(210 days)
Not Found
No
The summary describes a bacterial growth medium and its performance characteristics when used with automated instruments. There is no mention of AI or ML in the device description, intended use, or performance studies. The studies focus on analytical performance metrics like time to detection, recovery, and false rates, which are standard for this type of device and do not indicate the use of AI/ML for interpretation or analysis.
No.
The device is used to culture and recover microorganisms for diagnostic purposes, not to treat a condition or disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The device aids in the diagnosis of disease caused by pathogenic microorganisms".
No
The device described is a physical culture vial containing growth medium, not a software-only device. It is used in conjunction with hardware instruments (BD BACTEC™ fluorescent series instruments).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the vials are used in a "qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood." This is a diagnostic procedure performed in vitro (outside the body) on a biological sample (blood).
- Aids in Diagnosis: The "Additional information" section states that the device "aids in the diagnosis of disease caused by pathogenic microorganisms." This directly links the device's function to the diagnostic process.
- Device Description: The description confirms that the vials contain a "bacterial growth medium intended for use in the qualitative culture and recovery of aerobic microorganisms (bacteria and yeast) from blood." This further reinforces its use in laboratory testing of a biological sample.
- Use with Instruments: The device is designed for use with BD BACTEC™ fluorescent series instruments, which are automated systems used in clinical laboratories for blood culture and detection of microbial growth. This is a typical setup for IVD testing.
- Performance Studies: The description of the performance studies (Time to Detection, Percent Recovery, False Negative/Positive Rates) are all metrics relevant to the analytical performance of an IVD device used for microbial detection.
All these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes.
N/A
Intended Use / Indications for Use
BD BACTEC™ Plus Aerobic/F Culture Vials are used in a qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood. The principal use of this medium is with the BD BACTEC™ fluorescent series instruments.
Additional information
The device aids in the diagnosis of disease caused by pathogenic microorganisms and is automated on the BD BACTEC™ fluorescent series instruments.
Product codes (comma separated list FDA assigned to the subject device)
MDB
Device Description
The BD BACTECTM Plus Aerobic/F Culture Vials contain a bacterial growth medium intended for use in the qualitative culture and recovery of aerobic microorganisms (bacteria and yeast) from blood. It has been designed for blood volumes of three (3) to ten (10) milliliters and is used specifically with the BD BACTEC™ fluorescent-series instruments in monitoring of clinical blood specimens for the presence of microorganisms.
BD BACTECTM Plus Aerobic/F Culture Vials are supplied in a carton containing 50 vials. It is a nonsterile product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Blood
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance Studies:
- Instrument Time to Detection (TTD) Study:
- Study Type: Comparative study between modified and predicate device.
- Sample Size: 264 vials for 10-100 CFU/vial inoculum across two blood volumes (3 mL and 10 mL) and 45 vials for 0-1 and 1-10 CFU/vial inoculum across two blood volumes, on BACTEC™ FX instrument. Total of 264 + 45 + 45 = 354 vials per device for the BACTEC™ FX and BACTEC™ FX40.
- Key Results: No statistically relevant difference in time to detection for the modified device compared to the predicate device. Two isolates showed >10% difference in TTD at 10-100 CFU inoculum level in favor of the predicate device (Rothia mucilaginosa and Stenotrophomonas maltophilia), but further testing showed this was strain specific.
- Percent Recovery Study:
- Study Type: Comparative study using same organisms, blood volumes, vial lots, instruments, and inoculum levels as the TTD study.
- Key Results: No statistically relevant difference in recovery between the modified and predicate device.
- False Negative Rate Study:
- Study Type: Determined from the Percent Recovery study vials (444 vials: 264 + 90 + 90 per device) incubated for 120 hours on the BACTEC™ FX Instrument. All negative vials were subjected to terminal subculture.
- Sample Size: 115 instrument negative vials (57 modified, 58 predicate).
- Key Results: No false negative vials observed.
- False Positive Rate Study:
- Study Type: Inoculated modified and predicate devices with various volumes of human blood without organism.
- Sample Size: 120 vials per device (8 replicates from 3 lots, inoculated with 2, 4, 6, 8 or 10 mL of blood).
- Key Results: All vials were negative, and no false positive vials were observed.
- Instrument Compatibility Study:
- Study Type: Assessed performance equivalency (Recovery and TTD) across four BACTEC™ Fluorescent Series Instruments (BACTECTM FX, BACTECTM FX40, BACTECTM 9240 and BACTEC™ 9050).
- Sample Size: 264 paired sets per instrument for BACTECTM FX and BACTECTM FX40 (10-100 CFU/vial inoculum, same study design as TTD). 96 paired sets per instrument for BACTECTM 9240 and BACTECTM 9050 (subset of 16 organisms, same inoculum and blood volumes).
- Key Results: No recovery failures for either device on any instrument. No significant differences in TTD.
- Resin Performance Study (Antimicrobial Neutralization Capability):
- Study Type: Assessed resin performance using blood, antimicrobials, and organisms.
- Sample Size: 314 antibiotic/organism combinations per lot of media. Total of 1884 vials tested (3 lots per device).
- Key Results: No statistically significant difference in percent recovery between lot pairs. All negative vials were also negative on terminal subculture.
Clinical Studies:
Not applicable; seeded analytical studies were performed to compare the modified BD BACTECTM Plus Aerobic/F Culture Vials to the predicate BD BACTECT™ Plus Aerobic/F Culture Vials.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Percent Recovery (Sensitivity): Noted as no statistically relevant difference between modified and predicate. All organisms at 10-100 CFU and 1-10 CFU showed 100.0% recovery for the predicate device, with one exception down to 66.7% for Candida glabrata A66032 at 1-10 CFU/3mL in the modified device (44/45, 97.8%) and (43/45, 95.6%). For 0-1 CFU, it varied more (e.g., Candida albicans A18804: Predicate 100.0% (3/3) vs. Modified 33.3% (1/3) for 0-1 CFU/3mL; Pseudomonas aeruginosa A27853: Predicate 66.7% (2/3) vs. Modified 100.0% (3/3) for 0-1 CFU/10mL). Overall, 100.0% recovery for 10-100 CFU for both devices.
- False Negative Rate: 0% (no false negative vials observed).
- False Positive Rate: 0% (no false positive vials observed).
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.
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
§ 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.
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 seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 24, 2023
Becton, Dickinson and Company Susan Kircher Staff Regulatory Affairs Specialist 7 Loveton Circle Sparks, Maryland 21152
Re: K222591
Trade/Device Name: BD BACTEC Plus Aerobic/F Culture Vials Regulation Number: 21 CFR 866.2560 Regulation Name: Microbial Growth Monitor Regulatory Class: Class I, reserved Product Code: MDB Dated: August 25, 2022 Received: August 26, 2022
Dear Susan Kircher:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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
Ribhi Shawar, Ph.D. (ABMM) Branch Chief. General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222591
Device Name BD BACTEC™ Plus Aerobic/F Culture Vials
Indications for Use (Describe)
BD BACTEC™ Plus Aerobic/F Culture Vials are used in a qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood. The principal use of this medium is with the BD BACTECTM fluorescent series instruments.
Additional information
The device aids in the diagnosis of disease caused by pathogenic microorganisms and is automated on the BD BACTEC™ fluorescent series instruments.
| 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
Special 510(k) Summary
Summary Preparation Date: 8/25/2022
A. 510(k) Number:
B. Purpose of Submission:
To obtain a substantial equivalence determination for a premarket notification for the modified BD BACTECTM Plus Aerobic/F Culture Vials.
C. Measurand:
Aerobic microorganisms (bacteria and yeast) from blood
D. Type of Test:
Liquid culture medium for recovery of microorganisms from blood using fluorescent technology to detect increases in CO2 produced by the growth of microorganisms.
E. Applicant:
BD Diagnostic Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
Establishment Registration Number: 1119779
F. Proprietary and Established Name
BD BACTEC™ Plus Aerobic/F Culture Vials
G. Regulatory Information
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| MDB | Class I | 21 CFR § 866.2560 Microbial | |
| Growth Monitor | 83-Microbiology |
4
H. Intended Use/Indications for Use:
1. Intended Use:
BD BACTEC™ Plus Aerobic/F Culture Vials are used in a qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood. The principal use of this medium is with the BD BACTEC™ fluorescent series instruments.
Additional information
The device aids in the diagnosis of disease caused by pathogenic microorganisms and is automated on the BD BACTEC™ fluorescent series instruments.
-
Indication(s) for Use: 2.
Same as Intended Use -
Special Conditions for Use Statement: 3.
RX - For Prescription Use Only -
- Special Instrument Requirements:
The BD BACTEC™ fluorescent series instruments (BD BACTEC™ FX, BD BACTEC™ FX40, BD BACTEC™ 9240 and BD BACTECTM 9050) were evaluated using the software versions listed below.
- Special Instrument Requirements:
| Instrument | Software Version |
|---|---|
| BD BACTEC™ FX | 6.40A |
| BD BACTEC™ 9240 | 4.95A |
| BD BACTEC™ 9050 | 2.01A2 |
| BD BACTEC™ FX40 | 3.40A |
I. Device Description
The BD BACTECTM Plus Aerobic/F Culture Vials contain a bacterial growth medium intended for use in the qualitative culture and recovery of aerobic microorganisms (bacteria and yeast) from blood. It has been designed for blood volumes of three (3) to ten (10) milliliters and is used specifically with the BD BACTEC™ fluorescent-series instruments in monitoring of clinical blood specimens for the presence of microorganisms.
BD BACTECTM Plus Aerobic/F Culture Vials are supplied in a carton containing 50 vials. It is a nonsterile product.
5
J. Substantial Equivalence1 Information:
-
- Predicate Device Name:
BD BACTEC™ Plus Aerobic/F Culture Vials
- Predicate Device Name:
-
- Predicate Device 510(k) Number:
K113558
- Predicate Device 510(k) Number:
-
- Comparison with Predicate Device:
The similarities between the modified BD BACTEC™ Plus Aerobic/F Culture Vials and the current legally marketed predicate device, BD BACTEC™ Plus Aerobic/F Culture Vials (K113558) are summarized in comparison Table 1. The modified device formulation differs from that of the predicate device in the concentration of vitamins.
- Comparison with Predicate Device:
The modified BD BACTEC™ Plus Aerobic/F Culture Vials utilize the same specimens, test principles, and growth detection technology as the current legally marketed device.
1 The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug and Cosmetic Act, as amended, and as applied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.
6
Table 1. Comparison to the Predicate Device
| | BD BACTECTM Plus Aerobic/F Culture Vials
Predicate Device | BD BACTECTM Plus Aerobic/F Culture
Vials
Modified Device |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Class | I | Same |
| Product
Code | MDB | Same |
| Intended
Use | BD BACTECTM Plus Aerobic/F Culture Vials are used
in a qualitative procedure for the aerobic culture and
recovery of microorganisms (bacteria and yeast) from
blood. The principal use of this medium is with the BD
BACTECTM fluorescent series instruments. | BD BACTEC™ Plus Aerobic/F Culture
Vials are used in a qualitative procedure for
the aerobic culture and recovery of
microorganisms (bacteria and yeast) from
blood. The principal use of this medium is
with the BD BACTEC™ fluorescent series
instruments.
Additional information
The device aids in the diagnosis of disease
caused by pathogenic microorganisms and is
automated on the BD BACTECTM
fluorescent series instruments. |
| Organisms
Detected | Aerobic bacteria and yeasts | Same |
| Technology | If microorganisms are present in the test sample
inoculated into the BD BACTEC™ vial, CO2 will be
produced when the organisms metabolize the substrates
present in the vial. Increases in the fluorescence of the
vial sensor caused by the higher amount of CO2 are
monitored by the BD BACTECTM fluorescent series
instrument. Analysis of the rate and amount of CO2
increase enables the BD BACTEC™ fluorescent series
instrument to determine if the vial is positive, i.e., that
the test sample contains viable organisms. This
qualitative culture functions as an aid to diagnosis and
is automated on the BD BACTEC™ fluorescent series
instrument. | Same |
| Sample
Type | Blood | Same |
| Bottle
Material | Plastic | Same |
| Sample
Volume | 3-10 mL | Same |
| Growth
Media | 30 mL enriched Soybean-Casein Digest Broth | Same |
7
K. Principle of Operation:
If microorganisms are present in a test sample that is inoculated into the BD BACTEC™ Plus Aerobic/F Culture Vials, CO2 will be produced due to metabolism of substrates present in the vial. Increases in the fluorescence of the vial sensor caused by the higher amount of CO2 are monitored by BD BACTEC™ fluorescent series instruments. Analysis of the rate and amount of CO2 increase enables the BD BACTEC™ fluorescent series instrument to determine if the vial is positive, i.e., that the test sample contains viable organisms. This qualitative culture functions as an aid to diagnosis and is automated on the BD BACTEC™ fluorescent series instruments.
L. Performance Characteristics:
1. Analytical Performance
Six studies were conducted to demonstrate substantial equivalence between of the modified BD BACTEC™ Plus Aerobic/F Culture Vials to the current, legally marketed device, BD BACTEC™ Plus Aerobic/F Culture Vials (predicate). These studies included: Instrument Time to Detection, Percent Recovery (Sensitivity), False Negative Rate, False Positive Rate, BACTEC™ Instrument Compatibility, and Resin Performance (Antimicrobial Neutralization Capability).
Instrument Time to Detection
Instrument time to detection (TTD) was assessed using paired sets of the modified and predicate device. Three lots of each device were inoculated with blood volumes of 3 and 10 mL. All vials were inoculated with 44 organisms at a concentration of 10-100 CFU/vial. All vials were then placed into both a BACTEC™ FX and a BACTEC™ FX40 instrument resulting in a total of 264 vials at each blood volume condition. A subset of 15 organisms were also evaluated at a concentration of 0-1 and 1-10 CFU/vial at each blood volume on the BACTEC™ FX instrument for a total of 45 vials at each inoculum and blood volume condition. Data are summarized in Table 2.
There were two isolates that produced a > 10% difference at the 10-100 CFU inoculum level that were in favor of the predicate device. Rothia mucilaginosa and Stenotrophomonas maltophilia. Additional strains of each species were tested in triplicate. Results of this testing demonstrated the delay in TTD in the modified device was strain specific and not related to the organism species.
The results of this study indicate no statistically relevant difference in time to detection for the modified device when compared to the predicate device.
| Organism | Target
CFU | Blood
Volume
(mL) | Predicate Device
TTD (95% CI) [N] | Modified Device
TTD (95% CI) [N] | TTD Difference
(95%CI) [N] |
|-------------------------------------------|---------------|-------------------------------|--------------------------------------|-------------------------------------|--------------------------------|
| Abiotrophia defectiva
A49176 | 10-100 | 3 | 16.46 (16.340, 16.893)
[6] | 17.17 (16.872, 17.728)
[6] | 0.582 (0.250, 1.251) [6] |
| | | 10 | 16.26 (16.009, 16.674)
[6] | 17.18 (16.951, 17.484)
[6] | 0.917 (0.583, 1.168) [6] |
| Acinetobacter lwoffii
A17925 | 10-100 | 3 | 13.60 (13.242, 13.884)
[6] | 13.88 (13.771, 14.323)
[6] | 0.416 (-0.84, 0.916) [6] |
| | | 10 | 17.94 (14.579, 23.048)
[6] | 14.30 (14.106, 14.663)
[6] | -3.751 (-8.835, 0.084) [6] |
| Aggregatibacter
actinomycetemcomitans | 10-100 | 3 | 25.57 (25.059, 26.572)
[6] | 25.40 (24.307, 26.573)
[6] | -0.250 (-1.001, 0.334) [6] |
| Organism | Target
CFU | Blood
Volume
(mL) | Predicate Device
TTD (95% CI) [N] | Modified Device
TTD (95% CI) [N] | TTD Difference
(95%CI) [N] |
| NCTC 9710 | | 10 | 25.90 (25.242, 26.317) [6] | 26.09 (25.052, 26.242) [6] | -0.083 (-0.993, 1.000) [6] |
| Aerococcus viridins
A11563 | 10-100 | 3 | 11.12 (10.851, 12.060) [6] | 11.29 (11.016, 11.891) [6] | 0.083 (-0.584, 0.666) [6] |
| | | 10 | 11.71 (11.430, 12.069) [6] | 12.12 (11.707, 12.373) [6] | 0.415 (-0.168, 0.749) [6] |
| Alcaligenes faecalis
A8750 | 10-100 | 3 | 22.19 (21.250, 23.029) [6] | 21.39 (21.080, 21.913) [6] | -0.834 (-1.417, 0.166) [6] |
| | | 10 | 24.16 (21.867, 26.865) [6] | 21.03 (20.115, 22.738) [6] | -2.001 (-5.835, -1.168) [6] |
| Bacillus subtilis
A82 | 10-100 | 3 | 25.32 (24.552, 26.172) [6] | 24.31 (23.821, 24.839) [6] | -1.334 (-1.500, -0.249) [6] |
| | | 10 | 27.32 (27.073, 28.073) [6] | 26.41 (25.814, 27.083) [6] | -1.000 (-1.500, -0.666) [6] |
| Candida albicans
A18804 | 1-10 | 3 | 31.59 (31.423, 32.758) [3] | 28.09 (27.089, 28.091) [3] | -4.501 (-4.666, -3.333) [3] |
| | | 10 | 35.09 (31.277, 37.252) [3] | 28.92 (27.609, 29.084) [3] | -6.001 (-8.334, -3.668) [3] |
| | 0-1 | 3 | Only 1 paired detection* | Only 1 paired detection* | N/A |
| | | 10 | Only 1 paired detection* | Only 1 paired detection* | N/A |
| Candida auris
AR 0378 | 10-100 | 3 | 22.10 (19.895, 24.208) [6] | 19.67 (18.989, 20.622) [6] | -2.253 (-3.835, -0.831) [6] |
| | | 10 | 19.34 (18.843, 23.283) [6] | 19.17 (18.760, 19.427) [6] | -0.418 (-3.856, 0.166) [6] |
| Candida glabrata
A15545 | 10-100 | 3 | 67.47 (60.632, 76.150) [6] | 32.61 (30.880, 34.341) [6] | -34.364 (-42.309, 29.752) [6] |
| | | 10 | 60.13 (53.885, 72.461) [6] | 35.44 (33.083, 37.708) [6] | -24.274 (-35.169, -20.803) [6] |
| Candida glabrata
A66032 | 10-100 | 3 | 64.87 (61.875, 69.053) [6] | 29.59 (28.448, 31.744) [6] | -35.531 (-37.947, -32.531) [6] |
| | | 10 | 47.85 (42.084, 54.609) [6] | 28.11 (26.166, 29.345) [6] | -21.501 (-25.335, -14.084) [6] |
| | 1-10 | 3 | 96.79 (88.624, 101.123) [3] | 35.62 (34.122, 40.121) [3] | -56.667 (-67.000, -53.001) [3] |
| | | 10 | 100.28 (91.288, 105.620) [3] | 40.45 (37.951, 48.453) [3] | -62.334 (-65.168, -42.835) [3] |
| | 0-1 | 3 | Only 1 paired detection* | Only 1 paired detection* | N/A |
| | | 10 | Only 1 paired detection* | Only 1 paired detection* | N/A |
| Cardiobacterium
hominis
NCTC 10426 | 10-100 | 3 | 45.15 (40.061, 49.911) [6] | 44.90 (40.559, 50.410) [6] | 0.082 (-0.501, 1.165) [6] |
| | | 10 | 45.57 (41.238, 51.321) [6] | 45.48 (40.819, 50.821) [6] | -0.084 (-1.418, 0.499) [6] |
| Organism | Target
CFU | Blood
Volume
(mL) | Predicate Device
TTD (95% CI) [N] | Modified Device
TTD (95% CI) [N] | TTD Difference
(95%CI) [N] |
| Corynebacterium
jeikeium
A43216 | 10-100 | 3 | 28.98 (27.820, 30.150) [6] | 28.57 (28.313, 30.649) [6] | 0.499 (-0.668, 0.749) [6] |
| | 10-100 | 10 | 30.94 (26.827, 38.814) [6] | 31.35 (27.076, 39.813) [6] | 0.249 (-0.918, 2.333) [6] |
| | 10-100 | 3 | 64.54 (60.644, 68.285) [6] | 57.30 (55.226, 58.950) [6] | -7.084 (-9.835, -5.084) [6] |
| | | 10 | 73.23 (66.305, 88.745) [6] | 63.13 (59.888, 65.290) [6] | -10.269 (-23.536, -5.167) [6] |
| Cryptococcus
neoformans
A32045 | 1-10 | 3 | 69.99 (66.284, 71.491) [3] | 66.11 (60.950, 66.452) [3] | -5.040 (-5.334, -3.873) [3] |
| | 1-10 | 10 | 81.28 (77.613, 82.116) [3] | 69.28 (68.611, 71.318) [3] | -10.798 (-12.670, -8.337) [3] |
| | 0-1 | 3 | Only 1 paired detection* | Only 1 paired detection* | N/A |
| | | 10 | 82.80 (79.630, 90.300) [3] | 73.40 (69.833, 76.963) [2] | -7.816 (-12.965, -2.667) [2] |
| Eikinella corrodens
A23834 | 10-100 | 3 | 30.82 (29.809, 32.319) [6] | 32.31 (31.309, 33.151) [6] | -0.001 (0.166, 1.999) [6] |
| | 10-100 | 10 | 31.25 (30.054, 32.647) [6] | 30.91 (29.558, 32.311) [6] | -0.501 (-1.418, 0.749) [6] |
| Enterobacter cloacae
A35030 | 10-100 | 3 | 8.63 (8.525, 8.756) [6] | 8.76 (8.527, 8.959) [6] | -0.000 (-0.001, 0.332) [6] |
| | 10-100 | 10 | 9.03 (8.885, 9.420) [6] | 9.11 (8.883, 9.503) [6] | 0.082 (-0.168, 0.250) [6] |
| | 10-100 | 3 | 9.78 (9.589, 9.985) [6] | 9.92 (9.775, 10.153) [6] | 0.165 (-0.001, 0.333) [6] |
| | | 10 | 10.01 (9.926, 10.178) [6] | 10.07 (9.785, 10.343) [6] | -0.001 (-0.251, 0.333) [6] |
| Enterococcus faecalis
A29212 | 1-10 | 3 | 11.63 (11.296, 11.631) [3] | 11.21 (11.127, 11.296) [2] | -0.251 (-0.501, -0.001) [2] |
| | | 10 | 11.62 (11.459, 12.124) [3] | 11.95 (11.625, 11.956) [3] | 0.166 (-0.168, 0.333) [3] |
| | 0-1 | 3 | No paired detections* | No paired detections* | N/A |
| | | 10 | No paired detections* | No paired detections* | N/A |
| | 10-100 | 3 | 9.32 (9.153, 9.490) [6] | 9.24 (9.142, 9.417) [6] | -0.084 (-0.334, 0.248) [6] |
| | | 10 | 9.57 (9.307, 9.992) [6] | 9.48 (9.389, 10.072) [6] | -0.084 (-0.168, 0.332) [6] |
| Escherichia coli
A25922 | 1-10 | 3 | 10.61 (10.279, 11.114) [3] | 10.61 (10.444, 10.614) [3] | -0.168 (-0.500, 0.333) [3] |
| | | 10 | 11.78 (11.608, 12.109) [3] | 10.78 (10.774, 11.444) [3] | -0.833 (-1.333, -0.334) [3] |
| | 0-1 | 3 | 11.55 (11.465, 11.633) [2] | 11.80 (11.465, 12.131) [2] | 0.249 (-0.167, 0.666) [2] |
| | | 10 | 12.13 (12.126, 12.127) [2] | 12.13 (11.959, 12.294) [2] | -0.004 (-0.167, 0.160) [2] |
| Granulicatella adiacens
A43205 | 10-100 | 3 | 15.92 (15.318, 16.428) [6] | 15.59 (15.234, 15.832) [6] | -0.501 (-0.834, 0.332) [6] |
| | | 10 | 16.91 (15.992, 17.252) [6] | 16.75 (15.741, 17.084) [6] | -0.251 (-0.501, 0.166) [6] |
| Haemophilus influenzae
A19418 | 10-100 | 3 | 16.08 (14.383, 17.662) [6] | 15.95 (14.634, 17.579) [6] | -0.000 (-0.293, 0.334) [6] |
| | | 10 | 15.09 (14.631, 17.057) [6] | 15.51 (14.844, 17.223) [6] | 0.330 (-0.084, 0.581) [6] |
| Organism | Target
CFU | Blood
Volume
(mL) | Predicate Device
TTD (95% CI) [N] | Modified Device
TTD (95% CI) [N] | TTD Difference
(95%CI) [N] |
| | 1-10 | 3 | 15.78 (15.609, 16.108) [3] | 15.94 (15.774, 16.276) [3] | 0.166 (-0.334, 0.666) [3] |
| | | 10 | 16.27 (15.940, 16.606) [3] | 16.44 (16.270, 16.606) [3] | -0.001 (-0.168, 0.666) [3] |
| | 0-1 | 3 | No paired detections* | No paired detections* | N/A |
| | | 10 | No paired detections* | No paired detections* | N/A |
| Haemophilus influenzae,
type a | 10-100 | 3 | 16.45 (15.042, 17.271) [6] | 16.28 (14.625, 17.936) [6] | -0.001 (-0.584, 0.666) [6] |
| A9006 | | 10 | 16.44 (13.453, 18.931) [6] | 16.52 (13.787, 19.680) [6] | 0.416 (-0.084, 0.833) [6] |
| Haemophilus influenzae, | 10-100 | 3 | 17.63 (15.724, 19.783) [6] | 18.04 (15.392, 21.281) [6] | 0.416 (-0.585, 1.749) [6] |
| type b
A10211 | | 10 | 18.45 (14.137, 23.932) [6] | 20.20 (14.219, 27.097) [6] | 1.416 (-0.084, 3.667) [6] |
| | | 3 | 64.67 (54.259, 83.760) [6] | 68.34 (56.343, 82.507) [6] | 0.582 (-8.501, 12.416) [6] |
| | 10-100 | 10 | 53.20 (45.585, 61.004) [6] | 52.53 (49.085, 63.586) [6] | 2.583 (-2.168, 5.000) [6] |
| Haemophilus
parainfluenzae | 1-10 | 3 | 79.99 (77.319, 94.656) [3] | 69.49 (68.822, 74.987) [3] | -7.833 (-25.834, -5.001) [3] |
| A33392 | | 10 | 68.65 (56.652, 73.986) [3] | 75.49 (62.985, 77.985) [3] | 1.500 (-5.668, 21.333) [3] |
| | 0-1 | 3 | No paired detections* | No paired detections* | N/A |
| | | 10 | No paired detections* | No paired detections* | N/A |
| Kingella kingae | 10-100 | 3 | 16.32 (15.902, 16.653) [6] | 16.65 (15.995, 17.726) [6] | 0.416 (-0.334, 1.415) [6] |
| A23330 | | 10 | 16.56 (15.388, 18.325) [6] | 16.81 (15.302, 18.574) [6] | 0.083 (-0.251, 0.582) [6] |
| Klebsiella pneumoniae | 10-100 | 3 | 8.62 (8.596, 8.771) [6] | 8.53 (8.427, 8.689) [6] | -0.166 (-0.252, 0.083) [6] |
| A33495 | | 10 | 8.78 (8.615, 9.102) [6] | 8.78 (8.772, 9.104) [6] | 0.081 (-0.168, 0.248) [6] |
| Leuconostoc species | 10-100 | 3 | 32.22 (30.386, 34.989) [6] | 32.14 (28.562, 37.90) [6] | -0.667 (-4.668, 6.333) [6] |
| A21435 | | 10 | 32.81 (30.901, 48.995) [6] | 32.82 (30.813, 42.313) [6] | -0.584 (-6.681, 0.499) [6] |
| | 10-100 | 3 | 34.59 (33.819, 35.107) [6] | 33.84 (33.319, 34.855) [6] | -0.251 (-1.501, 0.249) [6] |
| | | 10 | 36.59 (36.090, 37.340) [6] | 36.75 (35.077, 37.852) [6] | 0.166 (-1.751, 1.249) [6] |
| Micrococcus luteus
A4698 | 1-10 | 3 | 38.17 (37.172, 39.670) [3] | 37.67 (37.669, 40.671) [3] | -0.501 (-2.000, 3.500) [3] |
| | | 10 | 39.17 (39.166, 41.665) [3] | 32.75 (24.832, 40.666) [2] | -7.667 (-16.833, 1.500) [2] |
| | 0-1 | 3 | No paired detections* | No paired detections* | N/A |
| | | 10 | Only 1 paired detection* | Only 1 paired detection* | N/A |
| Neisseria gonorrhoeae | | 3 | 23.09 (22.511, 23.265) [6] | 23.11 (22.586, 23.259) [6] | 0.083 (-0.582, 0.584) [6] |
| A10150 | 10-100 | 10 | 23.51 (22.608, 24.246) [6] | 23.09 (22.277, 23.579) [6] | -0.500 (-1.001, 0.084) [6] |
| Organism | Target
CFU | Blood
Volume
(mL) | Predicate Device
TTD (95% CI) [N] | Modified Device
TTD (95% CI) [N] | TTD Difference
(95%CI) [N] |
| Neisseria meningitidis
A13090 | 1-10 | 3 | 26.40 (25.400, 26.401)
[3] | 26.57 (26.563, 27.064)
[3] | 0.167 (0.166, 1.664) [3] |
| | | 10 | 24.94 (24.608, 26.730)
[3] | 26.11 (25.729, 26.276)
[3] | 1.333 (-1.001, 1.499) [3] |
| | 0-1 | 3 | Only 1 paired detection* | Only 1 paired detection* | N/A |
| | | 10 | Only 1 paired detection* | Only 1 paired detection* | N/A |
| | 10-100 | 3 | 33.57 (28.284, 46.981)
[6] | 36.57 (25.934, 44.647)
[6] | -2.334 (-6.970, 7.618) [6] |
| | | 10 | 18.27 (17.639, 18.821)
[6] | 18.19 (17.939, 18.354)
[6] | -0.085 (-0.585, 0.416) [6] |
| | 1-10 | 3 | 27.08 (26.581, 27.084)
[3] | 24.58 (24.581, 27.083)
[3] | -2.000 (-2.501, -0.000) [3] |
| | | 10 | 20.41 (20.412, 20.577)
[3] | 19.58 (19.076, 19.911)
[3] | -0.834 (-1.501, -0.500) [3] |
| | 0-1 | 3 | No paired detections* | No paired detections* | N/A |
| | | 10 | No paired detections* | No paired detections* | N/A |
| Pediococcus acidilactici
A25740 | 10-100 | 3 | 23.01 (22.067, 22.619)
[6] | 23.84 (23.065, 25.369)
[6] | 1.248 (0.582, 1.750) [6] |
| | | 10 | 20.62 (20.569, 20.842)
[6] | 21.59 (21.400, 22.449)
[6] | 1.000 (0.749, 1.667) [6] |
| Proteus mirabilis
A8259 | 10-100 | 3 | 12.67 (12.441, 12.975)
[6] | 11.72 (11.468, 11.971)
[6] | -1.084 (-1.336, -0.501) [6] |
| | | 10 | 15.14 (13.188, 19.930)
[6] | 11.94 (11.722, 12.264)
[6] | -3.168 (-7.918, -1.250) [6] |
| Providencia stuartii
A25825 | 10-100 | 3 | 10.62 (10.531, 10.866)
[6] | 10.37 (10.194, 10.621)
[6] | -0.251 (-0.584, -0.001) [6] |
| | | 10 | 11.28 (10.950, 11.455)
[6] | 11.03 (10.784, 11.203)
[6] | -0.251 (-0.418, -0.000) [6] |
| | 10-100 | 3 | 14.19 (14.091, 14.473)
[6] | 14.30 (14.090, 14.354)
[6] | 0.082 (-0.251, 0.166) [6] |
| | | 10 | 15.31 (14.515, 16.265)
[6] | 14.97 (14.515, 15.182)
[6] | -0.501 (-1.167, 0.249) [6] |
| Pseudomonas
aeruginosa
A27853 | 1-10 | 3 | 16.09 (15.584, 16.753)
[3] | 16.09 (15.919, 17.253)
[3] | 0.334 (-0.000, 0.501) [3] |
| | | 10 | 16.42 (16.415, 16.580)
[3] | 17.08 (17.082, 17.247)
[3] | 0.666 (0.666, 0.667) [3] |
| | 0-1 | 3 | 17.10 (16.433, 17.430)
[3] | 17.27 (16.932, 17.763)
[3] | 0.333 (-0.166, 0.833) [3] |
| | | 10 | 17.34 (17.259, 17.426)
[2] | 17.76 (17.757, 18.427)
[3] | 0.416 (0.333, 0.498) [2] |
| Rothia mucilaginosa
NCTC 10663 | 10-100 | 3 | 15.55 (14.882, 16.469)
[6] | 25.80 (23.551, 27.799)
[6] | 9.999 (7.999, 12.250) [6] |
| | | 10 | 15.80 (14.544, 16.811)
[6] | 20.38 (18.544, 21.810)
[6] | 4.667 (3.582, 5.332) [6] |
| Saccharomyces
cerevisiae
A9763 | 10-100 | 3 | 45.64 (40.508, 48.241)
[6] | 24.24 (23.505, 25.554)
[6] | -21.334 (-23.168, -16.585) [6] |
| | | 10 | 31.06 (28.740, 33.835)
[6] | 25.32 (23.310, 27.085)
[6] | -6.168 (-8.084, -3.668) [6] |
| Organism | Target
CFU | Blood
Volume
(mL) | Predicate Device
TTD (95% CI) [N] | Modified Device
TTD (95% CI) [N] | TTD Difference
(95%CI) [N] |
| Staphylococcus aureus
A25923 | 10-100 | 3 | 12.17 (11.785, 12.402)
[6] | 11.48 (11.256, 11.701)
[6] | -0.751 (-0.918, -0.252) [6] |
| | 10 | 11.42 (11.225, 11.613)
[6] | 10.61 (10.418, 10.892)
[6] | -0.751 (-1.167, -0.418) [6] | |
| Staphylococcus aureus
A25923 | 1-10 | 3 | 14.43 (13.927, 14.429)
[3] | 12.92 (12.595, 13.259)
[3] | -1.501 (-1.834, -0.668) [3] |
| | 10 | 12.75 (12.583, 12.923)
[3] | 12.42 (12.089, 12.750)
[3] | -0.168 (-0.834, -0.001) [3] | |
| Staphylococcus aureus
A25923 | 0-1 | 3 | Only 1 paired detection* | Only 1 paired detection* | N/A |
| | 10 | Only 1 paired detection* | Only 1 paired detection* | N/A | |
| Staphylococcus epidermidis
A12228 | 10-100 | 3 | 17.31 (17.091, 17.742)
[6] | 15.07 (14.719, 15.757)
[6] | -2.087 (-2.674, -1.833) [6] |
| | 10 | 15.91 (15.563, 16.671)
[6] | 14.91 (14.389, 15.503)
[6] | -1.089 (-1.338, -0.920) [6] | |
| Staphylococcus epidermidis
A12228 | 1-10 | 3 | 19.23 (19.068, 21.069)
[3] | 16.23 (16.066, 17.902)
[3] | -3.167 (-3.168, -2.834) [3] |
| | 10 | 17.73 (17.563, 18.064)
[3] | 17.56 (16.398, 18.562)
[3] | -0.501 (-1.334, -0.999) [3] | |
| Staphylococcus epidermidis
A12228 | 0-1 | 3 | Only 1 paired detection* | Only 1 paired detection* | N/A |
| | 10 | Only 1 paired detection* | Only 1 paired detection* | N/A | |
| Stenotrophomonas
maltophilia
A13637 | 10-100 | 3 | 27.07 (26.342, 27.610)
[6] | 29.34 (28.567, 32.775)
[6] | 2.494 (1.493, 5.666) [6] |
| | 10 | 26.59 (24.081, 29.353)
[6] | 32.51 (28.155, 35.103)
[6] | 5.0245 (4.074, 6.418) [6] | |
| Streptococcus
agalactiae
A12928 | 10-100 | 3 | 8.79 (8.594, 9.070) [6] | 8.96 (8.840, 9.317) [6] | 0.248 (-0.003, 0.415) [6] |
| | 10 | 9.21 (8756, 9.661) [6] | 9.12 (8.921, 9.326) [6] | -0.167 (-0.335, 0.248) [6] | |
| Streptococcus
pneumoniae
A6301 | 10-100 | 3 | 11.52 (11.282, 11.630)
[6] | 11.46 (11.043, 11.590)
[6] | -0.007 (-0.587, 0.249) [6] |
| | 10 | 12.20 (11.731, 12.380)
[6] | 12.04 (11.604, 12.230)
[6] | -0.254 (-0.675, 0.499) [6] | |
| Streptococcus
pneumoniae
A6303 | 10-100 | 3 | 11.15 (10.887, 11.542)
[6] | 11.13 (10.952, 11.396)
[6] | -0.004 (-0.424, 0.333) [6] |
| | 10 | 11.47 (11.131, 11.809)
[6] | 11.73 (11.372, 11.965)
[6] | 0.328 (-0.338, 0.662) [6] | |
| Streptococcus
pneumoniae
A6305 | 10-100 | 3 | 12.95 (12.697, 13.364)
[6] | 12.44 (12.277, 12.943)
[6] | -0.421 (-0.588, -0.336) [6] |
| | 10 | 13.38 (12.788, 13.941)
[6] | 13.19 (12.841, 13.462)
[6] | -0.084 (-1.016, 0.488) [6] | |
| Streptococcus
pneumoniae
A6305 | 1-10 | 3 | 13.27 (13.264, 13.762)
[3] | 14.10 (13.928, 15.436)
[3] | 0.832 (0.166, 2.166) [3] |
| | 10 | 14.93 (13.261, 15.593)
[3] | 15.34 (15.093, 15.591)
[2] | 0.083 (-0.499, 0.666) [2] | |
| Streptococcus
pneumoniae
A6305 | 0-1 | 3 | No paired detections* | No paired detections* | N/A |
| | 10 | No paired detections* | No paired detections* | N/A | |
| Streptococcus
pneumoniae | 10-100 | 3 | 12.11 (12.005, 12.402)
[6] | 12.17 (12.003, 12.504)
[6] | -0.001 (-0.168, 0.333) [6] |
| Organism | Target
CFU | Blood
Volume
(mL) | Predicate Device
TTD (95% CI) [N] | Modified Device
TTD (95% CI) [N] | TTD Difference
(95%CI) [N] |
| A700673 | | 10 | 12.59 (12.432, 12.827)
[6] | 12.68 (12.502, 12.910)
[6] | 0.166 (-0.251, 0.332) [6] |
| Streptococcus pyogenes | 10-100 | 3 | 10.16 (10.003, 10.387)
[6] | 10.41 (10.085, 10.554)
[6] | 0.249 (-0.084, 0.333) [6] |
| A19615 | | 10 | 10.81 (10.482, 10.982)
[6] | 10.57 (10.396, 10.896)
[6] | -0.168 (-0.501, 0.249) [6] |
| | 10-100 | 3 | 14.60 (14.078, 15.364)
[6] | 15.01 (14.576, 15.281)
[6] | 0.499 (-0.167, 0.499) [6] |
| Streptococcus sanguinis
A10556 | | 10 | 14.76 (14.429, 15.017)
[6] | 14.86 (14.513, 15.167)
[6] | 0.166 (-0.251, 0.416) [6] |
| | 1-10 | 3 | 16.56 (16.557, 16.892)
[3] | 18.06 (17.226, 19.056)
[3] | 1.166 (0.666, 2.499) [3] |
| | | 10 | 17.05 (16.721, 19.389)
[3] | 17.22 (17.053, 17.388)
[3] | 0.166 (-2.001, 0.333) [3] |
| | 0-1 | 3 | No paired detections* | No paired detections* | N/A |
| All organisms | | 10 | Only 1 paired detection* | Only 1 paired detection* | N/A |
| | 10-100 | 3 | 16.66 (15.809, 19.113) [264] | 17.331 (15.523, 20.786)
[264] | -0.002 (-0.168, -0.001) [264] |
| | | 10 | 17.083 (16.089, 18.906) [264] | 17.328 (15.387, 19.012)
[264] | -0.168 (-0.334, -0.001) [264] |
| | 1-10 | 3 | 19.23 (16.108, 27.083) [45] | 18.56 (16.150, 27.074) [44] | -0.501 (-2.417, -0.000) [44] |
| | | 10 | 18.06 (16.580, 24.943) [45] | 17.56 (17.053, 25.729) [43] | -0.499 (-1.001, -0.001) [43] |
| | 0-1 | 3 | 21.08 (16.433, 39.617)
[N=17] | 17.75 (14.443, 31.697)
[N=16] | -0.167 (-10.016, 0.499) [N=10] |
| | | 10 | 20.08 (13.274, 42.679)
[N=15] | 24.82 (18.093, 41.637)
[N=20] | -0.167 (-2.667, 0.498) [N=7] |
Table 2. Instrument Time to Detection Stratified by Organism. Inoculum and Blood Volume (Bootstrap analysis)
8
9
10
11
12
13
- At least two distinct values are required to generate a confidence interval
14
Percent Recovery
The percent recovery was also assessed using the same organisms, blood volumes, vial lots, instruments, and inoculum levels as defined in the TTD study.
The results of this testing indicated no statistically relevant difference in recovery and are summarized in Table 3.
Table 3. Percent Recovery Stratified by Organism, Inoculum and Blood Volume
| Organism | Target
CFU | Blood
Volume
(mL) | Predicate Device Percent
Recovery
(# positive bottles/# total
bottles) | Modified Device Percent
Recovery
(# positive bottles/ # total
bottles) |
|----------------------------------------------------|---------------|-------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Abiotrophia defectiva
A49176 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Acinetobacter Iwoffii
A17925 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Aggregatibacter actinomycetemcomitans
NCTC 9710 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Aerococcus viridins
A11563 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Alcaligenes faecalis
A8750 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Bacillus subtilis
A82 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Candida albicans
A18804 | 1-10 | 3 | 100.0% (3/3) | 100.0% (3/3) |
| | | 10 | 100.0% (3/3) | 100.0% (3/3) |
| | 0-1 | 3 | 100.0% (3/3) | 33.3% (1/3) |
| | | 10 | 33.3% (1/3) | 66.7% (2/3) |
| Candida auris
AR 0378 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Candida glabrata
A15545 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Candida glabrata
A66032 | 1-10 | 3 | 100.0% (3/3) | 100.0% (3/3) |
| | | 10 | 100.0% (3/3) | 100.0% (3/3) |
| | 0-1 | 3 | 33.3% (1/3) | 33.3% (1/3) |
| | | 10 | 33.3% (1/3) | 66.7% (2/3) |
| Cardiobacterium hominis
NCTC 10426 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Corynebacterium jeikeium
A43216 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Cryptococcus neoformans
A32045 | 1-10 | 3 | 100.0% (3/3) | 100.0% (3/3) |
| | | 10 | 100.0% (3/3) | 100.0% (3/3) |
| | 0-1 | 3 | 66.7% (2/3) | 33.3% (1/3) |
| | | 10 | 100.0% (3/3) | 66.7% (2/3) |
| Eikinella corrodens | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| Organism | Target
CFU | Blood
Volume
(mL) | Predicate Device Percent
Recovery
(# positive bottles/# total
bottles) | Modified Device Percent
Recovery
(# positive bottles/ # total
bottles) |
| A23834 | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Enterobacter cloacae
A35030 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Enterococcus faecalis
A29212 | 1-10 | 3 | 100.0% (3/3) | 66.7% (2/3) |
| | | 10 | 100.0% (3/3) | 100.0% (3/3) |
| | 0-1 | 3 | 0.0% (0/3) | 66.7% (2/3) |
| | | 10 | 33.3% (1/3) | 0.0% (0/3) |
| Escherichia coli
A25922 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| | 1-10 | 3 | 100.0% (3/3) | 100.0% (3/3) |
| | | 10 | 100.0% (3/3) | 100.0% (3/3) |
| | 0-1 | 3 | 66.7% (2/3) | 66.7% (2/3) |
| | | 10 | 66.7% (2/3) | 66.7% (2/3) |
| Granulicatella adiacens
A43205 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Haemophilus influenzae
A19418 | 1-10 | 3 | 100.0% (3/3) | 100.0% (3/3) |
| | | 10 | 100.0% (3/3) | 100.0% (3/3) |
| | 0-1 | 3 | 0.0% (0/3) | 33.3% (1/3) |
| | | 10 | 0.0% (0/3) | 0.0% (0/3) |
| Haemophilus influenzae
A9006 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Haemophilus influenzae
A10211 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Haemophilus parainfluenzae
A33392 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| | 1-10 | 3 | 100.0% (3/3) | 100.0% (3/3) |
| | | 10 | 100.0% (3/3) | 100.0% (3/3) |
| | 0-1 | 3 | 0.0% (0/3) | 33.3% (1/3) |
| | | 10 | 0.0% (0/3) | 33.3% (1/3) |
| Kingella kingae
A23330 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Klebsiella pneumoniae
A33495 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Leuconostoc species
A21435 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Micrococcus luteus
A4698 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| | 1-10 | 3 | 100.0% (3/3) | 100.0% (3/3) |
| | | 10 | 100.0% (3/3) | 66.7% (2/3) |
| | 0-1 | 3 | 0.0% (0/3) | 33.3% (1/3) |
| | | 10 | 33.3% (1/3) | 33.3% (1/3) |
| Neisseria gonorrhoeae
A10150 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Organism | Target
CFU | Blood
Volume
(mL) | Predicate Device Percent
Recovery
(# positive bottles/# total
bottles) | Modified Device Percent
Recovery
(# positive bottles/ # total
bottles) |
| Neisseria meningitidis
A13090 | 1-10 | 3 | 100.0% (3/3) | 100.0% (3/3) |
| | | 10 | 100.0% (3/3) | 100.0% (3/3) |
| | 0-1 | 3 | 66.7% (2/3) | 33.3% (1/3) |
| | | 10 | 33.35 (1/3) | 66.7% (2/3) |
| | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Pediococcus acidilactici
A25740 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Proteus mirabilis
A8259 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Providencia stuartii
A25825 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Pseudomonas aeruginosa
A27853 | 1-10 | 3 | 100.0% (3/3) | 100.0% (3/3) |
| | | 10 | 100.0% (3/3) | 100.0% (3/3) |
| | 0-1 | 3 | 100.0% (3/3) | 100.0% (3/3) |
| | | 10 | 66.7% (2/3) | 100.0% (3/3) |
| Rothia mucilaginosa
NCTC 10663 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Saccharomyces cerevisiae
A9763 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Staphylococcus aureus
A25923 | 1-10 | 3 | 100.0% (3/3) | 100.0% (3/3) |
| | | 10 | 100.0% (3/3) | 100.0% (3/3) |
| | 0-1 | 3 | 66.7% (2/3) | 33.3% (1/3) |
| | | 10 | 33.3% (1/3) | 66.7% (2/3) |
| | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Staphylococcus epidermidis
A12228 | 1-10 | 3 | 100.0% (3/3) | 100.0% (3/3) |
| | | 10 | 100.0% (3/3) | 100.0% (3/3) |
| | 0-1 | 3 | 66.7% (2/3) | 33.3% (1/3) |
| | | 10 | 33.3% (1/3) | 66.7% (2/3) |
| Stenotrophomonas maltophilia
A13637 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Streptococcus agalactiae
A12928 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Streptococcus pneumoniae
A6301 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Streptococcus pneumoniae
A6303 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Streptococcus pneumoniae | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| Organism | Target
CFU | Blood
Volume
(mL) | Predicate Device Percent
Recovery
(# positive bottles/# total
bottles) | Modified Device Percent
Recovery
(# positive bottles/ # total
bottles) |
| A6305 | 1-10 | 10 | 100.0% (6/6) | 100.0% (6/6) |
| | | 3 | 100.0% (3/3) | 100.0% (3/3) |
| | | 10 | 100.0% (3/3) | 66.7% (2/3) |
| | 0-1 | 3 | 0.0% (0/3) | 0.0% (0/3) |
| | | 10 | 0.0% (0/3) | 0.0% (0/3) |
| Streptococcus pneumoniae
A700673 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Streptococcus pyogenes
A19615 | 10-100 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| Streptococcus sanguinis
A10556 | 1-10 | 3 | 100.0% (6/6) | 100.0% (6/6) |
| | | 10 | 100.0% (6/6) | 100.0% (6/6) |
| | | 3 | 100.0% (3/3) | 100.0% (3/3) |
| | 0-1 | 10 | 100.0% (3/3) | 100.0% (3/3) |
| | | 3 | 0.0% (0/3) | 0.0% (0/3) |
| | 10 | 33.3% (1/3) | 33.3% (1/3) | |
| All organisms | 10-100 | 3 | 100.0% (264/264) | 100.0% (264/264) |
| | | 10 | 100.0% (264/264) | 100.0% (264/264) |
| | 1-10 | 3 | 100.0% (45/45) | 97.8% (44/45) |
| | | 10 | 100.0% (45/45) | 95.6% (43/45) |
| | 0-1 | 3 | 37.8% (17/45) | 35.6% (16/45) |
| | | 10 | 33.3% (15/45) | 44.4% (20/45) |
15
16
17
False Negative Rate
The false negative rate was determined from the Percent Recovery study which was conducted on the BACTEC™ FX Instrument, resulting in a total of 444 vials (264 + 90 + 90 per device). Following the 120-hour incubation protocol, there were 115 instrument negative vials (57 in the modified device and 58 in the predicate device). All negative vials failed to yield growth upon terminal subculture. As a result, there were no false negative vials observed in this study.
False Positive Rate
False positive rate was assessed by inoculating the modified and the predicate device with various volumes of blood. Eight replicates from each of 3 lots were inoculated with either 2, 4, 6, 8 or 10 mL of freshly drawn human blood without organism for a total of 120 vials per each device. All vials were negative following the 120-hour incubation protocol. No false positive vials were observed in this study.
Instrument Compatibility
The instrument compatibility study was designed to assess performance equivalency (Recovery and TTD) of the modified and predicate device across four BACTEC™ Fluorescent Series Instruments (BACTECTM FX, BACTECTM FX40, BACTECTM 9240 and BACTEC™ 9050). Testing on the BACTEC™ FX and BACTEC™ FX40 utilized an inoculum of 10-100 CFU/vial and the same study design and blood volumes as described in the TTD study for a total of 264 paired sets per instrument. Testing on the BACTECTM 9240 and BACTEC™ 9050 utilized a subset of 16 organisms at the same inoculum level and blood volumes as used in the BACTEC™ FX and BACTEC™ FX40 testing for a total of 96 pairs.
18
There were no recovery failures in any of the instruments for either the modified or predicate device. Additionally, there were no significant differences in TTD and these results are summarized in Table 4 and Table 5.
| BACTECTM
Instrument | Total Number
Positive Vials | Predicate Device
[TTD (95% CI)] | Modified Device
[TTD (95% CI)] | TTD Difference
(95% CI) |
|------------------------|--------------------------------|------------------------------------|-----------------------------------|----------------------------|
| BACTECTM FX | 264 | 16.28 (15.37, 17.81) | 16.42 (15.14, 18.47) | -0.001 (-0.168, -0.000) |
| BACTECTM FX40 | 264 | 17.40 (16.48, 19.56) | 18.07 (16.07, 20.11) | -0.168 (-0.334, -0.001) |
Table 4. BACTECTM FX and BACTECTM FX40 TTD (Bootstrap Analysis)
Table 5. BACTEC™ FX, BACTEC™ 9240 and BACTEC™ 9050 TTD (Bootstrap Analysis)
| BACTEC™
Instrument | Total Number
Positive Vials | Predicate Device
[TTD (95% CI)] | Modified Device
[TTD (95% CI)] | TTD Difference
(95% CI) |
|-----------------------|--------------------------------|------------------------------------|-----------------------------------|----------------------------|
| BACTEC™ FX | 96 | 13.52 (11.75, 15.46) | 13.12 (11.51, 14.61) | -0.167 (-0.415, 0.001) |
| BACTEC™ 9240 | 96 | 13.50 (11.09, 15.67) | 12.82 (11.00, 13.84) | -0.333 (-0.500, 0.000) |
| BACTEC™ 9050 | 96 | 13.92 (11.67, 16.50) | 13.17 (11.25, 14.67) | -0.167 (-0.334, 0.000) |
The results of this testing support the use of the modified device on all four BACTEC™ Fluorescent Series Instruments.
Resin Performance
Resin performance was assessed using 7 mL of blood, 17 antimicrobials and organisms representing a diversity of MICs to each antimicrobial agent, for a total of 314 antibiotic/organism combinations per lot of media. The recovery was stratified for each lot of the modified and the predicate device and is summarized in Table 6. There was no statistically significant difference observed between lot pairs. All negative vials were also negative on terminal subculture.
Table 6. Percent Recovery Stratified by Device and Lot
| Device and Lot | Total Vials
Tested | Negative
Vials | Percent Recovery |
|--------------------------|-----------------------|-------------------|------------------|
| Predicate Device - Lot A | 314 | 164 | 47.77 |
| Modified Device – Lot A | 314 | 166 | 47.13 |
| Predicate Device - Lot B | 314 | 151 | 51.91 |
| Modified Device – Lot B | 314 | 163 | 48.09 |
| Predicate Device - Lot C | 314 | 162 | 48.41 |
| Modified Device – Lot C | 314 | 159 | 49.36 |
| Combined data | 1884 | 965 | 48.78 |
2. Clinical Studies
Not applicable; seeded analytical studies were performed to compare the modified BD BACTECTM Plus Aerobic/F Culture Vials to the predicate BD BACTECT™ Plus Aerobic/F Culture Vials.
M. Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
N. Conclusion:
The studies conducted support the performance of the modified BD BACTEC™ Plus Aerobic/F Culture Vials as substantially equivalent to the predicate device.