a positive result for primary analysis. A secondary analysis specific to UTI pathogens (UTI-Associated) was also performed. Organisms isolated from reference colony counts of ≥5x104 CFU/mL were identified by MALDI.

Reproducibility Study:
Data Source: Fresh, culture-negative human urine spiked with Gram-negative (E. coli) and Gram-positive (E. faecalis) strains. Unspiked human urine was used as a negative sample.
Annotation Protocol: Samples were blinded and randomized prior to testing, and fresh specimens were prepared each day. Each reproducibility panel was tested by three (3) individual sites, with two (2) instruments per site and by two (2) operators in quadruplicate for six (6) non-consecutive days.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Limit of Detection (LoD) Study

Study Type: Analytical sensitivity study.
Sample Size: For each of 10 common and 7 rare UTI pathogens, two strains were spiked into fresh, culture-negative human urine. Each strain was tested in replicates of twenty (20) at the approximated density.
Key Results: The 216Dx has a LoD for most common and rare UTI pathogens that is approximately equivalent to the clinical cut-off of 10^4 CFU/mL.
- Common pathogens with LoD (CFU/mL):
  - E. coli (4.40x10³)
  - Proteus mirabilis (8.70x10³)
  - Enterobacter cloacae (6.67x10³)
  - Staphylococcus aureus (1.11x10³)
  - Klebsiella pneumoniae (1.37 x 10^4)
  - Enterococcus faecalis (2.33x10^4)
  - Enterococcus faecium (4.37x10^4)
- Rare UTI pathogens with LoD (CFU/mL):
  - Acinetobacter baumannii (1.60x10^4)
  - Citrobacter freundii/koseri (2.80 x 10^4)
  - Morganella morganii (4.23x10^4)
  - Actinobaculum schaalii (2.80x10^4)
  - Corynebacterium striatum (4.03x10^4)
- UTI pathogens with LoD higher than clinical cut-off (10^4 CFU/mL):
  - Pseudomonas aeruginosa (4.87x10^4)
  - Staphylococcus saprophyticus (2.20x10^4)
  - Streptococcus agalactiae (1.42x10^5)
  - Aerococcus spp. (1.77x10^5)
  - Corynebacterium urealyticum (2.63x10^5)

Linearity and Dynamic Range Study

Study Type: Analytical performance evaluation.
Sample Size: Three (3) Gram-negative and three (3) Gram-positive common UTI pathogens were spiked into negative human urine and serially diluted. Unspiked, culture-negative urine was also assessed.
Key Results: The dynamic range of detection for each Gram-negative and Gram-positive strain tested spans the range of the clinical cut-off. The system's reporting algorithm generates the expected result of Presumptive Positive/Presumptive Negative for multiple UTI pathogens.
- Organisms and density level (CFU/mL) at 100% positivity (4/4 samples):
  - E. coli (2.37×10^4)
  - K. pneumoniae (1.70x10^4)
  - E. faecalis (7.33x10^4)
  - S. aureus (2.1x10^4)
  - P. mirabilis (3.6x10^4)
  - E. faecium (4.03x10^4)
- Unspiked urine was 100% negative (4/4).

Reproducibility Study

Study Type: Reproducibility assessment.
Sample Size: Representative strains of E. coli (Gram-negative) and E. faecalis (Gram-positive) were spiked into fresh, culture-negative human urine at three levels ("Low", "Moderate", "High"). Unspiked human urine was used as a negative sample. Each panel was tested in quadruplicate.
Key Results:
- Performance for High and Moderate densities was ≥95% reproducible across sites and between operators.
- Performance ranged from 91.7-100% across six (6) operators, from 94.8-100% across sites, and from 91.7-100% across the six (6) days of testing.
- Negative samples demonstrated performance of 96.5%.
- E. coli:
  - High density: 98.61% positive (142/144)
  - Moderate density: 97.92% positive (141/144)
  - Low density: 86.81% positive (125/144)
  - High + Moderate Only: 98.26% positive (283/288)
- E. faecalis:
  - High density: 98.61% positive (142/144)
  - Moderate density: 98.61% positive (142/144)
  - Low density: 30.56% positive (44/144)
  - High + Moderate Only: 98.61% positive (284/288)
- Negative Control (Unspiked urine): 96.53% negative (139/144)

Analytical Inclusivity Study

Study Type: Analytical inclusivity assessment.
Sample Size: Multiple strains of 10 common (85 strains) and 7 rare (18 strains) UTI pathogens. All samples evaluated in quadruplicate.
Key Results:
- Common uropathogens: 98.8% positivity (336/340).
- Rare uropathogens: 100% positivity (72/72).
- Unspiked urine was 100% negative (8/8).

Interfering Substances/Microbial Interference Study

Study Type: Evaluation of 216Dx performance in the presence of potentially interfering substances or microorganisms.
Sample Size: Representative strains of four (4) Gram-negative and three (3) Gram-positive UTI pathogens at 2-3 X LoD density level. Total of nineteen (19) interfering substances and three (3) interfering organisms. All samples evaluated in replicates of four (4).
Key Results:
- Majority of potential substances do not interfere.
- Interferences noted at high concentrations:
  - Phenazopyridine (>200 µg/mL)
  - Blood (>0.0156%)
  - Bilirubin (>20 µg/mL)
  - Mucin (>0.039%, v/v)
  - Leukocytes (>10^6 cells/mL)
- Interference (false positivity) observed:
  - Talcum powder (0.4% w/v)
  - H. parainfluenzae (1.1x10^6 CFU/mL)
- Potential interference:
  - Acidic urine (pH 6.0) may interfere with positivity of Enterobacter cloacae at density levels of ≤5x10^4 CFU/mL.
  - Instances where S. aureus did not give positive results at density level of 10^4 CFU/mL.

Method Comparison Study

Study Type: Comparative study with reference cultures.
Sample Size: Three (3) geographically diverse sites, each testing approximately 1,000 urine samples (total 3,153 enrolled). 3,052 evaluable for primary analysis, 3,010/3,020 for secondary analysis depending on cutoff.
Key Results (Overall Performance for Bacterial Density of ≥5x10^4 CFU/mL):
- Primary Analysis: Bacteriuria
  - Sensitivity: 89.1% (714/801)
  - Specificity: 74.4% (1675/2251)
  - PPV: 55.3% (714/1290)
  - NPV: 95.1% (1675/1762)
- Secondary Analysis: UTI Associated
  - Sensitivity: 97.7% (592/606)
  - Specificity: 72.0% (1732/2404)
  - PPV: 46.8% (592/1264)
  - NPV: 99.2% (1732/1746)
Key Results (Performance for Subpopulation of ≥1x10^5 CFU/mL):
- Primary Analysis: Bacteriuria
  - Sensitivity: 93.6% (581/621)
  - Specificity: 70.8% (1722/2431)
  - PPV: 45.0% (581/1290)
  - NPV: 97.7% (1722/1762)
- Secondary Analysis: UTI Associated
  - Sensitivity: 98.6% (501/508)
  - Specificity: 69.5% (1745/2512)
  - PPV: 39.5% (501/1268)
  - NPV: 99.6% (1745/1752)
Additional analyses demonstrated substantial equivalence regarding patient gender and for both unpreserved and preserved samples.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Overall Performance for Bacterial Density of ≥5x10^4 CFU/mL (Primary Analysis: Bacteriuria)

Sensitivity: 89.1% (95% CI: 86.8%; 91.1%)
Specificity: 74.4% (95% CI: 72.6%; 76.2%)
PPV: 55.3% (95% CI: 52.6%; 58.0%)
NPV: 95.1% (95% CI: 93.9%; 96.0%)

Overall Performance for Bacterial Density of ≥5x10^4 CFU/mL (Secondary Analysis: UTI Associated)

Sensitivity: 97.7% (95% CI: 96.2%; 98.6%)
Specificity: 72.0% (95% CI: 70.2%; 73.8%)
PPV: 46.8% (95% CI: 44.1%; 49.6%)
NPV: 99.2% (95% CI: 98.7%; 99.5%)

Performance for Subpopulation of ≥1x10^5 CFU/mL (Primary Analysis: Bacteriuria)

Sensitivity: 93.6% (95% CI: 91.3%; 95.2%)
Specificity: 70.8% (95% CI: 69.0%; 72.6%)
PPV: 45.0% (95% CI: 42.3%; 47.8%)
NPV: 97.7% (95% CI: 96.9%; 98.3%)

Performance for Subpopulation of ≥1x10^5 CFU/mL (Secondary Analysis: UTI Associated)

Sensitivity: 98.6% (95% CI: 97.2%; 99.3%)
Specificity: 69.5% (95% CI: 67.6%; 71.2%)
PPV: 39.5% (95% CI: 36.9%; 42.2%)
NPV: 99.6% (95% CI: 99.2%; 99.8%)

Site 1 Performance for Bacterial Density of ≥5x10^4 CFU/mL (Primary Analysis: Bacteriuria)

Sensitivity: 94.9% (95% CI: 91.5%; 96.9%)
Specificity: 71.2% (95% CI: 67.8%; 74.4%)
PPV: 54.9% (95% CI: 50.4%; 59.3%)
NPV: 97.4% (95% CI: 95.7%; 98.4%)

Site 1 Performance for Bacterial Density of ≥5x10^4 CFU/mL (Secondary Analysis: UTI Associated)

Sensitivity: 99.1% (95% CI: 96.9%; 99.8%)
Specificity: 69.1% (95% CI: 65.7%; 72.2%)
PPV: 48.7% (95% CI: 44.2%; 53.2%)
NPV: 99.6% (95% CI: 98.6%; 99.9%)

Site 2 Performance for Bacterial Density of ≥5x10^4 CFU/mL (Primary Analysis: Bacteriuria)

Sensitivity: 83.3% (95% CI: 77.8%; 87.7%)
Specificity: 80.2% (95% CI: 77.3%; 82.8%)
PPV: 52.6% (95% CI: 47.3%; 57.9%)
NPV: 94.8% (95% CI: 92.9%; 96.2%)

Site 2 Performance for Bacterial Density of ≥5x10^4 CFU/mL (Secondary Analysis: UTI Associated)

Sensitivity: 97.2% (95% CI: 93.0%; 98.9%)
Specificity: 78.1% (95% CI: 75.2%; 80.7%)
PPV: 42.1% (95% CI: 36.9%; 47.5%)
NPV: 99.4% (95% CI: 98.5%; 99.8%)

Site 3 Performance for Bacterial Density of ≥5x10^4 CFU/mL (Primary Analysis: Bacteriuria)

Sensitivity: 88.2% (95% CI: 84.1%; 91.3%)
Specificity: 71.1% (95% CI: 67.6%; 74.3%)
PPV: 57.7% (95% CI: 53.3%; 62.1%)
NPV: 93.1% (95% CI: 90.6%; 94.9%)

Site 3 Performance for Bacterial Density of ≥5x10^4 CFU/mL (Secondary Analysis: UTI Associated)

Sensitivity: 96.6% (95% CI: 93.4%; 98.3%)
Specificity: 68.2% (95% CI: 64.8%; 71.4%)
PPV: 48.3% (95% CI: 43.8%; 52.8%)
NPV: 98.5% (95% CI: 97.0%; 99.2%)

Performance for Bacterial Density of ≥5x10^4 CFU/mL (Male) (Primary Analysis: Bacteriuria)

Sensitivity: 95.6% (95% CI: 90.5%; 97.9%)
Specificity: 78.9% (95% CI: 75.8%; 81.7%)
PPV: 45.2% (95% CI: 39.5%; 51.0%)
NPV: 99.0% (95% CI: 97.8%; 99.5%)

Performance for Bacterial Density of ≥5x10^4 CFU/mL (Male) (Secondary Analysis: UTI Associated)

Sensitivity: 97.1% (95% CI: 91.9%; 99.0%)
Specificity: 77.1% (95% CI: 74.0%; 80.0%)
PPV: 37.0% (95% CI: 31.5%; 42.9%)
NPV: 99.5% (95% CI: 98.5%; 99.8%)

Performance for Bacterial Density of ≥5x10^4 CFU/mL (Female) (Primary Analysis: Bacteriuria)

Sensitivity: 87.9% (95% CI: 85.2%; 90.1%)
Specificity: 72.2% (95% CI: 69.9%; 74.4%)
PPV: 58.2% (95% CI: 55.1%; 61.2%)
NPV: 93.1% (95% CI: 91.5%; 94.4%)

Performance for Bacterial Density of ≥5x10^4 CFU/mL (Female) (Secondary Analysis: UTI Associated)

Sensitivity: 97.8% (95% CI: 96.1%; 98.8%)
Specificity: 69.7% (95% CI: 67.5%; 71.9%)
PPV: 49.5% (95% CI: 46.4%; 52.7%)
NPV: 99.1% (95% CI: 98.3%; 99.5%)

Overall Performance for Bacterial Density of ≥5x10^4 CFU/mL (Unpreserved Samples) (Primary Analysis: Bacteriuria)

Sensitivity: 81.9% (95% CI: 75.2%; 87.1%)
Specificity: 78.8% (95% CI: 75.2%; 82.0%)
PPV: 52.2% (95% CI: 46.0%; 58.3%)
NPV: 93.9% (95% CI: 91.4%; 95.7%)

Overall Performance for Bacterial Density of ≥5x10^4 CFU/mL (Unpreserved Samples) (Secondary Analysis: UTI Associated)

Sensitivity: 96.0% (95% CI: 90.3%; 98.4%)
Specificity: 76.5% (95% CI: 72.9%; 79.7%)
PPV: 40.4% (95% CI: 34.4%; 46.7%)
NPV: 99.15% (95% CI: 97.8%; 99.7%)

Performance for Subpopulation of ≥1x10^5 CFU/mL (Unpreserved Samples) (Primary Analysis: Bacteriuria)

Sensitivity: 88.3% (95% CI: 81.4%; 92.9%)
Specificity: 76.1% (95% CI: 72.5%; 79.3%)
PPV: 42.2% (95% CI: 36.3%; 48.4%)
NPV: 97.1% (95% CI: 95.1%; 98.2%)

Performance for Subpopulation of ≥1x10^5 CFU/mL (Unpreserved Samples) (Secondary Analysis: UTI Associated)

Sensitivity: 97.5% (95% CI: 91.3%; 99.3%)
Specificity: 74.3% (95% CI: 70.8%; 77.6%)
PPV: 32.5% (95% CI: 26.9%; 38.7%)
NPV: 99.6% (95% CI: 98.5%; 99.9%)

Overall Performance for Bacterial Density of ≥5x10^4 CFU/mL (Preserved Samples) (Primary Analysis: Bacteriuria)

Sensitivity: 91.0% (95% CI: 88.5%; 92.9%)
Specificity: 72.9% (95% CI: 70.8%; 75.0%)
PPV: 56.1% (95% CI: 53.1%; 59.1%)
NPV: 95.5% (95% CI: 94.2%; 96.5%)

Overall Performance for Bacterial Density of ≥5x10^4 CFU/mL (Preserved Samples) (Secondary Analysis: UTI Associated)

Sensitivity: 98.0% (95% CI: 96.4%; 98.9%)
Specificity: 70.5% (95% CI: 68.4%; 72.6%)
PPV: 48.3% (95% CI: 45.3%; 51.4%)
NPV: 99.2% (95% CI: 98.6%; 99.6%)

Performance for Subpopulation of ≥1x10^5 CFU/mL (Preserved Samples) (Primary Analysis: Bacteriuria)

Sensitivity: 94.8% (95% CI: 92.5%; 96.4%)
Specificity: 69.1% (95% CI: 66.9%; 71.2%)
PPV: 45.7% (95% CI: 42.7%; 48.8%)
NPV: 98.0% (95% CI: 97.1%; 98.6%)

Performance for Subpopulation of ≥1x10^5 CFU/mL (Preserved Samples) (Secondary Analysis: UTI Associated)

Sensitivity: 98.8% (95% CI: 97.3%; 99.5%)
Specificity: 67.8% (95% CI: 65.7%; 69.9%)
PPV: 41.1% (95% CI: 38.2%; 44.2%)
NPV: 99.6% (95% CI: 99.1%; 99.8%)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K915796

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 866.2560 Microbial growth monitor.

(a)
Identification. A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I. With the exception of automated blood culturing system devices that are used in testing for bacteria, fungi, and other microorganisms in blood and other normally sterile body fluids, this device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 1, 2018

BacterioScan, Inc. % Fran White President MDC Associates, LLC. 180 Cabot Street Beverly, Massachusetts 01915

Re: K172412

Trade/Device Name: BacterioScan 216Dx System Regulation Number: 21 CFR 866.2560 Regulation Name: Microbial growth monitor Regulatory Class: Class I Product Code: OBQ Dated: August 7, 2017 Received: August 10, 2017

Dear Fran White:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR

1

Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ribhi Shawar -S For

Uwe Scherf, M. Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K172412

Device Name BacterioScan™ 216Dx™ System

Indications for Use (Describe)

The BacterioScan 216Dx System is a semi-automated, in vitro diagnostic system (consisting of an instrument, software, and disposable Multicuvettes) that analyzes light scattering to measure any bacterial growth directly from urine sample incubated in trypticase soy broth. The BacterioScan 216Dx is for qualitative determination (presumptive positive or presumptive negative) of bacteriuria at a density of ≥5x104 CFU/mL. The BacterioScan 216Dx results are intended for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of Urinary Tract Infections (UTIs),

The 216Dx System is not intended to provide bacterial identification, or differentiation. The system does not distinguish between growth of infecting, colonizing or contaminating bacteria, or if mixed urogenital flora are present. Presumptive positive urine samples must be cultured. Presumptive negative urine samples must be cultured if a low level of bacteriuria is suspected and is clinically relevant. The system also does not detect anaerobic bacteria, fungi/ yeasts, fastidious organisms or those associated with sterile pyuria.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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3

510(k) SUMMARY

Date of Summary	April 24, 2018
Product Name	BacterioScan™ 216Dx™ System
Sponsor	BacterioScan, Inc.
4041 Forest Park Avenue
St. Louis, MO 63108
Correspondent	MDC Associates, LLC
Fran White, President
180 Cabot Street
Beverly, MA 01915
Phone: (978) 705 5011
Fax: (800) 498 9121
Email: fran@mdcassoc.com

Device Trade or Proprietary Name

BacterioScan™ 216Dx™ System

Common Name

Microbial Growth Monitor System

Product Classification

866.2560 Microbial growth monitor

Classification

Class 1 Product code: QBQ

Substantial Equivalency

Comparison Of New Device With Predicate Device Table 1.

| Characteristic | BacterioScan™ 216Dx™ Laser Microbial
Growth Monitor System
(New Device) | BACTEC™ 9240 System
K915796
(Predicate Device) |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | The BacterioScan 216Dx System is a semi-
automated, in vitro diagnostic system
(consisting of an instrument, software, and
disposable Multicuvettes) that analyzes light
scattering to measure any bacterial growth
directly from urine sample incubated in
trypticase soy broth. The BacterioScan
216Dx is for qualitative determination
(presumptive positive or presumptive
negative) of bacteriuria at a density of
$≥5x104$ CFU/mL. The BacterioScan 216Dx
results are intended for use in conjunction
with other clinical and laboratory findings to | The BACTEC 9240 System (Instrument,
Aerobic and Anaerobic F Culture Vials) is
intended for the detection of aerobic and
anaerobic microorganisms (bacteria and
fungi) in clinical cultures of blood using a
fluorescence -based detection system. |
| Characteristic | BacterioScan™ 216Dx™ Laser Microbial
Growth Monitor System
(New Device) | BACTEC™ 9240 System
K915796
(Predicate Device) |
| | aid in the diagnosis of Urinary Tract
Infections (UTIs).

The 216Dx System is not intended to
provide bacteriuria levels, bacterial
identification, or differentiation. The
system does not distinguish between
growth of infecting, colonizing or
contaminating bacteria, or if mixed
urogenital flora are present. Presumptive
positive urine samples must be cultured.
Presumptive negative urine samples must
be cultured if a low level of bacteriuria is
suspected and is clinically relevant. The
system also does not detect anaerobic
bacteria, fungi/yeasts, fastidious organisms
or those associated with sterile pyuria. | |
| Sample | Direct | Same |
| Growth Media | Liquid | Same |
| Incubation | Required | Same |
| Technology | Continuous monitoring of bacterial growth
over a period of time in liquid medium
during incubation | Same |
| Qualitative
Output | Presumptive Positive/Presumptive Negative | Same |
| Differences | | |
| Sample Type | Urine | Blood |
| Detection
Technology | Laser light scattering analysis | Fluorescence analysis |
| Sample
Processing | 360 μL urine and 2.5 mL trypticase soy broth
(TSB) contained in one Multicuvette well | 5 – 7 mL blood and 40 mL enriched
soybean-casein digest broth with CO2
contained in one culture vial |
| Incubation Time | Approximately 3 hours | Up to 5 – 7 days for negatives; positive
ring/signal at any time |

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Intended Use

The BacterioScan 216Dx System is a semi-automated, in vitro diagnostic system (consisting of an instrument, software, and disposable Multicuvettes) that analyzes light scattering to measure any bacterial growth directly from urine sample incubated in trypticase soy broth. The BacterioScan 216Dx is for qualitative determination (presumptive positive or presumptive negative) of bacteriuria at a density of ≥5x104 CFU/mL. The BacterioScan 216Dx

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results are intended for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of Urinary Tract Infections (UTIs).

The 216Dx System is not intended to provide bacteriuria levels, bacterial identification, or differentiation. The system does not distinguish between growth of infecting, colonizing or contaminating bacteria, or if mixed urogenital flora are present. Presumptive positive urine samples must be cultured. Presumptive negative urine samples must be cultured if a low level of bacteriuria is suspected and is clinically relevant. The system also does not detect anaerobic bacteria, fungi/yeasts, fastidious organisms or those associated with sterile pyuria.

Results Interpretation

A "Presumptive Positive" result indicates that bacteriuria may be present in the sample at a density of ≥5x10 CFU/mL. Samples reported as Presumptive Positive must be cultured for bacteriuria levels, mixed flora evaluation, organism isolation/identification, and antimicrobial susceptibility testing.

A "Presumptive Negative" result may indicate either one of the following:

a. No bacteriuria is in the sample,
b. Bacteriuria is present at densities below 5x10" CFU/mL, or
c. Mixed urogenital flora contaminants (or other organisms not commonly associated with UTI) may be present in the sample, but not detected by the BacterioScan 216Dx.

Samples classified as Presumptive Negative by the 216Dx must be cultured if bacteriuria at densities of 5x10 CFU/ml. The Classification algorithm qualitatively assesses a result by analyzing periodic measurements taken throughout this incubation period.

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Performance Data

Limit of Detection

A limit of detection (LoD) study was conducted to determine the estimated analytical sensitivity (the lowest organism density detected with an approximate accuracy of ≥95%). For each species of common (10) or rare (7) UTI pathogens, two (2) strains were spiked into fresh, culture-negative human urine. For the initial LoD estimation for each strain, bacteria were spiked into urine, serially diluted to four (4) density levels at approximate clinical cutoff and tested in quadruplicate to determine the approximate LoD. Each strain was then tested in replicates of twenty (20) at the approximated density. LoD was confirmed when density level performance demonstrated >95% or ≥19/20 (Presumptive Positive). Some variation is noted by strain; the final LoD was determined and is reported as the higher of the values. The data demonstrate that the 216Dx has a LoD for most common and rare UTI pathogens that is approximately equivalent to the clinical cut-off of 10° CFU/mL.

The LoD in CFU/mL was confirmed by 100% (20/20) positivity for the following UTI pathogens. The common pathogens with LoD in parenthesis were: E. coli (4.40x103), Proteus mirabilis (8.70x103), Enterobacter cloacae (6.67x103), Staphylococcus aureus (1.11x10³), Klebsiella pneumoniae (1.37 x 10ª), Enterococcus faecalis (2.33x104), and Enterococcus faecium (4.37x104). The rare UTI pathogens were: Acinetobacter baumannii (1.60x10"), Citrobacter freundii/koseri (2.80 x 104), Morganella morganii (4.23x10"), Actinobaculum schaalii (2.80x10*), and Corynebacterium striatum (4.03x10*).

There were UTI pathogens noted to have a LoD that was higher than the clinical cut-off (10° CFU/mL) and are noted in the Limitation of product performance. They were: Pseudomonas aeruginosa (4.87x10~), Staphylococcus saprophyticus (2.20x10~), Streptococcus aqalactiae (1.42x105), Aerococcus spp. (1.77x105), and Corynebacterium urealyticum (2.63x105).

Linearity and Dynamic Range

Three (3) Gram-negative and three (3) Gram-positive common UTI pathogens were spiked into negative human urine and serially diluted to approximate clinical cut-off and tested in quadruplicate to assess the linearity and dynamic range of the 216Dx system. Unspiked, culture-negative urine was also assessed. Results confirm that the dynamic range of detection for each Gram-negative and Gram-positive strain tested spans the range of the clinical cut-off. Most of these results demonstrate that the system's reporting algorithm generates the expected result of Presumptive Positive/Presumptive Negative for multiple UTI pathogens. The following organisms were evaluated and the density level in CFU/mL at which 100% (4/4) samples were positive is indicated in parenthesis: E. coli (2.37×10˚), K. pneumoniae (1.70x10³), E. faecalis (7.33x10~), S. aureus (2.1x10~), P. mirabilis (3.6x10*), and E. faecium (4.03x10 ). E. faecium is noted in the Limitation of product performance. Unspiked urine was 100% negative (4/4).

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Reproducibility

This study was designed to demonstrate the reproducibility of the 216Dx detection of density levels of UTI-associated pathogens present in human urine. Representative strains of a Gram-negative (E. coli) and a Gram-positive (E. faecalis) were spiked into fresh, culturenegative human urine to achieve target densities at three (3) levels: "Low" (10,000 CFU/mL). Unspiked human urine was used as a negative sample. All samples were blinded and randomized prior to testing and fresh specimens were prepared each day for testing. Each reproducibility panel was tested by three (3) individual sites, with two (2) instruments per site and by two (2) operators in quadruplicate for six (6) non-consecutive days.

A summary of results is presented in Tables 2-7. Performance for High and Moderate densities was ≥95% reproducible across sites and between operators. Specifically, performance ranged from 91.7-100% across six (6) operators, from 94.8-100% across sites, and from 91.7-100% across the six (6) days of testing. Negative samples demonstrated performance of 96.5%.

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Table 2: Reproducibility Performance by Operator

| | Isolate | Density level
(CFU/mL range) | # of positive samples (% of total) | | | | | | Total
Positive/
Total Tested | % Positive
(95% CI) |
|--|--------------------|---------------------------------------------|------------------------------------|------------|------------|------------|------------|------------|------------------------------------|----------------------------|
| | | | Site 1 | | Site 2 | | Site 3 | | | |
| | | | Operator 1 | Operator 2 | Operator 1 | Operator 2 | Operator 1 | Operator 2 | | |
| | E. coli | High
(1.37x105-5.03x105) | 24 (100) | 24 (100) | 24 (100) | 24 (100) | 24 (100) | 22 (91.7) | 142/144 | 98.61%
(95.08%, 99.62%) |
| | | Moderate
(1.20x104-3.70x104) | 24 (100) | 24 (100) | 24 (100) | 24 (100) | 23 (95.8) | 22 (91.7) | 141/144 | 97.92%
(94.05%, 99.29%) |
| | | Low
(1.87x103-4.00x103) | 20 (83.3) | 19 (79.2) | 24 (100) | 24 (100) | 19 (79.2) | 19 (79.2) | 125/144 | 86.81%
(80.31%, 91.39%) |
| | | All levels
(1.87x103-5.03x105) | 68 (94.4) | 67 (93.1) | 72 (100) | 72 (100) | 66 (91.7) | 63 (87.5) | 408/432 | 94.44%
(91.87%, 96.24%) |
| | | High + Moderate Only
(1.20x104-5.03x105) | 48 (100) | 48 (100) | 48 (100) | 48 (100) | 47 (97.9) | 44 (91.7) | 283/288 | 98.26%
(96.00%, 99.26%) |
| | E. faecalis | High
(2.13x105-3.37x105) | 24 (100) | 24 (100) | 24 (100) | 24 (100) | 24 (100) | 22 (91.7) | 142/144 | 98.61%
(95.08%, 99.62%) |
| | | Moderate
(2.27x104-4.50x104) | 24 (100) | 24 (100) | 24 (100) | 24 (100) | 24 (100) | 22 (91.7) | 142/144 | 98.61%
(95.08%, 99.62%) |
| | | Low
(2.37x103-4.93x103) | 5 (20.8) | 4 (16.7) | 10 (41.7) | 12 (50.0) | 6 (25.0) | 7 (29.2) | 44/144 | 30.56%
(23.62%, 38.50%) |
| | | All levels
(2.37x103-3.37x105) | 53 (73.6) | 52 (72.2) | 58 (80.6) | 60 (83.3) | 54 (75.0) | 51 (70.8) | 328/432 | 75.93%
(71.68%, 79.72%) |
| | | High + Moderate Only
(2.27x104-3.37x105) | 48 (100) | 48 (100) | 48 (100) | 48 (100) | 48 (100) | 44 (91.7) | 284/288 | 98.61%
(96.48%, 99.46%) |

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Table 3: Negative Control Reproducibility Performance by Operator

Sample	Density level (CFU/mL range)	# of positive samples
		Site 1		Site 2		Site 3
		Operator 1	Operator 2	Operator 1	Operator 2	Operator 1	Operator 2
Unspiked urine	E. coli	High
(1.37x105-5.03x105)	Site 1
48 (100)	Site 2
48 (100)	Site 3
46 (95.8)	142/144	98.61%
(95.08%, 99.62%)
	Moderate
(1.20x104-3.70x104)	48 (100)	48 (100)	45 (93.8)	141/144	97.92%
(94.05%, 99.29%)
	Low
(1.87x103-4.00x103)	39 (81.3)	48 (100)	38 (79.2)	125/144	86.81%
(80.31%, 91.39%)
	All levels
(1.87x103-5.03x105)	135 (93.8)	144 (100)	129 (89.6)	408/432	94.44%
(91.87%, 96.24%)
	High + Moderate Only
(1.20x104-5.03x105)	96 (100)	96 (100)	91 (94.8)	283/288	98.26%
(96.00%, 99.26%)
E. faecalis	High
(2.13x105-3.37x105)	48 (100)	48 (100)	46 (95.8)	142/144	98.61%
(95.08%, 99.62%)
	Moderate
(2.27x104-4.50x104)	48 (100)	48 (100)	46 (95.8)	142/144	98.61%
(95.08%, 99.62%)
	Low
(2.37x103-4.93x103)	9 (18.8)	22 (45.8)	13 (27.1)	44/144	30.56%
(23.62%, 38.50%)
	All levels
(2.37x103-3.37x105)	105 (72.9)	118 (81.9)	105 (72.9)	328/432	75.93%
(71.68%, 79.72%)
	High + Moderate Only
(2.27x104-3.37x105)	96 (100)	96 (100)	92 (95.8)	284/288	98.61%
(96.48%, 99.46%)

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Table 5: Negative Control Reproducibility Performance by Site

| Sample | Density level
(CFU/mL range) | # of positive samples | | | Total Negative/
Total Tested | % Negative
(95% CI) |
|-------------------|---------------------------------|-----------------------|---|---|---------------------------------|----------------------------|
| Unspiked
urine | E. coli | High
(1.37x105-5.03x105) | 22 (91.7) | 24 (100) | 24 (100) | 24 (100) | 24 (100) | 24 (100) | 142/144 | 98.61%
(95.08%, 99.62%) |
| | Moderate
(1.20x104-3.70x104) | 22 (91.7) | 24 (100) | 24 (100) | 24 (100) | 23 (95.8) | 24 (100) | 141/144 | 97.92%
(94.05%, 99.29%) |
| | Low
(1.87x103-4.00x103) | 21 (87.5) | 23 (95.8) | 23 (95.8) | 21 (87.5) | 18 (75.0) | 19 (79.2) | 125/144 | 86.81%
(80.31%, 91.39%) |
| | All levels
(1.87x103-5.03x105) | 65 (90.3) | 71 (98.6) | 71 (98.6) | 69 (95.8) | 65 (90.3) | 67 (93.1) | 408/432 | 94.44%
(91.87%, 96.24%) |
| | High + Moderate Only
(1.20x104-5.03x105) | 44 (91.7) | 48 (100) | 48 (100) | 48 (100) | 47 (97.9) | 48 (100) | 283/288 | 98.26%
(96.00%, 99.26%) |
| E. faecalis | High
(2.13x105-3.37x105) | 22 (91.7) | 24 (100) | 24 (100) | 24 (100) | 24 (100) | 24 (100) | 142/144 | 98.61%
(95.08%, 99.62%) |
| | Moderate
(2.27x104-4.50x104) | 22 (91.7) | 24 (100) | 24 (100) | 24 (100) | 24 (100) | 24 (100) | 142/144 | 98.61%
(95.08%, 99.62%) |
| | Low
(2.37x103-4.93x103) | 4 (16.7) | 5 (20.8) | 12 (50.0) | 7 (29.2) | 13 (54.2) | 3 (12.5) | 44/144 | 30.56%
(23.62%, 38.50%) |
| | All levels
(2.37x103-3.37x105) | 48 (66.7) | 53 (73.6) | 60 (91.7) | 55 (76.4) | 61 (84.7) | 51 (70.8) | 328/432 | 75.93%
(71.68%, 79.72%) |
| | High + Moderate Only
(2.27x104-3.37x105) | 44 (91.7) | 48 (100) | 48 (100) | 48 (100) | 48 (100) | 48 (100) | 284/288 | 98.61%
(96.48%, 99.46%) |

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Table 7: Negative Control Reproducibility Performance by Day

| Sample | Density level
(CFU/mL range) | # of positive samples | | | | | | Total Negative/
Total Tested | % Negative
(95% CI) |
|-------------------|---------------------------------|-----------------------|---|---|---|---|---|---------------------------------|----------------------------|
| Unspiked
urine | 200 μg/mL), blood (>0.0156%), bilirubin (>20 µg/mL), mucin (>0.039%, v/v), and leukocytes (>10 cells/mL); talcum powder (0.4% w/v) and H. parainfluenzae (1.1x10 CFU/mL) demonstrated interference (i.e. false positivity), and acidic urine (pH 6.0) may interfere with the positivity of Enterobacter cloacae at density levels of ≤5x10* CFU/mL. Further, the study showed that there were instances in which S. aureus did not give positive results at density level of 10 CFU/mL. These interfering substances are noted in the limitation section of the labeling defining potential interference. Potential sources of interference have been specified in the Limitations section (see BacterioScan 216Dx Package Insert).

Method Comparison

A comparison study was conducted at three (3) geographically diverse sites, each testing approximately 1,000 urine samples received in the laboratory for routine urine culture. Samples were tested in accordance to BacterioScan instructions for use. Each urine was diluted to a 1:8 into TSB (360μL of urine with 2.5mL TSB). Controls were run each day of testing on each instrument used.

Reference cultures were performed simultaneously with 216Dx testing. Reference testing was performed using 1- and 10μL loops. Using each loop, colony count plates were performed in triplicate, and a median result was generated for each loop size. Median colony count was determined to be the reference result and were compared to the 216Dx result. Any colony counts at or above 5x10 ° CFU/mL are considered a positive result for primary analysis and a secondary analysis specific to UTI pathogens (UTI-Associated) was also performed. Organisms isolated from reference colony counts of ≥5x10* CFU/mL were identified by MALDI.

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The detection algorithm used by the BacterioScan 216Dx was designed to classify urine specimens containing UTI associated bacteria at a density of >5x10 ° CFU/mL. Samples measured and containing bacteriuria/total density of >5x10 € CFU/mL organisms is reported by the BacterioScan 216Dx to be "Presumptive Positive." Data were analyzed based on reference colony counts of ≥5x10 or ≥1x10 °CFU/mL and identification of isolated organisms by MALDI. In the secondary analysis, the common UTI pathogens (UTI Associated) encountered were: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Proteus mirabilis, Enterobacter cloacae, Pseudomonas aeruginosa, Enterococcus faecalis, Enterococcus faecium, Aerococcus urinae, Streptocccus agalactiae, and Staphylococcus aureus; the rare uropathogens encountered were Enterobacter aerogenes, Citrobacter freundii, Citrobacter koseri, Acinetobacter baumannii, Morqanella morqanii, Aerococcus sanquinicola, Corynebacterium striatum, and Staphylococcus saprophyticus.

The results of this comparative study demonstrate the performance of the 216Dx in detecting bacteria in urine with an emphasis on UTI-associated pathogens at densities ≥5x10* CFU/mL. Performance was also evaluated at bacterial densities >1x10* CFU/mL as a subpopulation. Of the 3,153 urine samples enrolled, there were a total of 3,052 evaluable specimens for primary analysis of bacteriuria. For the secondary analysis, the evaluable specimens were 3,010 for ≥5x10* CFU/mL but 3,020 for ≥1x10 ° CFU/mL because the identity of some organisms was not obtained in the reference culture at the defined cut-off of ≥5x10* CFU/mL. Performance at these levels demonstrates a substantial equivalence to the reference method in detecting bacteria in urine with an emphasis on UTI associated organisms at a clinically significant density of ≥5x10 € CFU/mL. Further analyses of the study data demonstrate that the BacterioScan 216Dx performance is substantially equivalent regarding patient gender. Analysis by study site can be found in Tables 10-12, patient gender (Tables 13, 14), and the urine specimens collected with (preserved) or without (unpreserved) preservatives prior to analysis (Tables 15-18).

All BacterioScan 216Dx results are presumptive.

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Overall Performance for Bacterial Density of ≥5x104 CFU/mL
Primary Analysis:
Bacteriuria			Secondary Analysis:
UTI Associated*
		Reference			Reference
		Positive	Negative	Total	Positive	Negative	Total
BacterioScan
216Dx	Positive	714	576	1290	592	672	1264
	Negative	87	1675	1762	14	1732	1746
	Total	801	2251	3052	606	2404	3010
Sensitivity		89.1% (714/801)	95% CI: 86.8%; 91.1%		97.7% (592/606)	95% CI: 96.2%; 98.6%
Specificity		74.4% (1675/2251)	95% CI: 72.6%; 76.2%		72.0 (1732/2404)	95% CI: 70.2%; 73.8%
PPV		55.3% (714/1290)	95% CI: 52.6%; 58.0%		46.8% (592/1264)	95% CI: 44.1%; 49.6%
NPV		95.1% (1675/1762)	95% CI: 93.9%; 96.0%		99.2% (1732/1746)	95% CI: 98.7%; 99.5%

Limited to bacterial pathogens encountered in the clinical studies

Table 9

Performance for Subpopulation of ≥1x105 CFU/mL
	Primary Analysis:
Bacteriuria			Secondary Analysis:
UTI Associated*
	Positive	Negative	Total	Positive	Negative	Total
BacterioScan
216Dx	581	709	1290	501	767	1268
Negative	40	1722	1762	7	1745	1752
Total	621	2431	3052	508	2512	3020
Sensitivity	93.6% (581/621)
95% CI: 91.3%; 95.2%			98.6% (501/508)
95% CI: 97.2%; 99.3%
Specificity	70.8% (1722/2431)
95% CI: 69.0%; 72.6%			69.5% (1745/2512)
95% CI: 67.6%; 71.2%
PPV	45.0% (581/1290)
95% CI: 42.3%; 47.8%			39.5% (501/1268)
95% CI: 36.9%; 42.2%
NPV	97.7% (1722/1762)
95% CI: 96.9%; 98.3%			99.6% (1745/1752)
95% CI: 99.2%; 99.8%

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Site 1 Performance for Bacterial Density of ≥5x104 CFU/mL
Primary Analysis:
Bacteriuria			Secondary Analysis:
UTI Associated*
		Reference	Reference
		Positive	Negative	Total	Positive	Negative	Total
BacterioScan
216Dx	Positive	258	212	470	226	238	464
	Negative	14	524	538	2	531	533
	Total	272	736	1008	228	769	997
Sensitivity		94.9% (258/272)			99.1% (226/228)
		95% CI: 91.5%; 96.9%			95% CI: 96.9%; 99.8%
Specificity		71.2% (524/736)			69.1% (531/769)
		95% CI: 67.8%; 74.4%			95% CI: 65.7%; 72.2%
PPV		54.9% (258/470)			48.7% (226/464)
		95% CI: 50.4%; 59.3%			95% CI: 44.2%; 53.2%
NPV		97.4% (524/538)			99.6% (531/533)
		95% CI: 95.7%; 98.4%			95% CI: 98.6%; 99.9%

Limited to bacterial pathogens encountered in the clinical studies

Table 11

Site 2 Performance for Bacterial Density of ≥5x10⁴ CFU/mL
Primary Analysis:
Bacteriuria			Secondary Analysis:
UTI Associated *
	Reference			Reference
	Positive	Negative	Total	Positive	Negative	Total
BacterioScan
216Dx	Positive	180	162	342	139	191	330
	Negative	36	655	691	4	681	685
	Total	216	817	1033	143	872	1015
Sensitivity		83.3% (180/216)			97.2% (139/143)
		95% CI: 77.8%; 87.7%			95% CI: 93.0%; 98.9%
Specificity		80.2% (655/817)			78.1% (681/872)
		95% CI: 77.3%; 82.8%			95% CI: 75.2%; 80.7%
PPV		52.6% (180/342)			42.1% (139/330)
		95% CI: 47.3%; 57.9%			95% CI: 36.9%; 47.5%
NPV		94.8% (655/691)			99.4% (681/685)
		95% CI: 92.9%; 96.2%			95% CI: 98.5%; 99.8%

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Site 3 Performance for Bacterial Density of ≥5x104 CFU/mL
Primary Analysis:
Bacteriuria			Secondary Analysis:
UTI Associated*
	Reference			Reference
		Positive	Negative	Total	Positive	Negative	Total
BacterioScan
216Dx	Positive	276	202	478	227	243	470
	Negative	37	496	533	8	520	528
	Total	313	698	1011	235	763	998
Sensitivity		88.2% (276/313)
95% CI: 84.1%; 91.3%			96.6% (227/235)
95% CI: 93.4%; 98.3%
Specificity		71.1% (496/698)
95% CI: 67.6%; 74.3%			68.2% (520/763)
95% CI: 64.8%; 71.4%
PPV		57.7% (276/478)
95% CI: 53.3%; 62.1%			48.3% (227/470)
95% CI: 43.8%; 52.8%
NPV		93.1% (496/533)
95% CI: 90.6%; 94.9%			98.5% (520/528)
95% CI: 97.0%; 99.2%

Limited to bacterial pathogens encountered in the clinical studies

Table 13

Performance for Bacterial Density of ≥5x104 CFU/mL (Male)
Primary Analysis:
Bacteriuria			Secondary Analysis:
UTI Associated *
		Reference	Reference
		Positive	Negative	Total	Positive	Negative	Total
BacterioScan
216Dx	Positive	127	154	281	101	172	273
	Negative	6	577	583	3	580	583
	Total	133	731	864	104	752	856
Sensitivity	95.6% (127/133)
95% CI: 90.5%; 97.9%				97.1% (101/104)
95% CI: 91.9%; 99.0%
Specificity	78.9% (577/731)
95% CI: 75.8%; 81.7%				77.1% (580/752)
95% CI: 74.0%; 80.0%
PPV	45.2% (127/281)
95% CI: 39.5%; 51.0%				37.0% (101/273)
95% CI: 31.5%; 42.9%
NPV	99.0% (577/583)
95% CI: 97.8%; 99.5%				99.5% (580/583)
95% CI: 98.5%; 99.8%

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Performance for Bacterial Density of ≥5x10⁴ CFU/mL (Female)
		Primary Analysis:
Bacteriuria			Secondary Analysis:
UTI Associated *
		Reference			Reference
		Positive	Negative	Total	Positive	Negative	Total
BacterioScan
216Dx	Positive	587	422	1009	491	500	991
	Negative	81	1094	1179	11	1152	1163
	Total	668	1520	2188	502	1652	2154
Sensitivity		87.9% (587/668)
95% CI: 85.2%; 90.1%			97.8% (491/502)
95% CI: 96.1%; 98.8%
Specificity		72.2% (1094/1520)
95% CI: 69.9%; 74.4%			69.7% (1152/1652)
95% CI: 67.5%; 71.9%
PPV		58.2% (587/1009)
95% CI: 55.1%; 61.2%			49.5% (491/991)
95% CI: 46.4%; 52.7%
NPV		93.1% (1094/1179)
95% CI: 91.5%; 94.4%			99.1% (1152/1163)
95% CI: 98.3%; 99.5%

Limited to bacterial pathogens encountered in the clinical studies

Table 15

Overall Performance for Bacterial Density of ≥5x104 CFU/mL (Unpreserved Samples)
		Primary Analysis:
Bacteriuria			Secondary Analysis:
UTI Associated*
		Positive	Negative	Total	Positive	Negative	Total
BacterioScan
216Dx	Positive	131	120	251	97	143	240
	Negative	29	446	475	4	465	469
	Total	160	566	726	101	608	709
Sensitivity		81.9% (131/160)
95% CI: 75.2%; 87.1%			96.0% (97/101)
95% CI: 90.3%; 98.4%
Specificity		78.8% (446/566)
95% CI: 75.2%; 82.0%			76.5% (465/608)
95% CI: 72.9%; 79.7%
PPV		52.2% (131/251)
95% CI: 46.0%; 58.3%			40.4% (97/240)
95% CI: 34.4%; 46.7%
NPV		93.9% (446/475)
95% CI: 91.4%; 95.7%			99.15% (465/469)
95% CI: 97.8%; 99.7%

19

Performance for Subpopulation of ≥1x105 CFU/mL (Unpreserved Samples)
		Primary Analysis:
Bacteriuria			Secondary Analysis:
UTI Associated *
		Reference			Reference
		Positive	Negative	Total	Positive	Negative	Total
BacterioScan
216Dx	Positive	106	145	251	78	162	240
	Negative	14	461	475	2	469	471
	Total	120	606	726	80	631	711
Sensitivity	88.3% (106/120)			97.5% (78/80)
	95% CI: 81.4%; 92.9%			95% CI: 91.3%; 99.3%
Specificity	76.1% (461/606)			74.3% (469/631)
	95% CI: 72.5%; 79.3%			95% CI: 70.8%; 77.6%
PPV	42.2% (106/251)			32.5% (78/240)
	95% CI: 36.3%; 48.4%			95% CI: 26.9%; 38.7%
NPV	97.1% (461/475)			99.6% (469/471)
	95% CI: 95.1%; 98.2%			95% CI: 98.5%; 99.9%

Limited to bacterial pathogens encountered in the clinical studies

Table 17

Overall Performance for Bacterial Density of ≥5x104 CFU/mL (Preserved Samples)
		Primary Analysis:
Bacteriuria			Secondary Analysis:
UTI Associated*
		Reference			Reference
		Positive	Negative	Total	Positive	Negative	Total
BacterioScan
216Dx	Positive	583	456	1039	495	529	1024
	Negative	58	1229	1287	10	1267	1277
	Total	641	1685	2326	505	1796	2301
Sensitivity	91.0% (583/641)
95% CI: 88.5%; 92.9%			98.0% (495/505)
95% CI: 96.4%; 98.9%
Specificity	72.9% (1229/1685)
95% CI: 70.8%; 75.0%			70.5% (1267/1796)
95% CI: 68.4%; 72.6%
PPV	56.1% (583/1039)
95% CI: 53.1%; 59.1%			48.3% (495/1024)
95% CI: 45.3%; 51.4%
NPV	95.5% (1229/1287)
95% CI: 94.2%; 96.5%			99.2% (1267/1277)
95% CI: 98.6%; 99.6%

20

| Table

18
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Performance for Subpopulation of ≥1x10⁵ CFU/mL (Preserved Samples)
Primary Analysis:			Secondary Analysis:
		Bacteriuria			UTI Associated
		Reference			Reference
		Positive	Negative	Total	Positive	Negative	Total
BacterioScan	Positive	475	564	1039	423	605	1028
216Dx	Negative	26	1261	1287	5	1276	1281
	Total	501	1825	2326	428	1881	2309
Sensitivity	94.8% (475/501)			98.8% (423/428)
	95% CI: 92.5%; 96.4%				95% CI: 97.3%; 99.5%
Specificity	69.1% (1261/1825)				67.8% (1276/1881)
	95% CI: 66.9%; 71.2%				95% CI: 65.7%; 69.9%
PPV	45.7% (475/1039)				41.1% (423/1028)
	95% CI: 42.7%; 48.8%				95% CI: 38.2%; 44.2%
NPV	98.0% (1261/1287)				99.6% (1276/1281)
	95% CI: 97.1%; 98.6%				95% CI: 99.1%; 99.8%

Limited to bacterial pathogens encountered in the clinical studies

The BacterioScan 216Dx detects bacteria in urine, with improved performance specific to organisms associated with UTI, and reduces turn-around-time from 24 hours to approximately three (3) hours, delivering a faster time to result for the majority of UTI specimens.

Statement of Safety and Effectiveness

The data presented demonstrates the safety and efficacy of the BacterioScan 216Dx System as compared to the reference method when the product Instructions for Use are followed.